Proposal for a Council Decision on the conclusion af an Agreement between the European Community and Canada on Mutual Recognition in relation to Conformity Assessment
Date: 1998-05-06
Institutions: European Commission
Subjects: Canada, agreement (EU), mutual recognition principle, quality label

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) 

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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: 
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. 

this  Article  refers 

to  the 

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) 

d) 

e) 

f) 

the level  of trade between the Community  and Canada for  the sectors  and  products 
covered; 

the  views  expressed  by  Member  States  and  European  industry  groups  on  the 
benefits  of mutual recognition; 

the precedential  nature  (if  any)  of  arriving  at a mutual  recognition  agreement  with 
Canada in the sectors covered; 

overall  consistency  with  Community  policy  objectives 
field  of 
standardisation,  certification,  designation  of  conformity  assessment  bodies  and  the 
removal  of technical barriers to trade. 

the 

in 

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) 

b) 

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 
i.e.  exporting  Party  may  be 
proportionately  greater, 

trade  facilitation  benefits 

the  other 

to 

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 
infrastructure  of  regulatory  requirements, 
standards, processes,  and  quality  systems, etc.) mutually recognised  as equivalent  will 
be accepted. 

the  supporting 

(including 

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 
the  MRA 
industry'  organisations  have  been  consulted  extensively  on 
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. 

2. 

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. 

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 
Medical Devices 
Telephonic & Telegraphic 
Equipment 
Electrical Equipment 
Recreational Craft 

Total 

TOTAL 

95 
79 
266 

0.8 
0.7 
2.3 

834 
27 
1300 
11707 

7.1 
0.2 
11.1 
100.0 

*MMJ^ÙÎt^^i,-

Pharmaceuticals 
Medical Devices 
Telephonic & 
Telegraphic Equipment 
Electrical Equipment 
Recreational Craft 

Total 

TOTAL 

351 
97 
38 

3.4 
0.9 
0.4 

838 
18 
1342 
10 337 

8.1 
0.2 
13.0 
100.0 

EU  TRADE  WITH  CANADA  1996  (MECU) 

IMPORT 

Products 

Canada 

EXPORT 

Pharmaceuticals 
Medical Device 
Telephonic & Telegraphic 
Equipment 
Electrical Equipment 
Recreational Craft 

Total 

TOTAL 

SOURCE: 

88 
104 
213 

0.8 
0.9 
1.9 

988 
24 
1416 
11478 

8.6 
0.2 
12.3 
100.0 

Pharmaceuticals 
Medical Devices 
Telephonic & 
Telegraphic Equipment 
Electrical Equipment 
Recreational Craft 

Total 

TOTAL 

411 
116 
53 

3.8 
1.1 
0.5 

881 
4 
1465 
10 689 

8.2 
0.3 
13.9 
100.0 

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. 

2. 

3. 

4. 

5. 

6. 

7. 

Framework 

Telecommunications Terminal Equipment 

Electromagnetic Compatibility (EMC) 

Electrical Safety 

Recreational Craft 

Good Manufacturing Practices 

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  Party  designating  or  withdrawing  designation  of  a  Conformity 

a) 
Assessment  Body shall forward its proposal in writing to the other  Party; 

in the event that the other  Party consents  to the  proposal  or upon  the 
b) 
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. 

regarding  confidence-building  activities,  emergency  actions  and 
2.  Communications 
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 
technical 
requirements; and 

the  applicable 

to  meet 

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 
radio 
telecommunications 
transmitters  and information technology  equipment : 

terminal  equipment, 

requirements 

for 

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  - 
certificates  in accordance with the regulatory  requirements of the other  Party. 

the  recognition  of  one  Party's  quality  management 

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) 

(b) 

(c) 

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. 

Conformity Assessment  Bodies designated under this Annex shall be recognized as 
competent to perform the conformity assessment activities for which they have been 
designated. 

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 

6.5 

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. 

