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<4, J« COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 06.05.1998 
COM( 1998) 271 final 
98/0167 (ACC) 
•."to Proposal for a Council Decision 
on the conclusion of an Agreement between the European Community and Canada 
on Mutual Recognition in relation to Conformity Assessment 
(presented by the Commission) 

i-6 
EXPLANATORY MEMORANDUM 
I. The Agreement 
On the basis of the negotiating directives issued by the Council on 21.9.92. the European 
Commission has negotiated and initialled an agreement on the mutual recognition of 
conformity assessment (Mutual Recognition Agreement, or MRA) with Canada. A Text 
of the Agreement initialled in June 1997 is annexed. 
This memorandum provides an assessment of the Agreement in the light of the 
negotiating directives approved by the Council, and recommends that the Council decide 
to approve the Agreement by means of a Council decision to that effect. 
LI Assessment of the Agreement 
The Commission considers that the initialled Agreement is in conformity with the 
Council's negotiating directives, takes account of the views expressed by the 113 MRA 
Committee, which gave detailed advice to the Commission during the negotiations, and 
provides benefits to the European Community. The Agreement does not contain a rule of 
origin. As for the United States this proved to be non-negotiable with Canada. 
Member States are in the process of designating a considerable number of conformity 
assessment bodies (CABs). Once these bodies have been provisionally accepted by 
Canada subject to formal acceptance by decision of the Joint Committee, the Secretariat 
of the Council will receive this list of CABs by way of a Commission Staff paper. 
Sufficient confidence exists between the Parties to the Agreement to allow them to 
proceed. 
Ll.l Framework Agreement 
The Agreement consists of a framework agreement and a series of sectoral annexes. An 
article-by-article assessment of the framework follows: 
Pre-amble : this sets out the basic objectives of the mutual recognition agreement in 
terms of trade facilitation 
Article I: Definitions: these are self-explanatory. 
Article H: General Obligations: this sets out the obligation of each Party to accept the 
conformity assessment results carried out to its requirements by the other Party, 
according to the terms of the sectoral annexes. Notably, the provision establishes 
acceptance of product certifications and authorisations of each Party. This Article also 
establishes the link between the basic obligations of the Agreement and its sectoral 
annexes. 
Article HI: Sectoral Coverage: this Article provides that the conformity assessment 
procedures to which the Agreement applies are specified in the individual sectoral 
annexes, and describes the content of the annexes. 
Article IV: Transitional Arrangements: this Article refers to the transitional 
arrangements set out in the annex, to the necessity of a time period for completion and 
the possibility of amending it, and the need to move to full implementation by the end of 
the period unless there is documentary evidence of a failure of competence. 
Article V: Civil Liability: this Article confirms the existing civil liability laws and 
responsibilities in the territories of the parties and provides for adequate arrangements to 
be made for such liabilities. It also provides for notification and mutual assistance in the 
event of a suit. 
Article VI: Conformity Assessment Bodies (CABs): this Article recognises that CABs 
operate to the requirements of the importing Party and that a designation constitutes a 
formal recognition by the designating Party that a CAB has the technical competence and 
has undertaken to comply with the importing Party's requirements. 
Article VII: Designating Authorities: this is a key provision requiring designating 
authorities to have the necessary formal powers over the bodies they designate. This 
article thus provides a treaty guarantee that Canada has the necessary authority to 
designate, suspend or withdraw bodies. 
Article VIII: Verification of Compliance By Conformity Assessment Bodies: this 
Article establishes the right for one Party to challenge the compliance of bodies in the 
other Party. Verification will be carried out by the Party in whose territory the CAB is 
located. The CAB will be suspended where disagreement over its status has been 
confirmed by the Joint Committee, unless otherwise decided by that Committee. As 
advised by Member States in the 113 Committee MRA Group, the right of verification 
has been closely circumscribed to prevent it from being carried out routinely or 
unilaterally. 
Article IX: Exchange of Information: a basic transparency provision. 
Article X: Monitoring of the Agreement: this Article ensures that bodies of each Party 
remain coordinated so as to be able, continuously, to correctly interpret the regulatory 
requirements of the other Party. 
Article XI: Joint Committee: this Article requires the establishment of a Joint 
Committee to administer the Agreement on behalf of the Parties. Duties of the Joint 
Committee include formally adopting changes to the Sectoral annexes to add or remove 
conformity assessment bodies, and discussing divergence of view. 
Article XI.4 sets out detailed procedures for designation of bodies and the right of the 
other Party to contest such designations according to certain rules. The Article does not 
give the Joint Committee the right to extend the scope and coverage of the agreement to 
include new sectors. This has to be mandated by the Parties. 
Article XII: Joint Sectoral Groups: this Article provides for the establishment of joint 
sectoral groups for individual sectoral annexes comprising the appropriate authorities and 
experts to assist the Joint Committee. 
Article XIII: Sectoral Contact Point, Management of Information, Assistance and 
Emergency Action: this provides for contact points to handle exchange of information, 
management of the agreement and emergency action. 
Article XIV: Safeguards: this Article provides that an importing Party retains all powers 
under its domestic law, and within its territory, to take measures against products 
certified by another Party. These powers must be exercised in accordance with the 
principle of non-discrimination. 
Article XV: Market Access: this Article provides that recognition by one Party is 
dependent on continued access being granted by the other Party for duly certified 
products, and on the continued existence of authorities capable of implementing the 
Agreement by that other. New conformity assessment procedures applying to covered 
products will be brought within the scope of the Agreement, unless jointly decided 
otherwise, so as to preserve negotiated market access benefits. 
Article XVI: Fees: this provides that a Party shall not charge fees for conformity 
assessments carried out by other Parties in accordance with the Agreement. 
Article XVII: Agreements with other countries: this Article provides that Mutual 
Recognition Agreements between Parties to this Agreement and other countries shall 
have no force in regard to the other Party to this Agreement. 
Articles XVIII, XIX, XX: these are standard institutional and legal provisions. It should 
be noted that the Agreement is of unlimited duration, and that there is no scope for a 
Party unilaterally to terminate an individual sectoral annex. 
1.1.2 The Sectoral Annexes 
There follows an assessment of the content of each sectoral annex in terms of its 
coverage, the type of mutual recognition arrangements envisaged for the sector, and the 
trade and other implications. In making this assessment, the Commission has kept in 
mind the following elements: 
a) whether the sectoral annex provides for genuine mutual recognition, i.e. whether all 
relevant conformity assessment procedures for a particular sector have been 
captured; 
b) whether the sectoral arrangements include evaluation of conformity not only to 
Federal law in Canada, but also to sub-Federal regulations where they exist; 
c) the level of trade between the Community and Canada for the sectors and products 
covered; 
d) the views expressed by Member States and European industry groups on the 
benefits of mutual recognition; 
e) the precedential nature (if any) of arriving at a mutual recognition agreement with 
Canada in the sectors covered; 
f) overall consistency with Community policy objectives in the field of 
standardisation, certification, designation of conformity assessment bodies and the 
removal of technical barriers to trade. 
The sectoral assessment is followed by an overall appreciation of the benefits of the 
Agreement. 
The Commission draws Member States' attention to the trade figures for each covered 
sector in the Annex to this note. These figures show that for every sector concerned, the 
Community has a rough trade balance with Canada. Third party certification (the subject 
of the MRA) applies most commonly to industrial products at the higher end of 
technology, in respect of which both the Community and Canada are major exporters. 
A priori, this may indicate that the trade facilitation benefits of the Mutual Recognition 
should accrue to both the Community and Canada. We note however, that trade flows 
only give a partial picture of the likely benefits. The balance of benefits depends on 
additional factors, in particular the following: 
a) the range of products within a sector subject to third party certification. Obviously, 
if in a given sector one Party has more comprehensive certification requirements, 
the trade facilitation benefits to the other i.e. exporting Party may be 
proportionately greater, 
b) the complexity and accessibility of the conformity assessment requirements of each 
Party, including the extent to which each Party applies internationally recognised 
standards or technical requirements for the sector in question. Generally, this is not 
a major issue in the case of Canada which has adopted international standards, 
regulations and conformity systems fairly systematically. 
The Commission notes that industrial groups consulted throughout the negotiations, such 
as Eurobit and Orgalime, while supporting the agreement, have not always been able to 
quantify the costs or time taken to obtain conformity assessment of their products in third 
countries, including Canada. It is therefore not feasible in every case to determine the 
extent of savings in time, cost or market opportunity of the arrangements set out in this 
agreement. This may only be possible once the agreement has been in operation for some 
time. What can be ascertained however is whether we have addressed industry's concern 
that any agreement provide reciprocal levels of market access, in terms of conformity 
assessment procedures. 
The Agreement also presents important advantages from the point of transparency, 
market access, avoidance of duplication especially of cost, and general facilitation of 
trade. This is of particular importance for small and medium sized companies. 
I 
10 
On the basis of a rough calculation it is estimated that this Agreement will create cost 
savings for the exporting industry of at least 20 MECU and an equivalent amount in 
terms of cost savings to exporters to the EU, some part of which will be passed on to 
European importers or consumers. 
Where relevant, the above factors are taken into account in the assessment of each 
sectoral annex. 
Pharmaceuticals Good Manufacturing Practice (GMP) 
This annex establishes mutual recognition of each Party's inspections of pharmaceutical 
sites according to the GMP standards of each, which are effectively equivalent. 
Recognition of inspection results and the ensuing certificate of GMP compliance removes 
the need for companies in each Party to be inspected by the authorities of the other Party. 
Each party accepts the GMP certificate issued by the exporting Party's authority and the 
products traded do not need further batch testing and control upon import. 
European industry and Member States' inspection authorities (Working Group on 
Inspection and control of medicinal products and the Pharmaceutical Committee) have 
been consulted at every step of the negotiation and support the arrangements negotiated. 
The Community is an important exporter to Canada, (see Annex). 
The scope of the Agreement is as broad as possible and covers all medicinal products, 
which have undergone one or a series of manufacturing processes, e.g. fabrication, 
repackaging, labelling, testing, wholesaling to which GMP applies. An indicative list of 
such products is also included (appendix 1 of sectoral annex). Veterinary immunologicals 
are not covered. 
The sectoral annex applies to all pharmaceutical products subject to GMP in either Party. 
This permits inspections to be carried out against each Party's domestic GMP 
requirements in most cases. In (marginal) cases where a product is classed as a 
pharmaceutical in one Party but not the other, the agreement enables the exporting party's 
inspection authority to certify GMP to the importing Party's requirements on a voluntary 
basis. 
The Agreement also lists the applicable legislation and relevant certifying authorities. It 
also sets out in a series of appendices (3 to 6) to the sectoral annex, guidelines for the 
setting up and functioning of a Joint Sectoral Group which will play an important role in 
the management of the Agreement, components of a GMP compliance programme, 
components of a two-way alert programme and the phases of a confidence-building 
period. 
The MR A on medicinal products / Drug GMP is built on three pillars: 
1) a GMP Compliance Program. Only certification by authorities with GMP Compliance 
Programs (including the supporting infrastructure of regulatory requirements, 
standards, processes, and quality systems, etc.) mutually recognised as equivalent will 
be accepted. 
