21998A1016(01)
Agreement on mutual recognition between the European Community and
Canada
Dates:
of document: 14/05/1998
of effect: 01/11/1998; Entry into force See Art 19 And OJ L
280/98 P. 66
of signature: 14/05/1998; London
end of validity: 99/99/9999
Authentic language: The official languages ; German ; English ;
Danish ; Spanish ; Finnish ; French ; Greek ; Italian ; Dutch ;
Portuguese ; Swedish
Author:
European Community ; Canada
Subject matter: Commercial policy ; External relations ; Technical
barriers
Directory code: 11404000
EUROVOC descriptor: mutual recognition principle ; sectoral
agreement ; sectoral planning ; Canada ; EC agreement ; EC joint
committee
Legal basis:
192E113................... Adoption
192E228-P2F1.............. Adoption
192E228-P3L1.............. Adoption
192E228-P4................ Adoption
Instruments cited:
276A0706(01)..............
294A1223(01)..............
294A1223(07)..............
Amended by:
Adopted by.... 398D0566.......... DP20/7/98
Amended by.... 202D0342.......... Amendment ANN from 27/03/2002
Subsequent related instruments:
Amendment proposed by 500PC0563.........
AGREEMENT on mutual recognition between the European Community and
Canada
The EUROPEAN COMMUNITY and the GOVERNMENT OF CANADA ('the Parties`),
CONSIDERING the traditional links of friendship that exist between
Canada and the European Community;
CONSIDERING that on the basis of past experience under the 1976
Framework Agreement on commercial and economic cooperation between
the European Communities and Canada, and in order to further develop
their dialogue in the area of standards as specified in the 1990
Declaration on EC-Canada relations, both Parties have expressed a
desire to establish a more formal framework for the conduct of
collaboration in the field of mutual recognition in relation to
conformity assessment;
CONSIDERING the Parties' interest in strengthening the rules
governing free and unhindered international trade;
CONSIDERING the improved conditions for trade between the Parties
which the mutual recognition of tests, certificates and marks of
conformity will bring about;
RECOGNISING the importance of maintaining their respective high
standards of health and safety;
BEARING IN MIND their status as Parties to the Agreement
Establishing the World Trade Organisation and conscious in
particular of their obligations under the World Trade Organisation
Agreement on Technical Barriers To Trade,
HAVE AGREED AS FOLLOWS:
Article I Definitions
General terms concerning conformity assessment used in this
Agreement and its Annexes shall have the meaning given in the
definitions contained in Guide 2 (1996 edition) of the International
Organisation for Standardisation and the International
Electrotechnical Commission, unless specifically defined otherwise
in this Agreement and its Sectoral Annexes. In addition, the
following terms and definitions shall apply to this Agreement:
- Agreement means the Framework Agreement and all the Sectoral
Annexes,
- conformity assessment means systematic examination to determine
the extent to which a product, process or service fulfils specified
requirements,
- conformity assessment body means a body engaged in the performance
of procedures for determining whether the relevant requirements in
technical regulations or standards are fulfilled,
- designating authority means a body with power to designate,
monitor, suspend designation or withdraw designation of conformity
assessment bodies under its jurisdiction,
- designation means the authorisation by a designating authority of
a conformity assessment body to perform conformity assessment
activities,
- Regulatory Authority means a government agency or other entity,
that exercises a legal right to control the use or sale of products
within a Party's jurisdiction, and may take enforcement action to
ensure that products marketed within its jurisdiction comply with
legal requirements.
In the event of an inconsistency between ISO/IEC Guide 2 and
definitions in this Agreement or its Annexes, the definitions in
this Agreement shall prevail.
Article II General obligations
2. The Government of Canada shall accept the results of conformity
assessment procedures, including certifications of compliance, as
required by the Canadian legislation and regulations identified in
the Sectoral Annexes, produced by designated conformity assessment
bodies or authorities in the European Community in accordance with
this Agreement.
3. The European Community shall accept the results of conformity
assessment procedures, including certifications of compliance, as
required by the European Community and Member States legislation and
regulations identified in the Sectoral Annexes, produced by
designated conformity assessment bodies or authorities in Canada in
accordance with this Agreement.
4. Where transitional rules have been specified in Sectoral Annexes,
the above rules will apply following the successful completion of
the transitional phase.
5. This Agreement shall not be construed to entail mutual acceptance
of standards or technical regulations of the Parties and, unless
otherwise specified in a Sectoral Annex, shall not entail the mutual
recognition of the equivalence of standards or technical
regulations.
Article III General coverage of the Agreement
1. This Agreement applies to conformity assessment procedures for
products covered by its Sectoral Annexes.
2. Each Sectoral Annex shall contain the following items, as
appropriate:
(a) a statement on the product scope and coverage;
(b) a description of the relevant legislative, regulatory and
administrative provisions pertaining to the conformity assessment
procedures and technical regulations;
(c) a list of designated conformity assessment bodies or
authorities, or a source from which to obtain such a list;
(d) a list of authorities responsible for designating the conformity
assessment bodies and the source of the procedures and criteria;
(e) a description of the mutual recognition obligations;
(f) a sectoral transition plan;
(g) a description of the joint sectoral group;
(h) a sectoral contact point in each Party's territory;
(i) guidelines for corrective actions.
3. For a given product or sector, the specific rules contained in
the relevant Sectoral Annex shall prevail over the more general
provisions of the Framework Agreement.
Article IV Transitional arrangements
1. The Parties agree to implement the transition commitments on
confidence building where included in the Sectoral Annexes.
3. The Parties may amend any transition period by mutual agreement
through the Joint Committee established under this Agreement, taking
account of recommendations made by the relevant joint sectoral
groups.
4. Passage from the transitional phase to conditions of full mutual
recognition shall proceed unless there is documented evidence
demonstrating a lack of technical competence in a Party's conformity
assessment.
Article V Civil liability
1. Nothing in this Agreement is intended to change or modify the law
in the territory of either Party applicable to civil liability of
manufacturers, distributors, suppliers, conformity assessment
bodies, designating bodies, regulatory authorities or governments,
to consumers or among each other, in respect of the design,
manufacture, testing, inspection, distribution or sale of products
that have undergone conformity assessment pursuant to this
Agreement.
2. The Parties agree that their respective conformity assessment
bodies are required to make adequate arrangements for liabilities
arising from their operations and activities under this Agreement.
The Parties, through the Joint Committee, shall from time to time
consider whether their respective conformity assessment bodies
continue to meet that requirement and whether the interests of the
Parties are adequately protected.
3. Each Party shall promptly notify the other Party of any suit or
other proceedings threatened or commenced in the territory of such
Party arising from or in connection with conformity assessment
performed by a conformity assessment body of the other Party.
4. Each Party shall cooperate with the other Party in the
investigation and defence of any suit or proceeding where the
interests of either Party are at risk. In particular, the Parties
shall render reasonable assistance in obtaining relevant documents
and access to material witnesses required in the investigation and
defence of such suits or proceedings.
Article VI Designating authorities
1. The Parties shall ensure that the designating authorities
responsible for designating the conformity assessment bodies
specified in the Sectoral Annexes shall have the necessary authority
to designate, monitor, suspend and withdraw the designations of such
bodies.
2. In the case of suspension of a designation or removal of such a
suspension, the designating authority of the Party concerned shall
immediately inform the other Party and the Joint Committee.
3. The Parties shall exchange information concerning the procedures
used to ensure that their designated conformity assessment bodies
continue to comply with the legislative, regulatory and
administrative provisions of this Agreement.
Article VII Conformity assessment bodies
1. The conformity assessment bodies designated in the territory of
the exporting Party shall operate to the requirements of the
importing Party and fulfil the conditions of eligibility for
conformity in relation to those requirements.
2. In designating such bodies, the designating authorities shall
specify, in each Annex, the scope of conformity assessment
activities for which such bodies have been designated.
3. The designation constitutes a formal judgment by the Party that
the conformity assessment body has demonstrated an acceptable level
of technical competence in providing services identified in the
designation and further has agreed to comply with the requirements
of the other Party, as set out in a Sectoral Annex.
4. In accordance with the terms of the Sectoral Annexes, each
designating authority will make available, if requested, a statement
of technical competence of its designated conformity assessment
bodies.
Article VIII Verification and suspension of conformity assessment
bodies
1. Each Party has the right to challenge the technical competence
and compliance of conformity assessment bodies under the
jurisdiction of the other Party. This right will be exercised under
exceptional circumstances only and justified, in an objective and
reasoned manner in writing, to the Joint Committee. The Joint
Committee will discuss such requests.
2. Where the Joint Committee, either on its own initiative or on a
recommendation from the relevant sectoral group, comes to the
conclusion that verification of technical competence or compliance
of a conformity assessment body operating in the territory of one of
the Parties is required, it will be carried out in a timely manner
by the Party in whose territory the body in question is located, or
by the Parties jointly if they agree. The Party may seek the
assistance of its designating authority in carrying out the
verification.
3. Unless decided otherwise by the Joint Committee, the contested
conformity assessment body will be suspended by the competent
designating authority from the time that a disagreement over the
status of that body has been confirmed in the Joint Committee. The
body in question shall remain suspended until agreement has been
reached in the Joint Committee on the future status of that body.
4. A certificate of conformity or other documentation for a product
issued by a conformity assessment body, that is subsequently removed
by the Joint Committee or designating authority, shall remain valid
unless there is a specific decision by the appropriate regulatory
authority based on health and safety considerations for the removal
of the product from the market.
Article IX Exchange of information
1. The Parties shall exchange information concerning the
implementation of the legislative, regulatory and administrative
provisions identified in the Sectoral Annexes.
2. Each Party shall inform the other Party of changes related to the
subject matter of this Agreement, and shall, except where
considerations of safety, health and environmental protection
require more urgent action, notify the other Party of the new
provisions at least sixty (60) days before their entry into force.
3. Each Party shall promptly notify the other Party of any changes
of its designating authorities and conformity assessment bodies.
Article X Monitoring of the Agreement
1. The Parties may hold ad hoc consultations within the Joint
Committee to ensure the satisfactory functioning of this Agreement.
2. One Party may request the other to carry out, on its behalf,
audits and re-evaluations of conformity assessment bodies working to
the requirements of the requesting Party. The requesting Party will
bear the costs of the audit.
3. In the interests of promoting a uniform application of the
conformity assessment procedures provided for in the laws and
regulations of the Parties, the designated conformity assessment
bodies shall take part, as appropriate, in interpretation sessions
conducted by the regulatory authorities in each Party in the
relevant areas covered by the Sectoral Annexes to this Agreement.
Article XI Joint Committee
1. There shall be established under this Agreement a Joint Committee
of the two Parties, which will be responsible for the effective
functioning of the Agreement.
2. The Joint Committee shall take its decisions and adopt its
recommendations by consensus of the Parties. It will meet at least
once a year unless it decides otherwise. It shall determine its own
rules of procedure. It may establish a joint sectoral group under a
Sectoral Annex, and may delegate specific tasks to those groups.
Each Party may invite its representatives from the joint sectoral
groups to attend meetings of the Joint Committee when its sectoral
interests are the subject of an agenda item.
3. The Joint Committee may consider any matter related to the
operation of this Agreement. In particular it shall be responsible
for:
(a) amending Sectoral Annexes;
(b) giving effect to the decision to designate or withdraw the
designation of a particular conformity assessment body;
(c) exchanging information concerning the procedures used by each
Party to ensure that the conformity assessment bodies specified in
the Sectoral Annexes maintain the necessary level of competence;
(d) determining the status of conformity assessment bodies whose
technical competence has been contested;
(e) exchanging information and notifying the Parties of
modifications of legislative, regulatory and administrative
provisions referred to in the Sectoral Annexes; and
(f) addressing any questions relating to the operation of this
Agreement and its Sectoral Annexes, including questions related to
health and safety, market access and the balance of rights and
obligations under the Agreement.