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 

7.2 

Any sub-contracting shall be in accordance with the sub-contracting  requirements of 
the other Party. 

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 

7.6 

7.7 

7.8 

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 

Each  Party  shall  establish  a  contact  point  to  provide  answers  to  all  reasonable 
inquiries from the other Party regarding procedures, regulations and complaints. 

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. 

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 

requirements  the relevant provisions of the sectoral annexes on  Electrical 

EMC 
Safety and EMC would (also) apply. 

Initialled on 30 May 1997 

37 

ATTACHMENT 1 

LEGISLATIVE.  REGULATORY  AND ADMINISTRATIVE  PROVISIONS 

EUROPEAN  COMMUNITY 

CANADA. 

Directive 
by 

Council 
supplemented 
93/97/EEC 
Directive  93/68/EEC 

as 
91/263/EEC, 
Directive 
Council 
and  amended  by  Council 

Telecommunications  Act 

Radiocommunication  Act 

Council  Directive  73/23/EEC  as  amended  by 
Council Directive  93/68/EEC 

Certification Standard CS-03 

CRTC Telecom  Decision No 82-14 

Council  Directive  89/336/EEC,  as  amended 
by  Council  Directives  92/31/EEC  and 
93/68/EEC 

Certification  Procedure CP-01 

Radiocommunication  Regulations 

European Commission  Decisions  established 
under  Council  Directives  91/263/EEC  and 
93/97/EEC. 

Radio  Standards  Procedure  (RSP)  #100: 
Radio Equipment Certification  Procedure 

The  EC  Member  States'  legislations  and 
regulations  in respect  of: 
(a)  non-harmonized  analogue  connection  to 
the  public  switched 
telecommunications 
network; 
(b) 
(civilian application). 

non-harmonized 

transmitters 

radio 

Handbook 
91/263/EEC  (ADLNB and ACTE approved). 

implementation 

the 

of 

of 

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 

CANADA 

In  specific  terms,  the  following  interfaces 
and services  are included: 

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 

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 
switched telecommunications networks 

to 

the  public 

Analogue  connections 
switched telecommunications networks 

to 

the  public 

radio 

All 
Radiocommunication  Regulations 
Appendix 1 ) with the exception of: 

transmitters 

to 
(See 

Initialled on 30 May 1997 

39 

EUROPEAN COMMUNITY 

CANADA 

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; 

including  all 

*  Medical  devices  and  active  implantable 
radio 
medical  devices 
transmitters  in connection with the  medical 
service 
telemetry 
radio  links  and  other  radio  equipment 
primarily  used in hospitals  and  health care 
facilities. 

instruments, 

including 

*  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; 

in  connection  with 

Aeronautical  equipment  including  all  radio 
transmitters 
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 

CANADA 

•  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. 

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 & 
MEMBER STATES 
Austria Bundesministerium  fur  wirtschaftliche 
Angelegenheiten, Sektion IX/2 

& 

Bundesministerium 

Ministry  of  Transport 

Ministere  de  PEconomie  ,  des 

Dept.  Of  Transport,  Energy  & 

BIPT 
Telestyrelsen 
Ministry 

Belgium 
Denmark 
Finland 
Telecommunications 
Germany 
Wirtschaft 
Greece 
Communications 
France 
finances et de I'industrie 
Ireland 
Communications 
Italy  Ministero 
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 
teknisk kontroll (SWEDAC) 
U.K.  Dept of Trade & Industry (DTI) 

Styrelsen for ackreditering och 

della  Communicazione 

I CANADA 

Industry  Canada  for  terminal  attachment, 
radio transmitters and  EMC 

Standards Council of Canada for  electrical 

of  safety 

fur  Standards  Council  of  Canada  for  quality 

management systems registrars 

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 

Canada 

(To be determined) 

