Agreement on mutual recognition between the European Community and Canada
Date: 1998-05-14
Institutions: Canada, European Community
Subjects: Canada, Community certification, EC conformity marking, agreement (EU), harmonisation of standards, mutual recognition principle, quality label, quality standard, sectoral agreement

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Official  Journal  of  the  European  Communities

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AGREEMENT

on  mutual  recognition  between  the  European  Community  and  Canada

TABLE OF CONTENTS

Page

1. Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

2. Telecommunications  terminal  equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

3. Electromagnetic  compatibility  (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23

4. Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28

5. Recreational  craft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

34

6. Good  manufacturing  practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

7. Medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

53

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Official  Journal  of  the  European  Communities

16.10.98

The  EUROPEAN  COMMUNITY  and  the  GOVERNMENT  OF  CANADA  (‘the  Parties’),

CONSIDERING  the  traditional  links  of  friendship  that  exist  between  Canada  and  the  European
Community;

CONSIDERING that on the basis of past experience under the 1976 Framework Agreement on commercial
and economic cooperation between the European Communities and Canada, and in order to further develop
their  dialogue  in  the  area  of  standards  as  specified  in  the  1990  Declaration  on  EC-Canada  relations,  both
Parties have expressed a desire to establish a more formal framework for the conduct of collaboration in the
field  of  mutual  recognition  in  relation  to  conformity  assessment;

CONSIDERING the Parties’ interest in strengthening the rules governing free and unhindered international
trade;

CONSIDERING  the  improved  conditions  for  trade  between  the  Parties  which  the  mutual  recognition  of
tests,  certificates  and  marks  of  conformity  will  bring  about;

RECOGNISING  the  importance  of  maintaining  their  respective  high  standards  of  health  and  safety;

BEARING  IN  MIND  their  status  as  Parties  to  the  Agreement  Establishing  the  World  Trade  Organisation
and  conscious  in  particular  of  their  obligations  under  the  World  Trade  Organisation  Agreement  on
Technical  Barriers  To  Trade,

HAVE  AGREED  AS  FOLLOWS:

Article  I

Definitions

of 

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) 
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:

International  Organisation 

the 

— 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
for  determining
technical

the  performance  of  procedures 
whether 
regulations  or  standards  are  fulfilled,

the  relevant  requirements 

in 

— designating  authority  means  a  body  with  power  to
designate,  monitor,  suspend  designation  or  withdraw
designation of conformity assessment bodies under its
jurisdiction,

— designation  means  the  authorisation  by  a  designating
authority of a conformity assessment body to perform
conformity  assessment  activities,

— Regulatory  Authority  means  a  government  agency  or
other entity, that exercises a legal right to control the
use  or  sale  of  products  within  a  Party’s  jurisdiction,
and  may  take  enforcement  action  to  ensure  that
products marketed within its jurisdiction comply with
legal requirements.

In  the  event  of  an 
inconsistency  between  ISO/IEC
Guide 2 and definitions in this Agreement or its Annexes,
the  definitions  in  this  Agreement  shall  prevail.

Article  II

General obligations

The Sectoral Annexes to this Framework Agreement

1.
constitute  integral  parts  of  this  Agreement.

assessment 

The  Government  of  Canada  shall  accept  the  results
2.
of 
including
conformity 
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.

procedures, 

assessment 

procedures, 

The  European  Community  shall  accept  the  results
3.
of 
including
conformity 
certifications of compliance, as required by the European
Community  and  Member  States 
legislation  and
regulations  identified  in  the  Sectoral  Annexes,  produced
assessment  bodies  or
by  designated 
authorities 
this
Agreement.

in  accordance  with 

in  Canada 

conformity 

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4. Where  transitional  rules  have  been  specified  in
Sectoral Annexes, the above rules will apply following the
successful  completion  of  the  transitional  phase.

The  Parties  agree  that  each  sectoral  transition  plan

2.
shall  specify  a  time  period  for  completion.

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.

3.
The  Parties  may  amend  any  transition  period  by
Joint  Committee
mutual  agreement 
established  under  this  Agreement,  taking  account  of
recommendations  made  by  the  relevant  joint  sectoral
groups.

through 

the 

Article  III

General  coverage  of  the  Agreement

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.

This  Agreement  applies  to  conformity  assessment
its  Sectoral

for  products  covered  by 

1.
procedures 
Annexes.

Each  Sectoral  Annex  shall  contain  the  following

2.
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

The  Parties  agree  to 

1.
implement  the  transition
commitments  on  confidence  building  where  included  in
the  Sectoral  Annexes.

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.

The  Parties  agree  that  their  respective  conformity
2.
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
in  the  territory  of  such  Party  arising  from  or 
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.

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Article  VI

Designating  authorities

The  Parties  shall  ensure  that  the  designating
1.
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.

bodies  under  the  jurisdiction  of  the  other  Party.  This
right  will  be  exercised  under  exceptional  circumstances
only  and  justified,  in  an  objective  and  reasoned  manner
in  writing,  to  the  Joint  Committee.  The  Joint  Committee
will  discuss  such  requests.

2. Where  the  Joint  Committee,  either  on  its  own
initiative  or  on  a  recommendation  from  the  relevant
sectoral  group,  comes  to  the  conclusion  that  verification
of  technical  competence  or  compliance  of  a  conformity
assessment  body  operating  in  the  territory  of  one  of  the
Parties  is  required,  it  will  be  carried  out  in  a  timely
manner  by  the  Party  in  whose  territory  the  body  in
question is located, or by the Parties jointly if they agree.
The  Party  may  seek  the  assistance  of  its  designating
authority  in  carrying  out  the  verification.

Unless  decided  otherwise  by  the  Joint  Committee,
3.
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.

In  designating 

2.
the  designating
authorities  shall  specify,  in  each  Annex,  the  scope  of
conformity  assessment  activities  for  which  such  bodies
have  been  designated.

such  bodies, 

The  designation  constitutes  a  formal  judgment  by
3.
the  Party  that  the  conformity  assessment  body  has
demonstrated an acceptable level of technical competence
in  providing  services  identified  in  the  designation  and
further  has  agreed  to  comply  with  the  requirements  of
the  other  Party,  as  set  out  in  a  Sectoral  Annex.

4.
In  accordance  with  the  terms  of  the  Sectoral
Annexes,  each  designating  authority  will  make  available,
if  requested,  a  statement  of  technical  competence  of  its
designated  conformity  assessment  bodies.

Article  VIII

Verification  and  suspension  of  conformity
assessment  bodies

Article  IX

Exchange  of  information

The  Parties  shall  exchange  information  concerning
1.
the  implementation  of  the  legislative,  regulatory  and
administrative  provisions 
the  Sectoral
Annexes.

identified 

in 

2.
Each  Party  shall  inform  the  other  Party  of  changes
related to the subject matter of this Agreement, and shall,
except  where  considerations  of  safety,  health  and
environmental  protection  require  more  urgent  action,
notify the other Party of the new provisions at least sixty
(60)  days  before  their  entry  into  force.

1.
Each  Party  has  the  right  to  challenge  the  technical
competence  and  compliance  of  conformity  assessment

3.
Each  Party  shall  promptly  notify  the  other  Party  of
any changes of its designating authorities and conformity
assessment  bodies.

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Article  X

Monitoring  of  the  Agreement

The  Parties  may  hold  ad  hoc  consultations  within
1.
the 
satisfactory
Joint  Committee 
functioning  of  this  Agreement.

ensure 

the 

to 

2. One Party may request the other to carry out, on its
behalf,  audits  and 
conformity
assessment  bodies  working  to  the  requirements  of  the
requesting Party. The requesting Party will bear the costs
of  the  audit.

re-evaluations  of 

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.

(d) determining  the  status  of  conformity  assessment
technical  competence  has  been

bodies  whose 
contested;

(e) exchanging  information  and  notifying  the  Parties
legislative,  regulatory  and
of  modifications  of 
administrative  provisions  referred  to  in  the  Sectoral
Annexes;  and

(f) addressing any questions relating to the operation of
this  Agreement  and  its  Sectoral  Annexes,  including
questions  related  to  health  and  safety,  market  access
and  the  balance  of  rights  and  obligations  under  the
Agreement.

4.
The following procedure shall apply to the inclusion
in  or  withdrawal  from  a  Sectoral  Annex  of  a  conformity
assessment  body:

(a) a  Party  designating  or  withdrawing  designation  of  a
its

conformity  assessment  body  shall 
proposal  in  writing  to  the  other  Party;

forward 

Article  XI

Joint  Committee

(b)

(c)

There  shall  be  established  under  this  Agreement  a
1.
Joint  Committee  of  the  two  Parties,  which  will  be
responsible 
the
effective 
Agreement.

functioning  of 

the 

for 

in  the  event  that  the  other  Party  consents  to  the
proposal  or  upon  the  expiry  of  60  days  without  an
objection  having  been  made,  the  inclusion  in  or
the
withdrawal 
conformity  assessment  body  shall  take  effect;  and

the  Sectoral  Annex  of 

from 

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
proposing  Party  to  carry  out  a  verification,  which
may  include  an  audit,  of  the  body  concerned,  in
accordance  with  the  provisions  of  this  Agreement.

the  Joint  Committee  may  request 

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;

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.

(b) giving effect to the decision to designate or withdraw
the designation of a particular conformity assessment
body;

The  responsibility  of  the  joint  sectoral  groups  may

2.
include  the  following:

(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;

(a) at  the  request  of  a  Party,  to  examine  specific
implementation  of  any
in  the 
problems  arising 
transitional plans for mutual recognition and to give
advisory  opinions  to  the  Joint  Committee  on  issues
of  mutual  concern;

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(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;

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.

(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  XV

Market  access

Each  Party’s  obligation 

1.
accord  mutual
recognition  within  the  terms  of  a  Sectoral  Annex  to  this
the  other  Party
Agreement 
continuing:

is  conditional  upon 

to 

Article  XIII

Sectoral  contact  point,  management  of  information,
assistance  and  emergency  action

(a)

to  provide  access  to  its  market  for  products  that,
having  been  subjected  to  conformity  assessment
procedures,  can  be  demonstrated  to  meet  the
applicable  technical  requirements;  and

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.

(b)

in  existence 

to  maintain 
legal  and  regulatory
authorities capable of implementing the provisions of
this  Agreement.

Communications 

2.
confidence-building
activities,  emergency  actions  and  regulatory  enforcement
for  products  subject  to  this  Agreement  will  normally  be
handled  directly  by  the  sectoral  contact  points.

regarding 

Article  XIV

Safeguards

1.
The appropriate regulatory authorities of each Party
retain  all  authority  under  the  applicable  law  of  that
Party,  to  interpret  and,  as  set  out  in  paragraph  2  below,
regulatory
enforce 
provisions. A regulatory authority of the importing Party
is  not  the  legal  representative  of  the  exporting  Party.

legislative  and 

respective 

their 

2. Where  a  Party 
introduces  new  or  additional
conformity  assessment  procedures  affecting  a  sector
covered  by  a  Sectoral  Annex,  the  Joint  Committee  shall,
unless  the  Parties  agree  otherwise,  bring  such  procedures
within  the  scope  of  this  Agreement  and  the  relevant
Annex.

3.
If,  upon  implementation  of  such  new  or  additional
requirements,  conformity  assessment  bodies  designated
by  the  other  Party  in  order  to  meet  such  requirements
have  not  been  recognised  by  the  Party  implementing  the
requirements, the other Party may suspend its obligations
under  the  Sectoral  Annex  in  question.

Article  XVI

Fees

2. When  a  Party  or  one  of  its  regulatory  authorities
has  reasons  to  believe  that  a  product  from  the  other
Party,  covered  under  a  Sectoral  Annex,  may  compromise
the  health  or  safety  of  persons  in  its  territory,  or
otherwise  fails  to  satisfy  a  requirement  of  the  applicable
Sectoral Annex, the Party in the receiving territory retains
all  powers  under  its  applicable  domestic  law  to  take  all
appropriate  and  immediate  measures  to  withdraw  such
products  from  the  market,  prohibit  their  placement  on
the  market,  restrict  their  free  movement,  or  initiate  a
product  recall.  The  regulatory  authority 
in  whose
territory  the  action  has  been  taken  shall  inform  its
counterparts  and  the  Joint  Committee  within  15  days  of
taking  such  action,  giving  its  reasons.

The  Parties  agree  that  border 

3.
inspections  and
checks  of  products  certified  to  the  importing  Party’s

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
in  mutual  recognition
Parties,  obligations  contained 
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.

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Article  XVIII

Territorial application

This  Agreement  and  its  Annexes  shall  apply,  on  the  one
hand,  to  the  territories  in  which  the  Treaty  establishing
the  European  Community  is  applied,  and  under  the
conditions  laid  down  in  that  Treaty  and,  on  the  other
hand,  to  the  territory  of  Canada.

Article  XIX

Entry  into  force,  modification  and  duration

1.
This  Agreement  and  its  Annexes  shall  enter  into
force  on  the  first  day  of  the  second  month  following  the
date  on  which  the  Parties  have  exchanged  diplomatic
notes  confirming  the  completion  of  their  respective
procedures  for  the  entry  into  force  of  this  Agreement.

This  Agreement  may  be  amended  by  the  written
2.
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.

Either  Party  may  terminate  this  Agreement  by

4.
giving  the  other  Party  six  months’  notice  in  writing.

Article  XX

Final  provisions

This  Agreement  and  the  Sectoral  Annexes  are  drawn  up
in  two  originals  in  the  Danish,  Dutch,  English,  Finnish,
French,  German,  Greek,  Italian,  Portuguese,  Spanish  and
Swedish  languages,  each  text  being  equally  authentic.

Hecho  en  Londres,  el  catorce  de  mayo  de  mil  novecientos  noventa  y  ocho.

Udfærdiget  i  London  den  fjortende  maj  nitten  hundrede  og  otteoghalvfems.

Geschehen  zu  London  am  vierzehnten  Mai  neunzehnhundertachtundneunzig.

(cid:139)ΕγØν(cid:229)  (cid:243)(cid:244)(cid:239)  Λ(cid:239)ν(cid:228)(cid:221)ν(cid:239),  (cid:243)(cid:244)Øς  (cid:228)(cid:229)κÆ(cid:244)(cid:219)(cid:243)(cid:243)(cid:229)ρØς  ΜÆØ(cid:239)υ  ł(cid:221)λØÆ  (cid:229)ννØÆκ(cid:222)(cid:243)ØÆ  (cid:229)ν(cid:229)νη(cid:139) ν(cid:244)Æ  (cid:239)κ(cid:244)ω(cid:139) .

Done  at  London  on  the  fourteenth  day  of  May  in  the  year  one  thousand  nine  hundred  and
ninety-eight.

Fait  à  Londres,  le  quatorze  mai  mil  neuf  cent  quatre-vingt-dix-huit.

Fatto  a  Londra,  addì  quattordici  maggio  millenovecentonovantotto.

Gedaan  te  London,  de  veertiende  mei  negentienhonderd  achtennegentig.

