Proposal for a Council Decision concerning the Community position within the Association Council established by the Europe Agreement between the European Communities and their Member States, of the one part, and the Czech Republic, of the other part, on the addition of annexes to the Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products (PECA)
Date: 2003-07-24
Institutions: European Commission
Subjects: Association Council (EU), Czechia, approval, industrial product, mutual recognition principle, product safety, protocol to an agreement

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 24.7.2003
COM(2003) 450 final

Proposal for a

COUNCIL DECISION

concerning the Community position within the Association Council established by the
Europe Agreement between the European Communities and their Member States, of the
one part, and the Czech Republic, of the other part, on the addition of annexes to the
Protocol to the Europe Agreement on Conformity Assessment and Acceptance of
Industrial Products (PECA)

(presented by the Commission)

EXPLANATORY MEMORANDUM

The  Europe  Agreement1  (EA)  establishing  an  Association  between 
the  European
Communities and their Member States, of the one part, and the Czech Republic, of the other
part, came into force on 1 February 1995. A Protocol2 to the EA on Conformity Assessment
and Acceptance of Industrial Products (PECA) was signed on 26 February 2001 and entered
into force on 1 July 2001.

The  PECA  facilitates  trade  through  the  elimination  of  technical  barriers  to  trade  in  the
(industrial) sectors which it covers. Annexes to the PECA specify these particular sectors (e.g.
hot-water  boilers,  gas  appliances)  and  list  the  relevant  Community  and  Czech  legislation,
notifying bodies and any specific arrangements, for example safeguard clauses.

Following analysis by the Commission services, it is now judged that the Czech Republic has
now aligned its legislation, administrative structures and procedures to such an extent that it is
now possible to consider the addition of seven new annexes to the existing ten which make up
its  PECA.  Five  of  the  annexes  concern  the  mutual  recognition  of  results  of  conformity
assessment  -  Non-Automatic  Weighing  Instruments  (NAWI),  Radio  Communication  and
Telecommunication Terminal Equipment (R&TTE), Medical Devices, Construction Products
and Good Laboratory Practice (GLP) Two of the new sectors concern the mutual acceptance
of industrial products - Metrology: Measuring Instruments and Metrology: Pre-Packaging.

Article 14 of the PECA empowers the Association Council to add new annexes. Article 3(3)
of  the  Decision  concluding  the  PECA3  specifies  that  the  position  to  be  taken  by  the
Community  in  the  Association  Council  in  such  cases  shall  be  determined  by  the  Council,
acting by qualified majority on a proposal by the Commission.

The attached Proposal has no financial implications.

For the reasons set out above, the Council is invited to adopt the annexed decision.

1

2

3

OJ L 360, 31.12.1994.
OJ L 135, 17.05.2001.
OJ L 135, 17.05.2001, p. 2.

2

                                                
Proposal for a

COUNCIL DECISION

concerning the Community position within the Association Council established by the
Europe Agreement between the European Communities and their Member States, of the
one part, and the Czech Republic, of the other part, on the addition of annexes to the
Protocol to the Europe Agreement on Conformity Assessment and Acceptance of
Industrial Products (PECA)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having  regard  to  the  Council  Decision  of  4  April  2001  on  the  conclusion  of  a  Protocol  on
Conformity Assessment and Acceptance of Industrial Products4 with the Czech Republic and
in particular Article 3(3) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

(3)

(4)

The Europe Agreement between the European Communities and their Member States,
on  the  one  part,  and  the  Czech  Republic,  on  the  other  part,  entered  into  force  on
1 February 19955.

The Protocol to the Europe Agreement on Conformity Assessment and Acceptance of
Industrial  Products  (PECA),  signed  in  Brussels  on  26  February  2001,  entered  into
force on 1 July 20016.

Article  14  of  the  Protocol  on  Conformity  Assessment  and  Acceptance  of  Industrial
Products foresees that the Association Council can decide to accept add new annexes
to the PECA.

The position of the Community should be  established with respect to  the  addition of
annexes  to  the  PECA  on  Non-Automatic  Weighing  Instruments  (NAWI),  Radio
Communication  and  Telecommunication  Terminal  Equipment  (R&TTE),  Medical
Devices,  Construction  Products,  Good  Laboratory  Practice  (GLP)  Metrology:
Measuring Instruments and Metrology: Pre-Packaging.

4

5

6

OJ L 135, 17.5.2001.
OJ L 360, 31.12.1994.
OJ L 156, 13.06.2001, p. 32.

3

                                                
HAS DECIDED AS FOLLOWS:

Sole Article

The position to be taken by the Community within the Association Council established by the
Europe Agreement between the European Communities and their Member States, of the one
part, and the Czech Republic, of the other part, on the addition of annexes to the Protocol to
the  Europe  Agreement  on  Conformity  Assessment  and  Acceptance  of  Industrial  Products
(PECA) is contained in the attached draft decision of the Association Council.

Done at Brussels,

For the Council
The President

4

ANNEX

DRAFT DECISION NO. …/03 OF THE ASSOCIATION COUNCIL ESTABLISHED BY THE EUROPE
AGREEMENT BETWEEN THE EUROPEAN COMMUNITIES AND THEIR MEMBER STATES , OF
THE ONE PART, AND THE CZECH REPUBLIC, OF THE OTHER PART

OF ….. 2003

ON THE ADDITION OF ANNEXES TO THE PROTOCOL TO THE EUROPE AGREEMENT ON
CONFORMITY ASSESSMENT AND ACCEPTANCE OF INDUSTRIAL PRODUCTS

THE ASSOCIATION COUNCIL,

Having  regard  to  the  Europe  Agreement7  establishing  an  association  between  the  European
Communities and their Member States, of the one part, and the Czech Republic of the other
part,

Having  regard  to  the  Protocol  to  the  Europe  Agreement  on  Conformity  Assessment  and
Acceptance of Industrial Products8, and in particular to Article 14 (b) thereof

Whereas  the  Protocol  on  Conformity  Assessment  and  Acceptance  of  Industrial  Products
(PECA) entered into force on 1 July 20019

Whereas Article 14 of the said protocol  foresees that the Association Council can decide to
add annexes to the PECA

Whereas  extension  of  the  PECA  to  cover  additional  sectors  will  further  eliminate  technical
barriers to trade between the parties

Whereas  it  is  considered  that  the  Czech  Republic  has  now  aligned  its  legislation,
administrative structures and procedures in the areas concerned

HAS DECIDED AS FOLLOWS:

Article 1

Following  the  alignment  of  the  relevant  Czech  legislation  administrative  structures  and
procedures, the following new annexes are hereby added to the PECA.

Mutual recognition of results of conformity assessment:

7

8

9

OJ L 360, 31.12.1994.
OJ L 135, 17.5.2001.
OJ L 156, 13.06.2001, p. 32.

5

                                                
Non-Automatic Weighing Instruments (NAWI)
Radio Communication and Telecommunication Terminal Equipment (R&TTE)
Medical Devices
Construction Products
Good Laboratory Practice (GLP)

Mutual acceptance of industrial products

Metrology: Measuring Instruments
Metrology: Pre-Packaging.

The text of these annexes is attached.

Article 2

This decision shall enter into force on the first day of the second month following its adoption
by the Association Council.

Done at Brussels, …. 2003

6

ANNEXE 2

ANNEXES ON MUTUAL RECOGNITION

OF RESULTS OF CONFORMITY ASSESSMENT

(continuing from existing annexes)

11.

12.

Non-Automatic Weighing Instruments

Radio Communication and Telecommunication Terminal Equipment

13. Medical Devices

14.

15.