Industry Canada 

Initialled on 30 Mav 1997 

44 

APPENDIX 1 

RADIO TRANSMITTERS STANDARDS LIST 
UNDER RADIOCOMMUNICATION REGULATIONS 

INTERFERENCE-CAUSING  EQUIPMENT STANDARDS 

Specification 

Title 

Issue 

Date 

ICES 001 

Industrial,  Scientific  and  Medical  Radio  Frequency 
Generators 

2 

August  13, 
1994 

ICES 003 

Digital  Apparatus 

3 

November 
22,1997 

ICES  0040 

Alternating Current  High Voltage  Power Systems 

1 

June 1991 

Initialled on 30 May 1997 

45 

RADIO STANDARDS SPECIFICATIONS 

Specification 

Title 

Issue 

Date 

RSS  118 

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 

Addendum to 118 

Annex A to 118 

Cellular System Mobile Station - Land 
Station Compatibility  Standard 

Supplement  1993-
1 

Supplement  1993-1 

to  Radio  Standards 

Specifications  (RSSs)  Nos. 118 

RSS  118. mod 

Amendment  N° 2 to RSS  118 

RSS 119 

Land Mobile And Fixed Radio 
Transmitters  and Receivers, 
27.41 - 960 MHz 

2 

'1 

5 

Aug. 19, 
1990 

Sept. 1, 
1990 

Oct. 22, 
1983 

June 12, 
1993 

Aug. 24, 
1996 

Aug. 24, 
1996 

RSS  123 

Low Power  Licensed 
Radiocommunication Devices 

1 
Provisional 

Feb. 24, 
1996 

RSS  125 

Land Mobile And Fixed Radio 
Transmitters  and Receivers, 1.705 to 
50.0 MHz, Primarily Amplitude  Modulated 

2 

Aug. 24, 
1996 

RSS  128 

800 MHz Dual-Mode Cellular Telephones 

1 
Drovisional 

June 12, 
1993 

Initialled on 30 May 1997 

46 

RSS  128. mod 

Amendments to RSS  128 

RSS  129 

800  MHz  Dual-Mode  CDMA  Cellular 

1 

Telephones 

Provisional 

RSS  129. mod 

Amendments to RSS-129 

RSS  130 

Digital Cordless Telephones in the Band 
944 to 948.5  MHz 

Annex  1  to  RSS 
130 

CT2Plus Class 2: Specification for the 
Canadian Common Air Interface for 
Digital Cordless Telephony, Including 
Public Access Services 

Attachment  1  to 
RSS  130 

European Telecommunications 
Standards Institute Interim Standard 
/I-ETS300 131 

2 

2 

Aug. 24, 
1996 

Feb. 24, 
1996 

Aug. 24, 
1996 

Jan.  23, 
1993 

Jan. 23, 
1993 

April 

1992 

RSS  131 

Radio Signal Enhancers for the Mobile 
Telephone Service 

1 
Provisional 

Feb. 24, 
1996 

RSS  133 

2 Ghz Personal Communications Services 

1 

Provisional 

Nov. 29, 
1997 

RSS  134 

900 MHz Narrowband Personal 
Communications Service 

1 
Provisional 

Aug. 24, 
1996 

RSS  135 

Digital Scanner Receivers 

RSS  136 

Land and Mobile Station 
Radiotelephone Transmitters and 
Receivers Operating in the 26.960 -
27.410 MHz General Radio Service 

1 
Provisional 

Oct. 26, 
1996 

5 

1, 

Jan. 
1977 

Initialled on 30 May 1997 

^ 

RSS  137 

cation and Monitoring Services (902-928 MHz) 

1 

RSS  210 

Low Power Licence-Exempt 
Radiocommunication Devices 

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 

Title 

Issue 

Date 

BETS-1 

BETS-3 

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 

BETS-4 

Technical  Standards  and  Requirements 
for Television Broadcasting  Transmitters 