4. The following procedure shall apply to the inclusion in or
withdrawal from a Sectoral Annex of a conformity assessment body:
(a) a Party designating or withdrawing designation of a conformity
assessment body shall forward its proposal in writing to the other
Party;
(b) in the event that the other Party consents to the proposal or
upon the expiry of 60 days without an objection having been made,
the inclusion in or withdrawal from the Sectoral Annex of the
conformity assessment body shall take effect; and
(c) in the event that the other Party challenges the technical
competence or compliance of a proposed conformity assessment body
within the said 60-day period, the Joint Committee may request the
proposing Party to carry out a verification, which may include an
audit, of the body concerned, in accordance with the provisions of
this Agreement.
Article XII Joint sectoral groups
1. The Joint Committee may establish joint sectoral groups for
individual Sectoral Annexes comprising the appropriate designating
and regulatory authorities and experts of the Parties. These groups
will address the specific conformity assessment and regulatory
issues related to a given sector.
2. The responsibility of the joint sectoral groups may include the
following:
(a) at the request of a Party, to examine specific problems arising
in the implementation of any transitional plans for mutual
recognition and to give advisory opinions to the Joint Committee on
issues of mutual concern;
(b) furnish information and advice on any matters relating to
implementation, and on the regulations, procedures and conformity
assessment system related to a particular Annex, as may be requested
by a Party;
(c) review various aspects of the implementation and operation of
each Sectoral Annex, including health and safety aspects; and
(d) consider issues of interpretation of requirements in the
Sectoral Annexes, and where appropriate to make recommendations to
the Joint Committee.
Article XIII Sectoral contact point, management of information,
assistance and emergency action
1. Each Party shall appoint and confirm in writing the names and
addresses of contact points to be responsible for activities under
each Sectoral Annex.
2. Communications regarding confidence-building activities,
emergency actions and regulatory enforcement for products subject to
this Agreement will normally be handled directly by the sectoral
contact points.
Article XIV Safeguards
1. The appropriate regulatory authorities of each Party retain all
authority under the applicable law of that Party, to interpret and,
as set out in paragraph 2 below, enforce their respective
legislative and regulatory provisions. A regulatory authority of the
importing Party is not the legal representative of the exporting
Party.
2. When a Party or one of its regulatory authorities has reasons to
believe that a product from the other Party, covered under a
Sectoral Annex, may compromise the health or safety of persons in
its territory, or otherwise fails to satisfy a requirement of the
applicable Sectoral Annex, the Party in the receiving territory
retains all powers under its applicable domestic law to take all
appropriate and immediate measures to withdraw such products from
the market, prohibit their placement on the market, restrict their
free movement, or initiate a product recall. The regulatory
authority in whose territory the action has been taken shall inform
its counterparts and the Joint Committee within 15 days of taking
such action, giving its reasons.
3. The Parties agree that border inspections and checks of products
certified to the importing Party's requirements shall be completed
as expeditiously as possible. With regard to any inspections related
to internal movement within their respective territories, the
Parties agree that these shall be completed in a manner no less
favourable than for like domestic goods.
Article XV Market access
1. Each Party's obligation to accord mutual recognition within the
terms of a Sectoral Annex to this Agreement is conditional upon the
other Party continuing:
(a) to provide access to its market for products that, having been
subjected to conformity assessment procedures, can be demonstrated
to meet the applicable technical requirements; and
(b) to maintain in existence legal and regulatory authorities
capable of implementing the provisions of this Agreement.
2. Where a Party introduces new or additional conformity assessment
procedures affecting a sector covered by a Sectoral Annex, the Joint
Committee shall, unless the Parties agree otherwise, bring such
procedures within the scope of this Agreement and the relevant
Annex.
3. If, upon implementation of such new or additional requirements,
conformity assessment bodies designated by the other Party in order
to meet such requirements have not been recognised by the Party
implementing the requirements, the other Party may suspend its
obligations under the Sectoral Annex in question.
Article XVI Fees
Each Party shall ensure that, for conformity assessment procedures
carried out pursuant to this Agreement and its Sectoral Annexes, no
fees are charged in its territory for conformity assessment services
provided by the other Party.
Article XVII Agreements with other countries
Except where there is written agreement between the Parties,
obligations contained in mutual recognition agreements concluded by
either Party with a country not party to this Agreement shall have
no force and effect with regard to the other Party.
Article XVIII Territorial application
This Agreement and its Annexes shall apply, on the one hand, to the
territories in which the Treaty establishing the European Community
is applied, and under the conditions laid down in that Treaty and,
on the other hand, to the territory of Canada.
Article XIX Entry into force, modification and duration
1. This Agreement and its Annexes shall enter into force on the
first day of the second month following the date on which the
Parties have exchanged diplomatic notes confirming the completion of
their respective procedures for the entry into force of this
Agreement.
2. This Agreement may be amended by the written agreement of the
Parties. Amendments to, or decisions to terminate Sectoral Annexes
will be made by the Parties through the Joint Committee.
3. The Parties may add Sectoral Annexes upon exchange of diplomatic
notes. Such Annexes shall take effect as part of this Agreement 30
days following the date on which the Parties have exchanged
diplomatic notes confirming the addition of such an Annex.
4. Either Party may terminate this Agreement by giving the other
Party six months' notice in writing.
Article XX Final provisions
This Agreement and the Sectoral Annexes are drawn up in two
originals in the Danish, Dutch, English, Finnish, French, German,
Greek, Italian, Portuguese, Spanish and Swedish languages, each text
being equally authentic.
Hecho en Londres, el catorce de mayo de mil novecientos noventa y
ocho.
Udfördiget i London den fjortende maj nitten hundrede og
otteoghalvfems.
Geschehen zu London am vierzehnten Mai
neunzehnhundertachtundneunzig.
øółżõ ėĮ˙ Ė˙żōčż˙, ėĮłĖ ōõśńĮąėėõęłĖ ĢńĄ˙į ščūłń õżżłńśŽėłń õżõżČżĮń
˙śĮž.
Done at London on the fourteenth day of May in the year one thousand
nine hundred and ninety-eight.
Fait š Londres, le quatorze mai mil neuf cent quatre-vingt-dix-huit.
Fatto a Londra, addü quattordici maggio millenovecentonovantotto.
Gedaan te London, de veertiende mei negentienhonderd achtennegentig.
Feito em Londres, em catorze de Maio de mil novecentos e noventa e
oito.
Tehty Lontoossa neljōntenōtoista pōivōnō toukokuuta vuonna
tuhatyhdeksōnsataayhdeksōnkymmentōkahdeksan.
Som skedde i London den fjortonde maj nittonhundranittioõtta.
Por la Comunidad Europea
For Det Europöiske Föllesskab
FŽr die Europōische Gemeinschaft
Ćłń Į÷ż ÅįęųĘńŪśČ Ź˙łżŽĮ÷Įń
For the European Community
Pour la Communautł europłenne
Per la Comunitš europea
Voor de Europese Gemeenschap
Pela Comunidade Europeia
Euroopan yhteisŠn puolesta
Põ Europeiska gemenskapens vōgnar
>REFERENCE TO A GRAPHIC>
Por el Gobierno de Canadń
For Canadas regering
FŽr die Regierung Kanadas
Ćłń Į÷ż śįņąęż÷ė÷ Į˙į ŹńżńōĄ
For the Government of Canada
Pour le gouvernement du Canada
Per il governo del Canada
Voor de regering van Canada
Pelo Governo do Canadń
Kanadan hallituksen puolesta
Põ Kanadas regerings vōgnar
>REFERENCE TO A GRAPHIC>
SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT, INFORMATION
TECHNOLOGY EQUIPMENT AND RADIO TRANSMITTERS
1. PURPOSE
The purpose of this Annex is to establish a framework for the
acceptance of test reports and, at the end of a transitional period,
certificates of conformity issued in the territory of one Party in
accordance with the regulatory requirements of the other Party, as
referenced in Attachment 1.
This Annex constitutes a Sectoral Annex to the Framework Agreement
on mutual recognition between Canada and the European Community.
2. SCOPE AND COVERAGE
2.1. The provisions of this Annex shall apply to the following types
of telecommunications terminal equipment, radio transmitters and
information technology equipment:
(a) equipment intended for connection to the public
telecommunications network in order to send, process or receive
information, whether the equipment is to be connected directly to
the 'termination` of the network or to interwork with such a
network, being connected directly or indirectly to the termination
point. The system of connection may be wire, radio, optical or other
electromagnetic means;
(b) equipment capable of being connected to a public
telecommunications network even if it is not its intended purpose,
including information technology equipment having a communication
port;
(c) those categories of radio transmitters defined and specified in
Attachment 2.
2.3. Both Parties agree that the following is an illustrative but
not exhaustive list of covered categories of radio transmitters:
- short range devices, including low power devices such as cordless
telephones/microphones,
- land mobile, including:
- private mobile radio (PMR/PAMR),
- mobile telecom,
- paging systems,
- terrestrial fixed,
- satellite mobile,
- satellite fixed,
- broadcast,
- radio determination.
3. THE APPROVAL REQUIREMENTS
3.1. This Annex shall apply to all mandatory approval requirements,
adopted within the territories of the Parties, by government
organisations and/or bodies which have the legal powers to enforce a
technical requirement, for the equipment referenced in Attachment 2.
The relevant technical requirements are specified under the
legislation referenced in Attachment 1.
4. CONFORMITY ASSESSMENT ACTIVITIES
4.1. Both Parties affirm that their conformity assessment bodies,
recognised under this Annex, are authorised to perform the following
activities with regard to each other's technical requirements for
telecommunications terminal equipment, radio transmitters and
information technology equipment:
- for terminal attachment and radio transmission requirements -
testing, issuing and acceptance of test reports, performance of
required technical evaluation and certification of compliance with
the requirements of the laws and regulations applicable in the
territories of the Parties for products covered under this Annex,
- for electromagnetic compatibility (EMC) - the recognition of each
other's certificates of compliance, suppliers' declaration and
technical construction file, as required. The detailed provisions
are described in the Sectoral Annex on ENC,
- for electrical safety/low voltage - the acceptance of testing and
certification of the covered products to the electrical safety
requirements of the other Party. The detailed provisions are
described in the Sectoral Annex on electrical safety,
- for quality management - the recognition of one Party's quality
management certificates in accordance with the regulatory
requirements of the other Party.
5. INSTITUTIONS
5.1. Designating authorities
(a) Designating authorities are those authorities and organisations
responsible for designating and assuring the competence of
conformity assessment bodies to test and certify equipment covered
by this Annex to the requirements of the other Party. The
designating authorities for the purpose of this Annex are listed in
Attachment 3. The designating authorities may seek the services of
their accreditation system in carrying out these responsibilities.
(b) Each Party shall notify the other within ten (10) working days
of changes in the identity of their designating authorities and
their authority to carry out the obligations under this Annex.
5.2. Designated conformity assessment bodies
(a) For the purpose of this Annex, each Party will designate
competent conformity assessment bodies to carry out conformity
assessment to the requirements of the other Party. Each Party shall
ensure that the designated bodies comply with the criteria and
standards set out in the regulatory requirements of the other Party.
In making designations, the Parties shall indicate the products and
procedures for which they have been designated. A list of designated
bodies, together with an indication of the products and procedures
for which they have been designated, is included in Attachment 4.
(b) Conformity assessment bodies designated under this Annex shall
be recognised as competent to perform the conformity assessment
activities for which they have been designated.
(c) Designation, suspension or withdrawal of conformity assessment
bodies under this Annex shall be in conformance with procedures
determined by the Joint Committee established under the Framework
Mutual Recognition Agreement.
(d) Where a complaint or any other circumstance arises concerning a
conformity assessment body's ability to perform under this Annex,
the appropriate designating authority must take action to the mutual
satisfaction of the Parties. Where necessary, such problems may be
considered by the Joint Committee established under the Framework
Mutual Recognition Agreement in order to reach a solution.