Construction Products

Good Laboratory Practice (GLP)

7

ANNEX ON MUTUAL RECOGNITION

OF RESULTS OF CONFORMITY ASSESSMENT:

 NON-AUTOMATIC WEIGHING INSTRUMENTS

 SECTION I

 COMMUNITY AND NATIONAL LAW

 Community law:

 National law:

 Council  Directive  90/384/EEC  of  20  June  1990  on 
the
harmonization of the laws of the Member States relating to non-
automatic weighing instruments

 Act  No.  22/1997  Coll.  (part  6/27.02.1997),  on  Technical
Requirements for Products and on Amendments to Some Acts, as
amended  by  Act  No.  71/2000  Coll.  (part  24/03.04.2000),  Act
No.  102/2001  Coll.  (part    41/21.03.2001),  Act    No.  205/2002
Coll. (part  82/24.05.2002) and ............. 10

 Act  No.  64/1986  Coll.  (part  23/03.11.1986),  of  the  Czech
National Council, on the Czech Trade Inspection, as amended by
Act No. 240/1992  Coll.  (part  49/29.05.1992),  Act    No.  22/1997
Coll.  (part  6/27.02.1997),  Act  No.  110/1997  Coll.  (part
38/19.05.1997), Act No. 71/2000 Coll. (part 24/03.04.2000), Act
No. 145/2000 Coll. (part 46/12.06.2000), Act No. 102/2001 Coll.
(part
(part 
122/07.09.2001),  Act  No.  205/2002  Coll.  (part    82/24.05.2002)
and .............

41/21.03.2001),  Act  No. 

321/2001  Coll. 

 Government  Order  No.  326/2002  Coll.  (part  119/19.07.2002),
that  lays  down  the  technical  requirements  for  non-automatic
weighing instruments.

 SECTION II

 NOTIFYING AUTHORITIES
European Community:

(cid:1)  Belgium:

Ministère des Affaires économiques / Ministerie van Economische
Zaken

(cid:1)  Denmark:

Erhvervsfremme Styrelsen

10

Footnote  (Point  of  Information,  not  to  be  included  in  final  text  agreed  by  Association  Council
Decision):
In a parallel, but separate process a different amendment is being made to Article 8 (Rule of Origin) of
the PECA. That change requires minor technical adjustments in the Czech Republic’s Act 22/1997 and
implementing  legislation.    The  Commission  has  been  consulted  on  these  technical  amendments  to
Act 22. The Czech Republic will supply the updated legislative reference numbers – for insertion in the
text before final approval of the Association Council Decision.

8

                                                
(cid:1)  Germany:

(cid:1)  Greece:

(cid:1)  Spain:

(cid:1)  France:

(cid:1)  Ireland:

(cid:1)  Italy:

(cid:1)  Luxembourg:

(cid:1)  Netherlands:

(cid:1)  Austria:

(cid:1)  Portugal:

(cid:1)  Finland:

(cid:1)  Sweden:

Bundesministerium für Wirtschaft und Technologie

Ministry of Development, Directorate of Technical Control

Ministerio de Fomento, Centro Español de Metrologia

Ministère de l'Économie, des  Finances et de l'Industrie, Direction
de l’Action Régionale et de la Petite et Moyenne Industrie, Sous-
Direction de la Métrologie

Department of Enterprise, Trade and Employment

Ministero delle Attività Produttive

Ministère de l’Économie

Ministerie van Economische Zaken

Bundesministerium für Wirtschaftliche Angelegenheiten

Servicio de Metrologia Legal, Instituto Português da Qualidade

Kauppa- ja teollisuusministerio / Handels- och industriministeriet

Styrelsen för ackreditering och teknisk kontroll (SWEDAC)

(cid:1)  United Kingdom: Department  of  Trade  and  Industry,  National  Weights  and

Measures Laboratory

 Czech Republic:

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví
 (Czech Office for Standards, Metrology and Testing)

SECTION III

NOTIFIED BODIES

European Community:

Bodies which have been notified by the Member States of the Community in accordance with
the  Community  law  of  Section  I  and  notified  to  the  Czech  Republic  in  accordance  with
Article 10 of this Protocol.

Czech Republic:

Bodies which have been designated/authorized by the Czech Republic in accordance with the
Czech national law of Section I and notified to the Community in accordance with Article 10
of this Protocol.

9

 
 
SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard Clauses

 A. Safeguard clause relating to industrial products.

1.  Where a Party has taken a measure to deny free access to its market for industrial products
bearing  the  CE  marking,  subject  to  this  Annex,  it  shall  immediately  inform  the  other
Party, indicating the reasons for its decision and how non compliance has been assessed.

2.  The  Parties  shall  consider  the  matter  and  the  evidence  brought  to  their  knowledge,  and

shall report to each other the results of their investigations.

3.  In  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that  such

products are not placed on the market.

4.  In  case  of  disagreement  on  the  outcome  of  such  investigations  the  matter  shall  be
forwarded to the Association Council who may decide to have an expertise carried out.

5.  Where the Association Council finds that the measure is:

(a)  unjustified,  the  national  authority  of  the  Party  who  has  taken  the  measure  shall

withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are

not placed on the market.

 B. Safeguard clause relating to harmonised standards.

1.  Where  the  Czech  Republic  considers  that  a  harmonised  standard  referred  to  in  the
legislation  defined  in  this  Annex,  does  not  meet  the  essential  requirements  of  such
legislation, it shall inform the Association Council giving the reasons thereof.

2.  The  Association  Council  shall  consider  the  matter  and  may  request  the  Community  to
proceed  in  accordance  with  the  procedure  provided  for  in  the  Community  legislation
identified in this Annex.

3.  The Community shall keep the Association  Council and  the other  Party informed of the

proceedings.

4.  The outcome of the procedure shall be notified to the other Party.

10

 ANNEX ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

 RADIO COMMUNICATION AND TELECOMMUNICATION TERMINAL EQUIPMENT

Community law: 

 National law:

 SECTION I

 COMMUNITY AND NATIONAL LAW

European  Parliament  and  Council  Directive  1999/5/EC  of  9
March  1999  on  the  approximation  of  the  laws  of  the  Member
States  relating  to  radio  communication  and  telecommunication
their
terminal  equipment  and 
conformity (OJ L 91, 07.04.1999, p. 10).

the  mutual  recognition  of 

Act  No.  22/1997  Coll.  (part  6/27.02.1997),  on  Technical
Requirements for Products and  on  Amendments  to  Some  Acts,
as amended by Act No. 71/2000 Coll. (part 24/03.04.2000), Act
No.  102/2001  Coll.  (part  41/21.03.2001),  Act    No.  205/2002
Coll. (part  82/24.05.2002) and .............

 Act  No.  64/1986  Coll.  (part  23/03.11.1986),  of  the  Czech
National  Council,  on  the  Czech  Trade  Inspection,  as  amended
by  Act  No.  240/1992  Coll. 
(part  49/29.05.1992),  Act
No.  22/1997 Coll. (part 6/27.02.1997),  Act  No.  110/1997  Coll.
(part 
(part
24/03.04.2000),  Act  No.  145/2000  Coll.  (part  46/12.06.2000),
  41/21.03.2001),  Act
Act  No.  102/2001  Coll. 
Act
122/07.09.2001), 
No. 
No. 205/2002 Coll. (part  82/24.05.2002) and .............

38/19.05.1997),  Act  No. 

71/2000  Coll. 

321/2001 

Coll. 

(part 

(part 

151/2000  Coll. 

 Act  No. 
on
Telecommunications  and  on  Amendments  to  Other  Acts,  as
amended by Act No. 274/2001  Coll.  (part  104/02.08.2001)  and
Act  No. 205/2002 Coll. (part  82/24.05.2002).

47/13.06.2000), 

(part 

 Government Order No. 426/2000 Coll., that lays down technical
requirements  for  radio  equipment  and  telecommunications
terminal  equipment  (part  119/13.12.2000),  as  amended  by
Government  Order  No.  483/2002  Coll.  (part  168/15.11.2002)
and ..............