11 
The elements of such a system are described in Appendix 4 of the sectoral annex to 
the Agreement. The European Community and Canada both operate such systems at 
present; 
2) a two-way alert system. The Joint Sectoral Group to be set up to manage this sector 
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 of the sectoral annex; 
3) a transition period of 18 months including a confidence building exercise. At the 
beginning of the transition period, the Joint Sectoral Group will elaborate a Joint 
Confidence Building Program. The implementation of this program will permit the 
determination of the capacity of each Party's authority to perform GMP compliance 
certification (guidance provided in Appendix 6 of the sectoral annex). This will 
comprise three phases, review and evaluation of laws and other documentation, 
evaluation of processes and procedures, and decision making on the success of the 
exercise and conclusions. 
While providing mutual benefits to pharmaceutical companies, and some savings to 
inspection authorities, we consider that the MRA in this sector establishes a good 
precedent for other negotiations. The present agreement also establishes mechanisms for 
longer-term cooperation between respective inspection authorities which will not only 
ensure the agreement continues to be properly applied, but will stimulate further 
harmonisation initiatives in other fields of medicines controls, such as Good Clinical and 
Laboratory Practices. The systems in place are largely similar and with equivalent 
coverage, and the Agreement is a very balanced one for these reasons. 
Medical Devices 
The sectoral annex provides for mutual recognition of certificates for medical devices 
subject to third party certification procedures in either Party, with a few specific 
exceptions. Coverage is therefore determined according to the two existing Community 
Directives for medical devices, and for Canada their domestic legislation in this field. 
The annex thus covers all conformity assessment procedures in the Parties, including 
final certification and approval. 
The Agreement provides for the full recognition of certificates issued by either side (with 
an additional brief supporting report to be issued with European certificates). 
Attachments I and II contain lists of designation authorities and Conformity Assessment 
Bodies (to be filled out after the confidence building exercise). 
The Agreement also provides that each Party shall respect the criteria laid down in the 
other Party's regulations or guidelines in designation of CABs (non-binding guidance is 
provided in Attachment V of the sectoral annex). 
The Parties will also ensure that a two-way alert system is in place at all times. 
The Agreement also provides for a transition period (18 months) which will evaluate the 
capabilities of the Regulatory / Designating Authorities, the designated Conformity 
Assessment Bodies and the functioning of a two-way alert system in accordance with a 
set of steps and criteria set out in Attachments III to IV of the sectoral annex. 
12 
The system to determine Conformity Assessment bodies capabilities will include both 
accreditation and other means. The Parties will also, during the transition, work to 
harmonise their assessment dossier. 
The requirements of third party premarket assessment are extensive on both sides and 
cover up to 90% of the field. In this respect therefore we consider that the agreement 
presents a balance of advantages to both parties. 
In the light of the above, we believe European industry is content with the proposed 
MRA in this sector. 
The Commission considers that the MRA in this sector sets the right precedents in terms 
of our long term objectives. All certification procedures are covered and a link between 
mutual recognition and harmonised procedures has been made. The prospect of an MRA 
with the Community was a major factor in Canada's recent overhauling of its legislation, 
which now closely resembles the EC system. 
Electrical Safety 
This Annex covers the testing and certification requirements set out in the EC's Low 
Voltage Directive and corresponding Canadian legislation and regulations at provincial 
level, including medical devices which are not covered by the EC Low Voltage Directive. 
European industry groups have been consulted on the proposed MRA and have expressed 
support provided that we ensure that any agreement provide for reciprocity of market 
access and not lead to the introduction of new and more onerous requirements. Given the 
existing openness of the EC regime, and the fact that the necessary Canadian legislation 
is covered under the sectoral annex, these requirements have clearly been met. While 
manufacturers self certification exists* in the EC third party certification is required for 
certain categories of products in Canada. It is also the case that in the past certification 
was required under each Provincial regulation. This is no longer the case as a result of the 
Agreement and one certificate issued by a designated European CAB will now suffice. 
There are therefore clear advantages in the Agreement from an EC perspective. 
The Agreement provides for a transitional arrangement of 18 months 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. During the transition period EC and Canadian CABs 
shall accept test reports issued by designated CABs in each others' territory provided they 
fulfil certain conditions. 
Electromagnetic Compatibility (EMC) 
In view of the "horizontal" application of EMC requirements to a wide range of electrical, 
machinery and telecommunications products, coverage of the EMC phenomenon in the 
MRA is necessary to achieve the objective of covering all relevant conformity assessment 
procedures. 
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. Both Parties also agree to recognise each 'other's suppliers 
declaration of compliance as required under their respective legislation. 
13 
The Agreement also provides for a transitional arrangement of 18 months. During this 
period the Parties will work together to ensure familiarity with each other's regulatory 
requirements, exchange information and review the work carried out by designated 
Conformity Assessment Bodies and demonstrate to each other's satisfaction their 
capability to carry out conformity assessment to the requirements of the other Party. 
Telecommunications Terminal Equipment 
There is a special annex oil Telecommunications equipment but both sectoral annexes on 
electrical safety and electromagnetic compatibility also apply. These annexes apply to all 
telecommunications terminal equipment (TTE) regulated under the relevant Community 
Directives, non-harmonised national legislation for analogue, and radio transmitters, and 
the corresponding Canadian legislation. 
The Agreement provides for recognition of the conformity assessment certificates (set out 
in detail in Art. 4 of the sectoral annex) of Conformity Assessment Bodies designated by 
the Parties. The Conformity Assessment Bodies will be required to comply with the 
criteria and standards set out in the regulatory requirements of the other Party (a list of 
Designating and Approval Bodies and Designated Bodies with an indication of the 
products and procedures for which the latter have been designated, have or will be set out 
in Attachments 3, 4 and 5 of the sectoral annex). The Agreement also lists the relevant 
Canadian standards (appendix 1). 
The Agreement provides for a transitional period of 18 months, during which time the 
Parties will recognise test reports issued by designated CABs, Also during this period the 
Parties will exchange information and develop a better understanding of the Parties' 
respective regulatory requirements, to develop mechanisms for exchanging information 
on changes to technical requirements to maintain and evaluate the work carried out by the 
designated Conformity Assessment Bodies during the transitional period. At the end of 
the transitional period the Parties will grant full mutual recognition of certificates of 
compliance. 
European industry' organisations have been consulted extensively on the MRA 
negotiations and have supported the objectives provided that access by means of 
recognition to all Canadian conformity assessment systems, including product approvals, 
is achieved. In this connection, the agreement provides for reciprocal recognition of all 
conformity assessment procedures including final certification without further product 
assessment by the importing party. 
Recreational Craft 
The sectoral annex for recreational craft applies to all recreational craft, including 
personal watercraft, which are subject to third party certification in the European 
Community or Canada. The Agreement covers all relevant legislation (Directive 94/25) 
and the Federal regulations in Canada (none exist at the Provincial level). While the 
Canadian system is largely based on manufacturer's self declaration, a limited third party 
intervention is still required and there is therefore a mutual advantage in concluding an 
agreement. 
The Parties will recognise certificates issues by each other's designated Conformity 
Assessment Bodies without any further assessment of the products to which they relate. 
14 
The Agreement provides for a transitional arrangement of 18 months in which the Parties 
will exchange information on and develop greater familiarity with their respective 
regulatory requirements, and carry out the policy legislative and regulatory changes 
necessary for the provisions of their annex. 
LI.3 Relations with EFT A States, members of the European Economic Area 
In accordance with the general information and consultation procedures set out in the 
EEA Agreement and Protocol 12 of the said Agreement, the Commission has kept EFTA 
/ EEA States regularly informed about developments in the negotiations and has informed 
them on the final result of the negotiations. 
The EFTA / EEA States have had preliminary talks with Canada for negotiating a mutual 
recognition agreement equivalent to the one to be concluded between the Community and 
Canada. 
LI.4 Overall Appreciation 
The Commission considers that the proposed MRAs create an acceptable balance of 
benefits for all parties overall, when all sectors are taken together. The overall trade 
balance with Canada would also suggest that the Agreement will work in favour of EC 
exporters. In all sectors the Community has secured effective market access - in terms of 
access to all mandatory procedures of the other party. Canada has accepted the 
Community's approach of reciprocally recognising not only testing, but also certificates 
and approvals of conformity to the other's requirements, including where applied through 
sub-Federal legislation. This is a significant development, and establishes a good 
precedent for other MRA negotiations. The agreement will allow Community exporters, 
if they so choose, to test and certify their products to Canadian requirements prior to 
export, and then access those markets without any further conformity assessment 
requirements. This will facilitate Community exports. European industry federations have 
been consulted on the agreement and have supported them. 
Since Canada generally bases its product standards and regulations, and criteria for 
accepting Community bodies on established international or European norms, this will 
enable European conformity assessment bodies to participate in the agreement and offer 
their services to European exporters. The Commission has received indications that a 
large number of EC conformity assessment bodies would be interested to work in the 
framework of this Agreement, and this indicates both their technical capacity and 
economic interest in the Agreement. *•©* 
In several sectors the agreement caters for the further development of the parties' 
regulatory regimes, with the aim of ensuring that future rules do not undermine the 
benefits of the agreement And in several sectors, the agreement will help to promote 
wider acceptance of the Community's regulatory approach and technical requirements. 
EL The Draft Council Decision 
A proposal for a Council decision on the conclusion of the Agreement is attached. The 
decision has two objectives: 
15 
a) to approve, on the basis of Articles 113 and 228 of the Treaty, the draft Agreement; 
and 
b) to establish the appropriate Community procedure to enable the Commission, assisted 
by the 113 Committee (Mutual Recognition), to represent the Community in the Joint 
Committee and in the Joint Sectoral Groups established by the Sectoral Annexes, and that 
the Community position in that Joint Committee and in the Joint Sectoral Groups in case 
of changes to the annexes and other sectoral questions be determined, in conformity with 
Article 228, paragraph 4 of the Treaty, by the Commission in consultation with the 113 
Committee. 
On this second aspect, it is noted that in Article XI of the Agreement, a Joint Committee 
of the Parties operates. This Joint Committee is responsible for the management of the 
Agreement and has the delegated power to amend existing sectoral annexes. Such right of 
amendment is restricted only to procedural issues concerned with implementation, 
essentially: amending the references to the regulations applicable to covered sectors; 
amending the annexes further to decisions to recognise, suspend, remove, or alter the 
scope of activity of conformity assessment bodies or designating authorities in the 
Agreement. The power to amend the framework agreement, to delete sectoral annexes or 
to add new sectoral annexes rests with the Parties. 
It is accordingly proposed that: 
a) the Commission, assisted by the 113 Committee (Mutual Recognition) should 
represent the Community in the Joint Committee and in the Joint Sectoral Groups 
established by the Sectoral Annexes, and that the Community position in that Joint 
Committee and in the Joint Sectoral Groups in case of changes to the annexes and other 
sectoral questions be determined, in conformity with Article 228, paragraph 4 of the 
Treaty, by the Commission following consultation of the above mentioned Committee. 
b) for all other issues, the Community position shall be determined by the Council, acting 
by qualified majority on a proposal from the Commission. 