BETS-5 

BETS-6 

BETS-8 

BETS-9 

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 

BETS-10 

Technical  Standards  and  Requirements 
the 
for  Television  Transmitters 
2,596-2,686  Mhz Band 

in 

BETS-11 

Technical  Requirements  Respecting the 
Identifications  of  Broadcasting  Stations 

1 

1 

1 

1 

1 

1 

1 

1 

1 

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 

Title 

Issue 

Date 

BTS1-1 

Broadcast Transmission Standard AM 
Broadcasting Stereophonic Operation 

1 
Provisional 

Feb. 6, 1988 

BTS1-2 

Broadcast Transmission Standard: AM 
Broadcasting RF Emission Limits 

1 
Provisional 

Nov. 1989 

BTS3 

BS.14 

Broadcasting Transmission Standard: 
Television Broadcasting 

2 

May 1990 

Broadcast Specification: Television 
Broadcast Videotext 

1 
Provisional 

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. 

2.2 

The  relevant  technical  requirements  are  specified  under  the  legislation  and 
regulations referenced in Attachment 1. 

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. 

Both Parties agree to  recognize each other's suppliers  declarations  of  compliance, 

3.2 
as required under their respective legislation 

4. INSTITUTIONS 

4.1 

DESIGNATING AUTHORITIES 

(a) 

(b) 

The Designating Authorities for the purpose of this annex are listed in 
Attachment 2. 

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) 

(b) 

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. 

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 

5.2 

The  mutual  recognition  provisions  of  this  Annex,  notably  Section  3  , will  take  effect 
18 months following the entry into force of this Annex. 

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 

6.2 

Any  sub-contracting  of  conformity  assessment  shall  be  in  accordance  with  the 
sub-contracting  requirements  of the other Party. 

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 

6.5 

Each  Party  shall  establish  a  contact  point  to  provide  answers  to  all  reasonable 
inquiries from the other Party  regarding procedures, regulations  and complaints. 

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 
92/31 /EEC, 93/68/EEC and 93/97/EEC 

91/263/EEC, 

Directives 

Council 

Radiocommunication Regulations 
(Appendix I) 

The  EC  Member  States'  legislation  and 
regulations 
non-harmonized  radio  transmitters  (civilian 
application). 

respect  of  EMC 

in 

for  The Category II Equipment Standards List 

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 

Austria 

Austria 

Austria 

Austria 

Austria 

fur  All 

equipment 
telecommunication  equipment 

except 

Bundesministerium 
wirtschaftliche 
Angelegenheiten 
IX/4 
Landstrasser  Haupstrasse 55-57 
1031 WIEN 

Abteilung 

Bundesministerium  fur 
offentliche Wirtschaft  und 
Verkehr 
Radetzkystrasse 2 
1030 WIEN 

Zulassungsburo 
Nordbergstrasse  15 
1091 WIEN 

Telecommunication  equipment 

Telecommunication  equipment 

fur  Wien,  Telecommunication  equipment 

und 

Fernmeldeburo 
Niederosterreich 
Burgenland 
Nordbergstrass  15 
1091 WIEN 

Fernmeldeburo  fur  Steiermark  Telecommunication  equipment 
und  Karten 
Neutorgasse 46 
8011 GRAZ 

Fernmeldeburo 
Oberosterreich  und Salzburg 
Domgasse 1 
4010 LINZ 

fur  Telecommunication  equipment 

Initialled on 30 May 1997 

Austria 

Belgium 

Belgium 

Belgium 

56 

Fernmeldeburo  fur  Tirol  und  Telecommunication  equipment 
Voralberg 
Maximilianstrasse 2 
6010  INNSBRUCK 

des 

Ministere 
Economiques 
Administration  de PEnergie 
Service 
Produits  Energetiques 
154, Bd Emile Jacqmain 
1210 BRUXELLES 