Feito  em  Londres,  em  catorze  de  Maio  de  mil  novecentos  e  noventa  e  oito.

Tehty  Lontoossa  neljäntenätoista  päivänä  toukokuuta  vuonna  tuhatyhdeksänsataayhdeksän-
kymmentäkahdeksan.

Som  skedde  i  London  den  fjortonde  maj  nittonhundranittioåtta.

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Por  la  Comunidad  Europea

For  Det  Europæiske  Fællesskab

Für  die  Europäische  Gemeinschaft

ΓØÆ  (cid:244)ην  Ευρω(cid:240)Æϊκη(cid:139) Κ(cid:239)Øν(cid:222)(cid:244)η(cid:244)Æ

For  the  European  Community

Pour  la  Communauté  européenne

Per  la  Comunità  europea

Voor  de  Europese  Gemeenschap

Pela  Comunidade  Europeia

Euroopan  yhteisön  puolesta

På  Europeiska  gemenskapens  vägnar

Por  el  Gobierno  de  Canadá

For  Canadas  regering

Für  die  Regierung  Kanadas

ΓØÆ  (cid:244)ην  κυ(cid:226)(cid:219)ρνη(cid:243)η  (cid:244)(cid:239)υ  ΚÆνÆ(cid:228)(cid:192)

For  the  Government  of  Canada

Pour  le  gouvernement  du  Canada

Per  il  governo  del  Canada

Voor  de  regering  van  Canada

Pelo  Governo  do  Canadá

Kanadan  hallituksen  puolesta

På  Kanadas  regerings  vägnar

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SECTORAL  ANNEX  ON  TELECOMMUNICATIONS  TERMINAL  EQUIPMENT,  INFORMATION
TECHNOLOGY  EQUIPMENT  AND  RADIO  TRANSMITTERS

1.

PURPOSE

The purpose of this Annex is to establish a framework for the acceptance of test reports and, at the
end  of  a  transitional  period,  certificates  of  conformity  issued  in  the  territory  of  one  Party  in
accordance  with  the  regulatory  requirements  of  the  other  Party,  as  referenced  in  Attachment  1.

This  Annex  constitutes  a  Sectoral  Annex  to  the  Framework  Agreement  on  mutual  recognition
between  Canada  and  the  European  Community.

2.

SCOPE  AND  COVERAGE

2.1.

The  provisions  of  this  Annex  shall  apply  to  the  following  types  of  telecommunications  terminal
equipment,  radio  transmitters  and  information  technology  equipment:

(a) equipment  intended  for  connection  to  the  public  telecommunications  network  in  order  to  send,
process  or  receive  information,  whether  the  equipment  is  to  be  connected  directly  to  the
‘termination’  of  the  network  or  to  interwork  with  such  a  network,  being  connected  directly  or
indirectly  to  the  termination  point.  The  system  of  connection  may  be  wire,  radio,  optical  or
other  electromagnetic  means;

(b) equipment  capable  of  being  connected  to  a  public  telecommunications  network  even  if  it  is  not
its  intended  purpose,  including  information  technology  equipment  having  a  communication
port;

(c)

those  categories  of  radio  transmitters  defined  and  specified  in  Attachment  2.

2.2. 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.

3.

THE  APPROVAL  REQUIREMENTS

3.1.

This Annex shall apply to all mandatory approval requirements, adopted within the territories of the
Parties,  by  government  organisations  and/or  bodies  which  have  the  legal  powers  to  enforce  a
technical  requirement,  for  the  equipment  referenced  in  Attachment  2.  The  relevant  technical
requirements  are  specified  under  the  legislation  referenced  in  Attachment  1.

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,  recognised  under  this  Annex,  are
authorised  to  perform  the  following  activities  with  regard  to  each  other’s  technical  requirements  for
telecommunications  terminal  equipment,  radio  transmitters  and  information  technology  equipment:

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— for terminal attachment and radio transmission requirements — testing, issuing and acceptance of
test reports, performance of required technical evaluation and certification of compliance with the
requirements  of  the  laws  and  regulations  applicable  in  the  territories  of  the  Parties  for  products
covered  under  this  Annex,

— for  electromagnetic  compatibility  (EMC)  —  the  recognition  of  each  other’s  certificates  of
compliance,  suppliers’  declaration  and  technical  construction  file,  as  required.  The  detailed
provisions  are  described  in  the  Sectoral  Annex  on  ENC,

— for  electrical  safety/low  voltage  —  the  acceptance  of  testing  and  certification  of  the  covered
products  to  the  electrical  safety  requirements  of  the  other  Party.  The  detailed  provisions  are
described  in  the  Sectoral  Annex  on  electrical  safety,

— for  quality  management  —  the  recognition  of  one  Party’s  quality  management  certificates  in

accordance  with  the  regulatory  requirements  of  the  other  Party.

4.2. Certificates  of  conformity  delivered  by  the  designated  conformity  assessment  bodies  of  each  Party
under  the  provisions  of  this  Annex  will  be  recognised  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  organisations  responsible  for  designating  and
assuring  the  competence  of  conformity  assessment  bodies  to  test  and  certify  equipment  covered
by this Annex to the requirements of the other Party. The designating authorities for the purpose
of  this  Annex  are  listed  in  Attachment  3.  The  designating  authorities  may  seek  the  services  of
their  accreditation  system  in  carrying  out  these  responsibilities.

(b) Each Party shall notify the other within ten (10) working days of changes in the identity of their
designating  authorities  and  their  authority  to  carry  out  the  obligations  under  this  Annex.

5.2. Designated  conformity  assessment  bodies

(a) For  the  purpose  of  this  Annex,  each  Party  will  designate  competent  conformity  assessment
bodies  to  carry  out  conformity  assessment  to  the  requirements  of  the  other  Party.  Each  Party
shall  ensure  that  the  designated  bodies  comply  with  the  criteria  and  standards  set  out  in  the
regulatory requirements of the other Party. In making designations, the Parties shall indicate the
products  and  procedures  for  which  they  have  been  designated.  A  list  of  designated  bodies,
together with an indication of the products and procedures for which they have been designated,
is  included  in  Attachment  4.

(b) Conformity  assessment  bodies  designated  under  this  Annex  shall  be  recognised  as  competent  to

perform  the  conformity  assessment  activities  for  which  they  have  been  designated.

(c) Designation,  suspension  or  withdrawal  of  conformity  assessment  bodies  under  this  Annex  shall
be  in  conformance  with  procedures  determined  by  the  Joint  Committee  established  under  the
Framework  Mutual  Recognition  Agreement.

(d) Where a complaint or any other circumstance arises concerning a conformity assessment body’s
ability  to  perform  under  this  Annex,  the  appropriate  designating  authority  must  take  action  to
the mutual satisfaction of the Parties. Where necessary, such problems may be considered by the
Joint  Committee  established  under  the  Framework  Mutual  Recognition  Agreement  in  order  to
reach  a  solution.

6.

TRANSITIONAL  ARRANGEMENT

6.1.

There  will  be  a  transitional  period  of  18  months  before  the  provisions  of  this  Annex,  notably
section  4,  become  fully  operational.

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6.2.

This  transitional  period  will  be  used  by  the  Parties:

(a)

to  exchange  information  on  and  develop  better  understanding  of  their  respective  regulatory
requirements;

(b)

to  develop  mutually  agreed  mechanisms  for  exchanging  information  on  changes  in  technical
requirements  or  methods  of  designating  conformity  assessment  bodies;

(c)

to  monitor  and  evaluate  the  work  carried  out  by  designated  conformity  assessment  bodies
operating  during  the  transitional  period.

6.3. During  the  transitional  period  the  Parties  will  also  reciprocally  recognise  test  reports  and  related
documents issued by designated conformity assessment bodies of the other party in accordance with
the  provisions  of  this  Annex.  To  this  end,  the  approving  authorities  listed  in  Attachment  5  shall
accept test reports and related documents, and evaluations from the designated bodies in the territory
of the other Party, for the purposes of approval, without imposing additional requirements, and shall
ensure  that:

— on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are

promptly  examined  for  completeness,

— the  applicant  is  informed  in  a  precise  and  complete  manner  of  any  deficiency,

— an  request  for  additional  information  is  limited  to  omissions,  inconsistencies  or  variances  from

the  technical  regulations  or  standards,

— procedures  for  equipment  modified  subsequent  to  a  determination  of  compliance,  are  limited  to

procedures  necessary  to  determine  continued  conformance,

— requirements and conformity assessment procedures applied to domestic products shall be applied
with  no  additional  requirements  or  variations  to  products  or  test  results  originating  from  the
other  Party.

6.4.

Each approving authority commits itself to issuing approvals or advising the applicant no later than
six (6) weeks from receipt of the test report and evaluation from a designated body in the territory of
the  other  Party.

6.5. At the end of the transitional period the Parties will proceed to full mutual recognition of certificates
of  compliance  issued  by  designated  bodies  in  the  other  Party.  Any  proposal  made  during  or  at  the
end  of  the  transitional  period  to  limit  the  scope  of  recognition  of  any  designated  conformity
assessment  body  or  to  exclude  it  from  the  list  of  bodies  designated  under  this  Annex  shall  be  based
on  objective  criteria  and  documented.  Any  such  body  may  apply  for  reconsideration  once  the
necessary  corrective  action  has  been  taken.  To  the  extent  possible,  the  Parties  will  implement  such
action  prior  to  the  expiry  of  the  transitional  period.

7.

ADDITIONAL  PROVISIONS

Subcontracting

7.1. Any  subcontracting  shall  be  in  accordance  with  the  subcontracting  requirements  of  the  other  Party.

7.2.

The  conformity  assessment  bodies  shall  record  and  retain  details  of  its  investigation  of  the
competence and compliance of its subcontractors and maintain a register of all subcontracting. These
details  will  be  available  to  the  other  Party  on  request.

Post-market  surveillance

7.3.

For  the  purpose  of  post-market  surveillance,  the  Parties  may  maintain  any  existing  labelling  and
numbering  requirements.  The  assignment  of  the  numbers  may  take  place  in  the  territory  of  the
exporting  Party.  The  numbers  will  be  allocated  by  the  importing  Party.

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7.4. When  a  report  of  misuse  of  a  mark  of  conformity  or  of  a  hazard  involving  an  approved  product
covered  under  this  Annex  has  occurred,  both  Parties  will  jointly  determine  the  scope  of  the  misuse
and  the  nature  and  degree  of  corrective  action  to  be  taken.

Joint  Telecommunications  Group

7.5.

The Joint Committee established under the Framework Mutual Recognition Agreement may appoint
a  Joint  Telecommunications  Group  which  shall  meet  as  required  to  discuss  technical,  conformity
assessment  and  technology  issues  relating  to  this  Annex.

Exchange  of  information  and  mutual  assistance

7.6.

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

7.7. As  provided  in  the  transitional  arrangements  set  out  in  section  6.2  the  Parties  may  jointly  sponsor
two seminars, one in Canada and one in the European Community, concerning the relevant technical
and  product  approval  requirements  during  the  first  year  after  the  Annex  enters  into  force.

7.8.

The  Parties  shall  also  inform  each  other  of  changes  to  relevant  regulations,  specifications,  test
methods, standards and administrative procedures within thirty (30) working days of their domestic
notification.

Regulatory  changes  and  updating  the  Annex

7.9.

In the event that there are changes to the regulations referenced in Attachment 1 or the introduction
of  new  regulations  affecting  conformity  assessment  procedures  taking  place  in  either  Party,  the
Parties  will  update  this  Annex.

Cross-referencing

7.10. Where products covered by this Annex are subject also to electrical safety or EMC requirements the

relevant  provisions  of  the  Sectoral  Annexes  on  electrical  safety  and  EMC  will  also  apply.

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Attachment  1

Legislative,  regulatory  and  administrative  provisions

European  Community

Canada

Directive 98/13/EC of the European Parliament and
of  the  Council

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

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

European  Commission  Decisions  established  under
Directive  98/13/EC

EC  Member  States’  legislations  and  regulations  in
respect  of:

(a) non-harmonised  analogue  connection  to  the

public  switched  telecommunications  network

(b) non-harmonised  radio  transmitters  (civilian

application)

Handbook  of  the 
98/13/EC  (ADLNB  and  ACTE  approved)

implementation  of  Directive

Telecommunications Act

Radiocommunication  Act

CRTC  Telecom  Decision  No  82-14

Certification  Standard  CS-03

Certification  Procedure  CP-01

Radiocommunication  Regulations

Radio  Standards  Procedure  (RSP)  No 100:  radio
equipment  certification  procedure

Canadian  Electrical  Code

Terminal  equipment  list  (TEL)

Radio  equipment  list  (REL)

Licence  exempt  radio  apparatus  standards  list

Broadcasting  certificate  exempt  radio  apparatus
standards  list

Category I  equipment  standards  list

Category II  equipment  standards  list

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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  basic  access

ISDN  primary  rate  access

ISDN  primary  rate  access

ISDN  telephony

X21/V.24/V.35  access

X25  access

PSTN  non-voice

ONP  leased  line  terminal  types:

— 64  kbit/sec

— 2 048  kbit/s  unstruktured

— 2 048  kbit/s  structured

— 34  Mbit/s  access

— 140  Mbit/s  access

— 2  wire  analogue

— 4  wire  analogue

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

— 1 544,0  kbps

— 45  Mbps

2  wire  analogue  tie  trunks/ops

4  wire  analogue  tie  trunks/ops

Analogue  connections 
telecommunications  networks

to 

the  public  switched

Analogue  connections 
telecommunications  networks

to 

the  public  switched

All  harmonised 
transmitters,  with  the  exception  of:

and  non-harmonised 

radio

— 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  or  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

radio 

All 
to
transmitters 
radiocommunication  regulations  (see  Appendix  1)
with  the  exception  of:

subject 

including  all  radio  transmitters 

— medical  devices  and  active  implantable  medical
devices 
in
connection  with  the  medical  service  including
instruments,  telemetry  radio  links  and  other
radio equipment primarily used in hospitals and
health  care  facilities

— spark  ignition  systems  of  vehicles  including  all
radio  transmitters  in  connection  with  the  spark
ignition  systems  of  vehicles

— radio equipment used by radio amateurs within
Article  1,  definition  53,  of  the  ITU  Radio
Regulations  unless  the  equipment  is  available
commercially

— maritime 

equipment 

radio
transmitters  in  connection  with  the  maritime
service,  either  ship-borne  or  shore  installations

including 

all 

— cable  and  wiring

— receive  only  radio  equipment  intended  to  be
used  solely  for  the  reception  of  sound  and  TV
broadcasting services

— receive  only  radio  equipment  intended  to  be
used  solely  for  the  reception  of  sound  and  TV
broadcasting services

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European  Community

Canada

— products, appliances and components within the
meaning  of  Article  2  of  Council  Regulation
(EEC)  No  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

— apparatus 

exclusively  used 

activities
for 
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

— aeronautical  equipment 

including  all  radio
transmitters in connection with the aeronautical
(civil)  service  either  air-borne  or  terrestrial
the  purpose  of  aircraft
installations, 
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)

for 

— apparatus 

exclusively  used 

activities
for 
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  electromagnetic  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  electromagnetic  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

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Attachment  3

Designating  authorities

European  Community  and  Member  States

Canada

Industry  Canada  for  terminal  attachment,  radio
transmitters  and  EMC

Standards  Council  of  Canada  for  electrical  safety

Standards  Council  of  Canada 
management  systems  registrars

for  quality

— Belgium

Institut  belge  des  services  postaux  et  des
télécommunications
Belgisch  instituut  voor  postdiensten  en
telecommunicatie

— Denmark

Telestyrelsen

— Germany

Bundesministerium  für  Wirtschaft

— Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Μ(cid:229)(cid:244)Æ(cid:230)(cid:239)ρω(cid:139) ν  κÆØ  Ε(cid:240)Øκ(cid:239)ØνωνØω(cid:139) ν
Ministry  of  Transport  and  Communications

— Spain

Ministerio  de  Fomento

— France

Ministère  de  l’économie,  des  finances  et  de
l’industrie

— Ireland

Department  of  Transport,  Energy  and
Communications

— Italy

Ispettorato  Generale  TLC

— Luxembourg

Administration  des  Postes  et
Télécommunications

— Netherlands

De  Minister  van  Verkeer  en  Waterstaat

— Austria

Bundesministerium  für  Wissenschaft  und
Verkehr

— Portugal

Instituto  das  Communicações  de  Portugal

— Finland

Liikenneministeriö/Trafikministeriet
Telehallintokeskus/Teleförvaltringscentralen

— Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC)

— United  Kingdom

Department  of  Trade  and  Industry

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Attachment  4

Designated  conformity  assessment  bodies

(This  should  give  name,  address,  telephone  and  fax  number,  contact  point,  products,  standards  and
conformity  assessment  procedures  for  which  designation  has  been  made,  by  reference  to  the  legislative
requirements  of  the  other  Party.)