6. TRANSITIONAL ARRANGEMENT
6.1. There will be a transitional period of 18 months before the
provisions of this Annex, notably section 4, become fully
operational.
6.2. This transitional period will be used by the Parties:
(a) to exchange information on and develop better understanding of
their respective regulatory requirements;
(b) to develop mutually agreed mechanisms for exchanging information
on changes in technical requirements or methods of designating
conformity assessment bodies;
(c) to monitor and evaluate the work carried out by designated
conformity assessment bodies operating during the transitional
period.
6.3. During the transitional period the Parties will also
reciprocally recognise test reports and related documents issued by
designated conformity assessment bodies of the other party in
accordance with the provisions of this Annex. To this end, the
approving authorities listed in Attachment 5 shall accept test
reports and related documents, and evaluations from the designated
bodies in the territory of the other Party, for the purposes of
approval, without imposing additional requirements, and shall ensure
that:
- on receipt of test reports, related documents and a first
evaluation of conformity, the dossiers are promptly examined for
completeness,
- the applicant is informed in a precise and complete manner of any
deficiency,
- an request for additional information is limited to omissions,
inconsistencies or variances from the technical regulations or
standards,
- procedures for equipment modified subsequent to a determination of
compliance, are limited to procedures necessary to determine
continued conformance,
- requirements and conformity assessment procedures applied to
domestic products shall be applied with no additional requirements
or variations to products or test results originating from the other
Party.
6.4. Each approving authority commits itself to issuing approvals or
advising the applicant no later than six (6) weeks from receipt of
the test report and evaluation from a designated body in the
territory of the other Party.
6.5. At the end of the transitional period the Parties will proceed
to full mutual recognition of certificates of compliance issued by
designated bodies in the other Party. Any proposal made during or at
the end of the transitional period to limit the scope of recognition
of any designated conformity assessment body or to exclude it from
the list of bodies designated under this Annex shall be based on
objective criteria and documented. Any such body may apply for
reconsideration once the necessary corrective action has been taken.
To the extent possible, the Parties will implement such action prior
to the expiry of the transitional period.
7. ADDITIONAL PROVISIONS
Subcontracting
7.1. Any subcontracting shall be in accordance with the
subcontracting requirements of the other Party.
7.2. The conformity assessment bodies shall record and retain
details of its investigation of the competence and compliance of its
subcontractors and maintain a register of all subcontracting. These
details will be available to the other Party on request.
Post-market surveillance
7.3. For the purpose of post-market surveillance, the Parties may
maintain any existing labelling and numbering requirements. The
assignment of the numbers may take place in the territory of the
exporting Party. The numbers will be allocated by the importing
Party.
7.4. When a report of misuse of a mark of conformity or of a hazard
involving an approved product covered under this Annex has occurred,
both Parties will jointly determine the scope of the misuse and the
nature and degree of corrective action to be taken.
Joint Telecommunications Group
7.5. The Joint Committee established under the Framework Mutual
Recognition Agreement may appoint a Joint Telecommunications Group
which shall meet as required to discuss technical, conformity
assessment and technology issues relating to this Annex.
Exchange of information and mutual assistance
7.6. Each Party shall establish a contact point to provide answers
to all reasonable inquiries from the other Party regarding
procedures, regulations and complaints.
6.2 the Parties may jointly sponsor two seminars, one in Canada and
one in the European Community, concerning the relevant technical and
product approval requirements during the first year after the Annex
enters into force.
7.8. The Parties shall also inform each other of changes to relevant
regulations, specifications, test methods, standards and
administrative procedures within thirty (30) working days of their
domestic notification.
Regulatory changes and updating the Annex
7.9. In the event that there are changes to the regulations
referenced in Attachment 1 or the introduction of new regulations
affecting conformity assessment procedures taking place in either
Party, the Parties will update this Annex.
Cross-referencing
7.10. Where products covered by this Annex are subject also to
electrical safety or EMC requirements the relevant provisions of the
Sectoral Annexes on electrical safety and EMC will also apply.
Attachment 1
Legislative, regulatory and administrative provisions
>TABLE POSITION>
Attachment 2
Coverage
>TABLE POSITION>
Attachment 3
Designating authorities
>TABLE POSITION>
Attachment 4
Designated conformity assessment bodies
(This should give name, address, telephone and fax number, contact
point, products, standards and conformity assessment procedures for
which designation has been made, by reference to the legislative
requirements of the other Party.)
Attachment 5
Approval authorities
>TABLE POSITION>
Appendix 1
RADIO TRANSMITTERS STANDARDS LIST UNDER RADIOCOMMUNICATION
REGULATIONS
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Additional radio standards specifications may be found in the
broadcasting regulatory section of the index.
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SECTORAL ANNEX ON ELECTROMAGNETIC COMPATIBILITY (EMC)
1. SCOPE AND COVERAGE
1.1. The provisions of this Annex shall apply to the following:
- electromagnetic compatibility of equipment as defined in Council
Directive 89/336/EEC of 3 May 1989 on the approximation of the laws
of the Member States relating to electromagnetic compatibility and
amendments thereto,
- electromagnetic compatibility of equipment regulated under
sections of the Canadian Radiocommunications Act.
2. THE REQUIREMENTS
2.1. The relevant technical requirements are specified under the
legislation and regulations referenced in Attachment 1.
3. CONFORMITY ASSESSMENT ACTIVITIES
3.1. Each Party agrees to recognise all of the other Party's
reports, certificates, and technical construction files, as
required, under their respective legislation without any further
assessment of the products.
4. INSTITUTIONS
4.1. Designating authorities
(a) The designating authorities for the purpose of this Annex are
listed in Attachment 2.
(b) Each Party shall notify the other within ten (10) working days
of changes in the identity of their designating authorities and
their authority to carry out the obligations under this Annex.
4.2. Designated conformity assessment bodies
(a) Conformity assessment bodies designated under this Annex shall
be recognised as competent to perform the conformity assessment
activities for EMC. Each Party shall ensure that the designated
bodies comply with the criteria and standards set out in the
regulatory requirements of the other Party. A list of designated
bodies is included in Attachment 3.
(b) Designation, suspension or withdrawal of conformity assessment
bodies under this Annex shall be in conformance with procedures
determined by the Joint Committee established under the Framework
Mutual Recognition Agreement.
5. TRANSITIONAL ARRANGEMENT
5.1. The mutual recognition provisions of this Annex, notably
section 3, will take effect 18 months following the entry into force
of this Annex.
2. exchange information and review the work carried out by
designated conformity assessment bodies; and
3. demonstrate to each other's satisfaction their capability to
carry out conformity assessment to the requirements of the other
Party.
6. ADDITIONAL PROVISIONS
Subcontracting
6.1. Any subcontracting of conformity assessment shall be in
accordance with the subcontracting requirements of the other Party.
6.2. The conformity assessment bodies shall record and retain
details of its investigation into the competence and compliance of
its subcontractors and maintain a register of all subcontracting.
These details will be available promptly to the other Party on
request.
Post-market surveillance
6.3. For the purpose of post-market surveillance, the Parties may
establish labelling, numbering or marking requirements. The
assignment of numbers or affixing of labels or marks may take place
in the territory of the exporting party.
Exchange of information and mutual assistance
6.4. Each Party shall establish a contact point to provide answers
to all reasonable inquiries from the other Party regarding
procedures, regulations and complaints.
6.5. The Parties shall also inform each other of changes to relevant
regulations, specifications, test methods, standards and
administrative procedures within thirty (30) working days of their
domestic notification.
Regulatory changes and updating the Annex
6.6. In the event that there are changes to the technical
regulations and conformity assessment procedures referenced in
Attachment 1 or in the event of the introduction of new regulations
in the jurisdiction of either Party, the Parties will update this
Annex.
Cross-referencing
6.7. Where products covered by this Annex are subject also to
electrical safety or radio or telecommunication attachment
requirements the relevant provisions of the Sectoral Annexes on
electrical safety, telecommunication terminal equipment, information
technology equipment and radio transmitters will also apply.
Attachment 1
Legislative, regulatory and administrative provisions
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Attachment 2
Designating authorities
The designating authority for Canada is Industry Canada.
The designating authorities for the European Community are as
follows:
- Belgium
Ministųre des Affaires Économiques
Ministerie van Economische Zaken
- Denmark
- for telecommunication equipment:
Telestyrelsen
- for other equipment:
Danmarks Elektriske Materielkontrol (DEMKO)
- Germany
Bundesministerium fŽr Wirtschaft
- Greece
ÕĘ˙įęóõč˙ ĢõĮńŠ˙ęžż śńł ÅĘłś˙łżųżłžż
Ministry of Transport and Communications
- Spain
- for telecommunication equipment:
Ministerio de Fomento
- for other equipment:
Ministerio de Industria y Energża
- France
Ministųre de l'łconomie, des finances et de l'industrie
- Ireland
Department of Transport, Energy and Communications
- Italy
Ministero dell'Industria, del Commercio e dell'Artigianato
- Luxembourg
Ministųre des Transports
- Netherlands
De Minister van Verkeer en Waterstaat
- Austria
- for telecommunication equipment:
Bundesministerium fŽr Wissenschaft und Verkehr
- for other equipment:
Bundesministerium fŽr wirtschaftliche Angelegenheiten
- Portugal
Instituto das Comunica÷įes de Portugal
- Finland
- for telecommunication equipment:
LiikenneministeriŠ/Trafikministeriet
- for other equipment:
Kauppa- ja teollisuusministeriŠ/Handels- och industriministeriet
- Sweden
Under the authority of the Government of Sweden:
Styrelsen fŠr ackreditering och teknisk kontroll (SWEDAC)
- United Kingdom
Department of Trade and Industry
Attachment 3
Designated conformity assessment bodies
(This should give name, address, telephone and fax number, contact
point, products, standards and conformity assessment procedures for
which designation has been made, by reference to the legislative
requirements of the other Party.)
Appendix 1
Interference-causing equipment standards
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SECTORAL ANNEX ON ELECTRICAL SAFETY
1. PURPOSE
1.1. The purpose of this Annex is to establish a framework for the
acceptance of electrical products through the recognition of
conformity assessment carried out by bodies which comply with the
requirements of the other Party, while maintaining the integrity of
the safety system in each of the Parties.
2. SCOPE AND COVERAGE
2.1. For access to the EC: the safety of electrical equipment
falling within the scope of the Low Voltage Directive (Council
Directive 73/23/EEC of 19 February 1973 as amended by Directive
93/68/EEC) (1).
2.2. For access to Canada: low voltage electrical equipment,
including medical devices, covered by the Canadian Electrical Code,
except for those products specifically excluded under the Low
Voltage Directive (other than medical devices).
3. RESPONSIBLE/DESIGNATING AUTHORITIES
4. TRANSITION PHASE
4.1. The transitional arrangements shall operate for a term of
eighteen (18) months from the time this MRA enters into force.
4.2. The purpose of the transition phase is to provide the
responsible/designating authorities with an opportunity to build
confidence and understanding of each other's procedures for
recognising CABs and in the ability of those bodies to carry out
their mandates. Successful completion of the transition phase should
result in the determination by the responsible authorities that
nominated CABs comply with the applicable criteria and are competent
to conduct conformity assessment activities acceptable to the other
Party.
5. OPERATION OF THE TRANSITION PHASE
5.1. During the transition phase, Canadian CABs shall accept test
reports and related documents issued by nominated CABs in the other
territory. For Community CABs, they must satisfy the following
requirements:
(a) be a participant in the International Electrotechnical
Commission (IEC) scheme of the IECEE for recognition of results of
testing to standards for safety of electrical equipment
(certification bodies (CB) scheme) under the IEC system for
conformity testing to standards for safety of electrical equipment
(IECEE) as defined in IECEE Document 02/1992-05; or
(b) have a contractual arrangement for acceptance of test data with
a certification organisation accredited by the Standards Council of
Canada.