11

 
 SECTION II

 NOTIFYING AUTHORITIES

European Community:

(cid:1)  Austria:

(cid:1)  Belgium:

(cid:1)  Denmark:

(cid:1)  Finland:

Bundesministerium für wirtschaftliche Angelegenheiten

Ministère des Affaires Economiques

 Ministerie van Economische Zaken

Telestyrelsen

Kauppa-ja teollisuusministeriö/Handels-och industriministeriet

For EMC aspects of telecommunications and radio equipment:

Liikenneministeriö/Trafikministeriet

(cid:1)  France:

Ministère de l'économie, des finances et de l'industrie. Secrétariat d'Etat
à l'industrie. Direction générale des stratégies industrielles

(cid:1)  Germany:

Bundesministerium für Wirtschaft und Technologie

(cid:1)  Greece:

(cid:1) 

(cid:1) 

Ireland:

Italy:

Ministry of Development

Department of Enterprise, Trade and Employment

Ministero delle Attività Produttive

(cid:1)  Luxembourg:

Ministère des Transports

(cid:1)  Netherlands:

Minister van Verkeer en Waterstaat

(cid:1) 

 Portugal:

Under the authority of the Government of Portugal:

Instituto Português da Qualidade.

(cid:1)  Spain:

Ministerio de Industria y Energía

Subdirección General de Seguridad y Calidad Industrial

For  EMC  aspects  of  telecommunications  and  radio  equipment:
Ministerio  de  Fomento.  Subdirección  General  de  Promoción  y
Normalización de Servicios de Telecomunicaciones.

(cid:1)  Sweden:

Under the authority of the Government of Sweden :

Styrelsen för ackreditering och teknisk kontrol (SWEDAC)

(cid:1)  United Kingdom: Department of Trade and Industry

12

 
 
Czech Republic: 

Úřad pro technickou normalizaci, metrologii a státní zkušebnictví

 (Czech Office for Standards, Metrology and Testing)

SECTION III

NOTIFIED BODIES

European Community:

Bodies  which  have  been  notified  by  the  Member  States  of  the  European  Community  in
accordance  with  the  Community  law  of  Section  I  and  notified  to  the  Czech  Republic  in
accordance with Article 10 of this Protocol.

Czech Republic:

Bodies  which  have  been  designated  by  the  Czech  Republic  in  accordance  with  the  Czech
national law of Section I and notified to the European Community in accordance with Article
10 of this Protocol.

SECTION IV

SPECIFIC ARRANGEMENTS

1.  Market Surveillance authorities

Each Party shall notify to the other Party the authorities established within its territory which
are  to  carry  out  the  surveillance  tasks  related  to  the  operation  of  the  respective  legislation
listed in Section I.

2.  Notification of interface regulations

Each  Party  shall  notify  to  the  other  Party  the  interfaces  which  they  have  regulated  in  their
respective territory. When classifying equipment the Community shall take due account of the
interfaces regulated in the Czech Republic.

3.  Application of essential requirements

Where  the  Commission  considers  adopting  a  Decision  to  apply  a  requirement  contained  in
article 3.3 of Directive 99/5/EC, the Czech Republic shall give its opinion on the issue in its
capacity of observer in the TCAM before the formal opinion of the Committee is requested.

4.  Notification of apparatus causing damage

Where  a  Party  considers  that  "apparatus  declared  to  be  compliant  with  the  respective
legislation causes serious damage to  a network or harmful radio  interference or harm to the
network  or  its  functioning"  and  has  authorized  the  operator  "to  refuse  connection,  to
disconnect  such  apparatus  or  to  withdraw  it  from  service",  the  Party  shall  notify  this
authorisation to the other Party.

13

 
5.  Safeguard Clauses

 A. Safeguard clause relating to industrial products

 1. Where a Party has taken a measure to deny free access to its market for industrial products
bearing the CE  marking, subject to the present  annex,  it shall immediately inform  the  other
Party, indicating the reasons for its decision and how non compliance has been assessed.

 2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall
report to each other the results of their investigations.

 3.  In  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that  such
products are not placed on the market.

 4.  In  case  of  disagreement  on  the  outcome  of  such  investigations  the  matter  shall  be
forwarded to the Association Council who may decide to have an expertise carried out.

 5. Where the Association Council finds that the measure is:

 a)  unjustified,  the  national  authority  of  the  Party  who  has  taken  the  measure  shall
withdraw it;

 b) justified, the Parties shall take appropriate measures to ensure that such products are
not placed on the market.

 B. Safeguard clause relating to harmonised standards.

 1.  Where  the  Czech  Republic  considers  that  a  harmonised  standard  referred  to  in  the
legislation  defined  in  the  present  annex,  does  not  meet  the  essential  requirements  of  such
legislation, it shall inform the Association Council giving the reasons thereof.

 2.  The  Association  Council  shall  consider  the  matter  and  may  request  the  European
Community  to  proceed  in  accordance  with  the  procedure  provided  for  in  the  Community
legislation identified in the present annex.

 3. The European Community shall keep the Association Council and the other Party informed
of the proceedings.

 4. The outcome of the procedure shall be notified to the other Party.

 C.  Safeguard  clause  relating  to  compliant  radio  products  not  intended  for  the  use  in  a
spectrum of one of the Parties

1.  Where a Member State or the Czech Republic takes a measure to "adopt any appropriate
measures with a view to:

prohibiting or restricting the placing on its market, and/or

requiring the withdrawal from its market,

of  radio  equipment,  including  types  of  radio  equipment,  which  has  caused  or  which  it
reasonably considers will cause harmful interference, including interference with existing or
planned  services  on  nationally  allocated  frequency  bands",  the  Party  shall  inform  the  other
Party, giving the reasons thereof.

14

2.  Where  the  other  Party  considers  that  the  measure  may  be  unjustified,  and  when  the
divergence of views can not be resolved to the satisfaction of both Parties, they may consult
the Association Council on the measure, giving their reasons.

3.  Where, after such consultation, the Association Council finds that the measure is:

a)  justified,  it  shall  immediately  inform  all  competent  national  authorities  of  both

Parties;

b)  unjustified, it shall immediately inform the competent authority in the Party which

took the measure and request its withdrawal.

15

ANNEX ON MUTUAL RECOGNITION

OF RESULTS OF CONFORMITY ASSESSMENT:

MEDICAL DEVICES

SECTION I

COMMUNITY AND NATIONAL LAW

Community law:

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 (OJ
L 189, 20.07.1990, p. 17), as last amended by Council Directive 93/68/EEC
of 22 July 1993 (OJ L 220, 30.08.1993, p. 1).

Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices
(OJ L 169,  12.07.1993,  p.  1),  as  last  amended  by  European  Parliament  and
Council Directive 98/79/EC of 27 October 1998 (OJ L 331, 07.12.1998, p. 1).

16

National law:

Act  No.  123/2000  Coll.  on  Medical  Devices,  and  Amendments  to  Some
Related Acts (part 36/12.05.2000), as amended by………...

Act No. 22/1997 Coll. (part 6/27.02.1997), on Technical Requirements
for  Products  and  on  Amendments  to  Some  Acts,  as  amended  by  Act
No. 71/2000 Coll. (part 24/03.04.2000), Act  No.  102/2001  Coll. (part
41/21.03.2001),  Act    No.  205/2002  Coll.  (part    82/24.05.2002)  and
............

Act  No.  64/1986  Coll.  (part  23/03.11.1986),  of  the  Czech  National
Council,  on  the  Czech  Trade  Inspection,  as  amended  by  Act
No. 240/1992 Coll. (part 49/29.05.1992), Act  No. 22/1997 Coll. (part
6/27.02.1997),  Act  No.  110/1997  Coll.  (part  38/19.05.1997),  Act
No. 71/2000 Coll. (part 24/03.04.2000), Act  No.  145/2000  Coll. (part
46/12.06.2000),    Act  No.  102/2001  Coll.  (part    41/21.03.2001),  Act
No.  321/2001  Coll.  (part  122/07.09.2001),  Act    No.  205/2002  Coll.
(part  82/24.05.2002) and .............

Government Order No. 181/2001 Coll. (part 69/08.06.2001), that  lays
down  the  technical  requirements  for  medical  devices,  as  amended  by
Government  Order  No.  336/2001  Coll.  (part  129/20.09.2001)  and
……….

Government Order No. 191/2001 Coll. (part 72/15.06.2001), that  lays
down  the  technical  requirements  for  active  implantable  medical
devices  as  amended  by  Government  Order  No.  337/2001  Coll.  (part
129/20.09.2001) and ………..
.