Equipements 

Affaires  Autorite 

federate 

coordination  de 
application  de 

la 
pour 
la  mise  en 
legislation 
la 

et  CEM 
et 
Haute 
surveillance  du  marche  pour 
tout  produit 

surveillance 

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 

et 

Ministere 

(aupres  des 

Institut  Beige  des  Services  Surveillance  du  marche  dans  le 
des  domaine  des  produits  relevant 
Postaux 
Telecommunications 
radio 
du 
Communications 
Plnfrastucture) 
Tour Astro 
Av. de I'Astronomie, 14, BP21 
1030  BRUXELLES 

des  emetteurs et recepteurs  radio. 
de  Reseau de telecommunication. 

perturbations 

et 

Denmark 

Finland 

Telestyrelsen 
Holsteinsgade  63 
2100  COPENHAGEN 

Ministry of Trade and Industry 
P.O.  Box 230 
00171  Helsinki 

manufacturing 

Industrial 
equipment 
Medical and scientific  apparatus 
Information 
technology 
equipment 
and 
Domestic 
household electronic  equipment 
Educational 
electronic 
equipment 
Lights  and fluorescent  lamps 

appliances 

Finland 

Telecommunications 
Administration Centre 
P.O.  Box 53 

I  00211  HELSINKI 

Telecommunications 
equipment 
Radio  equipment 

terminal 

| Telecommunications  networks 

Initialled on 30 Mav 1997 

Finland 

France 

Germany 

Germany 

Greece 

Ireland 

Italy 

Italy 

57 

keskus 

Turvatekniikan 
(TUKES) 
Safety Technology  Authority 
P.O.  Box 123 
Lonnrotinkatu  37 
00181  HELSINKI 

et 

des 
et  du 

Ministere de Plndustrie, des 
Postes 
Telecommunications 
Commerce  Exterieur 
Direction 
Generate 
Strategies  Industrielles 
Sous-Direction  de la Qualite pour 
I'lndustrie et la  Normalisation 
22, rue  Monge 
75005  PARIS 

des 

fur  Post  und  All equipment 

Bundesamt 
Telekommunikation (BAPT) 
Referat124 
Postfach 8001 
55003  MAINZ 

fur  Post  All equipment 

Telekommunikation 

Bundesministerium 
und 
(BMPT) 
Referat314 
Postfach 8001 53105 BONN 

Ministry  of Transport & 
Communications 
49, Syngrou Avenue 
11780 ATHENS 

Transport, 

of 

Department 
Energy and  Communications 
44 Kildare  Street 
Dublin 2 
Ministero 
Communicazioni  (DGRQS) 
Viale America 201 
00144  ROMA 

delle 

Ministero  dell'lndustria,  del 
Commercio e dell'Artigianato 
(DGSPC) 
Via Molise 2 
00187  ROMA 

Initialled on 30 Mav 1997 

Luxemburg 

Netherlands 

Portugal 

Spain 

Spain 

Sweden 

Sweden 

58 

Service de PEnergie de L' Etat 
B.P.  10 
2010  LUXEMBOURG 

Ministerie  van  Verkeer  en 
Waterstaat 
Hoofdirectie 
Telecommunicatie en Post 
Postbus 450 
9700ALGRONINGEN 

Instituto  das  Comunicacoes 
de 
Portugal (ICP) 
Av. J. Malhoa, 12 
1070LISBOA 

Ministerio  de Fomento 
Direccion 
General 
Telecomunicaciones 
Palacio de Telecomunicaciones 
Plaza de Cibeles, s/n. Planta 5a 
28014  MADRID 

de 

Equipos  de  telecomunicacion 

y  Todos  los  equipos  afectos  a  la 
los  equipos 

Directiva  excepto 

Industria 

Ministerio  de 
Energia 
Direccion  General  de  Calidad  y  de telecomunicacion. 
Seguridad  Industrial 
Paseo  de 
Planta 12 
28071  MADRID 

la  Castellana,  160 

Electrical 

National 
Board 
P.O.B. 1371 
11193 Stockholm 

Safety  National  co-ordinating  authority 
the  EMC 
for 
implementing 
legislation.  Supervision 
and 
market  surveillance  authority 
concerning  EMC for  all  products 
with 
radio 
the  exception  of 
transmitters 
equipment 
and 
intended  for  connection  to  the 
public 
telecommunications 
network 