5.2. During the transition phase, Community CABs will:
(a) test products to Canadian requirements;
(b) issue a comprehensive testing and evaluation file (i.e.
assessment data, reports) for submission by the manufacturer of the
tested products to a certification organisation in Canada.
5.3. Canadian certification organisations shall ensure that:
(a) they inform the applicant and the Community CAB in a precise and
complete manner of any deficiency;
(b) they limit any request for additional information or samples to
omissions, inconsistencies or variances from the technical
regulations or standards; and
(c) certification is done on the basis of existing procedures,
including the application of their mark.
6. MARKING OF CONFORMITY
6.1. During the transition phase, the Joint Committee shall develop
mutually acceptable mechanisms and procedures for marking of
products to be exported to Canada in order to indicate their
conformity with Canadian requirements. Such markings shall be under
the control of CABs recognised by the responsible/designating
authorities, provide for traceability, give sufficient information
to consumers, and not give rise to confusion with other markings of
conformity. For access to the EC market, the CE marking shall apply.
7. OPERATIONAL PHASE
7.1. During the operational phase, the Parties will proceed to full
mutual recognition of results of conformity assessment activities,
as required under their respective legislation. CABs recognised by
the responsible designating authorities shall operate as follows:
(a) for access to the EC market:
if a product is challenged under the Low Voltage Directive, a report
drawn up by a Canadian CAB recognised under this agreement shall be
considered by the EC as if it were a report drawn up by a European
notified body;
(b) for access to the Canadian market:
CABs from the EC will be accredited in accordance with Standards
Council of Canada (SCC) criteria for accreditation of certification
bodies recognised in Canada and will be issued a certificate of
accreditation. The following conditions are deemed to be equivalent
to those prescribed criteria:
(i) evidence of satisfactory performance in the transition phase;
and
(ii) accreditation by a European accreditation organisation
according to applicable and relevant ISO/IEC guides adapted to
Canadian and European conditions for accreditation of certification
organisations; and
(iii) evidence of procedures for follow-up of certification
activities including the identification of a contact point
responsible for initiating action with manufacturers of the products
when necessary.
7.2. The Parties will encourage the establishment of mutual
recognition agreements between the European accreditation
organisations and the SCC.
8. LIMITED SCOPE OR DENIAL OF RECOGNITION FOR THE PURPOSES OF
CERTIFICATION
8.1. Upon request, a CAB may be required to provide additional
documentary evidence to facilitate its passage from the transitional
to the operational phase.
8.2. In the event that a proposal is made during, or at the end of
the transition phase, requesting a responsible/designating authority
to limit the scope of recognition of any designated CAB or to
exclude it from the list of bodies accredited/designated, in
accordance with the procedures outlined in the Framework Agreement,
such a proposal shall be based on objective reasons and shall be
properly documented in writing to the Joint Committee.
9. FOLLOW UP OF CERTIFICATION ACTIVITIES
9.1. The authorities in each Party (see Attachments 1 and 2) retain
the right to question the performance of CABs operating in the
context of this Annex. (Upon reasoned request, the authorities in
one Party may request a copy of the certification report prepared to
its requirements in the territory of the exporting Party. This
report shall be provided promptly and without charge.)
10. JOINT ELECTRICAL SAFETY GROUP
10.1. The Joint Committee established under the Mutual Recognition
Agreement shall appoint a Joint Electrical Safety Group (JESG).
10.3. The Group may review issues of concern to either Party and no
one shall refuse a request by the other to address such issues.
10.4. The Group may issue recommendations to the Joint Committee
regarding concerns raised by the representatives of either Canada or
the EC.
10.5. The Group shall establish its own rules of procedures, and
take its decisions and adopt its recommendations by consensus of the
Parties.
(1) The categories of equipment and phenomena outside the scope of
the Directive are: electrical equipment for use in an explosive
atmosphere; electrical equipment for radiology and medical purposes;
electrical parts for goods and passenger lifts; electricity meters;
plugs and socket outlets for domestic use; electric fence
controllers; radio-electrical interference; specialised electrical
equipment, for use on ships, aircraft or railways, which complies
with the safety provisions drawn up by international bodies in which
Member States participate.
Attachment 1
Legislative, regulatory and administrative requirements and
regulatory authorities (re Articles 2(3) and 9(1))
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Attachment 2
Designating authorities
The authorities responsible for the designation of conformity
assessment bodies under this Agreement are:
(a) for the European Community:
- Belgium
Ministųre des Affaires Économiques
Ministerie van Economische Zaken
- Denmark
Boligministeriet
- Germany
Bundesministerium fŽr Arbeit und Sozialordnung
- Greece
ÕĘ˙įęóõč˙ ĮżĄĘĮįž÷Ė
Ministry of Development
- Spain
Ministerio de Industria y Energża
- France
Ministųre de l'łconomie, des finances et de l'industrie
- Ireland
Department of Enterprise and Employment
- Italy
Ministero dell'Industria, del Commercio e dell'Artigianato
- Luxembourg
Ministųre des Transports
- Netherlands
Staat der Nederlanden
- Austria
Bundesministerium fŽr wirtschaftliche Angelegenheiten
- Portugal
Under the authority of the Government of Portugal: Instituto
Portuguśs da Qualidade
- Finland
Kauppa- ja teollisuusministeriŠ/Handels- och industriministeriet
- Sweden
Under the authority of the Government of Sweden:
Styrelsen fŠr ackreditering och teknisk kontroll (SWEDAC)
- United Kingdom
Department of Trade and Industry
(b) for Canada:
- The Standards Council of Canada, a Federal Crown corporation
established by an Act of Parliament in 1970, amended in 1996.
SECTORAL ANNEX ON RECREATIONAL CRAFT
SECTION I
Scope and coverage
1.1. This Annex applies to all recreational craft, including
personal watercraft, which in the European Community or in Canada
are subject to a conformity assessment or approval procedure by an
independent conformity assessment or approval body.
1.2. The product coverage shall be as determined by the relevant
legislation of each party, which is:
(a) for the European Community:
recreational craft as defined in Article 1 of Directive 94/25/EC;
(b) for Canada:
pleasure craft as defined by the Canada Shipping Act, Chapter 1487,
Small Vessel Regulations as referenced in Transport Canada's
Publication No TP1332.
1.3. Parties agree that mutual recognition will operate under this
Annex according to the following arrangements:
(a) for evaluation against European Community requirements,
conformity assessment bodies designated by Canada will establish
certificates of compliance according to the provisions of Directive
94/25/EC. These certificates will be recognised in the European
Community without any further assessment of the products to which
they relate;
(b) for approval according to Canadian requirements, conformity
assessment bodies designated by the European Community will certify
the product according to the requirements set out in Chapter 1487 of
the Canada Shipping Act Small Vessel Regulations, and issue the
appropriate compliance plates and other required documentation.
Products so certified may be placed on the Canadian market without
undergoing any further approval procedures.
SECTION II
Legislative, regulatory and administrative requirements
2.1. For the European Community:
Directive 94/25/EC of the European Parliament and of the Council of
16 June 1994 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to
recreational craft.
2.2. For Canada:
Regulatory requirements - The Canada Shipping Act, Chapter 1487,
Small Vessel Regulations referenced in Transport Canada's
Publication No TP1332
Construction standards for small vessels which includes personal
watercraft as defined by and certified to ISO/DIS 13590.
SECTION III
Authorities responsible for designating the conformity assessment
bodies as specified by conformity assessment modules
1.
4.1. For the purpose of the Annex, each Party will designate
competent conformity assessment bodies to carry out conformity
assessment and approvals to the requirements of the other Party.
Such designation will be carried out according to the procedures set
out in the Mutual Recognition Framework Agreement. A list of
designated conformity assessment bodies, together with the products
and procedures for which they have been designated, is in Attachment
2.
4.2. Each Party will accept that the designated conformity
assessment bodies comply with the requirements for such bodies
established by the other Party.
These are:
(a) for the European Community, bodies which are notified bodies in
accordance with Directive 94/25/EC are deemed to be in compliance
with Canadian requirements.
A 'notified body` for the EC is a third party authorised to perform
the conformity assessment tasks specified in Directive 94/25/EC,
which has been appointed by a Member State from the bodies falling
within its jurisdiction. The notified body has the necessary
qualifications to meet the requirements laid down in Directive
94/25/EC and has been notified to the Commission and to the other
Member States;
(b) for Canada, the procedures and criteria for designation of
conformity assessment bodies shall comply with the relevant
provisions of Directive 94/25/EC.
SECTION V
Transitional arrangement
There will be a transitional arrangement of 18 months prior to the
operation of this Annex. During this transitional period, the
Parties will:
(a) exchange information on, and develop greater familiarity with,
their respective regulatory requirements; and
(b) carry out the policy, legislative and regulatory changes
necessary for the provisions of this Annex.
SECTION VI
Additional provisions
6.1. In accordance with the relevant provisions of the Mutual
Recognition Framework Agreement, the Parties shall ensure the
continued availability of the names of their respective notified
bodies or conformity assessment bodies, and will regularly supply
details of certifications issued in order to facilitate post-market
surveillance.
6.2. The Parties note that, to the extent that requirements for
electrical safety or electromagnetic compatibility apply to products
covered by this Sectoral Annex, the provisions of the Sectoral
Annexes on electrical equipment and electromagnetic compatibility
shall apply.
Attachment 1
Designating authorities
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Attachment 2
Designated conformity assessment bodies
- European Community:
notified bodies which have been notified by the Member States of the
European Community, and whose names and reference numbers have been
published in the Official Journal of the European Communities.
- Canada:
to be determined.
SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)
1. PURPOSE
1.1. This Mutual Recognition Agreement (MRA) Sectoral Annex on good
manufacturing practices (GMP) compliance certification pertaining to
medicinal products/drugs has been developed by the European
Community (EC) and Canada to:
(a) enhance bilateral regulatory cooperation;
(b) establish mutual recognition for GMP compliance certification
and acceptance of manufacturing authorisations/licences directly
issued by the authorities designated equivalent after the successful
completion of a confidence building exercise;
(c) develop an infrastructure for on-going
communications/consultations between Canada, the European
Commission, and the regulatory authorities of the EC Member States
to enable regulators to determine and maintain the equivalency of
their GMP compliance programmes.
2. GENERAL CONSIDERATIONS
2.1. The underlying premise behind a MRA for GMP compliance
certification is that it can be demonstrated that Canada and the EC
Member States have equivalent GMP compliance programmes, and
therefore the issuance of a certificate of manufacturing
authorisation/licence by an authority of one Party certifying that a
facility is in compliance with GMPs, would be all the evidence
required by the other Party to accept that facility as being in
compliance for the manufacturing/control of medicinal/drug products
or to issue a similar certificate of manufacturing
authorisation/licence. It should be understood that equivalent does
not mean identical but it does mean leading to the same result.
2.2. The acceptance by an authority of a certificate of
manufacturing authorisation/licence issued by the other authority
will depend on the successful completion of a confidence building
exercise and on an evaluation of its results. Only certification by
authorities with GMP compliance programmes (including the supporting
infrastructure of regulatory requirements, standards, processes, and
quality systems, etc.) mutually recognised as equivalent will be
accepted.
3. SCOPE AND COVERAGE
3.1. The provisions of this Annex will cover all medicinal
products/drugs which have undergone one or a series of manufacturing
process(es) (e.g. fabrication, repackaging, labelling, testing,
wholesaling activities) in Canada and in the European Community, and
to which good manufacturing practice (GMP) requirements apply in
both jurisdictions. Recognition will be limited to the manufacturing
process(es) carried out and subject to inspections in the respective
territories of the Parties.
3.2. This Annex may also apply, on a voluntary basis, to products
covered by the legislation of one Party but not the other if agreed
to by the authorities concerned.
3.3. The product coverage shall be as determined by the relevant
legislation of each Party. Appendix 1 names the legislations and
contains an indicative list of products concerned.