Attachment  5

Approval  authorities

European  Community  and  Member  States

Canada

(To  be  determined)

Industry  Canada

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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

ICES  003

Digital apparatus

ICES  004

Alternating  current  high  voltage  power
systems

2

3

1

13.8.1994

22.11.1997

6.1991

Radio  standards  specifications

Specification

Title

RSS  118

Land  and  subscriber  stations:  voice,
data  and  tone  modulated,  angle
modulation  radiotelephone  transmitters
and  receivers  operating  in  the  cellular
mobile  bands  824  to  849  MHz  and
869  to  894  MHz

Issue

2
Note  1

Date

19.8.1990

Addendum  to  118

1

1.9.1990

Annex  A  to  118

Cellular  system  mobile  station  —  land
station  compatibility  standard

Supplement  1993-1

Supplement  1993-1  to  radio  standards
specifications  (RSS)  118

RSS  118  mod.

Amendment  2  to  RSS  118

22.10.1983

12.6.1993

24.8.1996

RSS  119

RSS  123

RSS  125

Land  mobile  and  fixed  radio
transmitters  and  receivers,  27,41  to
960  MHz

5

24.8.1996

Low  power  licensed
radiocommunication devices

1
Provisional

24.2.1996

Land  mobile  and  fixed  radio
transmitters  and  receivers,  1,705  to
50,0  MHz,  primarily  amplitude
modulated

2

24.8.1996

RSS  128

800  MHz  dual-mode  cellular
telephones

1
Provisional

12.6.1993

RSS  128  mod.

Amendments  to  RSS  128

RSS  129

800  MHz  dual-mode  CDMA  cellular
telephones

1
Provisional

24.8.1996

24.2.1996

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Specification

Title

Issue

Date

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-ETS  300 131

2

2

24.8.1996

23.1.1993

23.1.1993

4.1992

RSS  135

Digital scanner receivers

RSS  131

RSS  133

RSS  134

RSS  136

RSS  137

RSS  210

Radio  signal  enhancers  for  the  mobile
telephone  service

1
Provisional

24.2.1996

2  Ghz  personal  communications
services

900  MHz  narrowband  personal
communications service

Land  and  mobile  stations
radiotelephone  transmitters  and
receivers  operating  in  the  26,960  to
27,410  MHz  general  radio  service

1
Provisional

1
Provisional

1
Provisional

29.11.1997

24.8.1996

26.10.1996

5

1.1.1977

Location  and  monitoring  services  (902
to  928  MHz)

1
Provisional

29.11.1997

Low  power  licence-exempt
radiocommunication devices

2

24.2.1996

Note  1: Supplement  1993-1  issued  12  June  1993  applies  to  RSS 118.

Additional  radio  standards  specifications  may  be  found  in  the  broadcasting  regulatory  section  of  the
index.

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Broadcast  equipment  technical  standards

Specification

Title

Issue

Date

BETS-1

BETS-3

BETS-4

BETS-5

BETS-6

BETS-8

BETS-9

BETS-10

BETS-11

Technical  standards  and  requirements
for  low  power  announce  transmitters
in  the  frequency  bands  525  to
1,705  kHz  and  88  to  107,5  MHz

Technical  standards  and  requirements
for  radio  apparatus  that  form  part  of
a  master  antenna  television  (MATV)
broadcasting

Technical  standards  and  requirements
for  television  broadcasting  transmitters

Technical  standards  and  requirements
for  AM  broadcasting  transmitters

Technical  standards  and  requirements
for  FM  broadcasting  transmitters

Technical  standards  and  requirements
for  FM  transmitters  operating  in  small
remote  communities

Technical  standards  and  requirements
for  television  transmitters  operating  in
small  remote  communities

Technical  standards  and  requirements
for  television  transmitters  in  the  2,596
to  2,686  MHz  band

Technical  requirements  respecting  the
identifications  of  broadcasting  stations

1

1

1

1

1

1

1

1

1

1.11.1996

1.11.1996

1.11.1996

1.11.1996

1.11.1996

1.11.1996

1.11.1996

1.11.1996

1.11.1996

Broadcast  specifications  and  standards

Specification

Title

Issue

Date

BTS  1-1

BTS  1-2

BTS  3

BS  14

Broadcast  transmission  standard  AM
broadcasting  stereophonic  operation

1
Provisional

6.2.1988

Broadcast  transmission  standard:  AM
broadcasting  RF  emission  limits

1
Provisional

11.1989

Broadcasting  transmission  standard:
television broadcasting

2

5.1990

Broadcast  specification:  television
broadcast  videotext

1
Provisional

19.6.1981

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SECTORAL  ANNEX  ON  ELECTROMAGNETIC  COMPATIBILITY  (EMC)

1.

SCOPE  AND  COVERAGE

1.1. The  provisions  of  this  Annex  shall  apply  to  the  following:

— electromagnetic  compatibility  of  equipment  as  defined  in  Council  Directive  89/336/EEC  of  3  May
1989  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  electromagnetic
compatibility  and  amendments  thereto,

— electromagnetic  compatibility  of  equipment  regulated  under  sections  of 

the  Canadian

Radiocommunications  Act.

2.

THE  REQUIREMENTS

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

Attachment  1.

2.2. Any requirements and conformity assessment procedures applied by one Party to its domestic products
shall  be  applied  with  no  additional  requirements  or  variations  to  products  or  conformity  assessment
results  originating  from  the  other  Party.

3.

CONFORMITY  ASSESSMENT  ACTIVITIES

3.1. Each  Party  agrees  to  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.

3.2. Both  Parties  agree  to  recognise  each  other’s  suppliers  declarations  of  compliance,  as  required  under

their respective legislation.

4.

INSTITUTIONS

4.1. Designating  authorities

(a) The  designating  authorities  for  the  purpose  of  this  Annex  are  listed  in  Attachment  2.

(b) Each Party shall notify the other within ten (10) working days of changes in the identity of their

designating  authorities  and  their  authority  to  carry  out  the  obligations  under  this  Annex.

4.2. Designated  conformity  assessment  bodies

(a) Conformity  assessment  bodies  designated  under  this  Annex  shall  be  recognised  as  competent  to
perform the conformity assessment activities for EMC. Each Party shall ensure that the designated
bodies comply with the criteria and standards set out in the regulatory requirements of the other
Party.  A  list  of  designated  bodies  is  included  in  Attachment  3.

(b) Designation, suspension or withdrawal of conformity assessment bodies under this Annex shall be
in  conformance  with  procedures  determined  by  the  Joint  Committee  established  under  the
Framework  Mutual  Recognition  Agreement.

5.

TRANSITIONAL  ARRANGEMENT

5.1. The  mutual  recognition  provisions  of  this  Annex,  notably  section  3,  will  take  effect  18  months

following  the  entry  into  force  of  this  Annex.

5.2. During  the  period  between  the  signing  of  the  Agreement  and  its  coming  into  effect,  the  Parties  will

work  together  to:

1. enhance  their  respective  familiarity  with  each  other’s  regulatory  requirements;

2. exchange  information  and  review  the  work  carried  out  by  designated  conformity  assessment

bodies;  and

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3. demonstrate to each other’s satisfaction their capability to carry out conformity assessment to the

requirements  of  the  other  Party.

6.

ADDITIONAL  PROVISIONS

Subcontracting

6.1. Any  subcontracting  of  conformity  assessment  shall  be  in  accordance  with  the  subcontracting

requirements  of  the  other  Party.

6.2. The  conformity  assessment  bodies  shall  record  and  retain  details  of  its  investigation  into  the
competence and compliance of its subcontractors and maintain a register of all subcontracting. These
details  will  be  available  promptly  to  the  other  Party  on  request.

Post-market  surveillance

6.3. For the purpose of post-market surveillance, the Parties may establish labelling, numbering or marking
requirements. The assignment of numbers or affixing of labels or marks may take place in the territory
of  the  exporting  party.

Exchange  of  information  and  mutual  assistance

6.4. Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other

Party  regarding  procedures,  regulations  and  complaints.

6.5. The  Parties  shall  also  inform  each  other  of  changes  to  relevant  regulations,  specifications,  test
methods,  standards  and  administrative  procedures  within  thirty  (30)  working  days  of  their  domestic
notification.

Regulatory  changes  and  updating  the  Annex

6.6.

In the event that there are changes to the technical regulations and conformity assessment procedures
referenced in Attachment 1 or in the event of the introduction of new regulations in the jurisdiction of
either  Party,  the  Parties  will  update  this  Annex.

Cross-referencing

6.7. Where  products  covered  by  this  Annex  are  subject  also  to  electrical  safety  or  radio  or
telecommunication  attachment  requirements  the  relevant  provisions  of  the  Sectoral  Annexes  on
electrical safety, telecommunication terminal equipment, information technology equipment and radio
transmitters  will  also  apply.

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Attachment  1

Legislative,  regulatory  and  administrative  provisions

European  Community

Canada

Council  Directive  89/336/EEC,  as  amended  by
Council  Directive  92/31/EEC 
and  Directive
98/13/EC  of  the  European  Parliament  and  of  the
Council

EC  Member  States’  legislation  and  regulations  in
respect  of  EMC 
radio
transmitters  (civilian  application)

for  non-harmonised 

Radiocommunication  Act

Radiocommunication  Regulations  (Appendix  I)

Category  II  equipment  standards  list

Attachment  2

Designating  authorities

The  designating  authority  for  Canada  is  Industry  Canada.

The  designating  authorities  for  the  European  Community  are  as  follows:

— Belgium

Ministère  des  Affaires  Économiques

Ministerie  van  Economische  Zaken

— Denmark

— for  telecommunication  equipment:

Telestyrelsen

— for  other  equipment:

Danmarks  Elektriske  Materielkontrol  (DEMKO)

— Germany

Bundesministerium  für  Wirtschaft

— Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Μ(cid:229)(cid:244)Æ(cid:230)(cid:239)ρω(cid:139) ν  κÆØ  Ε(cid:240)Øκ(cid:239)ØνωνØω(cid:139) ν

Ministry  of  Transport  and  Communications

— Spain

— for  telecommunication  equipment:

Ministerio  de  Fomento

— for  other  equipment:

Minsterio  de  Industria  y  Energía

— France

Ministère  de  l’économie,  des  finances  et  de  l’industrie

— Ireland

Department  of  Transport,  Energy  and  Communications

— Italy

Ministero  dell’Industria,  del  Commercio  e  dell’Artigianato

— Luxembourg

Ministère  des  Transports

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— Netherlands

De  Minister  van  Verkeer  en  Waterstaat

— Austria

— for  telecommunication  equipment:

Bundesministerium  für  Wissenschaft  und  Verkehr

— for  other  equipment:

Bundesministerium  für  wirtschaftliche  Angelegenheiten

— Portugal

Instituto  das  Comunicações  de  Portugal

— Finland

— for  telecommunication  equipment:

Liikenneministeriö/Trafikministeriet

— for  other  equipment:

Kauppa-  ja  teollisuusministeriö/Handels-  och  industriministeriet

— Sweden

Under  the  authority  of  the  Government  of  Sweden:

Styrelsen  för  ackreditering  och  teknisk  kontroll  (SWEDAC)

— United  Kingdom

Department  of  Trade  and  Industry

Attachment  3

Designated  conformity  assessment  bodies

(This  should  give  name,  address,  telephone  and  fax  number,  contact  point,  products,  standards  and
conformity  assessment  procedures  for  which  designation  has  been  made,  by  reference  to  the  legislative
requirements  of  the  other  Party.)

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Appendix  1

Interference-causing  equipment  standards

Specification

Title

Issue

Date

ICES  001

Industrial,  scientific  and  medical  radio
frequency  generators

ICES  003

Digital apparatus

ICES  004

Alternating  current  high  voltage  power
systems

2

3

1

13.8.1994

22.11.1997

6.1991

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SECTORAL  ANNEX  ON  ELECTRICAL  SAFETY

1.

PURPOSE

1.1.

The  purpose  of  this  Annex  is  to  establish  a  framework  for  the  acceptance  of  electrical  products
through  the  recognition  of  conformity  assessment  carried  out  by  bodies  which  comply  with  the
requirements  of  the  other  Party,  while  maintaining  the  integrity  of  the  safety  system  in  each  of  the
Parties.

1.2.

This  Annex  also  sets  out  procedures  for  the  recognition  of:

(a) conformity  assessment  bodies  (CABs)  in  Canada  by  the  European  Community  (EC);  and

(b) CABs  in  the  EC  by  Canada.

2.

SCOPE  AND  COVERAGE

2.1.

2.2.

For  access  to  the  EC:  the  safety  of  electrical  equipment  falling  within  the  scope  of  the  Low  Voltage
Directive  (Council  Directive  73/23/EEC  of  19  February  1973  as  amended  by  Directive
93/68/EEC) (1).

For  access  to  Canada:  low  voltage  electrical  equipment,  including  medical  devices,  covered  by  the
Canadian  Electrical  Code,  except  for  those  products  specifically  excluded  under  the  Low  Voltage
Directive  (other  than  medical  devices).

2.3.

The  legislative,  regulatory  and  administrative  requirements  applicable  in  each  Party  and  the
regulatory  authorities  responsible  for  electrical  safety  are  listed  in  Attachment  1.