National  Post  and  Telecom  Supervision 
surveillance 
Agency 
authority  concerning  EMC  for 
P.O.B. 5398 
radiotransmitters 
and 
10249 Stockholm 
equipment  intended 
to 
for  connection 
telecommunications  network 

the  public 

market 

and 

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 

Title 

Issue 

Date 

ICES 001 

Industrial,  Scientific  and  Medical  Radio  Frequency 
Generators 

2 

August  13, 
1994 

ICES 003 

Digital Apparatus 

3 

November 
22,1997 

ICES 0040 

Alternating Current High Voltage Power Systems 

1 

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 
Community  (EC); and 

(CABs) 

in  Canada  by 

the  European 

b) 

CABs in the EC by Canada. 

2. 

SCOPE AND  COVERAGE 

2.1 

2.2 

2.3 

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). 

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). 

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 

4.2 

The transitional arrangements shall operate for a term of eighteen  (18)  months 
from the time this MRA enters into force. 

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) 

b) 

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 

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) 

b) 

test products to Canadian requirements; 

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) 

b) 

they inform the applicant and the EC CAB in a precise and complete 
manner of any deficiency; 

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) 
according 
Canadian 
certification 

Accreditation  by  a  European  accreditation  organization 
to applicable  and  relevant  I SO/I EC Guides  adapted to 
and  European  conditions 
organizations; and 

for  accreditation  of 

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 

7.3 

The  Parties  will  encourage  the  establishment  of  mutual  recognition 
agreements between the European accreditation organizations and the SCC. 

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 

8.2 

Upon  request,  a  CAB  may  be  required  to  provide  additional  documentary 
evidence  to  facilitate  its  passage  from  the  transitional  to  the  operational 
phase. 

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 

9.2 

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). 

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 
in  the  provincial  /  territorial  legislation  is 
Council Directive 93/68/EEC 
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 
- 
- 
-  Luxembourg: Service de l'Energie de l'Etat 
-  Netherlands: Ministerie van Economische Zaken 
-  Portugal:  gnder  authority  of  the  Ministry  of  Industry:  Instituto  Portugees  da 

Ireland: Department of Enterprise, Trade and Employment 
Italy: Ministero dell'lndustria 

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. 

Initialled on 30 May 1997 

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) 

b) 

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. 

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) 

b) 

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 this Annex. 

Initialled on 30 May 1997 

73 

Section VI: Additional Provisions 

In  accordance  with  the  relevant  provisions  of  the  Mutual  Recognition  Framework 
6.1. 
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. 

Initialled on 30 May 1997 

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 

| 

Initialled on 30 May 1997 

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. 

Initialled on 30 Mav 1997 

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 
regulatory 
programmes 
requirements,  standards,  processes,  and  quality  systems,  etc.)  mutually 
recognized as equivalent will be accepted. 

infrastructure  of 

the  supporting 

(including 

2.3.  The MRA on Medicinal Products / Drug GMP is built on three pillars: 

a) 

b) 

c) 

the concept of a GMP compliance programme (Appendix  4 ) 

a "two-way" alert system (Appendix 5 ) 

a transition period including a confidence building exercise (Appendix 
6) 

Initiallad on 30 May  1997 

78 

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 
the  authorities 

if  agreed  to  by 

legislation  of  one  Party  but  not  the  other 
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 

Initiallad on 10 June 1997 

79 

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 ). 

Initiallad on 30 May  1997 

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. 