The Commission therefore proposes that the Council adopts the appended decisions, and 
indicates the person who, on behalf of the Community, signs the Agreement. 
Proposal for a Council Decision 
on the conclusion of an Agreement 
between the European Community and Canada 
on Mutual Recognition in relation to Conformity Assessment 
(.../.../EC) 
The Council of the European Union, 
Having regard to the Treaty establishing the European Community, and in particular 
Article 113 in conjunction with Article 228, paragraph (2), (3), first subparagraph, and 
(4) thereof, 
Having regard to the proposal of the Commission, 
Whereas the Agreement on Mutual Recognition in relation to Conformity Assessment 
between the European Community and Canada, initialled on 30 May / 10 June 1997, has 
been negotiated and should be approved, 
Whereas certain tasks for implementation have been attributed to the Joint Committee 
established by the Agreement, and in particular the power to amend the Sectoral Annexes 
thereto; 
Whereas the appropriate internal procedures should be established to ensure the good 
functioning of the Agreement, and whereas it is therefore necessary to delegate to the 
Commission the power to proceed to certain technical amendments of the Agreement and 
to take certain decisions for its implementation. 
Decides: 
Article 1 
The Agreement on Mutual Recognition in relation to Conformity Assessment between 
the European Community and Canada, including its Annexes are hereby approved on 
behalf of the European Community. 
The text of the Agreement and the Annexes are attached to this Decision. 
Article 2 
The President of the Council shall, on behalf of the Community, transmit the note 
provided for in Article XIX of the Agreement1. 
1 The date of entry into force of the Agreement will be published in the Official Journal of the European 
Communities. 
17 
Article 3 
1. The Commission shall represent the Community in the Joint Committee and in the Joint 
Sectoral Groups established by the Sectoral Annexes, provided for in Articles XI and XII 
of the Agreement, assisted by the special committee established under Article 113 of the 
EC Treaty (Mutual Recognition). The Commission shall proceed, after consultation with 
this committee, to the appointments, exchange of information and requests for 
verifications referred to in Articles DC, X, XI, paragraph 3, letters (c) and (e), XII (b) and 
XHI of the Agreement and the equivalent provisions of its Sectoral Annexes. 
2. The position to be taken by the Community in the Joint Committee or if appropriate by the 
Joint Sectoral Groups shall be determined, with regard to amendments of the Sectoral 
Annexes (Article XI, paragraph 3, letter (a) and paragraph 4 of the Agreement) and 
verification of compliance in accordance with Articles VIII and XI para 4 letter (c) of the 
Agreement by the Commission following consultation of the above mentioned special 
committee. 
In all other cases the position of the Community for a decision in the Joint Committee or 
Joint Sectoral Groups shall be determined by the Council, acting by qualified majority on 
a proposal from the Commission. The same procedure shall apply to decisions taken by 
the EC in the framework of Articles XV.3 and XIX.4. 
Done at Brussels, For the Council 
The President 
EU TRADE WITH CANADA 1995 (MECU) 
IMPORT EXPORT 
J22SMctl 
Pharmaceuticals 95 0.8 
Medical Devices 79 0.7 
Telephonic & Telegraphic 266 2.3 
Equipment 
Electrical Equipment 834 7.1 
Recreational Craft 27 0.2 
Total 1300 11.1 
TOTAL 11707 100.0 *MMJ^ÙÎt^^i,-
Pharmaceuticals 
Medical Devices 
Telephonic & 
Telegraphic Equipment 
Electrical Equipment 
Recreational Craft 
Total 
TOTAL 351 
97 
38 
838 
18 
1342 
10 337 3.4 
0.9 
0.4 
8.1 
0.2 
13.0 
100.0 
EU TRADE WITH CANADA 1996 (MECU) 
Products IMPORT 
Canada EXPORT 
Pharmaceuticals 88 0.8 
Medical Device 104 0.9 
Telephonic & Telegraphic 213 1.9 
Equipment 
Electrical Equipment 988 8.6 
Recreational Craft 24 0.2 
Total 1416 12.3 
TOTAL 11478 100.0 Pharmaceuticals 411 3.8 
Medical Devices 116 1.1 
Telephonic & 53 0.5 
Telegraphic Equipment 
Electrical Equipment 881 8.2 
Recreational Craft 4 0.3 
Total 1465 13.9 
TOTAL 10 689 100.0 
SOURCE: 
Pharmaceuticals: (ch 30) 
Medical Devices: (ch 9018, 9019, 9020, 9021, 9022) 
Telephonic & telegraphic Equipment: (ch 8517) 
Electrical Equipment: (ch 85) 
Recreational Craft: (ch 8903) 
Source: EUROSTAT (COMEXT) Brussels, 29 October 1997 
21 
AGREEMENT ON MUTUAL RECOGNITION 
BETWEEN CANADA AND THE EUROPEAN COMMUNITY 
TABLE OF CONTENTS 
1. Framework 
2. Telecommunications Terminal Equipment 
3. Electromagnetic Compatibility (EMC) 
4. Electrical Safety 
5. Recreational Craft 
6. Good Manufacturing Practices 
7. Medical Devices Page 1 
Page 10 
Page 29 
Page 41 
Page 49 
Page 55 
Page 73 
Initialled on 30 May 1997 
22 
AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY 
ASSESSMENT BETWEEN CANADA AND THE EUROPEAN COMMUNITY 
The Government of Canada and the European Community ("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 1: 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. 
Initialled on 30 May 1997 
23 
- 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 definition in this Agreement shall prevail. 
ARTICLE II: GENERAL OBLIGATIONS 
1. The Sectoral Annexes to this Framework Agreement constitute integral parts of this 
Agreement. 
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 
State 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. 
Initialled on 30 Mav 1997 
24 
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. 
2. The Parties agree that each Sectoral Transition Plan shall specify a time period for 
completion; 
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. 
Initialled on 30 Mav 1997 
25 
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. 
Initialled on 30 Mav 1997 
26 
3. The designation constitutes a formal judgement 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 their designated 
Conformity Assessment Bodies. 
ARTICLE VllhVERIFICATION 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 the other Party 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 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. 
Initialled on 30 May 1997 
27 
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. 
Initialled on 30 Mav 1997 
28 
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. 
Initialled on 30 May 1997 
29 
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 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 fifteen 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. 
Initialled on 30 May 1997 
Zo 
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 to the territory of Canada and to the territories in 
which the Treaty establishing the European Community is applied, and under the conditions 
laid down in that Treaty. 
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 
1. This Agreement and the Sectoral Annexes are drawn up in two originals in the Danish, 
Dutch, English, Finnish, French, German, Greek, Italian, Portugese, Spanish and Swedish 
languages, each text being equally authentic. 
| Initialled on 30 May 1997 
31 
EU-CANADA MRA 
SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL 
EQUIPMENT, INFORMATION TECHNOLOGY EQUIPMENT 
AND RADIO TRANSMITTERS 
** Initialled on 30 May 1997 
32 
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 of Conformity Assessment 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 electro-magnetic 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. 
2.2 A list of the interfaces and services covered by each Party is referenced at 
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 
Initialled on 30 Mav 1997 
33 
3. THE APPROVAL REQUIREMENTS 
3.1 This Annex shall apply to all mandatory approval requirements, adopted within the 
territories of the Parties, by government organizations 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. 
3.2 Any requirements and conformity assessment procedures applied to domestic 
products shall be applied with no additional requirements or variations to products or 
conformity assessment results originating from the other Party. 
4. CONFORMITY ASSESSMENT ACTIVITIES 
4.1 Both Parties affirm that their Conformity Assessment Bodies, recognized under this 
Annex, are authorized 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 to the requirements of the laws and regulations applicable 
in the territories of the Parties for products covered under this Annex; 
for electro-magnetic 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 EMC; 
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. 
4.2 Certificates of conformity delivered by the designated Conformity Assessment 
Bodies of each Party under the provisions of this Annex will be recognized by the 
authorities of the other Party without any further assessment of the products. 
5. INSTITUTIONS 
5.1 DESIGNATING AUTHORITIES 
(a) Designating Authorities are those authorities and organizations 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. 
Initialled on 30 May 1997 
34 
(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 recognized 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. 
Initialled on 30 Mav 1997 
35 
6.3 During the transitional period the Parties will also reciprocally recognize 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; 
any 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 
SUB-CONTRACTING 
7.1 Any sub-contracting shall be in accordance with the sub-contracting 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 sub-contracting. These details will be available to the other Party on request. 
Initialled on 30 May 1997 
36 
POST-MARKET SURVEILLANCE 
7.3 For the purpose of post-market surveillance, the Parties may maintain any existing 
labeling 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. 
7.7 As provided in the transitional arrangements set out in Section 6.2 above 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 would (also) apply. 
Initialled on 30 May 1997 
37 
ATTACHMENT 1 
LEGISLATIVE. REGULATORY AND ADMINISTRATIVE PROVISIONS 
EUROPEAN COMMUNITY CANADA. 
Council Directive 91/263/EEC, as 
supplemented by Council Directive 
93/97/EEC and amended by Council 
Directive 93/68/EEC 
Council Directive 73/23/EEC as amended by 
Council Directive 93/68/EEC 
Council Directive 89/336/EEC, as amended 
by Council Directives 92/31/EEC and 
93/68/EEC 
European Commission Decisions established 
under Council Directives 91/263/EEC and 
93/97/EEC. 
The EC Member States' legislations and 
regulations in respect of: 
(a) non-harmonized analogue connection to 
the public switched telecommunications 
network; 
(b) non-harmonized radio transmitters 
(civilian application). 