3.

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  recognising  CABs
and in the ability of those bodies to carry out their mandates. Successful completion of the transition
phase should result in the determination by the responsible authorities that nominated CABs comply
with the applicable criteria and are competent to conduct conformity assessment activities acceptable
to  the  other  Party.

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  Community  CABs,  they  must  satisfy  the  following
requirements:

(1) The  categories  of  equipment  and  phenomena  outside  the  scope  of  the  Directive  are:  electrical  equipment  for  use  in  an
explosive atmosphere; electrical equipment for radiology and medical purposes; electrical parts for goods and passenger
lifts; electricity meters; plugs and socket outlets for domestic use; electric fence controllers; radio-electrical interference;
specialised electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn
up  by  international  bodies  in  which  Member  States  participate.

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(a) be a participant in the International Electrotechnical Commission (IEC) scheme of the IECEE for
recognition  of  results  of  testing  to  standards  for  safety  of  electrical  equipment  (certification
bodies  (CB)  scheme)  under  the  IEC  system  for  conformity  testing  to  standards  for  safety  of
electrical  equipment  (IECEE)  as  defined  in  IECEE  Document  02/1992-05;  or

(b) have  a  contractual  arrangement  for  acceptance  of  test  data  with  a  certification  organisation

accredited  by  the  Standards  Council  of  Canada.

5.2. During  the  transition  phase,  Community  CABs  will:

(a)

test  products  to  Canadian  requirements;

(b)

issue a comprehensive testing and evaluation file (i.e. assessment data, reports) for submission by
the  manufacturer  of  the  tested  products  to  a  certification  organisation  in  Canada.

5.3. Canadian  certification  organisations  shall  ensure  that:

(a)

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

(b)

they  limit  any  request  for  additional  information  or  samples  to  omissions,  inconsistencies  or
variances  from  the  technical  regulations  or  standards;  and

(c) certification  is  done  on  the  basis  of  existing  procedures,  including  the  application  of  their

mark.

6.

MARKING  OF  CONFORMITY

6.1. During the transition phase, the Joint Committee shall develop mutually acceptable mechanisms and
procedures  for  marking  of  products  to  be  exported  to  Canada  in  order  to  indicate  their  conformity
with  Canadian  requirements.  Such  markings  shall  be  under  the  control  of  CABs  recognised  by  the
responsible/designating authorities, provide for traceability, give sufficient information to consumers,
and  not  give  rise  to  confusion  with  other  markings  of  conformity.  For  access  to  the  EC  market,  the
CE  marking  shall  apply.

7.

OPERATIONAL  PHASE

7.1. During  the  operational  phase,  the  Parties  will  proceed  to  full  mutual  recognition  of  results  of
conformity  assessment  activities,  as  required  under  their  respective  legislation.  CABs  recognised  by
the  responsible  designating  authorities  shall  operate  as  follows:

(a)

for  access  to  the  EC  market:

if  a  product  is  challenged  under  the  Low  Voltage  Directive,  a  report  drawn  up  by  a  Canadian
CAB recognised under this agreement shall be considered by the EC as if it were a report drawn
up  by  a  European  notified  body;

(b)

for  access  to  the  Canadian  market:

CABs  from  the  EC  will  be  accredited  in  accordance  with  Standards  Council  of  Canada  (SCC)
criteria  for  accreditation  of  certification  bodies  recognised  in  Canada  and  will  be  issued  a
certificate  of  accreditation.  The  following  conditions  are  deemed  to  be  equivalent  to  those
prescribed  criteria:

(i) evidence  of  satisfactory  performance  in  the  transition  phase;  and

(ii) accreditation by a European accreditation organisation according to applicable and relevant
ISO/IEC  guides  adapted  to  Canadian  and  European  conditions  for  accreditation  of
certification  organisations;  and

(iii) evidence of procedures for follow-up of certification activities including the identification of
a  contact  point  responsible  for  initiating  action  with  manufacturers  of  the  products  when
necessary.

7.2.

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

7.3.

Following the entry into force of the operational phase, the inclusion of additional CABs will be done
in  accordance  with  the  rules  set  out  in  the  Framework  Agreement  and  in  this  Annex.

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8.

LIMITED  SCOPE  OR  DENIAL  OF  RECOGNITION  FOR  THE  PURPOSES  OF
CERTIFICATION

8.1. Upon  request,  a  CAB  may  be  required  to  provide  additional  documentary  evidence  to  facilitate  its

passage  from  the  transitional  to  the  operational  phase.

8.2.

In  the  event  that  a  proposal  is  made  during,  or  at  the  end  of  the  transition  phase,  requesting  a
responsible/designating  authority  to  limit  the  scope  of  recognition  of  any  designated  CAB  or  to
exclude it from the list of bodies accredited/designated, in accordance with the procedures outlined in
the Framework Agreement, such a proposal shall be based on objective reasons and shall be properly
documented  in  writing  to  the  Joint  Committee.

8.3. A  CAB  which  has  been  granted  limited  recognition  or  has  been  denied  recognition,  may  apply  for

re-evaluation  after  corrective  action  has  been  taken.

9.

FOLLOW  UP  OF  CERTIFICATION  ACTIVITIES

9.1.

The authorities in each Party (see Attachments 1 and 2) retain the right to question the performance
of CABs operating in the context of this Annex. (Upon reasoned request, the authorities in one Party
may  request  a  copy  of  the  certification  report  prepared  to  its  requirements  in  the  territory  of  the
exporting  Party.  This  report  shall  be  provided  promptly  and  without  charge.)

9.2. CABs shall have in place a plan of action with their certification clients, for enabling the withdrawal
of  non-conforming  or  hazardous  products  from  the  market  place.  That  plan  shall  identify  a  contact
point  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  an  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.

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Attachment  1

Legislative,  regulatory  and  administrative  requirements  and  regulatory  authorities

(re  Articles  2(3)  and  9(1))

European  Comunity

Canada

Council  Directive  73/23/EEC  as  amended  by
Directive 98/13/EC of the European Parliament and
of  the  Council

EC  regulatory  authorities:  list  is  the  same  as  per
Attachment  2,  except  for  Sweden  which  has  the
following  regulatory  authority:

Elsäkerhetsverket  (National  electrical  safety  board)

The  Canadian  Electrical  Code  as  referenced  in  the
provincial/territorial 
the
responsibility  of  the  following  provincial/territorial
regulatory authorities:

is  under 

legislation 

— 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
Department  of  Public  Works  and  Services

— 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

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European  Comunity

Canada

— Quebec

Loi  sur  les  installations  électriques,
L.R.Q.,  Chapter  I-13.01
Règlement  sur  les  installations  électriques,
I-13.01,  R.3
Code  de  l’électricité  du  Québec
Régie  du  bâtiment  du  Québec

— 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
Transportation Services

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Attachment  2

Designating  authorities

The  authorities  responsible  for  the  designation  of  conformity  assessment  bodies  under  this  Agreement  are:

(a)

for  the  European  Community:

— Belgium

Ministère  des  Affaires  Économiques

Ministerie  van  Economische  Zaken

— Denmark

Boligministeriet

— Germany

Bundesministerium  für  Arbeit  und  Sozialordnung

— Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Αν(cid:192)(cid:240)(cid:244)υŒης

Ministry  of  Development

— Spain

Ministerio  de  Industria  y  Energía

— France

Ministère  de  l’économie,  des  finances  et  de  l’industrie

— Ireland

Department  of  Enterprise  and  Employment

— Italy

Ministero  dell’Industria,  del  Commercio  e  dell’Artigianato

— Luxembourg

Ministère  des  Transports

— Netherlands

Staat  der  Nederlanden

— Austria

Bundesministerium  für  wirtschaftliche  Angelegenheiten

— Portugal

Under  the  authority  of  the  Government  of  Portugal:  Instituto  Português  da  Qualidade

— Finland

Kauppa-  ja  teollisuusministeriö/Handels-  och  industriministeriet

— Sweden

Under  the  authority  of  the  Government  of  Sweden:

Styrelsen  för  ackreditering  och  teknisk  kontroll  (SWEDAC)

— United  Kingdom

Department  of  Trade  and  Industry

(b)

for  Canada:

— The Standards Council of Canada, a Federal Crown corporation established by an Act of Parliament

in  1970,  amended  in  1996.

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SECTORAL  ANNEX  ON  RECREATIONAL  CRAFT

SECTION  I

Scope  and  coverage

1.1. This  Annex  applies  to  all  recreational  craft,  including  personal  watercraft,  which  in  the  European
Community  or  in  Canada  are  subject  to  a  conformity  assessment  or  approval  procedure  by  an
independent  conformity  assessment  or  approval  body.

1.2. The  product  coverage  shall  be  as  determined  by  the  relevant  legislation  of  each  party,  which  is:

(a)

for  the  European  Community:

recreational  craft  as  defined  in  Article  1  of  Directive  94/25/EC;

(b)

for  Canada:

pleasure craft as defined by the Canada Shipping Act, Chapter 1487, Small Vessel Regulations as
referenced  in  Transport  Canada’s  Publication  No  TP1332.

1.3. Parties  agree  that  mutual  recognition  will  operate  under  this  Annex  according  to  the  following

arrangements:

(a)

(b)

for  evaluation  against  European  Community  requirements,  conformity  assessment  bodies
designated  by  Canada  will  establish  certificates  of  compliance  according  to  the  provisions  of
Directive 94/25/EC. These certificates will be recognised in the European Community without any
further  assessment  of  the  products  to  which  they  relate;

for approval according to Canadian requirements, conformity assessment bodies designated by the
European  Community  will  certify  the  product  according  to  the  requirements  set  out  in  Chapter
1487 of the Canada Shipping Act Small Vessel Regulations, and issue the appropriate compliance
plates  and  other  required  documentation.  Products  so  certified  may  be  placed  on  the  Canadian
market  without  undergoing  any  further  approval  procedures.

SECTION  II

Legislative,  regulatory  and  administrative  requirements

2.1. For  the  European  Community:

Directive  94/25/EC  of  the  European  Parliament  and  of  the  Council  of  16  June  1994  on  the
approximation of the laws, regulations and administrative provisions of the Member States relating to
recreational craft.

2.2. For  Canada:

Regulatory  requirements  —  The  Canada  Shipping  Act,  Chapter  1487,  Small  Vessel  Regulations
referenced  in  Transport  Canada’s  Publication  No  TP1332

Construction standards for small vessels which includes personal watercraft as defined by and certified
to  ISO/DIS  13590.

Authorities  responsible  for  designating  the  conformity  assessment  bodies  as  specified  by  conformity
assessment  modules

SECTION  III

3.1. For  the  European  Community:

Member  States  administrations  or  entities  as  indicated  in  Attachment  1.

3.2. For  Canada:

Canadian coastguard.

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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  authorised  to  perform  the  conformity  assessment
tasks  specified  in  Directive  94/25/EC,  which  has  been  appointed  by  a  Member  State  from  the
bodies falling within its jurisdiction. The notified body has the necessary qualifications to meet the
requirements  laid  down  in  Directive  94/25/EC  and  has  been  notified  to  the  Commission  and  to
the  other  Member  States;

(b)

for  Canada,  the  procedures  and  criteria  for  designation  of  conformity  assessment  bodies  shall
comply  with  the  relevant  provisions  of  Directive  94/25/EC.

SECTION  V

Transitional  arrangement

There  will  be  a  transitional  arrangement  of  18  months  prior  to  the  operation  of  this  Annex.  During  this
transitional  period,  the  Parties  will:

(a) exchange information on, and develop greater familiarity with, their respective regulatory requirements;

and

(b) carry  out  the  policy,  legislative  and  regulatory  changes  necessary  for  the  provisions  of  this  Annex.

SECTION  VI

Additional  provisions

6.1.

In  accordance  with  the  relevant  provisions  of  the  Mutual  Recognition  Framework  Agreement,  the
Parties  shall  ensure  the  continued  availability  of  the  names  of  their  respective  notified  bodies  or
conformity  assessment  bodies,  and  will  regularly  supply  details  of  certifications  issued  in  order  to
facilitate  post-market  surveillance.

6.2. The  Parties  note  that,  to  the  extent  that  requirements  for  electrical  safety  or  electromagnetic
compatibility apply to products covered by this Sectoral Annex, the provisions of the Sectoral Annexes
on  electrical  equipment  and  electromagnetic  compatibility  shall  apply.

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Attachment  1

Designating  authorities

For  the  European  Community

For  Canada

— Belgium

The  Canadian  coastguard

Ministère  des  communications  et  de
l’infrastructure
Ministerie  van  Verkeer  en  Infrastructuur

— Germany

Bundesministerium  für  Wirtschaft

— Spain

Ministerio  de  Fomento

— France

Ministère  de  l’équipment,  des  transports  et  du
logement
Ministère  de  l’économie,  des  finances  et  de
l’industrie

— Italy

Ministero  dell’Industria,  del  Commercio  e
dell’Artigianato

— Netherlands

De  Minister  van  Verkeer  en  Waterstaat

— Finland

Liikenneministeriö/Trafikministeriet

— Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC)

— United  Kingdom

Department  of  Trade  and  Industry

Attachment  2

Designated  conformity  assessment  bodies

— European  Community:

notified bodies which have been notified by the Member States of the European Community, and whose
names  and  reference  numbers  have  been  published  in  the  Official  Journal  of  the  European
Communities.

— Canada:

to  be  determined.

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SECTORAL  ANNEX  ON  GOOD  MANUFACTURING  PRACTICES  (GMP)

1.

PURPOSE

1.1.

This  Mutual  Recognition  Agreement  (MRA)  Sectoral  Annex  on  good  manufacturing  practices
(GMP)  compliance  certification  pertaining  to  medicinal  products/drugs  has  been  developed  by  the
European  Community  (EC)  and  Canada  to:

(a) enhance  bilateral  regulatory  cooperation;

(b) establish  mutual  recognition 

for  GMP  compliance  certification  and  acceptance  of
manufacturing  authorisations/licences  directly  issued  by  the  authorities  designated  equivalent
after  the  successful  completion  of  a  confidence  building  exercise;

(c) develop  an  infrastructure  for  on-going  communications/consultations  between  Canada,  the
European  Commission,  and  the  regulatory  authorities  of  the  EC  Member  States  to  enable
regulators  to  determine  and  maintain  the  equivalency  of  their  GMP  compliance  programmes.

2.

GENERAL  CONSIDERATIONS

2.1.

2.2.

The  underlying  premise  behind  a  MRA  for  GMP  compliance  certification  is  that  it  can  be
demonstrated  that  Canada  and  the  EC  Member  States  have  equivalent  GMP  compliance
programmes,  and  therefore  the  issuance  of  a  certificate  of  manufacturing  authorisation/licence  by
an  authority  of  one  Party  certifying  that  a  facility  is  in  compliance  with  GMPs,  would  be  all  the
evidence  required  by  the  other  Party  to  accept  that  facility  as  being  in  compliance  for  the
manufacturing/control of medicinal/drug products or to issue a similar certificate of manufacturing
authorisation/licence.  It  should  be  understood  that  equivalent  does  not  mean  identical  but  it  does
mean  leading  to  the  same  result.