3.4. For the purpose of this Annex, GMP includes the system whereby
the manufacturer receives the specifications of the product and/or
process from the marketing authorisation (MA)/drug identification
number (DIN) or licence holder or applicant and ensures the product
is made in compliance with the specifications (equivalent to
qualified person certification in the EC).
Good manufacturing practice (GMP) is that part of quality assurance
which ensures that products are consistently produced and controlled
to the quality standards:
- appropriate to their intended use, and
- required by the marketing authorisation or product specifications
and by assignment procedure of the drug identification number or the
licence.
3.5. Product or process oriented inspections will be carried out by
one Party at the request of the other Party. For pre-approval
inspections, the Parties agree to exchange pre-approval inspection
reports to the extent required under the importing Party's laws and
regulations, for the purpose of their respective product approval
procedures. Lot-to-lot release for biologicals is excluded from this
Agreement.
4. CONFIDENTIALITY
4.1. Each Party will protect from public disclosure any non-public
confidential technical, commercial and scientific information,
including trade secrets and proprietary information that is provided
by the other Party.
5. MANAGEMENT MECHANISMS
5.1. A joint sectoral group will be established for the purposes of
the management of this Sectoral Agreement. The joint sectoral group
will establish its composition and determine its own rules and
procedures. Its role is described in Appendix 3. The group will
include representatives of the therapeutic products programme in
Health Canada, of the European Commission, and of the relevant EC
authorities. It will be co-chaired by a member of each of the two
Parties.
6. RESOLUTION OF DIVERGENT VIEWS
7. TRANSITION PERIOD
7.1. Time frame
The confidence building period will commence upon the signing of the
MRA and is expected to be completed within 18 months.
7.2. Confidence building programme
At the beginning of the transitional period, the joint sectoral
group will elaborate a joint confidence building programme. The
implementation of this programme will permit the determination of
the capability of each Party's authority to perform GMP compliance
certification (guidance provided in Appendix 6).
7.3. Budget
Each of the Parties to the MRA will be responsible for the costs of
its participation in the confidence building activities.
7.4. Administrative provision
Medicinal products/drugs from manufacturing sites with a good track
record of compliance in the importing Party, and that have been
placed on a list of qualified sites, will be exempted from retesting
requirements. The list will be developed by the joint sectoral
group.
7.5. End of transitional period
7.5.1. At the end of the transitional period, the joint sectoral
group will proceed to a joint evaluation of the equivalency and
capabilities of the compliance programmes of the participating
authorities (Appendix 2).
7.5.2. Those determined as not being equivalent to the other Party's
GMP compliance programme will not be listed in Appendix 2 at the end
of the transitional period. Proposals to limit the recognition of
the equivalence of an authority or exclude it from the Appendix
should be based on objective criteria and documented evidence.
7.5.3. Authorities may be placed in Appendix 2 for specific
categories of manufacturing processes (e.g. biologicals,
radiopharmaceuticals). Excluded authorities (or not included for a
given manufacturing process) may apply for re-consideration of their
status once the necessary corrective measures have been taken.
8. OPERATIONAL PHASE
8.1. General provisions
8.1.1. The European Community and Canada agree that, for medicinal
products/drugs covered by this Annex, each Party will recognise the
conclusions of the GMP compliance programme carried out by the other
Party in its territory, and the relevant certificates of
manufacturing authorisations/licences granted by the deemed
equivalent authorities of the other Party listed in Appendix 2. In
addition, the certification by the manufacturer on the conformity of
each batch will be recognised by the other Party without re-control
at import.
8.1.2. Manufacturers located in Canada or a Member State of the
European Community whose relevant authority is not listed in
Appendix 2 or is not included for the relevant category
manufacturing processes may ask that an inspection be carried out by
any of the authorities listed in Appendix 2. The batch and the
compliance certificates issued according to this procedure will be
recognised by the other Party provided that equivalent enforcement
procedures against that facility can be subsequently ensured in case
of non-compliance.
8.1.3. With respect to medicinal products/drugs covered by the
pharmaceutical legislation of the importing Party but not the
exporting one, the locally competent inspection service willing to
carry out an inspection of the relevant manufacturing operations
shall inspect against its own GMPs if relevant, or, in the absence
of specific GMP requirements, against the applicable GMPs of the
importing Party. This will also be the case when the locally
applicable GMPs are not considered equivalent, in terms of quality
assurance of the finished products, to the GMPs of the importing
Party.
This provision may also apply to the manufacturer of active
pharmaceutical ingredients, intermediate products, and products
intended for use in clinical trials.
8.1.4. It will be the responsibility of the authorities covered by
the Annex to ensure that any suspension or withdrawal (total or
partial) of a manufacturing authorisation, which could affect the
protection of public health, is communicated to the other Party with
the appropriate degree of urgency as defined in the 'two-way` alert
programme.
Contact points will be agreed between both Parties to permit
authorities and manufacturers to inform the authorities of the other
Party with the appropriate speed in case of quality defect, batch
recalls, counterfeiting and other problems concerning quality, which
could necessitate additional controls or suspension of the
distribution of the product.
8.1.5. Certification of manufacturers
At the request of an exporter, an importer or of an authority of the
other Party, the authorities responsible for granting certificates
of manufacturing authorisations/licences and for the supervision of
the manufacture of medicinal products/drugs will certify that the
sites used for manufacture and/or control:
(a) are appropriately authorised to manufacture and/or control the
relevant medicinal product/drug or to carry out the relevant
specified operations,
(b) are regularly inspected by the authorities, and
(c) comply with the GMP requirements recognised as equivalent by the
two Parties.
The certificates of manufacturing authorisation/licence will also
identify the site(s) of manufacture. A Canadian and a European
Community example of such certificates are attached at Appendix 7
for illustrative purposes.
Certificates of manufacturing authorisations/licences will be issued
expeditiously, and the time taken should not exceed 30 days. In
cases when a new inspection has to be carried out, this period may
be extended to 60 days.
8.1.6. Batch certification
Each batch exported will be accompanied by a batch certificate
issued by the manufacturer ('self certification`) after a full
qualitative and quantitative analysis of all active constituents to
ensure that the quality of the products complies with the
requirements of the marketing authorisation/product approval.
When issuing this certificate, the manufacturer will take into
account the provisions of the current WHO certification scheme on
the quality of medicinal products/drugs moving in international
commerce. This certificate will attest that the batch meets the
specifications and has been manufactured in accordance with the
relevant marketing authorisation/product approval, detailing the
specifications of the product, the analytical methods referenced,
the analytical results obtained, and containing a statement that the
batch processing and packaging records were reviewed and found in
conformity with GMPs.
The batch certificate will be signed by the person responsible for
releasing the batch for sale or supply. In the European Community
the 'qualified person` is referred to in Article 21 of Directive
75/319/EEC, and in Canada, the nominated person responsible for
manufacturing quality control is as specified in the Food and Drug
Regulations, Division 2, Section C.02.014 (1).
8.1.7. Fees
The regime of inspection/establishment licence fees is determined by
the location of the manufacturer. The cost recovery programmes and
the fees pertaining to the issuance of manufacturing
authorisations/licences in each jurisdiction will remain the
responsibility of that jurisdiction.
The Parties shall endeavour to ensure that any fees imposed for
services will be cost-oriented and take into account relevant cost
factors. If no services are rendered by one Party, fees should not
be charged.
8.1.8. Each Party reserves the right to conduct its own inspection
for reasons identified to the other Party. Such inspections are to
be notified in advance to the other Party, which has the option of
joining the inspection. Recourse to this safeguard clause should be
an exception.
8.2. Information sharing
8.2.1. In accordance with the general provisions of the Annex, the
Parties will exchange all information necessary to determine and
maintain the equivalence of GMP compliance programmes. In addition,
the relevant authorities in Canada and in the EC will keep each
other informed of all new technical guidance, inspection procedures,
or changes in regulation (these include: guidance documents,
publications of references to standards, forms, documents relating
to the application of legal requirements). Each Party will consult
the other before adopting these changes to ensure the continued
equivalency of the GMP compliance programmes. Concerns will be
raised to the joint sectoral group.
8.2.2. Upon reasoned request, the relevant inspection service shall
forward a copy of the last inspection report of the manufacturing or
control site, in case analytical operations are contracted out. The
request may concern a 'full inspection report` or a 'detailed
report`. A 'full inspection report` comprises a site master file
(compiled by the manufacturer or by the inspectorate) and a
narrative report by the inspectorate. A 'detailed report` responds
to specific queries about a firm by the other Party. Parties will
ensure that such inspection reports are forwarded in no more than 30
days, this period being extended to 60 days should a new inspection
be carried out.
8.3. Two-way alert system
8.3.1. The joint sectoral group will ensure that an efficient and
effective 'two-way` alert system is in place at all times. Elements
of such a system are described in Appendix 5.
8.3.2. It shall be the responsibility of the authorities covered by
the Annex to ensure that any suspension or cancellation (total or
partial) of certification of compliance is communicated to the other
relevant authorities with the appropriate degree of urgency.
8.3.3. Each Party shall notify the other Party of any confirmed
problem reports, corrective actions, or recalls related to products
covered under the scope of this Annex. Each Party will respond to
special requests for information and will ensure that authorities
make available relevant information, as requested.
Contact points are identified in Appendix 5.
9. MONITORING OF THE AGREEMENT
9.1. The continuous monitoring of the GMP compliance programmes
determined to be equivalent at the conclusion of the confidence
building period and any subsequent decisions concerning that
equivalence must be made according to a mutually developed and
managed equivalence maintenance programme. This programme will be
managed by the joint sectoral group.
9.2. The Parties undertake to hold regular consultations, under the
auspices of the joint sectoral group set up under this Annex, to
ensure the continued relevancy and accuracy of this Annex. Canada
and Member State authorities may organise meetings to discuss
specific questions and issues.
10. APPENDICES
1. List of applicable legislation
1.1. For the European Community:
Directive 65/65/EEC as modified;
Directive 75/319/EEC as modified;
Directive 81/851/EEC as modified;
Directive 91/356/EEC as modified;
Directive 91/412/EEC as modified;
Regulation (EC) No 2309/93;
Directive 92/25/EEC;
Guide to good distribution practice (94/C 63/03);
Current version of the 'Guide to good manufacturing practice`,
Volume IV of Rules governing medicinal products in the European
Community.
2. Indicative list of products
Recognising that precise definitions of medicinal products and drugs
are to be found in the legislation referred to above, an indicative
list of products covered by the Agreement is given below:
- human pharmaceuticals including prescription and non-prescription
drugs, and medicinal gases,
- human biologicals including vaccines, stable medicinal products
derived from human blood or human plasma, biotherapeutics, and
immunologicals,
- human radiopharmaceuticals,
- veterinary pharmaceuticals, including prescription and
non-prescription drugs, and pre-mixes for the preparation of
veterinary medicated feeds,
- where appropriate, vitamins, minerals, herbal remedies and
homeopathic medicinal products, and
- active pharmaceutical ingredients or bulk pharmaceuticals (NB:
APIs are not GMP regulated).
Appendix 2
Authorities
For the European Community:
>TABLE POSITION>
For Canada:
Therapeutic products programme, Health Canada, Ottawa
Bureau of Veterinary Drugs, Food Directorate, Health Canada, Ottawa
Appendix 3
Joint sectoral group
A joint sectoral group (JSG) will be established to manage the
confidence building process and to monitor the operations of the MRA
thereafter.
The JSG will be co-chaired by a member from each Party and will
determine its own composition, ensuring, to as great a degree as
possible, consistent membership. The role of the JSG will be to
ensure communications with the Joint Committee and to manage the
transition period and to monitor the continued implementation of
this Annex including, but not limited to:
- making decisions on activities required to define and establish
the equivalence of compliance programmes and the 'two-way` alert
system,
- assessing the results of the confidence building exercise, and
determining which regulatory authorities are deemed equivalent. The
JSG will prepare a list of the equivalent regulatory agencies and
provide its recommendations to the Joint Committee,
- providing directions to experts that will conduct the evaluation
of the respective GMP compliances programmes, and undertake joint
activities (e.g. inspections, workshops) and
- making decisions on the necessary arrangements of the MRA
maintenance programme.