Handbook of the implementation of 
91/263/EEC (ADLNB and ACTE approved). Telecommunications Act 
Radiocommunication Act 
CRTC Telecom Decision No 82-14 
Certification Standard CS-03 
Certification Procedure CP-01 
Radiocommunication Regulations 
Radio Standards Procedure (RSP) #100: 
Radio Equipment Certification Procedure 
Canadian Electrical Code 
Terminal Equipment List (TEL) 
Radio Equipment List (REL) 
Licence Exempt Radio Apparatus Standards 
List 
Broadcasting Certificate Exempt Radio 
Apparatus Standards List 
The Category I Equipment Standards List 
The Category II Equipment Standards List 
Initialled on 30 Mav 1997 
38 
ATTACHMENT 2 
COVERAGE 
EUROPEAN COMMUNITY 
In specific terms, the following interfaces 
and services are included: 
ISDN Basic Rate Access 
ISDN Primary Rate Access 
ISDN Telephony 
X21A/.24A/.35 Access 
X25 Access 
PSTN Non-Voice 
ONP Leased Line Terminal types: 
-64 kbits/sec 
-2048 kbit/s unstructured 
-2048 kbit/s structured 
-34 Mbit/s access 
-140 Mbit/s access 
-2 wire analogue 
-4 wire analogue 
Analogue connections to the public 
switched telecommunications networks CANADA 
In specific terms, the following interfaces 
and services are included: 
ISDN Basic Access 
ISDN Primary Rate Access 
X.21 Access 
X.25 Access 
Digital Service Access 
-1.2 kbps 
-2.4 kbps 
-9.6 kbps 
-4.8 kbps 
-19.2 kbps 
-56.0 kbps 
-64.0 kbps 
-1,544 kbps 
-45 Mbps 
2 wire analogue tie-trunks/ops 
4 wire analogue tie-trunks/ops 
Analogue connections to the public 
switched telecommunications networks 
All radio transmitters to 
Radiocommunication Regulations (See 
Appendix 1 ) with the exception of: 
Initialled on 30 May 1997 
39 
EUROPEAN COMMUNITY 
All harmonised and non-harmonised radio 
transmitters, with the exception of: 
• a medical device within the meaning of 
Article 1 of Council Directive 93/42/EEC 
of 14 June 1993; 
• an active implantable medical device 
within the meaning of Article 1 of 
Council Directive 90/385/EEC of 20 
June 1990; 
• a component or separate technical unit of 
a vehicle within the meaning of Council 
Directive 72/245/EEC of 20 June 1972 of 
Council Directive 92/61/EEC of 30 June 
1992; 
• radio equipment used by radio amateurs 
within Article 1, definition 53, of the ITU 
radio regulations unless the equipment is 
available commercially; 
• equipment within the scope of Directive 
96/98/EC (The Marine Directive); 
• cable and wiring; 
• receive only radio equipment intended to 
be used solely for the reception of sound 
and TV Broadcasting Services; 
• products, appliances and components 
within the meaning of Article 2 of 
Council Regulation (EEC) 3922/91 of 16 
December 1991 on the harmonisation of 
technical requirements and 
administrative procedures in the field of 
civil aviation; 
• Air-traffic-management equipment and 
systems within the meaning of Article 1 
of Council Directive 93/65/EEC of 19 
July 1993 on the definition and use of 
compatible technical specifications for 
the procurement of air-traffic-
management equipment and systems; CANADA 
* Medical devices and active implantable 
medical devices including all radio 
transmitters in connection with the medical 
service including instruments, telemetry 
radio links and other radio equipment 
primarily used in hospitals and health care 
facilities. 
* spark ignition systems of vehicles 
including all radio transmitters in connection 
with the spark ignition systems of vehicles. 
* Radio equipment used by radio amateurs 
within Article 1, definition 53, of the ITU 
radio regulations unless the equipment is 
available commercially; 
* Maritime equipment including all radio 
transmitters in connection with the maritime 
service, either ship-bome or shore 
installations; 
* Cable and wiring 
* receive only radio equipment intended to 
be used solely for the reception of sound 
and TV Broadcasting Services; 
Aeronautical equipment including all radio 
transmitters in connection with the 
aeronautical (civil) service either air-borne 
or terrestrial installations, for the purpose of 
aircraft navigation, air traffic control, air 
safety and radio communication for the air 
traffic service (i.e. this does not include 
commercial telephone service to and from 
aircraft); 
* Apparatus exclusively used for activities 
concerning public security, defense, State 
security (including the economic well-being 
of the State when the activities relate to 
State security matters) and the activities of 
the State in areas of criminal law. 
In^-^d on 30 May 1997 
40 
EUROPEAN COMMUNITY 
• Apparatus exclusively used for activities 
concerning public security, defence, State 
security (including the economic well-
being of the State when the activities 
relate to State security matters) and the 
activities of the State in areas of criminal 
law. 
A radio transmitter is defined as being any 
radio frequency device or combination of 
devices intended for, or capable of being 
used for any transmission or emission of 
signs, signals, writing, images, sounds or 
intelligence of any nature by means of 
electro-magnetic waves of frequencies 
lower than 3 000 GHz propagated in space 
without artificial guide. For the purpose of 
this Annex no radiotransmitters using 
frequencies lower than 9 Khz are covered. CANADA 
A radio transmitter is defined as being any 
radio frequency device or combination of 
devices intended for, or capable of being 
used for any transmission or emission of 
signs, signals, writing, images, sounds or 
intelligence of any nature by means of 
electro-magnetic waves of frequencies 
lower than 3 000 GHz propagated in space 
without artificial guide. For the purpose of 
this Annex no radiotransmitters using 
frequencies lower than 9 Khz are covered 
Initialled on 30 May 1997 
41 
ATTACHMENT 3 
DESIGNATING AUTHORITIES 
EUROPEAN COMMUNITY & I CANADA 
MEMBER STATES 
Austria Bundesministerium fur wirtschaftliche Industry Canada for terminal attachment, 
Angelegenheiten, Sektion IX/2 radio transmitters and EMC 
Belgium BIPT 
Denmark Telestyrelsen Standards Council of Canada for electrical 
Finland Ministry of safety 
Telecommunications 
Germany Bundesministerium fur Standards Council of Canada for quality 
Wirtschaft management systems registrars 
Greece Ministry of Transport & 
Communications 
France Ministere de PEconomie , des 
finances et de I'industrie 
Ireland Dept. Of Transport, Energy & 
Communications 
Italy Ministero della Communicazione 
DGRQS and ISETI (radio transmitters) 
Luxembourg Administration des Postes et 
Telecommunications 
Netherlands Min Verkeer en Waterstaat, 
Telecom, en Post Dept 
Portugal Institute das Communicacoes 
Spain Ministerio de Obras Publicas y 
Transportes 
Sweden Styrelsen for ackreditering och 
teknisk kontroll (SWEDAC) 
U.K. Dept of Trade & Industry (DTI) 
Initialled on 30 May 1997 
42 
ATTACHMENT 4 
DESIGNATED CONFORMITY ASSESSMENT BODIES 
(This should give name, address, telephone and fax no., contact point, 
products, standards and conformity assessment procedures for which 
designation has been made, by reference to the legislative requirements 
of the other Party.) 
Initialled on 30 May 1997 
43 
ATTACHMENT 5 
APPROVAL AUTHORITIES 
European Community and Member 
States 
(To be determined) Canada 
Industry Canada 
Initialled on 30 Mav 1997 
44 
APPENDIX 1 
RADIO TRANSMITTERS STANDARDS LIST 
UNDER RADIOCOMMUNICATION REGULATIONS 
INTERFERENCE-CAUSING EQUIPMENT STANDARDS 
Specification 
ICES 001 
ICES 003 
ICES 0040 Title 
Industrial, Scientific and Medical Radio Frequency 
Generators 
Digital Apparatus 
Alternating Current High Voltage Power Systems Issue 
2 
3 
1 Date 
August 13, 
1994 
November 
22,1997 
June 1991 
Initialled on 30 May 1997 
45 
RADIO STANDARDS SPECIFICATIONS 
Specification 
RSS 118 
Addendum to 118 
Annex A to 118 
Supplement 1993-
1 
RSS 118. mod 
RSS 119 
RSS 123 
RSS 125 
RSS 128 Title 
Land and Subscriber Stations: Voice, 
Data and Tone Modulated, Angle 
Modulation Radiotelephone 
Transmitters and Receivers Operating in the 
Cellular Mobile Bands 
824 - 849 MHz and 869 - 894 MHz 
Cellular System Mobile Station - Land 
Station Compatibility Standard 
Supplement 1993-1 to Radio Standards 
Specifications (RSSs) Nos. 118 
Amendment N° 2 to RSS 118 
Land Mobile And Fixed Radio 
Transmitters and Receivers, 
27.41 - 960 MHz 
Low Power Licensed 
Radiocommunication Devices 
Land Mobile And Fixed Radio 
Transmitters and Receivers, 1.705 to 
50.0 MHz, Primarily Amplitude Modulated 
800 MHz Dual-Mode Cellular Telephones Issue 
2 
'1 
5 
1 
Provisional 
2 
1 
Drovisional Date 
Aug. 19, 
1990 
Sept. 1, 
1990 
Oct. 22, 
1983 
June 12, 
1993 
Aug. 24, 
1996 
Aug. 24, 
1996 
Feb. 24, 
1996 
Aug. 24, 
1996 
June 12, 
1993 
Initialled on 30 May 1997 
46 
RSS 128. mod 
RSS 129 
RSS 129. mod 
RSS 130 
Annex 1 to RSS 
130 
Attachment 1 to 
RSS 130 
RSS 131 
RSS 133 
RSS 134 
RSS 135 
RSS 136 Amendments to RSS 128 
800 MHz Dual-Mode CDMA Cellular 
Telephones 
Amendments to RSS-129 
Digital Cordless Telephones in the Band 
944 to 948.5 MHz 
CT2Plus Class 2: Specification for the 
Canadian Common Air Interface for 
Digital Cordless Telephony, Including 
Public Access Services 
European Telecommunications 
Standards Institute Interim Standard 
/I-ETS300 131 
Radio Signal Enhancers for the Mobile 
Telephone Service 
2 Ghz Personal Communications Services 
900 MHz Narrowband Personal 
Communications Service 
Digital Scanner Receivers 
Land and Mobile Station 
Radiotelephone Transmitters and 
Receivers Operating in the 26.960 -
27.410 MHz General Radio Service 1 
Provisional 
2 
2 
1 
Provisional 
1 
Provisional 
1 
Provisional 
1 
Provisional 
5 Aug. 24, 
1996 
Feb. 24, 
1996 
Aug. 24, 
1996 
Jan. 23, 
1993 
Jan. 23, 
1993 
April 
1992 
Feb. 24, 
1996 
Nov. 29, 
1997 
Aug. 24, 
1996 
Oct. 26, 
1996 
Jan. 1, 
1977 
Initialled on 30 May 1997 
^ 
RSS 137 
RSS 210 cation and Monitoring Services (902-928 MHz) 
Low Power Licence-Exempt 
Radiocommunication Devices 1 
rovisional 
2 ov. 29, 
1997 
Feb.24, 
1996 
Note 1: Supplement 1993-1 issued June 12, 1993 applies to RSS-118 and 182. 
Additional Radio Standards Specifications may be found in the Broadcasting Regulatory 
Section of the Index. 