The acceptance by an authority of a certificate of manufacturing authorisation/licence issued by the
other  authority  will  depend  on  the  successful  completion  of  a  confidence  building  exercise  and  on
an  evaluation  of  its  results.  Only  certification  by  authorities  with  GMP  compliance  programmes
(including  the  supporting  infrastructure  of  regulatory  requirements,  standards,  processes,  and
quality  systems,  etc.)  mutually  recognised  as  equivalent  will  be  accepted.

2.3.

The  MRA  on  medicinal  products/drug  GMP  is  built  on  three  pillars:

(a)

the  concept  of  a  GMP  compliance  programme  (Appendix  4);

(b) a  ‘two-way’  alert  system  (Appendix  5);

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

3.

SCOPE  AND  COVERAGE

3.1.

3.2.

3.3.

3.4.

The provisions of this Annex will cover all medicinal products/drugs which have undergone one or
a  series  of  manufacturing  process(es)  (e.g.  fabrication,  repackaging,  labelling,  testing,  wholesaling
activities) in Canada and in the European Community, and to which good manufacturing practice
(GMP)  requirements  apply  in  both  jurisdictions.  Recognition  will  be  limited  to  the  manufacturing
process(es)  carried  out  and  subject  to  inspections  in  the  respective  territories  of  the  Parties.

This  Annex  may  also  apply,  on  a  voluntary  basis,  to  products  covered  by  the  legislation  of  one
Party  but  not  the  other  if  agreed  to  by  the  authorities  concerned.

The product coverage shall be as determined by the relevant legislation of each Party. Appendix 1
names  the  legislations  and  contains  an  indicative  list  of  products  concerned.

For  the  purpose  of  this  Annex,  GMP  includes  the  system  whereby  the  manufacturer  receives  the
specifications  of  the  product  and/or  process  from  the  marketing  authorisation  (MA)/drug
identification  number  (DIN)  or  licence  holder  or  applicant  and  ensures  the  product  is  made  in
compliance  with  the  specifications  (equivalent  to  qualified  person  certification  in  the  EC).

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Good manufacturing practice (GMP) is that part of quality assurance which ensures that products
are  consistently  produced  and  controlled  to  the  quality  standards:

— appropriate  to  their  intended  use,  and

— required by the marketing authorisation or product specifications and by assignment procedure

of  the  drug  identification  number  or  the  licence.

3.5.

Product or process oriented inspections will be carried out by one Party at the request of the other
Party.  For  pre-approval  inspections,  the  Parties  agree  to  exchange  pre-approval  inspection  reports
to  the  extent  required  under  the  importing  Party’s  laws  and  regulations,  for  the  purpose  of  their
respective  product  approval  procedures.  Lot-to-lot  release  for  biologicals  is  excluded  from  this
Agreement.

4.

CONFIDENTIALITY

4.1.

4.2.

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.

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
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 Party’s authority to perform GMP compliance certification (guidance provided in
Appendix  6).

7.3.

Budget

Each  of  the  Parties  to  the  MRA  will  be  responsible  for  the  costs  of  its  participation  in  the
confidence  building  activities.

7.4.

Administrative  provision

Medicinal products/drugs from manufacturing sites with a good track record of compliance in the
importing  Party,  and  that  have  been  placed  on  a  list  of  qualified  sites,  will  be  exempted  from
retesting  requirements.  The  list  will  be  developed  by  the  joint  sectoral  group.

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7.5.

End  of  transitional  period

7.5.1. At the end of the transitional period, the joint sectoral group will proceed to a joint evaluation of
the  equivalency  and  capabilities  of  the  compliance  programmes  of  the  participating  authorities
(Appendix  2).

7.5.2.

Those  determined  as  not  being  equivalent  to  the  other  Party’s  GMP  compliance  programme  will
not be listed in Appendix 2 at the end of the transitional period. Proposals to limit the recognition
of  the  equivalence  of  an  authority  or  exclude  it  from  the  Appendix  should  be  based  on  objective
criteria  and  documented  evidence.

7.5.3. Authorities  may  be  placed  in  Appendix  2  for  specific  categories  of  manufacturing  processes  (e.g.
biologicals, radiopharmaceuticals). Excluded authorities (or not included for a given manufacturing
process) may apply for re-consideration of their status once the necessary corrective measures have
been  taken.

8.

OPERATIONAL  PHASE

8.1.

General provisions

8.1.1.

the  other  Party 

The  European  Community  and  Canada  agree  that,  for  medicinal  products/drugs  covered  by  this
Annex,  each  Party  will  recognise  the  conclusions  of  the  GMP  compliance  programme  carried  out
by 
the  relevant  certificates  of  manufacturing
authorisations/licences  granted  by  the  deemed  equivalent  authorities  of  the  other  Party  listed  in
Appendix 2. In addition, the certification by the manufacturer on the conformity of each batch will
be  recognised  by  the  other  Party  without  re-control  at  import.

territory,  and 

its 

in 

8.1.2. Manufacturers located in Canada or a Member State of the European Community whose relevant
authority  is  not  listed  in  Appendix  2  or  is  not  included  for  the  relevant  category  manufacturing
processes may ask that an inspection be carried out by any of the authorities listed in Appendix 2.
The batch and the compliance certificates issued according to this procedure will be recognised by
the  other  Party  provided  that  equivalent  enforcement  procedures  against  that  facility  can  be
subsequently  ensured  in  case  of  non-compliance.

8.1.3. With  respect  to  medicinal  products/drugs  covered  by  the  pharmaceutical  legislation  of  the
importing Party but not the exporting one, the locally competent inspection service willing to carry
out  an  inspection  of  the  relevant  manufacturing  operations  shall  inspect  against  its  own  GMPs  if
relevant,  or,  in  the  absence  of  specific  GMP  requirements,  against  the  applicable  GMPs  of  the
importing  Party.  This  will  also  be  the  case  when  the  locally  applicable  GMPs  are  not  considered
equivalent,  in  terms  of  quality  assurance  of  the  finished  products,  to  the  GMPs  of  the  importing
Party.

This  provision  may  also  apply  to  the  manufacturer  of  active  pharmaceutical  ingredients,
intermediate  products,  and  products  intended  for  use  in  clinical  trials.

8.1.4.

It  will  be  the  responsibility  of  the  authorities  covered  by  the  Annex  to  ensure  that  any  suspension
or withdrawal (total or partial) of a manufacturing authorisation, which could affect the protection
of  public  health,  is  communicated  to  the  other  Party  with  the  appropriate  degree  of  urgency  as
defined  in  the  ‘two-way’  alert  programme.

Contact  points  will  be  agreed  between  both  Parties  to  permit  authorities  and  manufacturers  to
inform the authorities of the other Party with the appropriate speed in case of quality defect, batch
recalls,  counterfeiting  and  other  problems  concerning  quality,  which  could  necessitate  additional
controls  or  suspension  of  the  distribution  of  the  product.

8.1.5. Certification  of  manufacturers

At  the  request  of  an  exporter,  an  importer  or  of  an  authority  of  the  other  Party,  the  authorities
responsible for granting certificates of manufacturing authorisations/licences and for the supervision
of  the  manufacture  of  medicinal  products/drugs  will  certify  that  the  sites  used  for  manufacture
and/or  control:

(a) are  appropriately  authorised 

to  manufacture  and/or  control 

the  relevant  medicinal

product/drug  or  to  carry  out  the  relevant  specified  operations,

(b) are  regularly  inspected  by  the  authorities,  and

(c) comply  with  the  GMP  requirements  recognised  as  equivalent  by  the  two  Parties.

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The certificates of manufacturing authorisation/licence will also identify the site(s) of manufacture.
A  Canadian  and  a  European  Community  example  of  such  certificates  are  attached  at  Appendix  7
for  illustrative  purposes.

Certificates  of  manufacturing  authorisations/licences  will  be  issued  expeditiously,  and  the  time
taken should not exceed 30 days. In cases when a new inspection has to be carried out, this period
may  be  extended  to  60  days.

8.1.6.

Batch  certification

Each  batch  exported  will  be  accompanied  by  a  batch  certificate  issued  by  the  manufacturer  (‘self
certification’)  after  a  full  qualitative  and  quantitative  analysis  of  all  active  constituents  to  ensure
that 
the  marketing
the  quality  of 
authorisation/product  approval.

the  products  complies  with 

the  requirements  of 

When issuing this certificate, the manufacturer will take into account the provisions of the current
WHO  certification  scheme  on  the  quality  of  medicinal  products/drugs  moving  in  international
commerce.  This  certificate  will  attest  that  the  batch  meets  the  specifications  and  has  been
manufactured  in  accordance  with  the  relevant  marketing  authorisation/product  approval,  detailing
the specifications of the product, the analytical methods referenced, the analytical results obtained,
and  containing  a  statement  that  the  batch  processing  and  packaging  records  were  reviewed  and
found  in  conformity  with  GMPs.

The  batch  certificate  will  be  signed  by  the  person  responsible  for  releasing  the  batch  for  sale  or
supply.  In  the  European  Community  the  ‘qualified  person’  is  referred  to  in  Article  21  of  Directive
75/319/EEC, and in Canada, the nominated person responsible for manufacturing quality control is
as  specified  in  the  Food  and  Drug  Regulations,  Division  2,  Section  C.02.014  (1).

8.1.7.

Fees

The  regime  of  inspection/establishment  licence  fees  is  determined  by  the  location  of  the
manufacturer.  The  cost  recovery  programmes  and  the  fees  pertaining  to  the  issuance  of
manufacturing  authorisations/licences  in  each  jurisdiction  will  remain  the  responsibility  of  that
jurisdiction.

The  Parties  shall  endeavour  to  ensure  that  any  fees  imposed  for  services  will  be  cost-oriented  and
take into account relevant cost factors. If no services are rendered by one Party, fees should not be
charged.

8.1.8.

Each Party reserves the right to conduct its own inspection for reasons identified to the other Party.
Such  inspections  are  to  be  notified  in  advance  to  the  other  Party,  which  has  the  option  of  joining
the  inspection.  Recourse  to  this  safeguard  clause  should  be  an  exception.

8.1.9.

The  decision  to  suspend  or  revoke  a  licence  will  rest  with  the  issuing  Party.

8.2.

Information  sharing

8.2.1.

In  accordance  with  the  general  provisions  of  the  Annex,  the  Parties  will  exchange  all  information
necessary to determine and maintain the equivalence of GMP compliance programmes. In addition,
the relevant authorities in Canada and in the EC will keep each other informed of all new technical
guidance,  inspection  procedures,  or  changes  in  regulation  (these  include:  guidance  documents,
publications  of  references  to  standards,  forms,  documents  relating  to  the  application  of  legal
requirements).  Each  Party  will  consult  the  other  before  adopting  these  changes  to  ensure  the
continued  equivalency  of  the  GMP  compliance  programmes.  Concerns  will  be  raised  to  the  joint
sectoral  group.

8.2.2. Upon  reasoned  request,  the  relevant  inspection  service  shall  forward  a  copy  of  the  last  inspection
report  of  the  manufacturing  or  control  site,  in  case  analytical  operations  are  contracted  out.  The
request  may  concern  a  ‘full  inspection  report’  or  a  ‘detailed  report’.  A  ‘full  inspection  report’
comprises  a  site  master  file  (compiled  by  the  manufacturer  or  by  the  inspectorate)  and  a  narrative
report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other
Party. Parties will ensure that such inspection reports are forwarded in no more than 30 days, this
period  being  extended  to  60  days  should  a  new  inspection  be  carried  out.

8.3.

Two-way  alert  system

8.3.1.

The joint sectoral group will ensure that an efficient and effective ‘two-way’ alert system is in place
at  all  times.  Elements  of  such  a  system  are  described  in  Appendix  5.

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8.3.2.

8.3.3.

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.

Each  Party  shall  notify  the  other  Party  of  any  confirmed  problem  reports,  corrective  actions,  or
recalls  related  to  products  covered  under  the  scope  of  this  Annex.  Each  Party  will  respond  to
special  requests  for  information  and  will  ensure  that  authorities  make  available  relevant
information,  as  requested.

Contact  points  are  identified  in  Appendix  5.

9.

MONITORING  OF  THE  AGREEMENT

9.1.

9.2.

9.3.

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.

The Parties undertake to hold regular consultations, under the auspices of the joint sectoral group
set  up  under  this  Annex,  to  ensure  the  continued  relevancy  and  accuracy  of  this  Annex.  Canada
and  Member  State  authorities  may  organise  meetings  to  discuss  specific  questions  and  issues.

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  81/851/EEC  as  modified;

Directive  91/356/EEC  as  modified;

Directive  91/412/EEC  as  modified;

Regulation  (EC)  No  2309/93;

Directive 92/25/EEC;

Guide  to  good  distribution  practice  (94/C  63/03);

Current  version  of  the  ‘Guide  to  good  manufacturing  practice’,  Volume  IV  of  Rules  governing
medicinal  products  in  the  European  Community.

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

Recognising that precise definitions of medicinal products and drugs are to be found in the legislation
referred  to  above,  an  indicative  list  of  products  covered  by  the  Agreement  is  given  below:

— human  pharmaceuticals  including  prescription  and  non-prescription  drugs,  and  medicinal  gases,

— human  biologicals  including  vaccines,  stable  medicinal  products  derived  from  human  blood  or

human  plasma,  biotherapeutics,  and  immunologicals,

— human radiopharmaceuticals,

— veterinary  pharmaceuticals,  including  prescription  and  non-prescription  drugs,  and  pre-mixes  for

the  preparation  of  veterinary  medicated  feeds,

— where  appropriate,  vitamins,  minerals,  herbal  remedies  and  homeopathic  medicinal  products,  and

— active  pharmaceutical  ingredients  or  bulk  pharmaceuticals  (NB:  APIs  are  not  GMP  regulated).