Initiallad on 30 May  1997 

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) 

b) 
c) 

are  appropriately  authorised,  to  manufacture  and/or  control  the 
relevant  medicinal product / drug or to carry out the relevant specified 
operations, 
are regularly inspected by the authorities, and 
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 

issued 
Certificates  of  manufacturing  authorisations/licences  will  be 
In 
expeditiously,  and  the  time  taken  should  not  exceed  30  calendar  days. 
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 
In  the  European  Community  the  "qualified 
the  batch  for  sale  or  supply. 
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. 

Initiallad on 30 May  1997 

83 

8.2. Information Sharing 

8.2.1 

In  accordance  with  the  general  provisions  of  the  Annex,  the  Parties  will 
to  determine  and  maintain  the 
exchange  all  information  necessary 
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. 

Initiallad on 30 May  1997 

84 

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: 

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 

Italy: 

Central Inspectorate, Ministry of Health, Rome 

Luxembourg: 

National Laboratory of Health, Luxembourg 

The Netherlands: 

Inspectorate for Health Care; Ministry of  Health, Welfare, and 
Sport, Rijswijk 

Portugal: 

Spain: 

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 

Sweden: 

Medical Products Agency, Uppsala 

United Kingdom: 

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 
corrective action) 
Codes of conduct/ethics 
Training/certification policies/guidelines 
Alert/crisis management  policies/procedures/guidelines 
Organizational  structure,  including  roles,  responsibilities  and  reporting 
relationships 

re-inspection, 

(inspection, 

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 
programmes 

to  ensure  effectiveness  of 

training 

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 
(develop  quality 
the  certification  . programme 
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 
in  both 
maintaining  the  same  high  standards  of  health  and  safety 
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. 

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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. 

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97 

The  Confidence  Building  Programme  should  include  the  following  actions  and 
activities: 

a) 

b) 

c) 

d) 

e) 

f) 

g) 

h) 

The  organization  of  seminars  aiming  to 
inform  Regulatory/Designating 
Authorities  and  Conformity  Assessment  Bodies  on  each  Party's  regulatory 
system, procedures and  requirements; 

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); 

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; 

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 
the  competency  of 
CABs. 
regulatory/designating  authorities or CABs can be requested by either Party; 

Additional  evidence  with 

respect 

to 

The  design,  development  and  testing  of  a  two-way  alert  system  (see 
guidance in Attachment  IV); 

The  establishment  of  contact  points  between  Regulatory/Designating 
Authorities  and CABs of both Parties; 

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 

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. 

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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 
Each  Party  shall  associate  Regulatory/Designating 
Authorities  and  Conformity  Assessment  Bodies  of  the  other  Party  in  activities  of 
exchange of information and experience. 

legal  requirements). 

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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. 

Initiallad on 30 May  1997 

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 

the  Conformity  Assessment  Bodies  For 

the  Conformity  Assessment  Bodies 

For 
Designated by Canada 

Designated by the European Community 

Austria 

Therapeutic  Federal  Ministry  of  Health  and  Consumer 

Canada 
Medical  Devices  Bureau, 
Products Directorate, Health Canada 

la  Sante  publique,  de 

Protection 
Belgium 
Ministere  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 

Initiallad on 30 May  1997 

103 

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 

Initiallad on 30 May  1997 

104 

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 
- 
assessment and certificates 

scope  and  format  of  abbreviated  reports,  conclusions  of  conformity 

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, 

reports, 
norms/frequency/procedures  for  re-audit  or  re-evaluation  and  corrective 
action 

timeliness 

quality 

and 

of 

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. 

Initiallad  on 30 May  1997 

106 

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 
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). 

that  meet 

Initiallad on 30 May  1997 

107 

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. 

Designating  Authorities  shall  only  designate  Conformity  Assessment  Bodies 
2. 
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. 

The  technical  capability  criteria  shall  be  based  on  internationally  accepted 
documents  supplemented  by  specific  interpretative  documents  developed  as 
appropriate from time to time. 

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. 

4. 

5. 