SECTION II

NOTIFYING AUTHORITIES

European Community:

(cid:1) 

Belgium:

Ministère de la Santé Publique, de l'Environment et de
l'Integration Sociale. Inspection Pharmaceutique/Ministerie van
Volksgezondheid, Leefmilieu en Sociale Integratie.
Farmaceutische Inspectie

Ministère des Affaires Economiques/Ministerie van
Economische Zaken.

(cid:1) 

(cid:1) 

(cid:1) 

(cid:1) 

Denmark:

Germany:

Greece:

Spain:

Sundhedsministeriet.

Bundesministerium für Gesundheit.

Υπουργείο Υγείας (Ministry of Health).

Ministerio de Ciencia y Tecnología.

17

(cid:1) 

France:

Agence  Française  de  Sécurité  Sanitaire  des  Produits  de  Santé
(AFSSAPS).

Ministère de l'économie, des finances et de l'industrie, Direction
Générale de l'Industrie, des Technologies de l'Information et des
Postes  (DIGITIP),  Sous-direction  de  la  chimie,  de  la  pharmacie
et des biotechnologies.

(cid:1) 

(cid:1) 

(cid:1) 

(cid:1) 

(cid:1) 

(cid:1) 

(cid:1) 

(cid:1) 

(cid:1) 

Ireland:

Italy:

Department of Health.

Ministero della Sanità.

Luxembourg:

Ministère de la Santé.

Netherlands:

Ministerie van Volksgezondheid, Welzijn en Sport; inspectie
Volksgezondheid.

Austria:

Portugal:

Finland:

Sweden:

Bundesministerium für soziale Sicherheit und Generationen.

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

Sosiaali-ja terveysministeriö/Social-och hälsovårdsministeriet.

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

United Kingdom:

Department of Health.

Czech Republic:

Úřad  pro 
zkušebnictví

technickou  normalizaci,  metrologii 

a 

státní

(Czech Office for Standards, Metrology and Testing)

SECTION III

NOTIFIED BODIES

European Community:

Bodies  which  have  been  notified  by  the  Member  States  of  the  Community  in  accordance  with  the
Community law of Section I and notified to the Czech Republic in accordance with Article 10 of this
Protocol.

Czech Republic:

Bodies which have been designated by the Czech Republic in accordance with the Czech national law
of Section I and notified to the Community in accordance with Article 10 of this Protocol.

18

SECTION IV

SPECIFIC ARRANGEMENTS

1.

Registration of the person responsible for placing devices on the market

Any manufacturer who places on the market of one of the Parties the medical devices
referred  to  in  Article  14  of  Directive  93/42/EEC  and  in  the  relevant  Czech  national
law shall inform the competent authorities of the Party in which he has his registered
place of business of the particulars referred to in these provisions.   The  Parties shall
reciprocally  recognise  that  registration.    The  manufacturer  shall  not  be  obliged  to
designate  a  person  responsible  for  placing  devices  on  the  market  established  in  the
territory of the other Party.

2.

Labelling of medical devices

Manufacturers of both Parties shall indicate their name or trade name and address on
the  label  of  medical  devices  as  specified  in  Annex  I,  point  13.3(a)  to  Directive
93/42/EEC  and  in  the  relevant  Czech  national  law.    They  shall  not  be  obliged  to
indicate the name and address of the person responsible for placing the device on the
market, of the representative or of the importer established within the territory of the
other Party on the label, outer packaging or instructions for use.

3.

Information exchanges

In accordance with Article 12 of this Protocol, the Parties shall in particular exchange
the information referred to in the relevant Community law and Czech national law, in
particular:

   – data relating to registration of manufacturers and devices,

   – data relating to certificates issued, modified, supplemented, suspended,   withdrawn

or refused,

   – data obtained in accordance with the vigilance procedure.

4.

Safeguard clause

A.

Safeguard clause relating to industrial products

1. Where  a  Party  has  taken  a  measure  to  deny  free  access  to  its  market  for
industrial  products  bearing  the  CE  marking,  subject  to  this  Annex,  it  shall
immediately  inform  the  other  Party,  indicating  the  reasons  for  its  decision
and how non-compliance has been assessed.

2.

3.

4.

The  Parties  shall  consider  the  matter  and  the  evidence  brought  to  their
knowledge and shall report to each other the results of their investigations.

In case of agreement, the Parties shall take appropriate measures to ensure
that such products are not placed on the market.

In  case  of  disagreement  on  the  outcome  of  such  investigations  the  matter
shall be forwarded  to the Association Council who may decide to  have  an
expertise carried out.

19

5. Where the Association Council finds that the measure is:

(a)

(b)

unjustified,  the  national  authority  of  the  Party  who  has  taken  the
measure shall withdraw it;

justified,  the  Parties  shall  take  appropriate  measures  to  ensure  that
such products are not placed on the market.

B.

Safeguard clause relating to harmonised standards

1. Where the Czech Republic considers that a harmonised standard referred to
in  the  legislation  defined  in  this  Annex  does  not  meet  the  essential
requirements  of  such  legislation,  it  shall  inform  the  Association  Council
giving the reasons thereof.

2.

3.

The  Association  Council  shall  consider  the  matter  and  may  request  the
Community to proceed in accordance with the procedure provided for in the
Community legislation identified in this Annex.

The  Community  shall  keep  the  Association  Council  and  the  other  Party
informed of the proceedings.

4.

The outcome of the procedure shall be notified to the other Party.

20

 ANNEX  ON MUTUAL RECOGNITION OF RESULTS OF CONFORMITY ASSESSMENT:

Community law:

National law:

 CONSTRUCTION PRODUCTS:

SECTION I

COMMUNITY AND NATIONAL LAW

Council  Directive  89/106/EEC  of  21  December  1988  on
the approximation of laws, regulations and administrative
provisions  of  the  Member  States  relating  to  construction
products  (OJ  L  040  ,  11.02.1989  p.  12),  as  amended  by
Council Directive 93/68/EEC of 22 July 1993 (OJ L 220,
30.08.1993, p. 1) and all of its implementing Commission
Decisions.

 Act  No.  22/1997  Coll.  (part  6/27.02.1997),  on  Technical
Requirements for Products and on  Amendments  to  Some
Acts,  as  amended  by  Act  No.  71/2000  Coll.  (part
(part
24/03.04.2000),  Act  No. 
41/21.03.2001),  Act 
(part
82/24.05.2002) and .............

102/2001  Coll. 
  No.  205/2002  Coll. 

 Act No. 64/1986 Coll. (part 23/03.11.1986), of the Czech
National  Council,  on  the  Czech  Trade  Inspection,  as
amended by Act No. 240/1992 Coll. (part 49/29.05.1992),
  No.  22/1997  Coll.  (part  6/27.02.1997),  Act
Act 
No. 110/1997 Coll. (part 38/19.05.1997), Act No. 71/2000
Coll.  (part  24/03.04.2000),  Act  No.  145/2000  Coll.  (part
(part
46/12.06.2000),  Act  No. 
102/2001  Coll. 
(part
321/2001  Coll. 
41/21.03.2001),  Act  No. 
122/07.09.2001),  Act  No.  205/2002  Coll. 
(part
82/24.05.2002) and .............

(part  79/
Government  Order  No.  190/2002  Coll. 
21.05.2002), that lays down the technical requirements for
construction  products  bearing 
the  CE  marking,  as
amended by …….

And implementing practice.

SECTION II

NOTIFYING AUTHORITIES

European Community

(cid:1)  Austria:

Bundesministerium für Wirtschaft und Arbeit

21

(cid:1)  Belgium:

(cid:1)  Denmark:

(cid:1)  Finland:

(cid:1)  France:

(cid:1)  Germany:

(cid:1)  Greece:

(cid:1) 

(cid:1) 

Ireland:

Italy:

(cid:1)  Luxembourg:

(cid:1)  Netherlands:

(cid:1)  Portugal:

Ministère des Communications et de l'Infrastructure /
Ministerie van Verkeer & Infrastructuur

Økonomi- og  Erhvervsministeriet, Erhvervs- og
Boligstyrelsen

Ympäristöministeriö/Miljöministeriet

Ministère de l'Equipement, des transports et du logement,
Direction générale de l'urbanisme, de l'habitat et de la
construction.