Initialled on 30 May 1997 
48 
BROADCAST EQUIPMENT TECHNICAL STANDARDS 
Specification 
BETS-1 
BETS-3 
BETS-4 
BETS-5 
BETS-6 
BETS-8 
BETS-9 
BETS-10 
BETS-11 Title 
Technical Standards and Requirements for 
Low Power Announce Transmitters in the 
Frequency Bands 525-1,705 kHz and 
88-107.5 MHz 
Technical Standards and Requirements for 
Radio Apparatus that Form Part of a 
Master Antenna Television (MATV) 
Broadcasting Undertaking 
Technical Standards and Requirements 
for Television Broadcasting Transmitters 
Technical Standards and Requirements 
for AM Broadcasting Transmitters 
Technical Standards and Requirements 
for FM Broadcasting Transmitters 
Technical Standards and Requirements 
for FM Transmitters Operating in Small 
Remote Communities 
Technical Standards and Requirements 
for Television Transmitters Operating in 
small 
Remote Communities 
Technical Standards and Requirements 
for Television Transmitters in the 
2,596-2,686 Mhz Band 
Technical Requirements Respecting the 
Identifications of Broadcasting Stations Issue 
1 
1 
1 
1 
1 
1 
1 
1 
1 Date 
Nov. 1,1996 
Nov. 1,1996 
Nov. 1,1996 
Nov. 1,1996 
Nov. 1, 1996 
Nov. 1,1996 
Nov. 1,1996 
Nov. 1,1996 
Nov. 1, 1996 
Initialled on 30 May 1997 
49 
BROADCAST SPECIFICATIONS AND STANDARDS 
Specification 
BTS1-1 
BTS1-2 
BTS3 
BS.14 Title 
Broadcast Transmission Standard AM 
Broadcasting Stereophonic Operation 
Broadcast Transmission Standard: AM 
Broadcasting RF Emission Limits 
Broadcasting Transmission Standard: 
Television Broadcasting 
Broadcast Specification: Television 
Broadcast Videotext Issue 
1 
Provisional 
1 
Provisional 
2 
1 
Provisional Date 
Feb. 6, 1988 
Nov. 1989 
May 1990 
June 19, 1981 
Initialled on 30 May 1997 
50 
EU-CANADA MRA 
SECTORAL ANNEX ON 
ELECTRO-MAGNETIC COMPATIBILITY 
(EMC) 
Initialled on 30 Mav 1997 
51 
1. SCOPE AND COVERAGE 
1.1. The provisions of this Annex shall apply to the following: 
• Electro-magnetic compatibility of equipment as defined in EC Council Directive 
89/336/EEC of May 3, 1989, on the approximation of the laws of the Member States 
relating to electro-magnetic 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. 
2.2 Any requirements and conformity assessment procedures applied by one party to its 
domestic products shall be applied with no additional requirements or variations to 
products or conformity assessment results originating from the other Party. 
3. CONFORMITY ASSESSMENT ACTIVITIES 
3.1 Each Party agrees to recognize 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. 
3.2 Both Parties agree to recognize each other's suppliers declarations of compliance, 
as required under their respective legislation 
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. 
Initialled on 30 May 1997 
52 
4.2 DESIGNATED CONFORMITY ASSESSMENT BODIES 
(a) Conformity Assessment Bodies designated under this Annex shall be recognized 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. 
5.2 During the period between the signing of the agreement and its coming into effect, 
the Parties will work together to 1) enhance their respective familiarity with each 
other's regulatory requirements; 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 
SUB-CONTRACTING 
6.1 Any sub-contracting of conformity assessment shall be in accordance with the 
sub-contracting 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 sub-contracting. 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. 
Initialled on 30 May 1997 
53 
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 would also apply. 
Initialled on 30 Mav 1997 
54 
ATTACHMENT 1 
LEGISLATIVE. REGULATORY AND ADMINISTRATIVE PROVISIONS 
EUROPEAN COMMUNITY I CANADA 
Council Directive 89/336/EEC, as amended Radiocommunication Act 
by Council Directives 91/263/EEC, 
92/31 /EEC, 93/68/EEC and 93/97/EEC Radiocommunication Regulations 
(Appendix I) 
The EC Member States' legislation and 
regulations in respect of EMC for The Category II Equipment Standards List 
non-harmonized radio transmitters (civilian 
application). 
Initialled on 30 May 1997 
55 
ATTACHMENT 2 
DESIGNATING AUTHORITIES 
The Designating Authority for Canada is Industry Canada. 
The Designating Authorities for the European Community are as in the following 
table: 
Member State Competent Authorities Sectors of Activity 
Austria Bundesministerium fur All equipment except 
wirtschaftliche telecommunication equipment 
Angelegenheiten Abteilung 
IX/4 
Landstrasser Haupstrasse 55-57 
1031 WIEN 
Austria Bundesministerium fur Telecommunication equipment 
offentliche Wirtschaft und 
Verkehr 
Radetzkystrasse 2 
1030 WIEN 
Austria Zulassungsburo Telecommunication equipment 
Nordbergstrasse 15 
1091 WIEN 
Austria Fernmeldeburo fur Wien, Telecommunication equipment 
Niederosterreich und 
Burgenland 
Nordbergstrass 15 
1091 WIEN 
Austria Fernmeldeburo fur Steiermark Telecommunication equipment 
und Karten 
Neutorgasse 46 
8011 GRAZ 
Austria Fernmeldeburo fur Telecommunication equipment 
Oberosterreich und Salzburg 
Domgasse 1 
4010 LINZ 
Initialled on 30 May 1997 
56 
Austria Fernmeldeburo fur Tirol und Telecommunication equipment 
Voralberg 
Maximilianstrasse 2 
6010 INNSBRUCK 
Belgium Ministere des Affaires Autorite federate pour la 
Economiques coordination de la mise en 
Administration de PEnergie application de la legislation 
Service Equipements et CEM 
Produits Energetiques Haute surveillance et 
154, Bd Emile Jacqmain surveillance du marche pour 
1210 BRUXELLES tout produit 
Belgium Ministere de I'Emploi et du Surveillance du marche dans le 
Travail domaine des produits relevant 
Administration de la Securite de la protection des travailleurs 
du Travail 
Rue Belliard, 51 
1040 BRUXELLES 
Belgium Institut Beige des Services Surveillance du marche dans le 
Postaux et des domaine des produits relevant 
Telecommunications (aupres des perturbations radio 
du Ministere des emetteurs et recepteurs radio. 
Communications et de Reseau de telecommunication. 
Plnfrastucture) 
Tour Astro 
Av. de I'Astronomie, 14, BP21 
1030 BRUXELLES 
Denmark Telestyrelsen 
Holsteinsgade 63 
2100 COPENHAGEN 
Finland Ministry of Trade and Industry Industrial manufacturing 
P.O. Box 230 equipment 
00171 Helsinki Medical and scientific apparatus 
Information technology 
equipment 
Domestic appliances and 
household electronic equipment 
Educational electronic 
equipment 
Lights and fluorescent lamps 
Finland Telecommunications Telecommunications terminal 
Administration Centre equipment 
P.O. Box 53 Radio equipment 
I 00211 HELSINKI | Telecommunications networks 
Initialled on 30 Mav 1997 
57 
Finland Turvatekniikan keskus 
(TUKES) 
Safety Technology Authority 
P.O. Box 123 
Lonnrotinkatu 37 
00181 HELSINKI 
France Ministere de Plndustrie, des 
Postes et des 
Telecommunications et du 
Commerce Exterieur 
Direction Generate des 
Strategies Industrielles 
Sous-Direction de la Qualite pour 
I'lndustrie et la Normalisation 
22, rue Monge 
75005 PARIS 
Germany Bundesamt fur Post und All equipment 
Telekommunikation (BAPT) 
Referat124 
Postfach 8001 
55003 MAINZ 
Germany Bundesministerium fur Post All equipment 
und Telekommunikation 
(BMPT) 
Referat314 
Postfach 8001 53105 BONN 
Greece Ministry of Transport & 
Communications 
49, Syngrou Avenue 
11780 ATHENS 
Ireland Department of Transport, 
Energy and Communications 
44 Kildare Street 
Dublin 2 
Italy Ministero delle 
Communicazioni (DGRQS) 
Viale America 201 
00144 ROMA 
Italy Ministero dell'lndustria, del 
Commercio e dell'Artigianato 
(DGSPC) 
Via Molise 2 
00187 ROMA 
Initialled on 30 Mav 1997 
58 
Luxemburg Service de PEnergie de L' Etat 
B.P. 10 
2010 LUXEMBOURG 
Netherlands Ministerie van Verkeer en 
Waterstaat 
Hoofdirectie 
Telecommunicatie en Post 
Postbus 450 
9700ALGRONINGEN 
Portugal Instituto das Comunicacoes 
de 
Portugal (ICP) 
Av. J. Malhoa, 12 
1070LISBOA 
Spain Ministerio de Fomento Equipos de telecomunicacion 
Direccion General de 
Telecomunicaciones 
Palacio de Telecomunicaciones 
Plaza de Cibeles, s/n. Planta 5a 
28014 MADRID 
Spain Ministerio de Industria y Todos los equipos afectos a la 
Energia Directiva excepto los equipos 
Direccion General de Calidad y de telecomunicacion. 
Seguridad Industrial 
Paseo de la Castellana, 160 
Planta 12 
28071 MADRID 
Sweden National Electrical Safety National co-ordinating authority 
Board for implementing the EMC 
P.O.B. 1371 legislation. Supervision and 
11193 Stockholm market surveillance authority 
concerning EMC for all products 
with the exception of radio 
transmitters and equipment 
intended for connection to the 
public telecommunications 
network 
Sweden National Post and Telecom Supervision and market 
Agency surveillance 
P.O.B. 5398 authority concerning EMC for 
10249 Stockholm radiotransmitters and 
equipment intended 
for connection to the public 
telecommunications network 
Initialled on 30 May 1997 
59 
United Kingdom Department of Trade and 
Industry 
Standards Policy Unit 
151 Buckingham Palace Road 
LONDON SW1W9SS 
Initialled on 30 Mav 1997 
60 
ATTACHMENT 3 
DESIGNATED CONFORMITY ASSESSMENT BODIES 
(This should give name, address, telephone and fax no., contact point, products, 
standards and conformity assessment procedures for which designation has been 
made, by reference to the legislative requirements of the other Party.) 
Initialled on 30 May 1997 
61 
APPENDIX 1 
INTERFERENCE-CAUSING EQUIPMENT STANDARDS 
Specification 
ICES 001 
ICES 003 
ICES 0040 Title 
Industrial, Scientific and Medical Radio Frequency 
Generators 
Digital Apparatus 
Alternating Current High Voltage Power Systems Issue 
2 
3 
1 Date 
August 13, 
1994 
November 
22,1997 
June 1991 
Initialled on 30 May 1997 
62 
EU-CANADA MRA 
SECTORAL ANNEX 
ON 
ELECTRICAL SAFETY 
Initialled on 30 May 1997 
63 
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, white maintaining the integrity of the 
safety system in each of the Parties. 
1.2. This Annex also sets out procedures for the recognition of: 
a) Conformity Assessment Bodies (CABs) in Canada by the European 
Community (EC); and 
b) CABs in the EC by Canada. 
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 93/68/EEC) (Footnote 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 EC LVD (other than Medical devices). 
2.3 The legislative, regulatory and administrative requirements applicable in each 
Party and the regulatory authorities responsible for electrical safety are listed 
in attachment 1. 
RESPONSIBLE/DESIGNATING AUTHORITIES 
3.1 Authorities set out in Attachment 2,are those organisations/public authorities 
responsible for assuring the competence and the control of CABs to certify 
electrical equipment in their territories to the requirements of the other Party. 
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 recognizing CABs and in the ability of those bodies to 
carry out their mandates. Successful completion of the transition phase should 
1 The categories of equipment outside the scope of the LVD are: electrical equipmetn 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 oulets for domestic use; electric fence controllers; radio-electrical 
interference. 
Initialled on 30 May 1997 
64 
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. 
4.3 During the transition phase, the authorities may jointly sponsor two seminars, 
one in Canada and one in the EC, concerning the relevant technical and 
product approval requirements. 
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 EC 
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 I EC 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 Organization accredited by the Standards Council of 
Canada. 