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Appendix  2

Authorities

For  the  European  Community:

Belgium

Inspection  générale  de  la  pharmacie

Denmark

Germany

Greece

Algemene  Farmaceutische  Inspectie

Laegemiddelstyrelsen

Bundesministerium  für  Gesundheit

ΕθνØκ(cid:222)ς  ˆργÆνØ(cid:243)µ(cid:222)ς  ΦÆρµ(cid:192)κ(cid:239)υ

Ministry  of  Health  and  Welfare

National  Drug  Organisation  (EOF)

Spain

— for  medicinal  products  for  human  use:

Ministerio  de  Sanidad  y  Consumo

Subdirección  General  de  Control  Farmacéutico

— for  medicinal  products  for  veterinary  use:

Ministerio  de  Agricultura,  Pesca  y  Alimentación  (MAPA)

Dirección  General  de  la  Producción  Agraria

France

— for  medicinal  products  for  human  use:

Ireland

Italy

Agence  du  Médicament

— for  veterinary  medicinal  products:

Agence  Nationale  du  Médicament  Vétérinaire

Irish  Medicines  Board

— for  medicinal  products  for  human  use:

Ministero  della  Sanità

Dipartimento  Farmaci  e  Farmacovigilanza

— for  medicinal  products  for  veterinary  use:

Ministero  della  Sanità

Dipartimento  alimenti  e  nutrizione  e  sanità  pubblica  veterinaria  —
Div.  IX

Luxembourg

Division  de  la  Pharmacie  et  des  Médicaments

Netherlands

De  Minister  van  Volksgezondheid,  Welzijn,  en  Sport

Inspectie  voor  de  Gezondheidszorg

Austria

Portugal

Finland

Sweden

Bundesministerium  für  Arbeit,  Gesundheit  und  Soziales

— for  human  and  veterinary  (non-immunologicals):

Instituto  da  Farmácia  e  do  Medicamento  —  INFARMED

— for veterinary immunologicals:

Direcção-Geral  de  Veterinaria

Lääkelaitos/Läkemedelsverket  (national  agency  for  medicines)

Läkemedelsverket  —  medical  products  agency

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United  Kingdom

— for  human  and  veterinary  (non-immunological):

Medicines  Control  Agency

— for veterinary immunologicals:

Veterinary  Medicines  Directorate

European  Community

Commission  of  the  European  Communities

European  Agency  for  the  Evaluation  of  Medicinal  Products  (EMEA)

For  Canada:

Therapeutic  products  programme,  Health  Canada,  Ottawa

Bureau  of  Veterinary  Drugs,  Food  Directorate,  Health  Canada,  Ottawa

Appendix  3

Joint  sectoral  group

A  joint  sectoral  group  (JSG)  will  be  established  to  manage  the  confidence  building  process  and  to  monitor
the  operations  of  the  MRA  thereafter.

The JSG will be co-chaired by a member from each Party and will determine its own composition, ensuring,
to  as  great  a  degree  as  possible,  consistent  membership.  The  role  of  the  JSG  will  be  to  ensure
communications  with  the  Joint  Committee  and  to  manage  the  transition  period  and  to  monitor  the
continued  implementation  of  this  Annex  including,  but  not  limited  to:

— making  decisions  on  activities  required  to  define  and  establish  the  equivalence  of  compliance

programmes  and  the  ‘two-way’  alert  system,

— assessing the results of the confidence building exercise, and determining which regulatory authorities are
deemed  equivalent.  The  JSG  will  prepare  a  list  of  the  equivalent  regulatory  agencies  and  provide  its
recommendations  to  the  Joint  Committee,

— providing  directions  to  experts  that  will  conduct  the  evaluation  of  the  respective  GMP  compliances

programmes,  and  undertake  joint  activities  (e.g.  inspections,  workshops)  and

— making  decisions  on  the  necessary  arrangements  of  the  MRA  maintenance  programme.

The JSG will meet as needed to adopt the confidence building working plan, resolve issues, and monitor the
progress of the confidence building exercise. The Joint Committee will be kept informed of the agendas and
conclusions  of  meetings  as  well  as  on  the  progress  made  during  the  transition  period.

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Appendix  4

Components  of  a  GMP  compliance  programme

1. Legislative  and  regulatory  requirements  and  scope

— empowering legislation and regulations including authority to enforce laws and regulations, powers
given to inspectors to conduct inspections, authority to remove violative products from the market,
etc.,

— suitable  controls  on  conflict  of  interest.

2. Regulatory  directives  and  policies

— procedures  for  designating  inspectors,

— enforcement  policies/guidelines/procedures  (inspection,  re-inspection,  corrective  action),

— codes  of  conduct/ethics,

— training/certification policies/guidelines,

— alert/crisis management policies/procedures/guidelines,

— organisational  structure,  including  roles,  responsibilities  and  reporting  relationships.

3. Good  manufacturing  practices  (GMP)  standards

— scope/detials  of  GMPs  necessary  for  the  control  of  the  manufacturing  of  drug  products,

— process  validation  requirements.

4.

Inspection  resources

— staffing  —  initial  qualifications,  certification  of  inspectors,

— number  of  inspectors  in  relation  to  size  of  industry  (in-house,  contract,  third  party),

— training/certification  programmes/processes  (e.g.  frequency  of  training),

— quality  assurance  mechanisms  to  ensure  effectiveness  of  training  programmes.

5.

Inspection  procedures  (pre-inspection,  inspection,  and  post-inspection  activities)

— inspection  strategy  (type,  scope,  scheduling,  focus  of  inspection,  notification  of  inspections,

risk-based  inspections),

— pre-inspection  preparation/requirements,

— format  and  content  of  inspection  reports  (including  support  tools,  e.g.  hardware),

— inspection  methodology  (access  to  and  review  of  firm’s  files  and  databases,  collection  of  evidence,

data  review,  sample  collection,  interviews),

— standard  operating  procedures  (SOPs)  for  inspection,

— post-inspection  activities  (procedures  for  report  issuance,  follow-up,  decision  making),

— storage  of  inspection  data.

6.

Inspection  performance  standards

— frequency/number  of  inspections,  quality  and  timeliness  of  inspection  reports,  norms/frequency/

procedures  for  re-inspection  and  corrective  action.

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7. Enforcement  powers  and  procedures

— provision  of  written  notices  of  violation  to  firms,

— non-compliance  management  procedures/mechanisms  (recall,  suspension,  quarantine  of  products,

licence  revocation,  seizure,  prosecution),

— appeal mechanisms,

— other  measures  to  promote  voluntary  compliance  by  firms.

8. Alert  and  crisis  systems

— alert mechanisms,

— crisis  management  mechanisms,

— alert  performance  standards  (appropriateness  and  timeliness  of  alert).

9. Analytical capability

— access  to  laboratories  with  capacity  to  handle  necessary  analysis,

— standard  operating  procedures  (SOPs)  for  analytical  support,

— processes  for  validation  of  analytical  methods.

10. Surveillance  programme/measures  (used  by  firms  and  by  regulatory  authority)

— sampling  and  audit  procedures,

— recall  monitoring  (including  effectiveness  controls  and  verification  of  procedures),

— consumer  complaint  system/procedures,

— adverse  reaction  reporting  system/procedures,

— drug  product  defect  reporting  system/procedures.

11. Quality  management  systems

— quality management/assurance system/procedures to ensure the ongoing suitability and effectiveness
of  policies,  procedures,  guidelines  and  systems  used  to  achieve  the  objectives  of  the  GMP
compliance  programme,  including  establishment  of  standards  and  annual  audit  and  review.

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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.  Tel.  (1-613)  947 03 69,
fax  (1-613)  952 77 56;  and

— for  the  European  Community,

the  Director  of  the  European  Agency  for  the  Evaluation  of  Medicinal  Products,  7  Westferry  Circus,
Canary  Wharf,  London  E14  4HB,  United  Kingdom.  Tel.  (44-171)  418 84 00,  fax  418 84 16.

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Appendix  6

Phases  of  a  confidence  building  period

The determination of the equivalency of the GMP compliance programmes by the joint sectoral group will
be  designed  around  the  following  three  phases:

1. Review  and  evaluation  of  documentation  (exchange  of  documentation)

— legal  instruments  (regulations/legislation/directives)/guidelines  on  GMPs,

— inspection  programmes  (scope,  policies,  directives,  procedures),

— crisis  management  systems  (scope,  criteria,  policies,  directives,  procedures),

— requirements  for  inspection  reports,

— analytical laboratory systems,

— alert  reports.

2. Evaluation  of  processes  and  procedures

— audit  of  systems  and  procedures,

— exchange/evaluation  of  reports,

— monitoring  of  alert  systems  including  handling  of  recalls,

— joint  inspections  of  manufacturers  to  determine  equivalency  of  inspection  methods,

— exchange  of  inspectors  or  organisation  of  joint  workshops  (optional).

3. Decision  making  on  the  success  of  the  exercise  and  conclusions

— evaluation  of  results  of  the  confidence  building  exercise,

— action  to  take,  development  of  options  and  solutions  to  address  issues,

— determination  of  competent  agencies  that  meet  evaluation  criteria,

— establishment  of  the  conditions  and  mechanisms  for  on-going  maintenance  of  the  certification
programme  (develop  quality  management  system,  audit  mechanism  and  a  consultation/on-going
dialogue  process).

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Appendix  7

Certificate of pharmaceutical manufacturer in the framework of the Agreement on mutual recognition between Canada
and the European Community, Sectoral Annex on medicinal products GMP inspection and batch certification

As requested by the  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (*)

on  . . ./. . ./. . .  (date)  (reference:  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ), the competent

authority of  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (**)  confirms the following:

The  company  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

whose legally registered address is:  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

has been authorised, under Directive 75/319/EEC (Article 16) and Directive 81/851/EEC (Article 24) transposed in the national

legislation of  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(**),  under  the  authorisation  reference  number

covering the following site(s)  of  manufacture (and contract testing laboratories, if any):

1.

2.

3.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

to carry out the following manufacturing operations:

+ complete  manufacture (***)

+ partial manufacture (***),  i.e.  (detail  of  manufacturing  operations  authorised):  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

for the following medicinal product:  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

for  human  use/use  in  animals (***).

From the knowledge gained during inspections of this manufacturer, the latest of which was conducted on . . ./. . ./. . . (date), it
is considered that the company complies with the good manufacturing practice requirements referred to in the Agreement on
Mutual  Recognition  between  Canada  and  the  European  Community.

. . ./. . ./. . . (date)

For the competent authority

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Name  and  signature  of  the  officer  responsible)

(*) Insert exporting or importing firm or Health Canada.

(**) Insert European Community Member State or European Community as required.

(***) Delete  that  which  does  not  apply.

L 280/50

EN

Official  Journal  of  the  European  Communities

16.10.98

Health
Canada

Santé
Canada

Establishment Licence

Licence  Number
100001-A
Numéro de la licence

P R O G R A M M E D E S
P R O D U I T S
THÉRAPEUTIQUES

THERAPEUTIC
P R O D U C T S
P R O G R A M M E

Licence d’établissement

This licence is issued in accordance with the Food and Drugs Act &
Regulations (Division 1A & 2) for the following activities and
categories of drugs:

Cette licence est délivrée conformément à la Loi et aux Règlements
sur les aliments et drogues (titres 1A et 2) pour les activités et les
catégories de drogues suivantes:

NO / NON

Pharmaceutical
Prod. pharmaceutique

Vaccines
Vaccins

Blood (3)
Sang

Schedule D (4)
L’annexe D

Schedule C (5)
L’annexe  C

(6)

STERILE /
STÉRILE

Fabricate
Manufacturer

Package / label
Emballer-étiqueter

Test (1)
Test

Distribute (2)
Distribuer

Import
Importer

Wholesale
Vendre en gros

(1) Perform the tests, including any examinations required under Division 2 / Analyser conformément au titre 2.
(2) Distribute as set out in paragraph C.01.A.003 (a) and/or (b) / Distribuer au sens de l’alinéa C.01.A.003 (a) et/ou (b).
(3) Whole blood and its components / Sang entier et ses composants.
(4) Drugs  listed  in  Schedule  D  to  the  Act,  other  than  vaccines  or  whole  blood  and  its  components  /  Drogue  visée  à  l’annexe  D  de  la  Loi,  autre  qu’un  vaccin  ou  que  le  sang  entier  et  ses

composants.

(5) Drugs listed in Schedule C to the Act / Drogue visée à l’annexe C de la Loi.
(6) Drugs listed in the Schedule to Part G of the Food and Drug Regulations, drugs listed in Schedule F to the Food and Drug Regulations, narcotics as defined in section 2 of the Narcotic Control
Regulations / Drogue  visée  à  l’annexe  de  la  Partie  G  des  Règlements  sur  les  aliments  et  drogues,  drogue  visée  à  l’annexe  F  des  Règlements  sur  les  aliments  et  drogues,  stupéfiants  au  sens  de
l’article 2 des Règlements sur les stupéfiants.

Issued On / Émise le:

1998-01-01

MINISTER OF HEALTH

Countersigned: Director General, Therapeutic Products Directorate
Contresigné par: Directeur général, Direction des produits thérapeutiques

MINISTRE DE LA SANTÉ

This licence is the property of the Therapeutic Products Directorate and must be returned upon demand.
Cette licence appartient à la direction des produits thérapeutiques et doit être retournée sur demande.

16.10.98

EN

Official  Journal  of  the  European  Communities

L 280/51

Health
Canada

Santé
Canada

Establishment Licence

Licence  Number
100125-A
Numéro de la licence

P R O G R A M M E D E S
P R O D U I T S
THÉRAPEUTIQUES

THERAPEUTIC
P R O D U C T S
P R O G R A M M E

Licence d’établissement

This licence is issued in accordance with the Food and Drugs Act &
Regulations (Division 1A & 2) for the following activities and
categories of drugs:

Cette licence est délivrée conformément à la Loi et aux Règlements
sur les aliments et drogues (titres 1A et 2) pour les activités et les
catégories de drogues suivantes:

NO / NON

Pharmaceutical
Prod. pharmaceutique

Vaccines
Vaccins

Blood (3)
Sang

Schedule D (4)
L’annexe D

Schedule C (5)
L’annexe  C

(6)

STERILE /
STÉRILE

Fabricate
Manufacturer

Package / label
Emballer-étiqueter

Test (1)
Test

Distribute (2)
Distribuer

Import
Importer

Wholesale
Vendre en gros

(1) Perform the tests, including any examinations required under Division 2 / Analyser conformément au titre 2.
(2) Distribute as set out in paragraph C.01.A.003 (a) and/or (b) / Distribuer au sens de l’alinéa C.01.A.003 (a) et/ou (b).
(3) Whole blood and its components / Sang entier et ses composants.
(4) Drugs  listed  in  Schedule  D  to  the  Act,  other  than  vaccines  or  whole  blood  and  its  components  /  Drogue  visée  à  l’annexe  D  de  la  Loi,  autre  qu’un  vaccin  ou  que  le  sang  entier  et  ses

composants.

(5) Drugs listed in Schedule C to the Act / Drogue visée à l’annexe C de la Loi.
(6) Drugs listed in the Schedule to Part G of the Food and Drug Regulations, drugs listed in Schedule F to the Food and Drug Regulations, narcotics as defined in section 2 of the Narcotic Control
Regulations / Drogue  visée  à  l’annexe  de  la  Partie  G  des  Règlements  sur  les  aliments  et  drogues,  drogue  visée  à  l’annexe  F  des  Règlements  sur  les  aliments  et  drogues,  stupéfiants  au  sens  de
l’article 2 des Règlements sur les stupéfiants.

This licence is subject to the additional conditions as indicated in
the attached:

Cette licence est assujettie aux conditions supplémentaires
indiquées dans le feuillet ci-joint:

Foreign Site Annex / Annexe concernant les sites étrangers

Issued On / Émise le:

1998-01-01

MINISTER OF HEALTH

Countersigned: Director General, Therapeutic Products Directorate
Contresigné par: Directeur général, Direction des produits thérapeutiques

MINISTRE DE LA SANTÉ

This licence is the property of the Therapeutic Products Directorate and must be returned upon demand.
Cette licence appartient à la direction des produits thérapeutiques et doit être retournée sur demande.