Ministère de l'Economie des Finances et de l'Industrie,
Direction générale de l'Industrie des technologies et de
l'information et des Postes (DIGITIP), SQUALPI.

Bundesministerium für Verkehr, Bau-und Wohnungswesen

Ministry  for  Environment  Physical  Planning  and  Public
Works

Department of the Environment and Local Government

Ministero delle Attività Produttive

Ministère de l'Économie-Service de l’Energie de l’État

Ministerie  van  Volkshuisvesting,  Ruimtelijke  Ordening  en
Milieubeheer. Directoraat Generaal van de Volkshuisvesting

Ministério 
Indústria/Instituto Português da Qualidade (IPQ)

Economia. 

da 

Direcçao-General 

da

(cid:1)  Spain:

Ministerio de Fomento.

Ministerio de Ciencia y Tecnología.

(cid:1)  Sweden:

Under the authority of the Government of Sweden:

Styrelsen för ackreditering och teknisk kontroll (SWEDAC)

(cid:1)  United Kingdom: Department of Transport, Local Government and the Regions

Czech Republic

Úřad  pro 
zkušebnictví

technickou  normalizaci,  metrologii  a  státní

(Czech Office for Standards, Metrology and Testing)

22

SECTION III

European Community

NOTIFIED BODIES

Bodies  which  have  been  notified  by  the  Member  States  of  the  Community  in
accordance with the Community law of Section I and notified to the Czech Republic
in accordance with Article 10 of this Protocol.

Czech Republic

Bodies  which  have been authorised by  the  Czech  Republic  in  accordance  with  the
national law of Section I and notified to the Community in accordance with Article
10 of this Protocol.

 SECTION IV

SPECIFIC ARRANGEMENTS

 Safeguard Clauses

 A. Safeguard clause relating to products

1.  Where a Party has taken a measure to deny free access to its market for products
bearing the CE marking, subject to this Annex, it shall immediately inform the
other Party, indicating the reasons for its decision and how non compliance has
been assessed.

2.  The  Parties  shall  consider  the  matter  and  the  evidence  brought  to  their
knowledge, and shall report to each other the results of their investigations.

3.  In case of agreement, the Parties shall take appropriate measures to ensure that

such products are not placed on the market.

4.  In case of disagreement on the outcome of such investigations the matter shall be
forwarded  to  the  Association  Council  who  may  decide  to  have  an  expertise
carried out.

5.  Where the Association Council finds that the measure is:

(a)  unjustified, the national authority of the Party who has taken the measure

shall withdraw it;

(b) justified,  the  Parties  shall  take  appropriate  measures  to  ensure  that  such

products are not placed on the market.

 B. Safeguard clause relating to harmonised standards

1.  Where  the  Czech  Republic  considers  that  a  harmonised  standard  referred  to  in
the  legislation  defined  in  the  present  annex,  does  not  meet  the  essential
requirements of such legislation, it shall inform the Association Council giving
the reasons thereof.

23

2.  The  Association  Council  shall  consider  the  matter  and  may  request  the
Community  to  proceed  in  accordance  with  the  procedure  provided  for  in  the
Community legislation identified in this Annex.

3.  The Community shall keep the Association Council and the other Party informed

of the proceedings.

4.  The outcome of the procedure shall be notified to the other Party.

24

ANNEX ON MUTUAL RECOGNITION

OF RESULTS OF CONFORMITY ASSESSMENT:

GOOD LABORATORY PRACTICE

SECTION I

COMMUNITY AND NATIONAL LAW

Community law:

Good Laboratory Practice

Council Directive 87/18/EEC of 18 December 1986 on the
harmonisation  of  laws,  regulations  and  administrative
provisions  relating  to  the  application  of  the  principles  of
good  laboratory  practice  and  the  verification  of  their
applications  for  tests  on  chemical  substances  (OJ L 15,
17.1.87,  p.  29)  as  last  amended  by  Commission  Directive
1999/11/EC of 8 March 1999 (OJ L 77, 23.3.99, p. 8).

89/569/EEC:  Council  Decision  of  28  July  1989  on  the
acceptance  by  the  European  Economic  Community  of  an
OECD  decision  /  recommendation  on  compliance  with
laboratory  practice  (OJ  L  315,
principles  of  good 
28.10.1989, p. 1).

Monitoring of Good Laboratory Practice

Council  Directive  88/320/EEC  of  9  June  1988  on  the
inspection  and  verification  of  Good  Laboratory  Practice
(GLP)  (OJ  L  145,  11.06.88,  p. 35),  as  last  amended  by
Commission  Directive1999/12/EC  of  8 March 1999  (OJ  L
77, 23.3.99, p. 22).

Medicinal Products for Human Use

Directive  2001/83/EC  of  the  European  Parliament  and  of
the  Council  of  6  November  2001  on  the  Community  code
relating  to  medicinal  products  for  human  use  (OJ  L  311,
28.11.2001, p. 67).

Veterinary Medicinal Products

Directive 2001/82/ECof the European Parliament and of the
Council  of  6  November  2001  on  the  Community  code
relating  to  veterinary  medicinal  products  (OJ  L  311,
28.11.2001, p. 1).

Chemical substances (except medicinal products for human
or  veterinary  use,  cosmetic  products,  foodstuffs,  animal
feedingstuffs, pesticides, radioactive substances)

Council  Directive  92/32/EEC  (OJ  L  154,  5.6.1992,  p.  1)

25

for 

the  seventh 

amending 
time  Council  Directive
67/548/EEC  on  the  approximation  of  the  laws,  regulations
and  administrative  provisions  relating  to  the  classification,
packaging  and  labelling  of  dangerous  substances  (OJ  196,
16.8.1967, p. 1).

Existing chemicals

Council Regulation (EEC) No 793/93 of 23 March 1993 on
the  evaluation  and  control  of 
the  risks  of  existing
substances (OJ L 084, 05/04/1993, p.1).

Dangerous preparations

Directive  1999/45/EC  of  the  European  Parliament  and  of
the Council of 31 May 1999 concerning the approximation
of the laws, regulations and administrative provisions of the
Member States relating to the classification, packaging and
labelling of dangerous preparations (OJ L 200, 30/07/1999,
p.1).

Cosmetics

Council  Directive  93/35/EEC  of  14  June  1993  (OJ  L  151,
23/06/1993,  p.  32)  amending  for  the  6th  time  Council
Directive  76/768/EEC  of  27 
the
approximation of the laws of the Member States relating to
cosmetic products (OJ L 53, 25/02/1977, p. 30).

July  1976  on 

Feed additives

Council  Directive 87/153/EEC of 16 February  1987  fixing
guidelines  for  the  assessment  of  additives  in  animal
nutrition (OJ L 64, 07/03/1987, p. 19).

Commission  Directive  94/40/EEC  of  22  July  1994
amending  Council  Directive  87/153/EEC  fixing  guidelines
for  the  assessment  of  additives  in  animal  nutrition  (OJ  L
208, 11/08/1994, p. 15).

Pesticides

Council Directive 91/414/EEC of 15 July 1991 concerning
the placing of plant protection products on the market (OJ L
230, 19/08/1991, p.1).

Foodstuffs

Council  Directive  89/397/EEC  of  14  June  1989  on  the
official control of foodstuffs (OJ L 186, 30/06/1989, p. 23).

Council  Directive  93/99/EEC  of  29  October  1993  on  the
subject  of  additional  measures  concerning  the  official

26

control of foodstuffs (OJ L 290, 24/11/1993, p. 14).