5.2 During the transition phase, EC 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 Organization in Canada. 
5.3 Canadian Certification Organizations shall ensure that: 
a) they inform the applicant and the EC 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. 
Initialled on 30 May 1997 
65 
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 recognized 
by the Responsible/Designating Authorities, provide for traceability, give 
sufficient information to consumers, and not give rise to confusion with other 
markings of conforrhity. 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 recognized by the Responsible/Designating 
Authorities shall operate as follows: 
a) For access to the EC market: 
If a product is challenged under the LVD, a report drawn up by a Canadian 
CAB recognized 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 recognized 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 organization 
according to applicable and relevant I SO/I EC Guides adapted to 
Canadian and European conditions for accreditation of 
certification organizations; and 
iii) Evidence of procedures for follow-up of certification activities 
including the identification of a contact point who shall be 
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 organizations and the SCC. 
7.3 Following the entry into force of the operational phase, the inclusion of 
additional CABs will be done in accordance with the rules set out in the 
Framework Agreement and in this Annex. 
Initialled on 30 May 1997 
66 
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. 
8.3 A CAB which has been granted limited recognition or has been denied 
recognition, may apply for re-evaluation after corrective action has been 
taken. 
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). 
9.2 CABs shall have in place a plan of action with their certification clients, for 
enabling the withdrawal of non-conforming or hazardous products from the 
marketplace. That plan shall identify a contact point who shall be responsible 
for initiating action with manufacturers of the products in question. 
10. JOINT ELECTRICAL SAFETY GROUP 
10.1 The Joint Committee established under the Mutual Recognition Agreement 
shall appoint a Joint Electrical Safety Group (JESG). 
10.2 The Group (JESG) shall consist of a equal number of representatives from 
Canada and the EC. 
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. 
Initialled on 30 May 1997 
67 
ATTACHMENT 1 
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE 
REGULATORY AUTHORITIES (Re. Articles 2.3 and 9.1) REQUIREMENTS AND 
European Community Canada 
Council Directive 73/23/EEC as amended by The Canadian Electrical Code as referenced 
Council Directive 93/68/EEC in the provincial / territorial legislation is 
under the responsibility of the following 
EU Regulatory Authorities: list is the same provincial / territorial Regulatory Authorities: 
as per Attachment 2 
Alberta: 
The Safety Codes Act, 
Statutes of Alberta, 1991, Chapter S-0.5; 
Alberta Department of Labour, Technical 
and Safety Services; 
British Columbia: 
Electrical Safety Act, Chapter 109 
Electrical Safety Regulation, 
B.C. Reg 253/96 
__ Ministry of Municipal Affairs & Housing; 
Manitoba: 
The Manitoba Hydro Act, 1976 
Provincial Regulations 126-94 amended in 
September 1995 
Manitoba Hydro; 
New Brunswick: 
The Electrical Installation and Inspection Act 
84-165 The General Regulation 
82-215 The Lighting Protection Regulation 
Department of Advanced Education and 
Labour; 
Newfoundland: 
Public Safety Act 
Electrical Regulations, 1996 
Department of Government Services and 
Lands; 
Northwest Territories: 
Electrical Protection Act, 
R.S.N.W.T. 1988, C.E-3 
I Department of Public Works and Services; 
Initialled on 30 May 1997 
68 
Nova Scotia: 
The Electrical Installation and Inspection Act 
Nova Scotia Department of Labour; 
Ontario: 
The Power Corporation Act, 
Revised Statutes of Ontario, 1990, 
Chapter P18, Section III 
Ontario Regulation 612-94 
Ontario Hydro; 
Prince Edward Island: 
The Electrical Inspection Act 
The Electrical Inspection Act Regulations 
Department of Community Affairs and 
Attorney General; 
Quebec: 
Loi sur les installations electriques, 
L.R.Q., Chapter 1-13.01 
Reglement sur les installations electriques, 
1-13.01, R.3 
Code de 1'electricite du Quebec 
Regie du batiment du Quebec; 
Saskatchewan: 
The Electrical Inspection Act, 1993 
Electrical Inspection Regulations 
SaskPower; 
Yukon: 
The Electrical Protection Act 
OIC 1992-017 Electrical Protection Act 
Yukon Regulations 
Yukon Department of Community and 
I Transportation Services 
Initialled on 30 May 1997 
69 
ATTACHMENT 2 
DESIGNATING AUTHORITIES 
1. The Authorities responsible for the designation of conformity assessment bodies under 
this agreement are: 
a) For the European Community: 
- Austria: Bundesministerium fur wirtschaftliche Angelegenheiten 
- Belgium: Ministère des Affaires Economiques/Ministerie van Economische Zaken 
- Denmark: Elektricitetsradet 
- Finland: Ministry of Trade and Industry 
- France: Ministère de l'Economie, des Finances et de l'Industrie 
- Germany: Bundesministerium fur Arbeit und Sozialordnung 
- Greece: Ministry of Development 
- Ireland: Department of Enterprise, Trade and Employment 
- Italy: Ministero dell'lndustria 
- Luxembourg: Service de l'Energie de l'Etat 
- Netherlands: Ministerie van Economische Zaken 
- Portugal: gnder authority of the Ministry of Industry: Instituto Portugees da 
Qualidade 
- Spain: Ministerio de Industria y Energia 
- Sweden: under authority of the Government of Sweden: Styrelsen for 
ackreditering och teknisk controll (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. 
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70 
EU-CANADA MRA 
SECTORAL ANNEX 
FOR 
RECREATIONAL CRAFT 
72 
71 
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 #TP1332. 
t.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 Directives 94/25 EEC. These certificates will be recognized in the 
European Community without any further assessment of the products to which they 
relate. 
b) for approval 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 
European Parliament and European Council Directive 94/25 EEC on The Approximation of 
the Laws, Regulations and Administration Provisions of the Member States Relating to 
Recreational Craft. 
2.2. for Canada 
Regulatory Requirements - The Canada Shipping Act, Chapter 1487, Small Vessel 
Regulations which referenced in Transport Canada's Publication #TP1332 Construction 
Standards for Small Vessels which includes Personal Watercraft as defined by and certified 
to ISO/DIS 13590. 
Initialled on 30 May 1997 
72 
Section III: Authorities Responsible for Designating the Conformity Assessment Bodies as 
Specified bv Conformity Assessment Modules 
3.1. for the European Community 
Member States Administrations or entities as indicated in Attachment 1 
3.2. for Canada 
Canadian Coast Guard 
Section IV Procedures for Designating Conformity Bodies 
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 authorized 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. 
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73 
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. 
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74 
Attachment 1 : Designating Authorities. 
For the European Community For Canada 
Member States Administrations as indicated The Canadian Coast Guard 
in the Directive 94/25/EEC, Article 9.1 | 
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75 
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. 
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76 
EU-CANADA MRA 
SECTORAL ANNEX ON 
GOOD MANUFACTURING PRACTICES 
(GMP) 
Initiallad on 30 May 1997 
77 
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 Authorizations / 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 Authorization / 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 Authorization / 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 
recognized as equivalent will be accepted. 
2.3. The MRA on Medicinal Products / Drug GMP is built on three pillars: 
a) the concept of a GMP compliance programme (Appendix 4 ) 
b) a "two-way" alert system (Appendix 5 ) 
c) a transition period including a confidence building exercise (Appendix 
6) 
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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) (eg 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. The 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 MA / 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). 
The 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 Authorization (MA) or product 
specifications and by assignment procedure of the Drug 
Identification Number (DIN) 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 Jaws and regulations, for the purpose of their respective 
product approval procedures. Lot-to-lot release for biologicals is excluded 
from this Agreement 
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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. 
4.2. Each Party reserves the right to make public the results of any conformity 
assessment, including the conclusions of inspection reports, provided by the 
other Party, in situations in which public health safety may be affected. 
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 the relevant EC authorities. It will be co-chaired by a 
member of each of the two Parties. 
6. Resolution of Divergent Views 
6.1. Divergent views which have not been resolved between the authorities will be 
referred to the Joint Sectoral Group for resolution. In the case of inability of 
the Joint Sectoral Group to resolve these divergent views, either Party may 
bring the matter to the attention of the Joint Committee. 
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 Parly's authority to perform GMP 
compliance certification (guidance provided in AppendixG ). 
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80 
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 this Appendix 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 recognize the conclusions of the 
GMP compliance programme carried out by the other Party in- its territory, 
and the relevant Certificates of Manufacturing Authorizations / 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. 
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81 
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 recognized 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 
authorization, 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 
Authorizations / 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 Authorization / 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. 
InitiaUad on 30 May 1997 
82 
Certificates of manufacturing authorisations/licences will be issued 
expeditiously, and the time taken should not exceed 30 calendar days. In 
cases when a new inspection has to be carried out, this period may be 
extended to 60 calendar 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 Authorization / 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 Authorization / 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 Authorizations / 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. 
8.1.9. The decision to suspend or revoke a licence will rest with the issuing Party. 
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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 calendar days, this 
period being extended to 60 calendar 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. 
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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 organize meetings to discuss specific questions and issues. 
9.3. Authorities must participate in maintenance activities, as established under 
the Joint Sectoral Group, in order to maintain their status as listed in 
Appendix 2. 
10. Appendices 
10.1. Appendices 1 and 2 constitute integral parts of this annex. 
10.2. Appendices 3,4, 5, 6 and 7 are general guidelines. 
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Appendix 1 
1. List of Applicable Legislation 
1.1 For the European Community 
Directive 65/65 EEC as modified 
Directive 75/319 EEC as modified 
Directive 81/352 EEC as modified 
Directive 91/356 EEC as modified 
Directive 91/412 EEC as modified 
Regulation N° (EC) 2309/93 
Directive 25/92 & Guide to Good Distribution Practice 
Current version of the Guide To Good Manufacturing Practice, Volume IV of 
Rules Governing Medicinal Products in the European Community. 
1.2 For Canada: 
Food and Drugs Act and Regulations, Health of Animals Act and Regulations 
for the issuance of permits for materials of animal origin. 
2. Indicative list of Products 
Recognizing that precise definitions of medicinal products and drugs are to be found 
in the legislations 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 (Note: APIs are 
not GMP regulated) 
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Appendix 2 
AUTHORITIES 
For the European Community: 
Austria: 
Belgium: 
Denmark: 
Finland: 
France: 
Germany: 
Greece: 
Ireland: 
Italy: 
Luxembourg: 
The Netherlands: 
Portugal: 
Spain: 
Sweden: 
United Kingdom: Austrian Inspection Service, Federal Ministry of Health and 
Consumer Protection, Vienna 
Pharmaceutical Inspectorate, Ministry of Social Affairs, Public 
Health and Environment; Brussels 
Medicines Inspectorate, Medicines Division, National Board of 
Health, Bronshoj 
National Agency for Medicines, Ministry of Social Affairs and 
Health, Helsinki 
Agency of Medicine, Paris 
National Agency of Veterinary Medicine, Paris 
Federal Ministry of Health, Bonn 
Paul-Ehrlich Institute, Langen 
16 Landers 
National Drug Organization (EOF), Ministry of Health, Athens 
National Drugs Advisory Board, Department of Health, 
Dublin 
Central Inspectorate, Ministry of Health, Rome 
National Laboratory of Health, Luxembourg 
Inspectorate for Health Care; Ministry of Health, Welfare, and 
Sport, Rijswijk 
Pharmacies and Pharmaceutical Inspection, National Institute 
of Pharmacy and of Medicine (INFARMED), Lisbon 
Sub-directorate General for Pharmaceutical Control, 
Directorate General for Pharmacies and Sanitary Products, 
Ministry of Health and Consumers, Madrid 
Medical Products Agency, Uppsala 
Medicines Control Agency, London 
Veterinary Medicines Directorate, Surrey 
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For Canada: 
Therapeutic Products Programme, Health Canada, Ottawa. 