The JSG will meet as needed to adopt the confidence building working
plan, resolve issues, and monitor the progress of the confidence
building exercise. The Joint Committee will be kept informed of the
agendas and conclusions of meetings as well as on the progress made
during the transition period.
Appendix 4
Components of a GMP compliance programme
1. Legislative and regulatory requirements and scope
- empowering legislation and regulations including authority to
enforce laws and regulations, powers given to inspectors to conduct
inspections, authority to remove violative products from the market,
etc.,
- suitable controls on conflict of interest.
2. Regulatory directives and policies
- procedures for designating inspectors,
- enforcement policies/guidelines/procedures (inspection,
re-inspection, corrective action),
- codes of conduct/ethics,
- training/certification policies/guidelines,
- alert/crisis management policies/procedures/guidelines,
- organisational structure, including roles, responsibilities and
reporting relationships.
3. Good manufacturing practices (GMP) standards
- scope/detials of GMPs necessary for the control of the
manufacturing of drug products,
- process validation requirements.
4. Inspection resources
- staffing - initial qualifications, certification of inspectors,
- number of inspectors in relation to size of industry (in-house,
contract, third party),
- training/certification programmes/processes (e.g. frequency of
training),
- quality assurance mechanisms to ensure effectiveness of training
programmes.
5. Inspection procedures (pre-inspection, inspection, and
post-inspection activities)
- inspection strategy (type, scope, scheduling, focus of inspection,
notification of inspections, risk-based inspections),
- pre-inspection preparation/requirements,
- format and content of inspection reports (including support tools,
e.g. hardware),
- inspection methodology (access to and review of firm's files and
databases, collection of evidence, data review, sample collection,
interviews),
- standard operating procedures (SOPs) for inspection,
- post-inspection activities (procedures for report issuance,
follow-up, decision making),
- storage of inspection data.
6. Inspection performance standards
- frequency/number of inspections, quality and timeliness of
inspection reports, norms/frequencyprocedures for re-inspection and
corrective action.
7. Enforcement powers and procedures
- provision of written notices of violation to firms,
- non-compliance management procedures/mechanisms (recall,
suspension, quarantine of products, licence revocation, seizure,
prosecution),
- appeal mechanisms,
- other measures to promote voluntary compliance by firms.
8. Alert and crisis systems
- alert mechanisms,
- crisis management mechanisms,
- alert performance standards (appropriateness and timeliness of
alert).
9. Analytical capability
- access to laboratories with capacity to handle necessary analysis,
- standard operating procedures (SOPs) for analytical support,
- processes for validation of analytical methods.
10. Surveillance programme/measures (used by firms and by regulatory
authority)
- sampling and audit procedures,
- recall monitoring (including effectiveness controls and
verification of procedures),
- consumer complaint system/procedures,
- adverse reaction reporting system/procedures,
- drug product defect reporting system/procedures.
11. Quality management systems
- quality management/assurance system/procedures to ensure the
ongoing suitability and effectiveness of policies, procedures,
guidelines and systems used to achieve the objectives of the GMP
compliance programme, including establishment of standards and
annual audit and review.
Appendix 5
Components of a 'two-way` alert programme
1. Documentation
- definition of a crisis/emergency and under what circumstances an
alert is required,
- standard operating procedures (SOPs),
- mechanism of health hazards evaluation and classification,
- language of communication and transmission of information.
2. Crisis management system
- crisis analysis and communication mechanisms,
- establishment of contact points,
- reporting mechanisms.
4. Quality assurance system
- pharmacovigilance programme,
- surveillance/monitoring of implementation of corrective action.
Contact points
For the purpose of this agreement, the contact points for any
technical question, such as exchange of inspection reports,
inspectors training sessions, technical requirements, will be:
- for Canada,
the Director-General, Therapeutic Products Programme, Health Canada,
2nd Floor, Health Protection Building, AL: 0702A, Tunney's Pasture,
Ottawa, Ontario, K1A OL2, Canada. Tel. (1-613) 947 03 69, fax
(1-613) 952 77 56; and
- for the European Community,
the Director of the European Agency for the Evaluation of Medicinal
Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, United
Kingdom. Tel. (44-171) 418 84 00, fax 418 84 16.
Appendix 6
Phases of a confidence building period
The determination of the equivalency of the GMP compliance
programmes by the joint sectoral group will be designed around the
following three phases:
1. Review and evaluation of documentation (exchange of
documentation)
- legal instruments (regulations/legislation/directives)/guidelines
on GMPs,
- inspection programmes (scope, policies, directives, procedures),
- crisis management systems (scope, criteria, policies, directives,
procedures),
- requirements for inspection reports,
- analytical laboratory systems,
- alert reports.
2. Evaluation of processes and procedures
- audit of systems and procedures,
- exchange/evaluation of reports,
- monitoring of alert systems including handling of recalls,
- joint inspections of manufacturers to determine equivalency of
inspection methods,
- exchange of inspectors or organisation of joint workshops
(optional).
3. Decision making on the success of the exercise and conclusions
- evaluation of results of the confidence building exercise,
- action to take, development of options and solutions to address
issues,
- determination of competent agencies that meet evaluation criteria,
- establishment of the conditions and mechanisms for on-going
maintenance of the certification programme (develop quality
management system, audit mechanism and a consultation/on-going
dialogue process).
Appendix 7
Certificate of pharmaceutical manufacturer in the framework of the
Agreement on mutual recognition between Canada and the European
Community, Sectoral Annex on medicinal products GMP inspection and
batch certification
>START OF GRAPHIC>
As requested by the . (*) on . . ./. . ./. . . (date) (reference: .
), the competent authority of . (**) confirms the following:
The company .
whose legally registered address is: .
has been authorised, under Directive 75/319/EEC (Article 16) and
Directive 81/851/EEC (Article 24) transposed in the national
legislation of . (**), under the authorisation reference number
covering the following site(s) of manufacture (and contract testing
laboratories, if any):
3. .
.
to carry out the following manufacturing operations:
+ complete manufacture (***)
+ partial manufacture (***), i.e. (detail of manufacturing
operations authorised): .
.
for the following medicinal product: .
for human use/use in animals (***).
From the knowledge gained during inspections of this manufacturer,
the latest of which was conducted on . . ./. . ./. . . (date), it is
considered that the company complies with the good manufacturing
practice requirements referred to in the Agreement on Mutual
Recognition between Canada and the European Community.
. . ./. . ./. . . (date)
For the competent authority
. (Name and signature of the officer responsible)
(*) Insert exporting or importing firm or Health Canada.
(**) Insert European Community Member State or European Community as
required.
(***) Delete that which does not apply.
>END OF GRAPHIC>
>REFERENCE TO A GRAPHIC>
>REFERENCE TO A GRAPHIC>
>START OF GRAPHIC>
Health Santł
Canada Canada
Establishment Licence
Licence Number
100001-A
Numłro de la licence
P R O G R A M M E D E S PRODUITS
THÉRAPEUTIQUES
THERAPEUTIC
PRODUCTS
P R O G R A M M E
Licence d'łtablissement
This licence is issued in accordance with the Food and Drugs Act &
Regulations (Division 1A & 2) for the following activities and
categories of drugs:
Cette licence est dłlivrłe conformłment š la Loi et aux Rųglements
sur les aliments et drogues (titres 1A et 2) pour les activitłs et
les catłgories de drogues suivantes:
STERILE / NO / NON STÉRILE
Pharmaceutical Prod. pharmaceutique
Vaccines Vaccins
Blood (3) Sang
Schedule D (4) L'annexe D
Schedule C (5) L'annexe C
(6)Fabricate Manufacturer
Package / label Emballer-łtiqueter
Test (1) Test
Distribute (2) Distribuer
Import Importer
Wholesale Vendre en gros
(1) Perform the tests, including any examinations required under
Division 2 / Analyser conformłment au titre 2.
(2) Distribute as set out in paragraph C.01.A.003 (a) and/or (b) /
Distribuer au sens de l'alinła C.01.A.003 (a) et/ou (b).
(3) Whole blood and its components / Sang entier et ses composants.
(4) Drugs listed in Schedule D to the Act, other than vaccines or
whole blood and its components / Drogue visłe š l'annexe D de la
Loi, autre qu'un vaccin ou que le sang entier et ses composants.
(5) Drugs listed in Schedule C to the Act / Drogue visłe š l'annexe
C de la Loi.
(6) Drugs listed in the Schedule to Part G of the Food and Drug
Regulations, drugs listed in Schedule F to the Food and Drug
Regulations, narcotics as defined in section 2 of the Narcotic
Control Regulations / Drogue visłe š l'annexe de la Partie G des
Rųglements sur les aliments et drogues, drogue visłe š l'annexe F
des Rųglements sur les aliments et drogues, stupłfiants au sens de
l'article 2 des Rųglements sur les stupłfiants.Issued On / Émise
le:1998-01-01
MINISTER OF HEALTH
MINISTRE DE LA SANTÉ
Countersigned: Director General, Therapeutic Products Directorate
Contresignł par: Directeur głnłral, Direction des produits
thłrapeutiques
This licence is the property of the Therapeutic Products Directorate
and must be returned upon demand. Cette licence appartient š la
direction des produits thłrapeutiques et doit śtre retournłe sur
demande.
>END OF GRAPHIC>
>REFERENCE TO A GRAPHIC>
>REFERENCE TO A GRAPHIC>
>START OF GRAPHIC>
Health Santł
Canada Canada
Establishment Licence
Licence Number
100125-A
Numłro de la licence
P R O G R A M M E D E S PRODUITS
THÉRAPEUTIQUES
THERAPEUTIC
PRODUCTS
P R O G R A M M E
Licence d'łtablissement
This licence is issued in accordance with the Food and Drugs Act &
Regulations (Division 1A & 2) for the following activities and
categories of drugs:
Cette licence est dłlivrłe conformłment š la Loi et aux Rųglements
sur les aliments et drogues (titres 1A et 2) pour les activitłs et
les catłgories de drogues suivantes:
STERILE / NO / NON STÉRILE
Pharmaceutical Prod. pharmaceutique
Vaccines Vaccins
Blood (3) Sang
Schedule D (4) L'annexe D
Schedule C (5) L'annexe C
(6)
Fabricate Manufacturer
Package / label Emballer-łtiqueter
Test (1) Test
Distribute (2) Distribuer
Import Importer
Wholesale Vendre en gros
(1) Perform the tests, including any examinations required under
Division 2 / Analyser conformłment au titre 2.
(2) Distribute as set out in paragraph C.01.A.003 (a) and/or (b) /
Distribuer au sens de l'alinła C.01.A.003 (a) et/ou (b).
(3) Whole blood and its components / Sang entier et ses composants.
(4) Drugs listed in Schedule D to the Act, other than vaccines or
whole blood and its components / Drogue visłe š l'annexe D de la
Loi, autre qu'un vaccin ou que le sang entier et ses composants.
(5) Drugs listed in Schedule C to the Act / Drogue visłe š l'annexe
C de la Loi.
(6) Drugs listed in the Schedule to Part G of the Food and Drug
Regulations, drugs listed in Schedule F to the Food and Drug
Regulations, narcotics as defined in section 2 of the Narcotic
Control Regulations / Drogue visłe š l'annexe de la Partie G des
Rųglements sur les aliments et drogues, drogue visłe š l'annexe F
des Rųglements sur les aliments et drogues, stupłfiants au sens de
l'article 2 des Rųglements sur les stupłfiants. This licence is
subject to the additional conditions as indicated in the attached:
Cette licence est assujettie aux conditions supplłmentaires
indiqułes dans le feuillet ci-joint:
Foreign Site Annex / Annexe concernant les sites łtrangers
Issued On / Émise le:1998-01-01
MINISTER OF HEALTH
MINISTRE DE LA SANTÉ
Countersigned: Director General, Therapeutic Products Directorate
Contresignł par: Directeur głnłral, Direction des produits
thłrapeutiques
This licence is the property of the Therapeutic Products Directorate
and must be returned upon demand. Cette licence appartient š la
direction des produits thłrapeutiques et doit śtre retournłe sur
demande.