L 280/52

EN

Official  Journal  of  the  European  Communities

16.10.98

Health
Canada

Santé
Canada

Establishment Licence

Licence  Number
100125-A
Numéro de la licence

P R O G R A M M E D E S
P R O D U I T S
THÉRAPEUTIQUES

THERAPEUTIC
P R O D U C T S
P R O G R A M M E

Licence d’établissement

Foreign Site Annex / Annexe concernant les sites étrangers

The following sites are considered to be in GMP Compliance:

Les sites suivants sont considérés comme étant conformes aux BPF:

Company Name /
Nom de l’entreprise

Street/Rue:

Activity/Activite:

FABRICATE / FABRICATION
PACKAGE / CONDITIONNEMENT

Category/Catégorie:

PHARMACEUTICAL / MÉDICAMENT

City/Ville:

Country/Pays:

Sterile/Stérile
NO / NON

16.10.98

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SECTORAL  ANNEX  ON  MEDICAL  DEVICES

1.

PURPOSE

1.1. This  Mutual  Recognition  Agreement  (MRA)  Annex  on  conformity  assessment  and  compliance
certification  pertaining  to  medical  devices  has  been  developed  by  the  European  Community  and
Canada  to  enhance  bilateral  medical  device  regulatory  cooperation  while  facilitating  global  trade  and
maintaining  the  same  high  standards  of  health  and  safety  in  both  jurisdictions.

1.2. Furthermore 

this  Annex  calls 

for  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.

the  development  of  an 

infrastructure 

for 

2.

SCOPE  AND  COVERAGE

2.1. This Annex applies to all medical devices which in Canada or the European Community are subject to
conformity  assessment  procedures,  including  scientific  technical  evaluations  of  high  risk  medical
devices  and  quality  systems  assessments,  by  a  conformity  assessment  body.

2.2. The  product  coverage  shall  be  as  determined  by  the  relevant  legislation  of  each  Party,  which  is:

(a)

for  the  European  Community:

— Council  Directive  90/385/EEC  of  20  June  1990  on  the  approximation  of  the  laws  of  the

Member  States  relating  to  active  implantable  medical  devices,  as  amended,

— Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices;

(b)

for  Canada:

— the  Food  and  Drugs  Act  and  Medical  Devices  Regulations  (proposed  for  promulgation  1998)

as  amended  from  time  to  time,

— the  Canadian  Electrical  Code  (as  it  relates  to  medical  devices),

— the  Radiation  Emitting  Devices  Act  and  Regulations  as  amended  from  time  to  time  (as  they

relate  to  medical  devices).

It  shall  not,  however,  apply  to  the  following  products:

— in  vitro  diagnostic medical devices,

— devices incorporating, as an integral part, a substance which, if used separately, may be considered

to  be  a  medicinal  product,

— breast  implants,

— medical  devices  incorporating  tissues  of  human  or  animal  origin.  However,  medical  devices
incorporating  tissues  of  animal  origin  and  where  the  device  is  intended  to  come  into  contact  with
intact  skin  only,  will  be  included  within  the  scope  of  this  Sectoral  Annex.

Both Parties may, however, decide by common agreement, to extend the application of this Annex to
the  aforementioned  or  any  other  medical  devices.

3.

CONFIDENTIALITY

3.1. Each  Party  will  protect  from  public  disclosure  any  non-public  confidential  technical,  commercial  and
scientific  information,  including  trade  secrets  and  proprietary  information  provided  by  the  other
Party.

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.

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4.

RESOLUTION  OF  DIVERGENT  VIEWS

4.1. Divergent  views  which  have  not  been  resolved  between  the  regulatory  authorities  will  be  referred  to
the  joint  sectoral  group  for  resolution.  In  the  event  that  the  joint  sectoral  group  is  unable  to  resolve
these  divergent  views,  either  Party  may  bring  the  matter  to  the  attention  of  the  Joint  Committee.

5. MANAGEMENT MECHANISM

5.1. A  joint  sectoral  group  will  be  established  for  the  purposes  of  management  of  this  Sectoral  Annex.  Its
role  will  be  to  make  decisions  concerning  the  definition,  establishment,  and  evaluation  of  conformity
assessment  procedures  and  programmes,  the  establishment  of  the  ‘two-way’  alert  programme,  the
management  of  the  confidence  building  period  and  the  definition  of  a  maintenance  programme
supporting  the  continued  operation  of  the  MRA.  The  group  will  include  representatives  of  Health
Canada and of the European Community’s competent authorities and co-chaired by a member of each
of  the  two  Parties.

6.

TRANSITION  PERIOD

6.1. Time  frame

The  confidence  building  period  will  commence  upon  the  signing  of  the  MRA  and  is  expected  to  be
completed  within  18  months.

6.2. Confidence  building  programme

At  the  beginning  of  the  transitional  period,  the  joint  sectoral  group  will  elaborate  a  joint  confidence
building  programme  (guidance  provided  in  Attachment  III).  The  implementation  of  this  programme
shall  establish  each  Party’s  capability  to  perform  conformity  assessments  in  compliance  with  the
requirements  and  procedures  of  the  other  Party.  The  evidence  shall  provide  practical  relevance  to  the
decisions  regarding  the  operational  phase.

The  confidence  building  programme  should  include  the  following  actions  and  activities:

(a)

(b)

(c)

the  organisation  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 manufacturer’s technical submission against the requirements of the intended market for that
device, will be undertaken. Full reports and recommendations shall be exchanged for comparison.
A  certificate  of  compliance  can  be  issued  by  the  body  responsible  for  the  relevant  market  during
this  inter-comparison  study.  The  inter-comparison  study  should  take  place  on  a  sampling  basis
comprising  a  sufficient  number  of  cases  spread  over  the  range  of  different  medium  to  high-risk
technologies  with  the  involvement  of  each  Party’s  regulatory/designating  authorities  and  CABs.
Additional  evidence  with  respect  to  the  competency  of  regulatory/designating  authorities  and
CABs  can  be  requested  by  either  Party;

(d)

for  quality  systems  assessments,  an  inter-comparison  exercise  which  would  consist  of  the
participation of regulatory/designating authorities in audits carried out by CABs of the other Party
on  the  basis  of  requirements  of  the  other  Party.  Audit  management,  methods  and  reports  will  be
compared.  The  inter-comparison  study  should  take  place  on  a  sampling  basis  comprising  a
sufficient number of cases spread over the range of different technologies with the involvement of
each Party’s regulatory/designating authorities and CABs. Additional evidence with respect to the
competency  of  regulatory/designating  authorities  or  CABs  can  be  requested  by  either  Party;

(e)

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

(f)

the  establishment  of  contact  points  between  regulatory/designating  authorities  and  CABs  of  both
Parties;

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L 280/55

(g)

the  participation  in  information  exchange  meetings  with  particular  focus  on  conformity
assessment  and  vigilance,  including  participation  in  staff  training  sessions.  The  exchange  of  staff
will  also  be  encouraged;  and

(h) during  the  confidence  building  programme,  where  one  Party  has  developed  sufficient  confidence
in  the  evaluation  methods  and  results  of  the  other,  it  may  at  its  own  discretion,  establish  the
relevant  document  of  compliance  permitting  market  access  for  its  own  jurisdiction  based  on  the
evaluation  reports  of  the  other  Party  without  the  full  submission.

Participation  in  activities  referenced  under  (c)  and  (d)  should  be  understood  as  means  to  provide,  on
an exemplary basis, supplementary evidence in relation to the process of designation and surveillance
of  CABs.

6.3. Budget

Each of the Parties to the MRA will be responsible for the costs of its participation in the confidence
building activities.

6.4. End  of  transition  period

No  later  than  18  months  after  the  entry  into  force  of  this  Agreement,  the  joint  sectoral  group  shall
proceed to a joint evaluation of the experience gained. This evaluation will cover the adequacy of the
confidence  building  programme,  the  capabilities  of  regulatory/designating  authorities  and  the
capabilities  of  the  designated  conformity  assessment  bodies.

Recommendations  to  list  CABs  in  Attachment  II  of  this  Annex  shall  be  made  by  participating
regulatory/designating authorities, listed in Attachment I, to the joint sectoral group on the basis of the
results of the confidence building programme. Conformity assessment bodies that have been accepted
by  the  joint  sectoral  group  will  be  listed  in  Attachment  II  with  an  indication  of  their  specific
conformity  assessment  expertise  and  the  fields  of  medical  device  technologies  for  which  they  are
recognised.  The  corresponding  regulatory/designating  authority  responsible  for  a  CAB  will  also  be
listed in Attachment II. Proposals to limit the recognition of capabilities of CABs should be based on
objective evidence and documented. The joint sectoral group may recommend that a CAB not be listed
in  Attachment  II,  provided  there  is  documented  evidence  demonstrating  its  lack  of  capabilities.
Excluded  CABs  may  apply  for  reconsideration  of  their  status  once  the  necessary  corrective  measures
have  been  taken  and  confirmed.

Where  no  agreement  on  any  of  the  above  matters  has  been  reached  in  the  joint  sectoral  group,  the
matter  will  be  referred  to  the  Joint  Committee  under  the  Framework  Agreement.

The Parties shall enter into the operational phase provided that there is representation of each Party’s
CABs  in  Attachment  II.

The  Agreement  will  also  be  re-examined  at  the  end  of  the  transitional  period  to  take  account  of  the
regulatory  evolution  of  each  Party.  Consideration  shall  be  given  to  a  single  submission/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.

The  European  Community  and  Canada  agree  that,  for  medical  devices  covered  by  this  Annex,  each
Party  will  recognise  the  conclusions  of  the  conformity  assessment  carried  out  by  the  other  Party  and
the  certificate  of  compliance  granted  by  the  conformity  assessment  body  of  the  other  Party,  without
further  reassessment.

For evaluation against European requirements, Health Canada or other conformity assessment bodies
designated  by  Canada  shall  establish  the  conclusions  of  completed  conformity  assessment  as  referred
to in the active implantable medical device and the medical device Directives, and issue the appropriate
certificate  of  compliance.  The  responsible  authorities  in  the  European  Community  will,  without  any
further  reassessment,  accept  the  certification  as  evidence  of  compliance  with  the  premarket
requirements  of  the  relevant  European  Directives.

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For  evaluating  against  Canadian  requirements,  the  European  CABs  shall  establish  the  conclusions  of
the  examination  and  submit  to  Health  Canada  an  abbreviated  supporting  report  and  certificate  of
compliance  which  includes  such  conclusions.  Based  on  these  documents,  and  without  any  further
reassessment,  Health  Canada  will  accept  the  certification  as  evidence  of  compliance  with  the
premarket  requirements  of  the  Canadian  medical  devices  Regulations.

Each Party shall make available to the other Party, upon reasoned request, any information which has
been  reviewed  as  part  of  the  assessment  of  a  medical  device  for  the  purpose  of  issuing  certificates  of
compliance.

Each  Party  reserves  the  right,  at  any  time,  to  question  information  with  respect  to  the  designation
process  or  the  performance  of  conformity  assessments  against  the  requirements  of  its  regulatory
regime.  Furthermore,  each  Party  reserves  the  right  to  conduct  its  own  conformity  assessments  for
reasons  identified  to  the  other  Party.  Justification  for  such  action  shall  be  based  on  documented
evidence  and  notification  is  to  be  provided  in  advance  to  the  other  Party.  Recourse  to  this  action
should  be  an  exception.

7.2. Procedures  for  designation  of  CABs

The  procedures  to  be  followed  by  the  designating  authorities  of  each  Party  in  designating  CABs  shall
respect  the  criteria  laid  down  in  the  other  Party’s  regulations  or  guidelines  (non-binding  guidance  is
provided  in  Attachment  V).

7.3.

Information  sharing

In  accordance  with  the  general  provisions  of  the  Annex,  the  Parties  will  exchange  all  information
necessary  to  determine  and  maintain  equivalence  of  conformity  assessment  procedures.  In  addition,
each  Party  shall  share  with  the  other  Party  information  generated  within  the  framework  of  its
regulatory  system  which  is  relevant  for  the  operation  of  conformity  assessment  procedures  (i.e.
guidance  documents,  publications  of  references  to  standards,  forms,  documents  relating  to  the
application  of  legal  requirements).  Each  Party  shall  associate  regulatory/designating  authorities  and
conformity  assessment  bodies  of  the  other  Party  in  activities  of  exchange  of  information  and
experience.

In  special  cases,  particularly  emergency  situations,  all  those  involved  in  the  implementation  of  this
Annex will endeavour to provide all documentation requested by one of the Parties in an expeditious
manner.

7.4. Two-way  alert  system

The joint sectoral group will ensure that an efficient and effective ‘two-way’ alert system is in place at
all  times.  Elements  of  such  a  system  are  described  in  Attachment  IV.

Each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls
related to products that it has evaluated under the terms of this Agreement. Each Party will respond to
special  requests  for  information  on  particular  devices  and  will  ensure  that  its  designated  authorities
and  conformity  assessment  bodies  make  available  relevant  information  on  these  devices,  as
requested.

It  shall  be  the  responsibility  of  the  regulatory  authorities  covered  by  this  Annex  to  ensure  that  any
suspension  or  cancellation  (total  or  partial)  of  a  certificate  of  compliance  is  communicated  to  each
other  with  the  appropriate  degree  of  urgency.

7.5. Fees

The  regime  of  registration  or  conformity  assessment  fees  is  determined  by  the  location  of  the
manufacturer. The cost recovery programmes and the fees pertaining to the issuance of a certificate of
compliance  in  each  jurisdiction  will  remain  the  responsibility  of  that  jurisdiction.  Conformity
assessment fees will not be charged by one Party to manufacturers located on the territory of the other
Party, where the conformity assessment was conducted by a conformity assessment body located in the
other  Party’s  territory.

7.6. Monitoring  of  the  Agreement

The continuous monitoring of the equivalency of designation processes and conformity assessments for
each  Party’s  requirements  that  have  been  determined  to  be  equivalent  at  the  conclusion  of  the
confidence  building  programme,  and  any  subsequent  decisions  concerning  that  equivalence,  must  be
made  according  to  mutually  developed  and  managed  equivalence  maintenance  and  implementation
activities.  This  will  be  managed  by  the  joint  sectoral  group.

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The  Parties  will  undertake  to  hold  regular  consultations,  within  the  joint  sectoral  group  set  up  under
this  Annex  to  ensure  the  continued  relevancy  and  accuracy  of  this  Annex.  The  regulatory/designating
authorities  and  conformity  assessment  bodies  will  organise  meetings  to  discuss  specific  questions  and
issues.

Conformity  assessment  bodies  and  regulatory/designating  authorities  must  continue  participation  in
maintenance activities, as established by the joint sectoral group, within the framework of this Annex
in  order  to  maintain  their  status  under  this  Annex  as  indicated  in  Attachment  II.