Bureau of Veterinary Drugs, Food Directorate, Health Canada, 
Ottawa 
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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. 
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Appendix 4 
COMPONENTS OF A GMP COMPLIANCE PROGRAMME 
1. Legislative and Regulatory Requirements and Scope 
e 
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 
Organizational structure, including roles, responsibilities and reporting 
relationships 
3. Good Manufacturing Practices (GMP) Standards 
Scope/details 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 
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6. Inspection Performance Standards 
Frequency/number of inspections, quality and timeliness of inspection 
reports, norms/frequency/procedures 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 firm 
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 firm and by regulatory authority) 
Sampling and audit procedures 
Recall monitoring (including effectiveness controls and verifications 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 G MP compliance programme, including 
establishment of standards and annual audit and review. 
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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 
3. Enforcement Procedures 
Follow-up mechanisms 
Corrective action procedures 
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. Telephone 1-613-957-
0369, Fax 1-613-952-7756; and 
for the European Community, 
the Director of the Evaluation of Medicinal Products Agency, 7, 
Westferry Circus, Canary Wharf, UK - London E14 4HB, England. 
Telephone +44-171 -418 8400, Fax 418 8416. 
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92 h 3 
Appendix 6 
PHASES OF A CONFIDENCE BUILDING PERIOD 
The determination of the equivalency of the G MP 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/Legislations 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 organization 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). 
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EU-CANADA MRA 
SECTORAL ANNEX 
ON 
MEDICAL DEVICES 
InitiaUad on 30 May 1997 
95 
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 
- Directive 90/385/EEC relating to active implantable medical devices (OJL 
189 of 20 July 1990), as amended. 
- Directive 93/42/EEC relating to medical devices (OJL 169 of 12 July 
1993), as amended. 
(b) for Canada 
- The Food and Drugs Act and Medical Devices Regulations (proposed for 
promulgation 1997) 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. 
Initiallad on 30 May 1997 
96 
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. 
3.2. Each Party reserves the right to make public the results of any conformity 
assessment reports in situations where public health may be affected. 
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 ubable 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 program 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 Program 
At the beginning of the transitional period, the Joint Sectoral Group will elaborate a 
joint Confidence Building Program (guidance provided in Attachment III). The 
implementation of this program 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. 
Initiallad on 30 May 1997 
97 
The Confidence Building Programme should include the following actions and 
activities: 
a) The organization 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 manufacturers 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 or 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 Program, 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. 
Initialladon 30 May 1997 
98 
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 eighteen 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 Program, 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 Designating/Regulatory Authorities, listed in Attachment I, to the Joint 
Sectoral Group on the basis of the results of the Confidence Building Program. 
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 recognized. 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 re-consideration 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/evaluation/quality 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. 
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99 
The European Community and Canada agree that, for medical devices covered by 
this Annex, each Party will recognize 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 re-assessment. 
For evaluation against European requirements, Health Canada or other Conformity 
Assessment Bodies designated by Canada shall establish the conclusions of 
completed conformity assessments 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 re-assessment, 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 re-assessment, 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. 
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100 
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 Program, 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 organize 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. 
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101 
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 
Program. 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: 
for Canada and 
for the European Community [15 member states and the Commission] 
8. ATTACHMENTS 
Attachments I and II constitute integral parts of this Annex. Attachments III, IV and V 
are general guidelines. 
«* Initiallad on 30 May 1997 
102 
ATTACHMENT! 
REGULATORY / DESIGNATING AUTHORITIES ELIGIBLE TO PARTICIPATE IN 
THIS AGREEMENT 
For the Conformity Assessment Bodies For the Conformity Assessment Bodies 
Designated by Canada Designated by the European Community 
Canada Austria 
Medical Devices Bureau, Therapeutic Federal Ministry of Health and Consumer 
Products Directorate, Health Canada Protection 
Belgium 
Ministere de la Sante publique, de 
I'Environment et de Integration sociale 
Ministerie van Volksgezondheid, Leefmilieu en 
Sociale Integratie 
Denmark 
Sundhedsministeriet 
Finland 
Sosiaali-ja terveysministerio 
Germany 
Bundesministerium fur Gesundheit 
Greece 
Ministry of Health 
Spain 
Ministerio Sanidad y Consumo 
France 
Ministere de I'Emploi et de la Solidarity 
Ireland 
Department of Health 
Italy 
Ministero della Sanita 
Luxembourg 
Ministere de la Sante 
Netherlands 
Ministerie van Volksgezondheid, Welzijn en 
Sport 
Portugal 
Ministerio da Saude 
Sweden 
Under the authority of the Government of 
Sweden: 
Styrelsen for ackreditering och teknisk controll 
(SWEDAC) 
United Kingdom 
I Department of Health 
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ATTACHMENT II 
DESIGNATED CONFORMITY ASSESSMENT BODIES AND THEIR RESPECTIVE 
DESIGNATING AUTHORITIES 
For Canada For the European Community 
To be completed after the Confidence Building To be completed after the Confidence Building 
Program | Program 
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ATTACHMENT III 
PHASES AND ELEMENTS OF A CONFIDENCE BUILDING PROGRAM 
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 
- Organizational 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 
Initiallad on 30 May 1997 
le>S 
- 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 (appropriateness 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 verifications of 
procedures) 
- Consumer complaint systems/procedures 
- Adverse incident reporting systems/procedures 
12. Quality Management Systems 
- Quality management/assurance systems/procedures to ensure the ongoing 
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. 
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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 organization of joint workshops 
(optional). 
C. Decision Makino 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). 
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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 
3. Enforcement Procedures 
- Follow-up mechanisms 
- Corrective action procedures 
4. Quality Assurance System 
- Vigirance programme 
- Surveillance/monitoring of implementation of corrective action 
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108 
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. 
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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/I EC guides); and either, 
(ii) the accreditation body participates in mutual recognition arrangements 
where they are 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: 
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- 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 thé 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 facsimile (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. 
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111 
E. Monitoring 
11. Designating Authorities shall maintain, or cause to maintain, ongoing 
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. 
V 
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. 
14. Designating Authorities shall consult, as necessary, with the relevant 
regulatory authorities of the other Party to ensure that all regulatory 
requirements are identified and are satisfactorily addressed. 
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112 
Financial Statement 1998-2002 
External trade relations - Mutual Recognition Agreement 
1. TITLE 
External Trade Relations-
Mutual Recognition Agreements with United States, Canada, Australia, New Zealand and 
Israel. 
2. BUDGETARY HEADINGS: B7-8500 
A-7010 
3. LEGAL BASIS 
• Article 113 of the Treaty of Rome 
• Proposal for Council decisions N°.... on the implementation by the European 
Commission of mutual recognition agreements with United States, Canada, Australia, 
New Zealand and Israel. 
DESCRIPTION OF OPERATION : 
4.1 General objective: 
The purpose of these agreements is to establish mutual recognition of certification of 
conformity of products with technical regulations or standards of partners to the 
agreement. 
The major actions which will be pursued by the Commission under this budget line 
will be the following: 
• Confidence-building activities to facilitate the proper implementation of the 
Agreement. 
• Management of the Agreements and maintenance of the necessary degree of 
confidence. 
The Commission will be assisted by experts, particularly in regard to sectoral 
activities. It will however remain the final arbiter in the management of these 
agreements. 
4.2 Duration of the action: means foreseen for its renewal: 
The general action undertaken will be of an indefinite duration. The initial period of 
confidence-building required by the Agreements will require a more intensive effort 
and expenditure, but this should be substantially less after 2 years. However, during the 
life of the Agreements a continued effort will be needed to ensure management and 
maintenance of confidence. 
5. CLASSIFICATION OF EXPENDITURE/REVENUE 
5.1 Non-compulsory expenditure ("DNO") 
5.2 Differentiated appropriation ("CD") 
5.3 Type of revenue involved: 
None 
113 
6. TYPE OF EXPENDITURE/REVENUE 
- 100% subsidy: No 
- subsidy for co-financing with other sources in the public or private sector? 
Yes, this may be envisaged as a method of funding. Subsidies not normally exceeding 
50% will be provided to professional associations and other responsible organisations 
for activities related to the implementation of the Agreement. 
- Interest subsidy: No 
- Others 
Financing of events, acquisition of studies, publications and conferences. 
- Should the action prove an economic success, is there provision for all, or part 
of the Community contribution to be reimbursed? 
Not relevant 
- Will the proposed operation cause any changes in the level of revenue ? 
No 
7. FINANCIAL IMPACT ON APPROPRIATIONS FOR OPERATIONS 
7.1 Method of calculating the total cost of the operation: 
The estimation of costs is based on the anticipated requirements in terms of expenses 
related to training, seminars, workshops, travel of experts, verification of conformity 
assessment bodies, information and studies. The total estimated cost is based on the 
sum of the individual actions. 
A range of different actions are foreseen to meet the objectives of the budget-line and 
costs will vary depending on the nature of action undertaken. Even for similar types of 
action (e.g. seminars) costs will vary depending on the scope of the action and the 
degree of specialisation needed. 
The costs of specific actions will be determined either: 
• by the Commission when it organises activities itself, e.g. seminars 
• following invitations to tender issued by the Commission 
• following requests for subsidies. In such cases, projects are selected according to 
how well they meet the criteria which have been established for selection. 
Subsidies are based on a percentage of total costs and usually the Community 
funding is limited to a maximum of 50%. 
A. Attendance at Joint Committee 
These will be attended by Commission officials and some national experts. Travel 
and per diem expenses should be foreseen within the normal range of such expenses. 
114 
B. Attendance at Joint Sectoral Groups 
These will also be attended by Commission officials and given the nature of these 
meetings a larger contingent of national experts. Travel and per diem expenses 
should be foreseen within the normal range of such expenses. 
C. Workshops and Seminars 
These will be held to familiarise economic and other operators with the requirements 
of the Agreement The cost of these seminars will vary according to the subject 
matter and location, and will include organisational costs (when in Europe) and 
substantial travel costs when in the territory of the partner country. Organisational 
costs in Europe will cost c. 3000 ECUs each. The number of seminars will vary 
depending on the individual industrial sectors covered by the Agreement. 
D. Verification actions 
The competence of the conformity assessment bodies (CABs) will in many cases 
have to be checked, more so in the initial period of the Agreement, but as a matter of 
course throughout the life of the Agreement to maintain confidence in the system. 