>END OF GRAPHIC>
>REFERENCE TO A GRAPHIC>
>REFERENCE TO A GRAPHIC>
>START OF GRAPHIC>
Health Santł
Canada Canada
Establishment Licence
Licence Number
100125-A
Numłro de la licence
P R O G R A M M E D E S PRODUITS
THÉRAPEUTIQUES
THERAPEUTIC
PRODUCTS
P R O G R A M M E
Licence d'łtablissement
Foreign Site Annex / Annexe concernant les sites łtrangers
The following sites are considered to be in GMP Compliance: Les
sites suivants sont considłrłs comme łtant conformes aux BPF:
Company Name / Nom de l'entreprise
Street/Rue:
City/Ville:
Country/Pays:
Activity/Activite:
FABRICATE / FABRICATION
PACKAGE / CONDITIONNEMENT
Category/Catłgorie:
PHARMACEUTICAL / MÉDICAMENT
Sterile/Stłrile
NO / NON
>END OF GRAPHIC>
SECTORAL ANNEX ON MEDICAL DEVICES
1. PURPOSE
1.1. This Mutual Recognition Agreement (MRA) Annex on conformity
assessment and compliance certification pertaining to medical
devices has been developed by the European Community and Canada to
enhance bilateral medical device regulatory cooperation while
facilitating global trade and maintaining the same high standards of
health and safety in both jurisdictions.
1.2. Furthermore this Annex calls for the development of an
infrastructure for on-going communications/consultations between
regulatory and/or designating authorities and conformity assessment
bodies of each Party to enable regulators to determine and maintain
the equivalence of their medical device conformity assessment
capabilities and to develop a cooperative approach to post-market
vigilance.
2. SCOPE AND COVERAGE
2.1. This Annex applies to all medical devices which in Canada or
the European Community are subject to conformity assessment
procedures, including scientific technical evaluations of high risk
medical devices and quality systems assessments, by a conformity
assessment body.
2.2. The product coverage shall be as determined by the relevant
legislation of each Party, which is:
(a) for the European Community:
- Council Directive 90/385/EEC of 20 June 1990 on the approximation
of the laws of the Member States relating to active implantable
medical devices, as amended,
- Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices;
(b) for Canada:
- the Food and Drugs Act and Medical Devices Regulations (proposed
for promulgation 1998) as amended from time to time,
- the Canadian Electrical Code (as it relates to medical devices),
- the Radiation Emitting Devices Act and Regulations as amended from
time to time (as they relate to medical devices).
It shall not, however, apply to the following products:
- in vitro diagnostic medical devices,
- devices incorporating, as an integral part, a substance which, if
used separately, may be considered to be a medicinal product,
- breast implants,
- medical devices incorporating tissues of human or animal origin.
However, medical devices incorporating tissues of animal origin and
where the device is intended to come into contact with intact skin
only, will be included within the scope of this Sectoral Annex.
Both Parties may, however, decide by common agreement, to extend the
application of this Annex to the aforementioned or any other medical
devices.
3. CONFIDENTIALITY
3.1. Each Party will protect from public disclosure any non-public
confidential technical, commercial and scientific information,
including trade secrets and proprietary information provided by the
other Party.
4. RESOLUTION OF DIVERGENT VIEWS
4.1. Divergent views which have not been resolved between the
regulatory authorities will be referred to the joint sectoral group
for resolution. In the event that the joint sectoral group is unable
to resolve these divergent views, either Party may bring the matter
to the attention of the Joint Committee.
5. MANAGEMENT MECHANISM
5.1. A joint sectoral group will be established for the purposes of
management of this Sectoral Annex. Its role will be to make
decisions concerning the definition, establishment, and evaluation
of conformity assessment procedures and programmes, the
establishment of the 'two-way` alert programme, the management of
the confidence building period and the definition of a maintenance
programme supporting the continued operation of the MRA. The group
will include representatives of Health Canada and of the European
Community's competent authorities and co-chaired by a member of each
of the two Parties.
6. TRANSITION PERIOD
6.1. Time frame
The confidence building period will commence upon the signing of the
MRA and is expected to be completed within 18 months.
6.2. Confidence building programme
At the beginning of the transitional period, the joint sectoral
group will elaborate a joint confidence building programme (guidance
provided in Attachment III). The implementation of this programme
shall establish each Party's capability to perform conformity
assessments in compliance with the requirements and procedures of
the other Party. The evidence shall provide practical relevance to
the decisions regarding the operational phase.
The confidence building programme should include the following
actions and activities:
(a) the organisation of seminars aiming to inform
regulatory/designating authorities and conformity assessment bodies
on each Party's regulatory system, procedures and requirements;
(b) the conduct of workshops aiming to provide, for
regulatory/designating authorities, a common understanding and
exchange of information regarding requirements and procedures for
the designation and surveillance of conformity assessment bodies
(CABs);
(c) for scientific technical evaluations, an inter-comparison
exercise which would consist of parallel evaluations (double blind
evaluations), made by the conformity assessment body in each
territory, of a manufacturer's technical submission against the
requirements of the intended market for that device, will be
undertaken. Full reports and recommendations shall be exchanged for
comparison. A certificate of compliance can be issued by the body
responsible for the relevant market during this inter-comparison
study. The inter-comparison study should take place on a sampling
basis comprising a sufficient number of cases spread over the range
of different medium to high-risk technologies with the involvement
of each Party's regulatory/designating authorities and CABs.
Additional evidence with respect to the competency of
regulatory/designating authorities and CABs can be requested by
either Party;
(d) for quality systems assessments, an inter-comparison exercise
which would consist of the participation of regulatory/designating
authorities in audits carried out by CABs of the other Party on the
basis of requirements of the other Party. Audit management, methods
and reports will be compared. The inter-comparison study should take
place on a sampling basis comprising a sufficient number of cases
spread over the range of different technologies with the involvement
of each Party's regulatory/designating authorities and CABs.
Additional evidence with respect to the competency of
regulatory/designating authorities or CABs can be requested by
either Party;
(e) the design, development and testing of a two-way alert system
(see guidance in Attachment IV);
(f) the establishment of contact points between
regulatory/designating authorities and CABs of both Parties;
(g) the participation in information exchange meetings with
particular focus on conformity assessment and vigilance, including
participation in staff training sessions. The exchange of staff will
also be encouraged; and
(h) during the confidence building programme, where one Party has
developed sufficient confidence in the evaluation methods and
results of the other, it may at its own discretion, establish the
relevant document of compliance permitting market access for its own
jurisdiction based on the evaluation reports of the other Party
without the full submission.
Participation in activities referenced under (c) and (d) should be
understood as means to provide, on an exemplary basis, supplementary
evidence in relation to the process of designation and surveillance
of CABs.
6.3. Budget
Each of the Parties to the MRA will be responsible for the costs of
its participation in the confidence building activities.
6.4. End of transition period
No later than 18 months after the entry into force of this
Agreement, the joint sectoral group shall proceed to a joint
evaluation of the experience gained. This evaluation will cover the
adequacy of the confidence building programme, the capabilities of
regulatory/designating authorities and the capabilities of the
designated conformity assessment bodies.
Recommendations to list CABs in Attachment II of this Annex shall be
made by participating regulatory/designating authorities, listed in
Attachment I, to the joint sectoral group on the basis of the
results of the confidence building programme. Conformity assessment
bodies that have been accepted by the joint sectoral group will be
listed in Attachment II with an indication of their specific
conformity assessment expertise and the fields of medical device
technologies for which they are recognised. The corresponding
regulatory/designating authority responsible for a CAB will also be
listed in Attachment II. Proposals to limit the recognition of
capabilities of CABs should be based on objective evidence and
documented. The joint sectoral group may recommend that a CAB not be
listed in Attachment II, provided there is documented evidence
demonstrating its lack of capabilities. Excluded CABs may apply for
reconsideration of their status once the necessary corrective
measures have been taken and confirmed.
Where no agreement on any of the above matters has been reached in
the joint sectoral group, the matter will be referred to the Joint
Committee under the Framework Agreement.
The Parties shall enter into the operational phase provided that
there is representation of each Party's CABs in Attachment II.
The Agreement will also be re-examined at the end of the
transitional period to take account of the regulatory evolution of
each Party. Consideration shall be given to a single
submission/evaluationquality systems assessment which simultaneously
satisfies the requirements of each jurisdiction.
7. OPERATIONAL PHASE
7.1. General obligations
The provisions of this section will apply only to conformity
assessment carried out in the Parties' respective territories by
conformity assessment bodies recognised under this Sectoral Annex.
The European Community and Canada agree that, for medical devices
covered by this Annex, each Party will recognise the conclusions of
the conformity assessment carried out by the other Party and the
certificate of compliance granted by the conformity assessment body
of the other Party, without further reassessment.
For evaluation against European requirements, Health Canada or other
conformity assessment bodies designated by Canada shall establish
the conclusions of completed conformity assessment as referred to in
the active implantable medical device and the medical device
Directives, and issue the appropriate certificate of compliance. The
responsible authorities in the European Community will, without any
further reassessment, accept the certification as evidence of
compliance with the premarket requirements of the relevant European
Directives.
For evaluating against Canadian requirements, the European CABs
shall establish the conclusions of the examination and submit to
Health Canada an abbreviated supporting report and certificate of
compliance which includes such conclusions. Based on these
documents, and without any further reassessment, Health Canada will
accept the certification as evidence of compliance with the
premarket requirements of the Canadian medical devices Regulations.
Each Party shall make available to the other Party, upon reasoned
request, any information which has been reviewed as part of the
assessment of a medical device for the purpose of issuing
certificates of compliance.
Each Party reserves the right, at any time, to question information
with respect to the designation process or the performance of
conformity assessments against the requirements of its regulatory
regime. Furthermore, each Party reserves the right to conduct its
own conformity assessments for reasons identified to the other
Party. Justification for such action shall be based on documented
evidence and notification is to be provided in advance to the other
Party. Recourse to this action should be an exception.
7.2. Procedures for designation of CABs
The procedures to be followed by the designating authorities of each
Party in designating CABs shall respect the criteria laid down in
the other Party's regulations or guidelines (non-binding guidance is
provided in Attachment V).
7.3. Information sharing
In accordance with the general provisions of the Annex, the Parties
will exchange all information necessary to determine and maintain
equivalence of conformity assessment procedures. In addition, each
Party shall share with the other Party information generated within
the framework of its regulatory system which is relevant for the
operation of conformity assessment procedures (i.e. guidance
documents, publications of references to standards, forms, documents
relating to the application of legal requirements). Each Party shall
associate regulatory/designating authorities and conformity
assessment bodies of the other Party in activities of exchange of
information and experience.
In special cases, particularly emergency situations, all those
involved in the implementation of this Annex will endeavour to
provide all documentation requested by one of the Parties in an
expeditious manner.
7.4. Two-way alert system
The joint sectoral group will ensure that an efficient and effective
'two-way` alert system is in place at all times. Elements of such a
system are described in Attachment IV.
Each Party shall notify the other Party of any confirmed problem
reports, corrective actions, or recalls related to products that it
has evaluated under the terms of this Agreement. Each Party will
respond to special requests for information on particular devices
and will ensure that its designated authorities and conformity
assessment bodies make available relevant information on these
devices, as requested.
It shall be the responsibility of the regulatory authorities covered
by this Annex to ensure that any suspension or cancellation (total
or partial) of a certificate of compliance is communicated to each
other with the appropriate degree of urgency.