Parties may request the addition of regulatory/designating authorities or conformity assessment bodies
to  Attachment  II.  The  procedure  for  the  acceptance  of  new  regulatory/designating  authorities  will  be
as  described  in  the  confidence  building  programme.  Conformity  assessment  bodies  will  be  added  to
Attachment II upon recommendation from a regulatory/designating authority and joint decision by the
joint  sectoral  group.

7.7. Contact  points

Contact points are identified in order to permit regulatory authorities and manufacturers to inform the
regulatory authorities of the other Party with the appropriate speed in case of quality defects, recalls,
and adverse incidents, which could necessitate additional controls or, suspension of the distribution of
the  product  or,  suspension  or  cancellation  of  a  certificate  of  compliance.

For  the  purpose  of  this  Agreement,  the  contact  points  will  be:

for  Canada: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,  and

for  the  European  Community  (the  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.

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Attachment  I

Regulatory/designating  authorities  eligible  to  participate  in  this  Agreement

For  the  conformity  assessment  bodies  designated  by
Canada

For  the  conformity  assessment  bodies  designated  by
the  European  Community

Canada

— Belgium

Therapeutic  products  programme,  Health  Canada

Ministère  de  la  santé  publique,
de  l’environnement  et  de  l’intégration  sociale
Ministerie  van  Volksgezondheid,  Leefmilieu  en
Sociale Integratie

— Denmark

Sundhedsministeriet

— Germany

Bundesministerium  für  Gesundheit

— Greece

Υ(cid:240)(cid:239)υργ(cid:229)(cid:221)(cid:239)  Υγ(cid:229)(cid:221)Æς
Ministry  of  Health

— Spain

Ministerio  de  Sanidad  y  Consumo

— France

Ministère  de  l’emploi  et  de  la  solidarité
Ministère  de  l’économie,  des  finances
et  de  l’industrie

— Ireland

Department  of  Health

— Italy

Ministero  della  Sanità

— Luxembourg

Ministère  de  la  Santé

— Netherlands

Staat  der  Nederlanden

— Austria

Bundesministerium  für  Arbeit,  Gesundheit  und
Soziales

— Portugal

Ministerio  da  Saude

— Finland

Sosiaali- ja terveysministeriö/Social- och
hälsovårdsministeriet

— Sweden

Under  the  authority  of  the  Government  of
Sweden:
Styrelsen  för  ackreditering  och  teknisk  kontroll
(SWEDAC),  designating  authority
Socialstyrelsen, regulatory authority

— United  Kingdom

Department  of  Health

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Attachment  II

Designated  conformity  assessment  bodies  and  their  respective  designating  authorities

For  Canada

For  the  European  Community

To  be  completed  after  the  confidence  building
programme

To  be  completed  after  the  confidence  building
programme

Attachment  III

Phases  and  elements  of  a  confidence  building  programme

A. REVIEW AND EVALUATION OF ELEMENTS OF CONFORMITY ASSESSMENT (EXCHANGE OF

DOCUMENTATION)

1. Legislative  and  regulatory  requirements  and  scope

— empowering  legislation  and  regulations  including  authority  to  enforce  laws  and  regulations,
powers  given  to  evaluators  and  auditors,  authority  to  remove  violative  products  from  the
market, etc.,

— suitable  controls  on  conflict  of  interest.

2. Regulatory  directives  and  policies

— procedures  for  determining  competency  of  evaluators/auditors,

— enforcement policies/guidelines/procedures,

— codes  of  conduct/ethics,

— training/certification policies/guidelines,

— alert/crisis management policies/procedures/guidelines,

— organisational  structure,  including  roles,  responsibilities  and  reporting  relationships.

3. Quality  audit  management,  methodology  and  practices

— scope/details  of  operating  standards,  etc.,

— auditor  qualifications,  numbers,  training,  quality  assurance,  contracting,  etc.

4. Scientific  technical  evaluation  methodology  and  practices

— scope/details  of  operating  standards,  etc.,

— evaluator  qualifications,  numbers,  training,  quality  assurance,  contracting,  etc.

5. Evaluation  and  auditing  reports

— scope  and  format  of  reports,

— content  requirements,

— storage,  retrieval  and  access  to  reports,

— scope  and  format  of  abbreviated  reports,  conclusions  of  conformity  assessment  and

certificates.

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6. Auditing  and  evaluation  procedures

— audit  and  evaluation  strategy  (type,  scope,  scheduling,  focus,  notification,  risk),

— pre-audit  or  evaluation  preparation/requirements,

— methodology  (access  to  and  review  of  firm’s  files  and  databases,  collection  of  evidence,  data

review,  sample  collection,  interviews),

— post  audit  and  evaluation  activities  (procedures  for  report  issuance,  follow-up,  decision

making),

— collection/storage  of  and  access  to  data.

7. Auditing  and  evaluation  performance  standards

— frequency/number, quality and timeliness of reports, norms/frequency/procedures for re-audit or

re-evaluation  and  corrective  action.

8. Enforcement  powers  and  procedures

— provision  of  written  notices  of  violations  to  firms,

— non-compliance  management  procedures/mechanisms 
products,  certificate  revocation,  seizure,  prosecution),

(recall,  suspension,  quarantine  of

— appeal mechanisms,

— other  measures  to  promote  voluntary  compliance  by  firm.

9. Alert  and  crisis  systems

— alert mechanisms,

— crisis  management  mechanisms,

— alert  performance  standards  (appropriationess  and  timeliness  of  alert).

10. Analytical capability

— access  to  laboratories  with  capacity  to  handle  necessary  analysis,

— standard  operating  procedures  for  analytical  support,

— processes  for  validation  of  analytical  methods.

11. Surveillance  programme/measures  (used  by  manufacturers  and  by  regulatory  authorities)

— sampling  and  audit  procedures,

— recall  monitoring  (including  effectiveness  controls  and  verification  of  procedures),

— consumer  complaint  systems/procedures,

— adverse  incident  reporting  systems/procedures.

12. Quality  management  systems

— quality  management/assurance  systems/procedures  to  ensure  the  on-going  suitability  and
effectiveness of policies, procedures, guidelines and systems used to achieve the objectives of the
conformity  assessment  programme,  including  establishment  of  standards  and  annual  audit  and
review.

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B.

INTER-COMPARISON  EXERCISE

— audit  of  systems  and  procedures,

— conduct  of  parallel  evaluations  (double  blind),

— criteria  for  clinical  trial  data,

— exchange/evaluation  of  reports,

— monitoring  of  alert  systems  including  handling  of  recalls,

— joint  audits  of  manufacturers  to  determine  equivalency  of  audit  methods,

— exchange  of  evaluators/auditors  or  organisation  of  joint  workshops  (optional).

C. DECISION  MAKING  ON  THE  SUCCESS  OF  THE  INTER-COMPARISON  STUDY

— evaluation  of  results,

— action  to  take,  development  of  options  and  solutions  to  address  issues,

— determination  of  competent  conformity  assessment  bodies  that  meet  evaluation  criteria,

— establishment  of  the  conditions  and  mechanisms  for  on-going  maintenance  of  the  MRA  (develop

quality  management  system,  audit  mechanism  and  a  consultation/on-going  dialogue  process).

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Attachment  IV

Components  of  a  ‘two-way’  alert  programme

1. Documentation

— definition  of  a  crisis/emergency  and  under  what  circumstances  an  alert  is  required,

— standard  operating  procedures  (SOPs),

— mechanism  of  health  hazards  evaluation  and  classification,

— language  of  communication  and  transmission  of  information.

2. Crisis  management  system

— crisis  analysis  and  communication  mechanisms,

— access  to  manufacturer’s  submissions,  adverse  incident  reports  and  conformity  assessment  body

reports,

— establishment  of  contact  points,

— reporting  mechanisms.

3. Enforcement  procedures

— follow-up  mechanisms,

— corrective  action  procedures.

4. Quality  assurance  system

— vigilance programme,

— surveillance/monitoring  of  implementation  of  corrective  action.

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Attachment  V

Guidelines:  procedures  for  the  designation  and  monitoring  of  conformity  assessment  bodies

A. GENERAL  REQUIREMENTS  AND  CONDITIONS

1. Designating  authorities  shall  only  designate  legally  identifiable  entities  as  conformity  assessment

bodies.

2. Designating authorities shall only designate conformity assessment bodies able to demonstrate that
they  understand,  have  experience  relevant  to,  and  are  competent  to  apply  the  conformity
assessment requirements and procedures of the legislative, regulatory and administrative provisions
of  the  other  Party  for  which  they  are  designated.

3. Demonstration  of  technical  capabilities  shall  be  based  on:

— technological  knowledge  of  the  relevant  products,  processes  or  services,

— understanding of the technical standards and the general risk protection requirements for which

designation  is  sought,

— the  experience  relevant  to  the  applicable  legislative,  regulatory  and  administrative  provisions,

— the  physical  capability  to  perform  the  relevant  conformity  assessment  activity,

— an  adequate  management  of  the  conformity  assessment  activities  concerned,  and

— any other circumstance necessary to give assurance that the conformity assessment activity will

be  adequately  performed  on  a  continuous  basis.

4. The technical capability criteria shall be based on internationally accepted documents supplemented

by  specific  interpretative  documents  developed  as  appropriate  from  time  to  time.

5. The  Parties  shall  encourage  harmonisation  of  designation  and  conformity  assessment  procedures
through  cooperation  between  designating  authorities  and  conformity  assessment  bodies  by  means
of  coordination  meetings,  participation  in  mutual  recognition  arrangements,  and  working  group
meetings.  Where  accreditation  bodies  participate  in  the  designation  process  they  should  be
encouraged  to  participate  in  mutual  recognition  arrangements.

B. SYSTEM  TO  DETERMINE  CONFORMITY  ASSESSMENT  BODIES’  CAPABILITIES

6. The  designating  authorities  may  apply  the  following  processes  to  determine  the  technical
capabilities  of  conformity  assessment  bodies.  If  necessary,  a  Party  will  indicate  to  the  designating
authority  the  possible  ways  to  demonstrate  capabilities.

(a) Accreditation

Accreditation  shall  constitute  a  presumption  of  technical  capability  in  relation  to  the
requirements  of  the  other  Party  when:

(i)

the  accreditation  process  is  conducted  in  conformance  with  the  relevant  international
documentation  (EN  45000  series  or  ISO/IEC  guides);  and  either,

(ii)

(iii)

the accreditation body participates in mutual recognition arrangements where it is subject
to peer evaluation, which involves evaluation by individuals with recognised expertise in
the  field  of  the  work  being  evaluated  of  the  capabilities  of  accreditation  bodies  and
conformity  assessment  bodies  accredited  by  them,  or

the  accreditation  body,  operating  under  the  authority  of  a  designating  authority,  takes
part,  in  accordance  with  procedures  to  be  agreed,  in  comparison  programmes  and
exchanges  of  technical  experience  in  order  to  ensure  the  continued  confidence  in  the
technical competence of the accreditation bodies and conformity assessment bodies. Such
programmes  may  include  joint  assessments,  special  cooperation  programmes  or  peer
evaluation.

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When  a  conformity  assessment  body  is  only  accredited  to  evaluate  a  product,  process  or
service  for  compliance  with  particular  technical  specifications,  designation  shall  be  limited  to
those  technical  specifications.

When  a  conformity  assessment  body  seeks  designation  to  evaluate  a  particular  product,
process  or  service  for  compliance  with  essential  requirements,  the  accreditation  process  shall
incorporate  elements  which  will  permit  assessment  of  the  capability  (technological  knowledge
and understanding of the generally stated risk protection requirements of the product, process
or  service  or  their  use)  of  the  conformity  assessment  body  to  evaluate  compliance  with  those
essential  requirements.

(b) Other  means

When  appropriate  accreditation  is  not  available  or  when  special  circumstances  apply,  the
designating  authorities  shall  require  the  conformity  assessment  bodies  to  demonstrate  their
capabilities  through  other  means  such  as:

— participation  in  regional/international  mutual  recognition  arrangements  or  certification

systems,

— regular  peer  evaluations,

— proficiency  testing,  and

— comparisons  between  conformity  assessment  bodies.

C. EVALUATION  OF  THE  DESIGNATION  SYSTEM

7. Once  the  designation  systems  to  evaluate  the  capabilities  of  conformity  assessment  bodies  have
been  defined  by  each  Party,  the  other  Party  may,  in  consultation  with  the  designating  authorities,
check  that  the  systems  give  sufficient  assurance  that  the  designation  of  the  conformity  assessment
bodies  satisfies  its  requirements.

D. FORMAL  DESIGNATION

8. Designating  authorities  shall  consult  the  conformity  assessment  bodies  within  their  jurisdiction  in
order  to  determine  their  willingness  to  be  designated  under  the  terms  of  this  Agreement.  Such
consultation  should  include  those  conformity  assessment  bodies  who  do  not  operate  under  the
respective  legislative,  regulatory,  and  administrative  requirements  of  their  own  Party,  but  which
may,  nevertheless,  be  interested  and  capable  of  working  to  the  legislative,  regulatory,  and
administrative  requirements  of  the  other  Party.

9. Designating  authorities  shall  inform  their  Party’s  representatives  on  the  joint  sectoral  group,
established  under  this  Agreement,  of  the  conformity  assessment  bodies  to  be  included  in  or
withdrawn  from  Section  XX  of  the  Sectoral  Annexes.  Designation,  suspension  or  withdrawal  of
designation  of  conformity  assessment  bodies  shall  take  place  in  accordance  with  the  provisions  of
this  Agreement  and  the  rules  of  procedure  of  the  joint  sectoral  group.

10. When  advising  their  Party’s  representative  on  the  joint  sectoral  group  established  under  this
Agreement,  of  the  conformity  assessment  bodies  to  be  included  in  the  Sectoral  Annexes,  the
designating  authority  shall  provide  the  following  details  in  respect  of  each  conformity  assessment
body:

(a)

the  name;

(b)

the  postal  address;

(c)

the  fax  number;

(d)

the  range  of  products,  processes,  standards  or  services  it  is  authorised  to  assess;

(e)

the  conformity  assessment  procedures  it  is  authorised  to  carry  out;  and

(f)

the  designation  procedure  used  to  determine  capabilities.

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E. MONITORING

11. Designating authorities shall maintain, or cause to maintain, on-going surveillance over designated
conformity  assessment  bodies  by  means  of  regular  audit  or  assessment.  The  frequency  and  nature
of  such  activities  shall  be  consistent  with  international  best  practices  or  as  agreed  by  the  joint
sectoral  group.

12. Designating  authorities  shall  require  designated  conformity  assessment  bodies  to  participate  in
proficiency  testing  or  other  appropriate  comparison  exercises  where  such  exercises  are  technically
possible  within  reasonable  cost.

13. Designating  authorities  shall  consult  as  necessary  with  their  counterparts,  to  ensure  the
maintenance  of  confidence  in  conformity  assessment  processes  and  procedures.  This  consultation
may  include  joint  participation  in  audits  related  to  conformity  assessment  activities  or  other
assessments  of  designated  conformity  assessment  bodies,  where  such  participation  is  appropriate
and  technically  possible  within  reasonable  cost.

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.