National law:

Good  Laboratory  Practice  and  Monitoring  of  Good
Laboratory Practice

Act  No.  157/1998  Coll.  (Part  54,  13.07.1998),  on
chemicals and chemical preparations and amendment some
other  Acts,  as  amended  by  Act.  No.  352/1999  Coll.  (Part
111,  30.12.1999),  Act  No.  132/2000  Coll.  (Part  39,
17.05.2000), Act No. 258/2000 Coll. (Part 74, 11.08.2000),
Act No. 458/2000 Coll. (Part 131, 29.12.2000) and Act No.
185/2001 Coll. (Part 71, 14.06.2001).

Decree of the Ministry of Environment No. 283/2001 Coll.
(Part 106, 07.08.2001), establishing the principles of good
laboratory  practice,  the  procedure  for  verification  of  their
compliance, the procedure for granting certificates and the
procedure  for  monitoring  of  compliance  with  the  good
laboratory  practice  principles  (good  laboratory  practice
principles).

Decree  of  the  Ministry  of  Health  and  the  Ministry  of
Agriculture  No. 504/2000  Coll.  (Part 147,  30.12.2000)
laying  down  the  good  laboratory  practice  in  the  field  of
pharmaceuticals.

Methodical  document  No.  11  Bulletin  of  Ministry  of
Environment  (Part  12,  01.01.2001),  National  program  of
GLP;  Monitoring  of  compliance  with  good  laboratory
practice  principles,  conducting  of  inspections  of  test
facilities and study audits.

Documents of good laboratory practice, Official Journal of
SUKL No. 8/2000 (SLP-2).

Monitoring procedures for good laboratory practice (GLP)
and guidance for the conduct of test facility inspections and
study audits, Official Journal of SUKL No. 12/2001 (SLP-
3).

National GLP programme – Components of procedures for
good  laboratory  practice  monitoring,  Official  Journal  of
SUKL No. 12/2001 (SLP-4).

Medicinal Products

Act  No. 79/1997  Coll. 
(Part 26,  15.04.1997),  on
pharmaceuticals  and  on  amendments  to  some  Acts  as
(Part 47,
by  Acts  No. 149/2000  Coll. 
amended 
13.06.2000),  No. 153/2000  Coll.  (Part 49,  21.06.2000),
No. 258/2000  Coll.  (Part 74,  11.08.2000),  No. 102/2001

27

Coll.  (Part 41,  21.03.2001),  No. 138/2002  Coll.  (Part 57,
15.04.2002),  No. 309/2002  Coll.  (Part 114,  12.07.2002),
and No. 320/2002 Coll. (Part 117, 18.07.2002).

Chemical substances (except medicinal products for human
or  veterinary  use,  cosmetic  products,  foodstuffs,  animal
feedingstuffs, pesticides, radioactive substances)

Act  No.  157/1998  Coll.  (Part  54,  13.07.1998),  on
chemicals and chemical preparations and amendment some
other  Acts,  as  amended  by  Act.  No.  352/1999  Coll.  (Part
111,  30.12.1999),  Act  No.  132/2000  Coll.  (Part  39,
17.05.2000), Act No. 258/2000 Coll. (Part 74, 11.08.2000),
Act No. 458/2000 Coll. (Part 131, 29.12.2000) and Act No.
185/2001 Coll. (Part 71, 14.06.2001).

Pesticides

Act  No.  147/1996  Coll.  (Part  43,  31.05.1996),  on
phytosanitary  care  and  amendment  some  connected  Acts,
as  amended  by  Act  No.  409/2000  Coll.  (Part  115,
29.11.2000)  and  by  Act  No.  314/2001  Coll.  (Part  121,
06.09.2001).

Decree  No.  91/2002  Coll.  (Part  40,  20.03.2002),  on
preparations for plant protection.

Biocides

Act  No.  120/2002  Coll.  (Part  52,  09.04.2002),  on
conditions  of  placing  of  biocidal  products  and  active
substances on the market and amendment some connected
Acts.

Cosmetics

Act  No.  258/2000  Coll.  (Part  74,  11.08.2000),  on
protection of public health and amendment some connected
Acts,  as  amended  by  Act  No.  254/2001  Coll.  (Part  98,
(Part  104,
25.07.2001),  Act  No.  274/2001  Coll. 
02.08.2001),  Act  No.  13/2002  Coll.  (Part  7,  16.01.2002),
Act  No.  76/2002  Coll.  (Part  34,  01.03.2002),  Act  No.
86/2002 Coll. (Part 38, 12.03.2002) and Act No. 120/2002
Coll. (Part 52, 09.04.2002).

SECTION II

NOTIFIED TEST FACILITIES

1.

For the purpose of this Annex, the term ‘notified test facilities’ means the test facilities
recognised under each Party's GLP monitoring programme.

28

2.

3.

Each Party shall provide the other Party at least annually with a list of the test facilities
which, in the light of the results of the inspections and study audits conform to the GLP
principles  as  well  as  of  the  dates  of  inspection  or  study  audit,  their  GLP  compliance
status, and the area of expertise in accordance with point 4 of the Appendix to Annex III
of the OECD Decision-Recommendation of 2 October 1989 C(89)87(Final).

Each Party shall notify without delay the other Party when a listed test facility under its
jurisdiction  fails  to  conform  to  the  GLP  principles  to  an  extent  which  may  jeopardise
the  integrity  or  authenticity  of  any  such  studies  it  conducts.  The  test  facility  will  be
deleted from the list established in accordance with the preceding paragraph.

SECTION III

NOTIFYING AUTHORITIES

For  the  purpose  of  this  Annex,  the  term  ‘notifying  authorities’  means  the  GLP  monitoring
authorities of the Parties.

European Community

Belgium

Institut Scientifique de la Santé Publique – Louis Pasteur
Bureau d’Assurance de Qualité
Rue Juliette Wytsman 14
B-1050 Bruxelles

All products

Wetenschappelijk Instituut Volksgezondheid (WIV)
Bureau Kwaliteitszorg
Juliette Wytsmanstraat 14

B 1050 Brussel

Denmark

Erhvervs- og Boligstyrelsen
Dahlerups Pakhus
Langelinie Allé 17
DK-2100 København

Lægemiddelstyrelsen
Frederikssundsvej 378
DK-2700 Brønshøj

Germany

Bundesministerium für Umwelt, Naturschutz
und Reaktorsicherheit
Kennedyallee 5
D-53175 Bonn

29

Industrial  chemicals  and
pesticides

Pharmaceuticals

All products

Greece

General Chemical State Laboratory
An. Tsoha 16
GR-11521 Athens

Spain

Ministerio de Sanidad y Consumo
Agencia Española de Medicamento
Subdirección General de Seguridad de los Medicamentos
Paseo del Prado 18-20
E-28014 Madrid

Ministerio de Agricultura, Pesca y Alimentación
Secretaria General de Agricultura y Alimentación
Dirección General de Agricultura
Subdirección General de Medios de Producción Agricolas
Avda. Ciudad de Barcelona, 118
E-28007 Madrid

Ministerio de Industria y Energia
Subdirector General de Seguridad Industrial
Paseo de la Castellana 160
PLA 12
E-28046 Madrid

France

All products

Pharmaceuticals  and
cosmetics

Foodstuffs

Industrial chemicals

Secrétariat du Groupe Interministeriel des Produits Chimiques
Le Bervil
12 rue Villiot DiGITIP 2
F-75572 Paris CEDEX 12

Industrial chemicals,
pesticides and products
other than medicinal and
cosmetic products

Agence française de sécurité sanitaire des produits de santé
(AFSSAPS)
143 Boulevard Anatole France
F-93285 Saint-Denis

Pharmaceuticals other than
veterinary  products  and
cosmetics

Agence française de sécurité sanitaire des aliments
(AFSSA/ANMV)
BP 90203
La Haute Marche - Javené
35302 Fougères cedex

Ireland

The Irish National Accreditation Board
Wilton Park House
Wilton Place
Dublin 2

30

Foodstuffs,  food  additives
and  veterinary  medicinal
products

All products

Ireland

Italy

Ministero della Sanita
Dipartimento della Prevenzione
GLP Compliance Monitoring Unit
Via della Sierra Nevada 60
I-00144 Roma