This will involve on-site assessment by teams of experts of conformity assessment 
bodies in the partner country in the initial stages, and subsequently investigation of 
complaints. This expenditure will be essential in all sectors of the Agreement (... in 
number) and may involve numerous CABs in each sector including at subfederal or 
local level in certain cases. 
E. Production and dissemination of information 
Certain costs may need to be incurred for the dissemination of information. Guides to 
regulations and assessment procedures may be needed typically at a cost of 10 000 
ECUs. 
115 
7.2 Breakdown by elements of the operation 
"Trade Agreements with important Trading Partners' 
For 1998, this involves the following calculation: 
Budget Heading 
Joint Committee 
B7-8500 
Sectoral Groups 
B7-8500 
Seminars 
B7-8500 
Verifications 
B7-8500 
Information 
B7-8500 
B7-8500 Total Amounts 
(Ecus) 
12 940 
57 680 
103 540 
142 150 
10 000 
326 310 Method of calculation 
No. of missions 
Bxl 2 
Bxl 2 
Aus/NZ 2 
Israel 1 
Bxl 16 
US 8 
CAN 8 
US 10 
CAN 10 
Aus/NZ 14 
Bxl 28 
US 18 
CAN 18 
Aus/NZ 12 
Israel 1 
150 Standard Unit cost 
US: Travel: 2 000 Ecus; 
per diem: 185 Ecus 
CAN: Travel: 1 750 
Ecus; per diem: 170 Ecus 
Aus / NZ: Travel: 3 200 
Ecus; per diem: 190 Ecus 
Brussels: Travel: 800 
Ecus; perdiem: 110 Ecus 
In Ecus 
(current prices) 
Breakdown 
A. Joint Committee 
B. Joint Sectoral Groups 
C. Seminars 
D. Verifications 
E. Information 
Total Year 
1998 
12.940 
57 680 
103 540 
142 150 
10 000 
326 310 Year 
1999 
13 760 
57 680 
96 310 
142 150 
10 000 
319 900 2000 
12 940 
57 680 
48 430 
10 000 
129 050 2001 
13 760 
57 680 
48 430 
119 870 2002 
12 940 
57 680 
48 430 
119 050 Total 
1998-2002 
66 340 
288 400 
199 850 
429 590 
30 000 
1 014 180 
From the year 2000 on the estimates are for information. 
116 
7.3 Indication of the timetable for commitment and payment appropriations 
1000 Ecus 
Schedule of 
Commitment 
Payment 
appropriations 
1998 
1999 
2000 
2001 
2002 
2003 
Total Year 
1998 
326 1999 
319 2000 
129 2001 
119 2002 
119 2003 
and 
following 
years 
119 Total 
1131 
• 
326 
326 319 
319 129 
129 119 
119 119 
119 119 
119 326 
319 
129 
119 
119 
119 
1131 
8. WHAT ANTI-FRAUD MEASURES ARE PLANNED IN THE PROPOSAL FOR 
THE OPERATION ? 
Methods of control (submission of reports, etc.) will be included in all contracts 
between the Commission and beneficiaries. 
A close cooperation with the delegations of the Commission and the participation of 
a representative of the Commission at events in third countries will check on the spot 
the work to ensure that it corresponds with the terms of reference, contract provisions 
and required professionalism. 
The checks take place before the final payment The same rule applies to the financial 
incentives paid to participating companies. Where appropriate, agreements also 
require organisations to submit financial accounts certified by their auditors. 
In those cases involving cooperation with EU industrial federations the accounts are 
further checked at the Annual General Meeting of the federations concerned. 
9. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 
9.1. Specific objectives of the proposed operation, population targeted 
- The specific objectives of mutual recognition agreements are: 
• to avoid duplication of certification by economic operators. 
• to promote exports, employment, competitivity and investment. 
• to reduce costs, in particular for small and medium-sized enterprises and ultimately 
for the consumer. 
- Target population 
The target population are the exporting companies, business associations, chambers 
of commerce and public institutions of the European Union and the general consumer 
which will benefit, or have an interest in, the mutual recognition of certification. 
117 
9.2. Reasons for the operation 
- Needfor intervention from the Community budget 
Under Article 113 of the Treaty of Rome the Community has exclusive competence 
for commercial policy and these agreements have been negotiated in accordance with 
a mandate of the Council of Ministers and in consultation with the 113 Committee. 
The Commission will be responsible for implementation and management of the 
agreements. 
- Choice of methods of intervention 
* advantages over alternative measures (comparative advantages) 
* analysis of similar operations at Community or national level 
* results and expected multipliers 
The choice of management method (Joint Committee and Joint Sectoral Groups) have 
been set out in the Agreements and constitute a minimum necessary for the proper 
functioning of the Agreement. The Agreements also contain provisions for the use of 
seminars in the initial phases to ensure familiarity with other systems. 
These seminars and verifications are also designed to build mutual confidence; 
verifications will also be required to ensure this confidence is maintained throughout the 
life of the agreements. Confidence and its maintenance are keys to the successful 
operation of the agreements. 
The importance of this budget is justified when put in perspective with the trade involved 
in these agreements and the yearly savings for EU exporters which are expected 
(estimated on a yearly basis at 190 millions ECUs for EU exporters to the US, 20 mio in 
the case of exports to Canada and 40 mio in the case of exports to Australia and New 
Zealand). 
- Main factors of uncertainty which could affect the specific results of the 
operation. 
* None 
9.3 Monitoring and evaluation of the operation 
- Performance indicators selected 
* Output indicators 
* indicators of impact, following the objectives chosen 
In the case of these Agreements, success can be quantified by trade facilitation through 
avoidance of duplication of testing and certification and costs. Yearly estimated 
savings for the European Community are indicated above (9.2). 
Success can also be measured by increased EU exports and this factor will be taken 
into consideration although export performance is subject to such a wide range of 
variables (e.g. changes in exchange rates) that this can never be the sole factor for 
evaluation. 
118 
- Evaluation of results 
Progress in the attainment of the Agreements objectives wiU be monitored by 
Commission officials, Committees established under the Agreements and by the 
economic operators concerned. 
Details and frequency of the planned evaluation 
The evaluation of the effectiveness and usefulness of the agreements wil be regularly 
monitored by the Commission and by the Committees established under the agreements at 
their annual meetings. The first major evaluation will be at the end of the confidence-
building period. 
10. ADMINISTRATIVE EXPENSES 
Actual mobilisation of the necessary administrative resources will depend on the 
Commission's annual decision on the allocation of resources, taking into account the 
number of staff and additional amounts authorised by the budgetary authority. There is no 
request for additional staff. 
10.1 Effect on the number of posts 
Type of post 
Officials A 
B 
C 
Other resources 
Total Staff to be assigned to 
managing the operation 
Permanent 
posts 
DGI 
+ 
sectoral DGs 
3.5 
1 
None 
4.5 Temporary 
posts 
None Source 
Existing 
resources in the 
DGsor 
departments 
concerned 
3.5 
1 
4.5 Additional 
resources 
None Duration 
permanent 
10.2 Overall financial impact of human resources: 4.5 staff (107 500 Ecus per staff 
member per year = 483 750 Ecus). 
10.3 Increase in other adrninistrative expenditure as a result of the operation (A-7010: 
travel expenses) 
The expenses set out below relate to travel expenses for officials of the Commission 
attending meetings of the Joint Committee, joint sectoral groups, seminars and 
verifications, when these are outside Brussels. These will be taken care of by the relevant 
budget allocations of various Directorates Generals involved. 
119 
For 1998 this involves the following calculation: 
Budget heading 
Joint Committee 
A-7010 
Sectoral Groups 
A-7010 
Seminars 
A-7010 
Verifications 
A-7010 
A-7010 Total Amounts (ECU) 
22 120 
20 680 
20 680 
142 150 
205 630 Method of calculation 
No. of missions 
Aus/NZ 4 
Israel 4 
US 4 
CAN 4 
US 4 
CAN 4 
Aus/NZ 
US 18 
CAN 18 
Aus/NZ 12 
Israel 1 
73 Standard Unit cost 
US: Travel: 2 000 ECUs; 
per diem: 185 Ecus 
CAN: Travel: 1 750 
Ecus; per diem: 170 Ecus 
Aus / NZ: Travel: 3 200 
Ecus; per diem: 190 Ecus 
In ECU 
A. Joint 
Committee 
B Joint Sectoral 
Groups 
C. Seminars 
D. Verifications 
TOTAL Year 
1998 
22120 
20 680 
20 680 
142 150 
205 630 Year 
1999 
20 680 
20 680 
18 260 
142 150 
201 770 2000 
22120 
20 680 
48 430 
91230 2001 
20 680 
20 680 
48 430 
89 790 2002 
22 120 
20 680 
48 430 
91230 Total 
1998-2002 
107 720 
103 400 
38 940 
429 590 
679 650 
l2o 
IMPACT ASSESSMENT FORM 
THE IMPACT OF THE PROPOSAL ON BUSINESS 
with special reference to small and medium-sized enterprises 
Title of proposal 
Proposal for a Council Decision on the conclusion of an Agreement between the 
European Community and Canada on Mutual Recognition in relation to Conformity 
Assessment 
Reference number 
The proposal 
The legislation is necessary to conclude an Agreement between the European Community 
and Canada on Mutual Recognition in relation to Conformity Assessment, Certificates 
and Markings. This is an agreement negotiated and initialled by the Commission in 
accordance with the mandate and negotiating directives provided by the Council on 
21/9/92. 
The impact on business 
The business sectors affected are telecommunications terminal equipment, electrical 
equipment, recreational craft, medicinal products, and medical devices. 
The Agreement permits certification of conformity with technical regulations on product 
safety, etc, to be conducted in Europe for exports destined for Canada. This avoids the 
necessity for further certification by Canadian conformity assessment bodies before 
putting them on the Canadian market. 
The Agreement therefore presents important advantages from the point of view of 
transparency, market access, avoidance of duplication especially of cost and general 
facilitation of trade. This is of particular importance for small and medium-sized 
enterprises. 
The Agreement covers a wide range of sectors spread throughout the Community and an 
extensive range of firms in these sectors both large and small, the advantages are not 
limited to specific geographical areas in the Community. 
Businesses will have to comply with Canadian regulations and procedures, but the 
certification, as stated above, will be conducted by conformity assessment bodies located 
in the Community and designated by the Member States, and not in Canada. 
The Agreement will substantially reduce certification costs and improve prospects for 
exports, employment, investment and competitiveness by European firms. 
li\ 
The Agreement does not contain measures to take account of the specific situation of 
small and medium-sized firms, but by its nature and by reducing certification costs which 
are the same for all firms, the agreement will benefit small and medium sized enterprises 
to a greater extent proportionately than larger firms. 
Consultation 
The main trade organisations in each sector eg Eurobit, Orgalime, EFPIA, have been 
consulted and have universally declared their support for the Agreement. 
12-2-
ISSN 0254-1475 
COM(98) 271 final 
DOCUMENTS 
EN 11 08 06 10 
Catalogue number : CB-CO-98-289-EN-C 
ISBN 92-78-35528-3 
Office for Official Publications of the European Communities 
L-2985 Luxembourg