7.5. Fees
The regime of registration or conformity assessment fees is
determined by the location of the manufacturer. The cost recovery
programmes and the fees pertaining to the issuance of a certificate
of compliance in each jurisdiction will remain the responsibility of
that jurisdiction. Conformity assessment fees will not be charged by
one Party to manufacturers located on the territory of the other
Party, where the conformity assessment was conducted by a conformity
assessment body located in the other Party's territory.
7.6. Monitoring of the Agreement
The continuous monitoring of the equivalency of designation
processes and conformity assessments for each Party's requirements
that have been determined to be equivalent at the conclusion of the
confidence building programme, and any subsequent decisions
concerning that equivalence, must be made according to mutually
developed and managed equivalence maintenance and implementation
activities. This will be managed by the joint sectoral group.
The Parties will undertake to hold regular consultations, within the
joint sectoral group set up under this Annex to ensure the continued
relevancy and accuracy of this Annex. The regulatory/designating
authorities and conformity assessment bodies will organise meetings
to discuss specific questions and issues.
Conformity assessment bodies and regulatory/designating authorities
must continue participation in maintenance activities, as
established by the joint sectoral group, within the framework of
this Annex in order to maintain their status under this Annex as
indicated in Attachment II.
Parties may request the addition of regulatory/designating
authorities or conformity assessment bodies to Attachment II. The
procedure for the acceptance of new regulatory/designating
authorities will be as described in the confidence building
programme. Conformity assessment bodies will be added to Attachment
II upon recommendation from a regulatory/designating authority and
joint decision by the joint sectoral group.
7.7. Contact points
Contact points are identified in order to permit regulatory
authorities and manufacturers to inform the regulatory authorities
of the other Party with the appropriate speed in case of quality
defects, recalls, and adverse incidents, which could necessitate
additional controls or, suspension of the distribution of the
product or, suspension or cancellation of a certificate of
compliance.
For the purpose of this Agreement, the contact points will be:
>START OF GRAPHIC>
for Canada:. , and
for the European Community (the 15 Member States and the
Commission).
>END OF GRAPHIC>
8. ATTACHMENTS
Attachments I and II constitute integral parts of this Annex.
Attachments III, IV and V are general guidelines.
Attachment I
Regulatory/designating authorities eligible to participate in this
Agreement
>TABLE POSITION>
Attachment II
>TABLE POSITION>
Attachment III
Phases and elements of a confidence building programme
A. REVIEW AND EVALUATION OF ELEMENTS OF CONFORMITY ASSESSMENT
(EXCHANGE OF DOCUMENTATION)
1. Legislative and regulatory requirements and scope
- empowering legislation and regulations including authority to
enforce laws and regulations, powers given to evaluators and
auditors, authority to remove violative products from the market,
etc.,
- suitable controls on conflict of interest.
2. Regulatory directives and policies
- procedures for determining competency of evaluators/auditors,
- enforcement policies/guidelines/procedures,
- codes of conduct/ethics,
- training/certification policies/guidelines,
- alert/crisis management policies/procedures/guidelines,
- organisational structure, including roles, responsibilities and
reporting relationships.
3. Quality audit management, methodology and practices
- scope/details of operating standards, etc.,
- auditor qualifications, numbers, training, quality assurance,
contracting, etc.
4. Scientific technical evaluation methodology and practices
- scope/details of operating standards, etc.,
- evaluator qualifications, numbers, training, quality assurance,
contracting, etc.
5. Evaluation and auditing reports
- scope and format of reports,
- content requirements,
- storage, retrieval and access to reports,
- scope and format of abbreviated reports, conclusions of conformity
assessment and certificates.
6. Auditing and evaluation procedures
- audit and evaluation strategy (type, scope, scheduling, focus,
notification, risk),
- pre-audit or evaluation preparation/requirements,
- methodology (access to and review of firm's files and databases,
collection of evidence, data review, sample collection, interviews),
- post audit and evaluation activities (procedures for report
issuance, follow-up, decision making),
- collection/storage of and access to data.
7. Auditing and evaluation performance standards
- frequency/number, quality and timeliness of reports,
norms/frequency/procedures for re-audit or re-evaluation and
corrective action.
8. Enforcement powers and procedures
- provision of written notices of violations to firms,
- non-compliance management procedures/mechanisms (recall,
suspension, quarantine of products, certificate revocation, seizure,
prosecution),
- appeal mechanisms,
- other measures to promote voluntary compliance by firm.
9. Alert and crisis systems
- alert mechanisms,
- crisis management mechanisms,
- alert performance standards (appropriationess and timeliness of
alert).
10. Analytical capability
- access to laboratories with capacity to handle necessary analysis,
- standard operating procedures for analytical support,
- processes for validation of analytical methods.
11. Surveillance programme/measures (used by manufacturers and by
regulatory authorities)
- sampling and audit procedures,
- recall monitoring (including effectiveness controls and
verification of procedures),
- consumer complaint systems/procedures,
- adverse incident reporting systems/procedures.
12. Quality management systems
- quality management/assurance systems/procedures to ensure the
on-going suitability and effectiveness of policies, procedures,
guidelines and systems used to achieve the objectives of the
conformity assessment programme, including establishment of
standards and annual audit and review.
B. INTER-COMPARISON EXERCISE
- audit of systems and procedures,
- conduct of parallel evaluations (double blind),
- criteria for clinical trial data,
- exchange/evaluation of reports,
- monitoring of alert systems including handling of recalls,
- joint audits of manufacturers to determine equivalency of audit
methods,
- exchange of evaluators/auditors or organisation of joint workshops
(optional).
C. DECISION MAKING ON THE SUCCESS OF THE INTER-COMPARISON STUDY
- evaluation of results,
- action to take, development of options and solutions to address
issues,
- determination of competent conformity assessment bodies that meet
evaluation criteria,
- establishment of the conditions and mechanisms for on-going
maintenance of the MRA (develop quality management system, audit
mechanism and a consultation/on-going dialogue process).
Attachment IV
Components of a 'two-way` alert programme
1. Documentation
- definition of a crisis/emergency and under what circumstances an
alert is required,
- standard operating procedures (SOPs),
- mechanism of health hazards evaluation and classification,
- language of communication and transmission of information.
2. Crisis management system
- crisis analysis and communication mechanisms,
- access to manufacturer's submissions, adverse incident reports and
conformity assessment body reports,
- establishment of contact points,
- reporting mechanisms.
4. Quality assurance system
- vigilance programme,
- surveillance/monitoring of implementation of corrective action.
Attachment V
Guidelines: procedures for the designation and monitoring of
conformity assessment bodies
A. GENERAL REQUIREMENTS AND CONDITIONS
1. Designating authorities shall only designate legally identifiable
entities as conformity assessment bodies.
2. Designating authorities shall only designate conformity
assessment bodies able to demonstrate that they understand, have
experience relevant to, and are competent to apply the conformity
assessment requirements and procedures of the legislative,
regulatory and administrative provisions of the other Party for
which they are designated.
3. Demonstration of technical capabilities shall be based on:
- technological knowledge of the relevant products, processes or
services,
- understanding of the technical standards and the general risk
protection requirements for which designation is sought,
- the experience relevant to the applicable legislative, regulatory
and administrative provisions,
- the physical capability to perform the relevant conformity
assessment activity,
- an adequate management of the conformity assessment activities
concerned, and
- any other circumstance necessary to give assurance that the
conformity assessment activity will be adequately performed on a
continuous basis.
4. The technical capability criteria shall be based on
internationally accepted documents supplemented by specific
interpretative documents developed as appropriate from time to time.
5. The Parties shall encourage harmonisation of designation and
conformity assessment procedures through cooperation between
designating authorities and conformity assessment bodies by means of
coordination meetings, participation in mutual recognition
arrangements, and working group meetings. Where accreditation bodies
participate in the designation process they should be encouraged to
participate in mutual recognition arrangements.
B. SYSTEM TO DETERMINE CONFORMITY ASSESSMENT BODIES' CAPABILITIES
6. The designating authorities may apply the following processes to
determine the technical capabilities of conformity assessment
bodies. If necessary, a Party will indicate to the designating
authority the possible ways to demonstrate capabilities.
(a) Accreditation
Accreditation shall constitute a presumption of technical capability
in relation to the requirements of the other Party when:
(i) the accreditation process is conducted in conformance with the
relevant international documentation (EN 45000 series or ISO/IEC
guides); and either,
(ii) the accreditation body participates in mutual recognition
arrangements where it is subject to peer evaluation, which involves
evaluation by individuals with recognised expertise in the field of
the work being evaluated of the capabilities of accreditation bodies
and conformity assessment bodies accredited by them, or
(iii) the accreditation body, operating under the authority of a
designating authority, takes part, in accordance with procedures to
be agreed, in comparison programmes and exchanges of technical
experience in order to ensure the continued confidence in the
technical competence of the accreditation bodies and conformity
assessment bodies. Such programmes may include joint assessments,
special cooperation programmes or peer evaluation.
When a conformity assessment body is only accredited to evaluate a
product, process or service for compliance with particular technical
specifications, designation shall be limited to those technical
specifications.
When a conformity assessment body seeks designation to evaluate a
particular product, process or service for compliance with essential
requirements, the accreditation process shall incorporate elements
which will permit assessment of the capability (technological
knowledge and understanding of the generally stated risk protection
requirements of the product, process or service or their use) of the
conformity assessment body to evaluate compliance with those
essential requirements.
(b) Other means
When appropriate accreditation is not available or when special
circumstances apply, the designating authorities shall require the
conformity assessment bodies to demonstrate their capabilities
through other means such as:
- participation in regional/international mutual recognition
arrangements or certification systems,
- regular peer evaluations,
- proficiency testing, and
- comparisons between conformity assessment bodies.
C. EVALUATION OF THE DESIGNATION SYSTEM
7. Once the designation systems to evaluate the capabilities of
conformity assessment bodies have been defined by each Party, the
other Party may, in consultation with the designating authorities,
check that the systems give sufficient assurance that the
designation of the conformity assessment bodies satisfies its
requirements.
D. FORMAL DESIGNATION
8. Designating authorities shall consult the conformity assessment
bodies within their jurisdiction in order to determine their
willingness to be designated under the terms of this Agreement. Such
consultation should include those conformity assessment bodies who
do not operate under the respective legislative, regulatory, and
administrative requirements of their own Party, but which may,
nevertheless, be interested and capable of working to the
legislative, regulatory, and administrative requirements of the
other Party.
9. Designating authorities shall inform their Party's
representatives on the joint sectoral group, established under this
Agreement, of the conformity assessment bodies to be included in or
withdrawn from Section XX of the Sectoral Annexes. Designation,
suspension or withdrawal of designation of conformity assessment
bodies shall take place in accordance with the provisions of this
Agreement and the rules of procedure of the joint sectoral group.
10. When advising their Party's representative on the joint sectoral
group established under this Agreement, of the conformity assessment
bodies to be included in the Sectoral Annexes, the designating
authority shall provide the following details in respect of each
conformity assessment body:
(a) the name;
(b) the postal address;
(c) the fax number;
(d) the range of products, processes, standards or services it is
authorised to assess;
(e) the conformity assessment procedures it is authorised to carry
out; and
(f) the designation procedure used to determine capabilities.
E. MONITORING
11. Designating authorities shall maintain, or cause to maintain,
on-going surveillance over designated conformity assessment bodies
by means of regular audit or assessment. The frequency and nature of
such activities shall be consistent with international best
practices or as agreed by the joint sectoral group.
12. Designating authorities shall require designated conformity
assessment bodies to participate in proficiency testing or other
appropriate comparison exercises where such exercises are
technically possible within reasonable cost.
13. Designating authorities shall consult as necessary with their
counterparts, to ensure the maintenance of confidence in conformity
assessment processes and procedures. This consultation may include
joint participation in audits related to conformity assessment
activities or other assessments of designated conformity assessment
bodies, where such participation is appropriate and technically
possible within reasonable cost.