Luxembourg

Ministère de l’Economie
19-21 Boulevard Royal
L–2449 Luxembourg

Netherlands

Ministerie van Volksgezondheid, Welzijn en Sport
Inspectorate for Health Protection, Commodities and
Veterinary Public Health.
GLP Department
P.O. Box 16.108
2500 BC s’Gravenhage
Netherlands

Austria

All products

All products

All products

Bundesministerium für Land- und Forstwirtschaft, Umwelt und
Wasserwirtschaft
Abteilung I/3
Stubenbastei 5
A-1010 Wien

All products

Portugal

Instituto Português da Qualidade
Ministério da Indústria e Comércio
Rua C à Av. dos Très Vales
P-2825 Monte da Caparica

Instituto Nacional de Farmacia e do Medicamento.
Parque de Saúde de Lisboa
Avenida do Brasil 53
P-1700 Lisboa

Finland

Industrial  chemicals  and
pesticides

Pharmaceuticals and
veterinary drugs

Sosiaali- ja terveydenhuollon tuotevalvontakeskus
Kemikaaliosasto
Säästöpankinranta 2 A

All products

31

PL 210
FIN-00531 Helsinki

Sweden

Läkemedelsverket
Box 26
S-751 03 Uppsala

Styrelsen för ackreditering och teknisk kontroll (SWEDAC)
Box 2231
S-103 15 Stockholm

United Kingdom

Department of Health
GLP Monitoring Authority
Hannibal House
Market Towers
1 Nine Elms Lane
London SW8 5NQ
United Kingdom

Pharmaceuticals 
hygiene 
products

and 

and
cosmetic

All other products

All products

Czech Republic
Státní ústav pro kontrolu léčiv - SUKL (State Institute for Drug
Control)
Šrobárova 48
100 41  Praha 10
Czech Republic

Pharmaceuticals

National GLP Monitoring Authority
T. G. Masaryk Water Research Institute
ASLAB
Podbabska 30
160 62 Prague 6
Czech Republic

All other products

32

SECTION IV

SPECIFIC ARRANGEMENTS

1.

Scope and coverage

1.1. The  provisions  of  this  Annex  apply  to  the  non-clinical  testing  of  chemicals
(including  pharmaceuticals)  according  to  Good  Laboratory  Practice  (GLP),
being either substances or preparations, covered by the legislative, regulatory
and administrative requirements listed in section I.

1.2. Unless  specific  definitions  are  given,  the  definition  of  terms  in  the  OECD
Principles  of  Good  Laboratory  Practice  as  contained  in  Annex  II  to  OECD
Council Decision of 12 May 1981 C(81)30(Final), the Guides for Compliance
Monitoring Procedures for Good Laboratory Practice as contained in Annex I
to Council Decision-Recommendation of 2 October 1989 C(89)87(Final), the
GLP  Consensus  Document  "The  Application  of  the  GLP  Principles  to  Field
Studies"  (OECD  Series  on  Principles  of  Good  Laboratory  Practice  and
Compliance Monitoring, Number 6), and all amendments made thereto,  shall
apply.

1.3. The  Parties  recognise  the  equivalence  of  each  other's  GLP  compliance
programmes  that  are  in  accordance  with  the  legislative,  regulatory,  and
administrative  requirements  listed  in  Section  I,  which  requirements  are
consistent  with  the  OECD  Decision-Recommendation  of  2  October  1989
C(89)87(Final).  The  Parties  mutually  accept  the  conclusions  of  study  audits
and  test  facility  inspections  on  the  GLP  compliance  status  performed  by  the
competent authorities referred to in Section III.

1.4. Test facility inspections and/or study audits shall be carried out in accordance
with  the  legislative,  regulatory,  and  administrative  requirements  of  the  Party
under  the  jurisdiction  of  which  the  studies  and  data  generated  therefrom  are
produced.

1.5. Each Party recognises studies and data generated therefrom produced by a test
facility of the other Party as studies and data generated therefrom produced by
the  test  facilities  complying  with  the  GLP  principles  under  its  own
jurisdiction, provided that the test facility is included in the list established in
accordance with Section II.

2.

Safeguard clause procedure

2.1. Each Party may request further test facility inspections or study audits if there
is  a  documented  doubt  as  to  whether  a  study  was  conducted  in  accordance
with GLP.

33

2.2. The Party from which the data are originating shall consider the matter and the
evidence brought to its knowledge. It shall report to the other Party the results
of its investigations.

2.3.

2.4.

In case of agreement, the Party from which the data are originating shall take
appropriate measures to rectify the situation of the test facility.

If,  in  exceptional  cases,  doubts  persist  and  the  requesting  Party  can  justify  a
special concern, it may designate one or more experts of its authorities listed
in  Section  III  to  participate  in  a  laboratory  inspection  or  an  audit  of  a  study
conducted  jointly  by  the  authorities  of  the  Parties  upon  decision  of  the
Association Council.

3.

Cooperation

3.1. Each  Party  may,  on  request,  participate  as  an  observer  in  an  inspection  of  a
test facility conducted by the competent authorities of the other Party with the
consent  of  the  test  facility  concerned  in  order  to  maintain  a  continuing
understanding of the other Party's inspection procedures.

3.2. The  Parties  shall  supply  each  other  with  additional  information  on  a  test
facility inspection or study audit in response to a reasonable request from the
other Party.

34

ANNEXES ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS

1. 

2. 

Metrology - measuring instruments

Metrology - pre-packaging

35

ANNEX ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS:

METROLOGY – MEASURING INSTRUMENTS

SECTION I
COMMUNITY AND NATIONAL LAW

Community law:

Council  Directive  80/181/EEC  on  the  approximation  of  the
laws of the Member States relating to units of measurement and
on the repeal of Directive 71/354/EEC, amended by:

Council Directive 85/1/EEC

Council Directive 89/617/EEC

European Parliament and Council Directive 1999/103/EC.

Council  Directive  71/316/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  common  provisions  for
both  measuring  instruments  and  methods  of    metrological
control, amended by:

Council Directive 72/427/EEC

Council Directive 83/575/EEC

Council Directive 87/354/EEC

Council Directive 87/355/EEC

Council Directive 88/665/EEC.

Council  Directive  75/410/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  continuous  totalizing
weighing machines.

Council  Directive  78/1031/EEC  on  the  approximation  of  the
laws of the Member States relating to automatic checkweighing
and weight grading machines.

Council Directive 75/33/EEC on the approximation of the laws
of the Member States relating to cold-water meters.

Council  Directive  79/830/EEC  on  the  approximation  of  the
laws of the Member States relating to hot-water meters.

Council  Directive  71/319/EEC  on  the  approximation  of  the
laws of the Member States  relating  to  meters for liquids  other
than water.

36

Council  Directive  71/348/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  ancillary  equipment  for
meters for liquids other than water.

Council  Directive  77/313/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  measuring  systems  for
liquids other than water

Adaptation to technical progress:

Commission Directive 82/625/EEC.

Council  Directive  71/318/EEC  on  the  approximation  of  the
laws of the Member States relating to gas volume meters

Adaptations to technical progress:

Commission Directive 74/331/EEC

Commission Directive 78/365/EEC

Commission Directive 82/623/EEC.

Council  Directive  76/891/EEC  on  the  approximation  of  the
laws of the Member States relating to electrical energy meters

Adaptation to technical progress:

Commission Directive 82/621/EEC.

Directive 73/362/EEC on the approximation of the laws of the
Member States relating to material measures of length

Adaptations to technical progress:

Council Directive 78/629/EEC

Commission Directive 85/146/EEC.

Council  Directive  76/765/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  alcohol  meters  and
alcohol hydrometers

Adaptation to technical progress:

Commission Directive 82/624/EEC.

Council  Directive  76/766/EEC  on  the  approximation  of  the
laws of the Member States relating to alcohol tables.

Council  Directive  71/317/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  5  to  50  kilogramme
medium accuracy rectangular bar weights and 1 gramme to 10
kilogramme medium accuracy cylindrical weights.