Initiallad on 30 May  1997 

109 

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; 

the  accreditation  process  is  conducted  in  conformance  with  the  relevant 

(i) 
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 

the  accreditation  body,  operating  under  the  authority  of  a  Designating 
(iii) 
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: 

Initiallad on 30 May  1997 

110 

-  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. 

9. 

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. 

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. 

Initiallad on 30 Mav 1997 

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. 

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. 

V 

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. 

Initiallad on 30 May 1997 

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. 

B.  Attendance at Joint Sectoral Groups 

114 

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 

Amounts 
(Ecus) 

Joint Committee 

12 940 

B7-8500 

Sectoral Groups 
B7-8500 

Seminars 

B7-8500 

57 680 

103 540 

Verifications 

142 150 

Method of calculation 

No. of missions 
Bxl 
Bxl 
Aus/NZ 
Israel 
Bxl 
US 
CAN 
US 
CAN 
Aus/NZ 
Bxl 
US 
CAN 
Aus/NZ 
Israel 

2 
2 
2 
1 
16 
8 
8 
10 
10 
14 
28 
18 
18 
12 
1 

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 

B7-8500 

Information 
B7-8500 
B7-8500 

10 000 

Total 

326 310 

150 

In Ecus 
(current prices) 

Breakdown 

Year 
1998 

Year 
1999 

2000 

2001 

2002 

Total 
1998-2002 

A. Joint Committee 

12.940 

13 760 

12 940 

13 760 

12 940 

66 340 

B. Joint Sectoral Groups 

57 680 

57 680 

57 680 

57 680 

57 680 

288 400 

C. Seminars 

103 540 

96 310 

199 850 

D. Verifications 

142 150 

142 150 

48 430 

48 430 

48 430 

429 590 

E. Information 

10 000 

10 000 

10 000 

30 000 

Total 

326 310 

319 900 

129 050 

119 870 

119 050 

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 

Year 
1998 

1999 

2000 

2001 

2002 

1000 Ecus 
2003 
and 
following 
years 

Total 

326 

319 

129 

119 

119 

119 

1131 

Schedule of 
Commitment 
Payment 
appropriations 
1998 
1999 
2000 
2001 
2002 
2003 

326 

319 

• 

129 

119 

119 

Total 

326 

319 

129 

119 

119 

326 
319 
129 
119 
119 
119 

1131 

119 

119 

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 

Staff to be assigned to 
managing the operation 

Permanent 
posts 

Temporary 
posts 

DGI 
+ 
sectoral DGs 
3.5 

Officials 

A 

B 

Source 

Duration 

Additional 
resources 

Existing 
resources in the 
DGsor 
departments 
concerned 

None 

3.5 

None 

permanent 

C 

Other resources 
Total 

None 

1 

4.5 

1 

4.5 

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. 

For 1998 this involves the following calculation: 

119 

Budget heading 

Amounts  (ECU) 

Method  of calculation 

Joint Committee 

A-7010 
Sectoral Groups 

A-7010 
Seminars 

A-7010 
Verifications 

22 120 

20 680 

20 680 

A-7010 

142 150 

A-7010 

Total 

205 630 

No. of missions 
Aus/NZ 
Israel 

4 
4 

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 

US 
CAN 

US 
CAN 
Aus/NZ 
US 
CAN 
Aus/NZ 
Israel 

4 
4 

4 
4 

18 
18 
12 
1 
73 

Year 
1998 

Year 
1999 

2000 

2001 

2002 

Total 
1998-2002 

In ECU 

22120 

20 680 

22120 

20 680 

22 120 

107 720 

20 680 

20 680 

20 680 

20 680 

20 680 

103 400 

A. Joint 
Committee 
B Joint Sectoral 
Groups 

C. Seminars 

20 680 

18 260 

38 940 

D. Verifications 

142 150 

142 150 

48 430 

48 430 

48 430 

429 590 

TOTAL 

205 630 

201 770 

91230 

89 790 

91230 

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