Council  Directive  74/148/EEC  on  the  approximation  of  the

37

National law:

laws of the Member States relating to relating to weights from 1
milligramme to 50 kilogramme of above medium accuracy.

Council Directive 77/95/EEC on the approximation of the laws
of the Member States relating to taximeters.

Council  Directive  86/217/EEC  on  the  approximation  of  the
laws of the Member States relating to tyre pressure gauges for
motor vehicles.

Council  Directive  71/347/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  the  measuring  of  the
standard mass per storage volume of grain.

Council  Directive  71/349/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  the  calibration  of  the
tanks of vessels.

ACT  No.  505/1990  Coll.  (part  83/17.12.1990),  on  Metrology,
as amended by ACT No. 119/2000 Coll. (part 35/10.05.2002),
ACT No. 137/2002 Coll. (part 57/15.04.2002) and ……..

DECREE  No.  262/2000  Coll.  (part  125/30.07.2002),  of  the
Ministry  of  Industry  and  Trade  ensuring  uniformity  and
accuracy  of  measuring  instruments  and  measurements,  as
amended by DECREE No. 344/2002 Coll.

DECREE  No.  345/2002  Coll.  (part  125/30.07.2002),  of  the
Ministry  of  Industry  and  Trade,  that  specifies  measuring
  and  measuring
instruments  for  mandatory 
instruments  subject to type approval.

  verification 

DECREE  No.  264/2000  Coll.  (part  77/17.08.2000),  of  the
Ministry  of  Industry  and  Trade,  that  relates  to  basic  units  of
measurement and other units and to their indications.

DECREE  No.    332/2000  Coll.  (part  91/26.09.2000),  of  the
lays  down  some
Ministry  of  Industry  and  Trade, 
procedures  for  type  approval  and  verification  of    specified
measuring 
instruments  bearing  EEC  mark,  as  amended
by ……..

that 

DECREE  No.  333/2000  Coll.  (part  91/26.09.2000),  of  the
Ministry of Industry and  Trade, that relates to hot-water meters
bearing EEC mark, as amended by ……..

DECREE  No.    334/2000  Coll.  (part  91/26.09.2000),  of  the
Ministry  of  Industry  and  Trade,  that  relates  to  cold-water
meters bearing EEC mark, as amended by ……..

DECREE  No.  335/2000  Coll.  (part  91/26.09.2000),  of  the
Ministry  of    Industry  and  Trade,  that  lays  down  requirements

38

for taximeters bearing EEC mark, as amended by ……..

DECREE  No.  336/2000  Coll.  (part  91/26.09.2000),  of  the
Ministry  of  Industry  and  Trade,  that  relates  to  gas  volume
meters bearing EEC mark, as amended by ……..

DECREE  No.  338/2000  Coll.  (part  91/26.09.2000),  of  the
Ministry of Industry and Trade, that lays down requirements for
electrical  energy  meters  bearing  EEC  mark,  as  amended
by ……..

DECREE  No.  339/2000  Coll.  (part  91/26.09.2000),  of  the
Ministry of Industry and Trade, that lays down requirements for
material  measures  of  length  bearing  EEC  mark,  as  amended
by ……..

DECREE  No.  21/2001  Coll.  (part  6/16.01.2001),  of  the
Ministry of Industry and Trade, that lays down requirements for
meters for liquids other than water bearing the EEC  mark  and
for ancillary equipment for these meters, as amended by ……..

DECREE  No.  22/2001  Coll.  (part  6/16.01.2001),  of  the
Ministry of  Industry and  Trade, that relates to requirements for
measuring systems for liquids other than water bearing the EEC
mark, as amended by ……..

DECREE  No.  249/2001  Coll.  (part  97/24.07.2001),  of  the
Ministry of Industry and Trade that lays down requirements for
automatic  checkweighing  and  weight  grading  instruments
bearing EEC mark, as amended by ……..

DECREE  No.  250/2001  Coll.  (part  97/24.07.2001),  of  the
Ministry of Industry and Trade, that lays down requirements for
continuous totalising weighing instruments bearing EEC mark,
as amended by ……..

DECREE  No.  29/2002  Coll.  (part  12/29.01.2002)  of  the
Ministry  for  Industry  and  Trade,  that  lays  down  requirements
for  measuring  instruments  of  the  standard  mass  per  storage
volume of grain bearing EEC mark, as amended by ……..

DECREE  No.  30/2002  Coll.  (part  12/29.01.2002)  of  the
Ministry for Industry and Trade, that lays down methods for the
calibration  of  the  tanks  used  as  measuring  instruments  placed
on vessels and bearing EEC mark, as amended by ……..

DECREE  No.  31/2002  Coll.  (part  12/29.01.2002)  of  the
Ministry of Industry and Trade, that lays down requirements for
alcoholmeters  and  alcohol  hydrometers  bearing  EEC  mark,  as
amended by ……..

DECREE  No.  32/2002  Coll.  (part  12/29.01.2002)  of  the
Ministry of Industry and Trade, that lays down requirements for
weights  of  from  1  mg  to  50  kg  of  above-medium  accuracy
bearing EEC mark, as amended by ……..

39

DECREE  No.  33/2002  Coll.  (part  12/29.01.2002)  of  the
Ministry of Industry and Trade, that lays down requirements for
5 to 50 kg medium accuracy rectangular bar weights and 1 g to
10 kg medium accuracy cylindrical weights bearing EEC mark,
as amended by ……..

40

SECTION II
SPECIFIC ARRANGEMENTS

Safeguard Clauses

A.

Safeguard clause relating to industrial products.

1. Where a Party has taken a measure to deny free access to its market for industrial
products  subject  to  this  Annex,  it  shall  immediately  inform  the  other  Party,
indicating the reasons for its decision and how non-compliance has been assessed.

2.

3.

4.

The Parties shall consider the matter and the evidence brought to their knowledge,
and shall report to each other the results of their investigations.

In  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that
such products are not placed on the market.

In case of disagreement on the outcome of such investigations the matter shall be
forwarded to the Association Council who may decide to have an expertise carried
out.

5. Where the Association Council finds that the measure is:

(a)

(b)

unjustified,  the  national  authority  of  the  Party  who  has  taken  the  measure
shall withdraw it;

justified,  the  Parties  shall  take  appropriate  measures  to  ensure  that  such
products are not placed on the market.

41

ANNEX ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS:

METROLOGY – PRE-PACKAGING

SECTION I

Community law:

Council  Directive  75/106/EEC  on  the  approximation  of  the
laws of the Member States relating to the making-up by volume
of certain pre-packaged liquids,

amended by:

Council Directive 79/1005/EEC

Council Directive 85/10/EEC

Council Directive 88/316/EEC

Council Directive 89/676/EEC

Adaptation to technical progress:

Commission Directive 78/891/EEC.

Council  Directive  75/107/EEC  on  the  approximation  of  the
laws of the Member States relating to bottles used as measuring
containers.

Council  Directive  76/211/EEC  on  the  approximation  of  the
laws of the Member States relating to the making-up by weight
or by volume of certain pre-packaged products

Adaptation to technical progress:

Commission Directive 78/891/EEC.

Council  Directive  80/232/EEC  on  the  approximation  of  the
laws  of  the  Member  States  relating  to  the  ranges  of  nominal
quantities  and  nominal  capacities  permitted  for  certain  pre-
packaged products, amended by:

Council Directive 86/96/EEC

Council Directive 87/356/EEC.

National law:

ACT  No.  505/1990  Coll.  (part  83/17.12.1990),  on  Metrology,
as amended by ACT No. 119/2000 Coll. (part 35/10.05.2002),

42

ACT No. 137/2002 Coll. (part 57/15.04.2002) and ……..

DECREE No. 328/2000 Coll. (91/26.09.2000), of the Ministry
of Industry and Trade that relates to the method of making-up
by weight or by volume of certain prepackaged products.

DECREE No. 329/2000 Coll. (91/26.09.2000), of the Ministry
of Industry and Trade that relates to the method of making-up
by volume of certain prepackaged liquid products.

DECREE No. 330/2000 Coll. (91/26.09.2000), of the Ministry
of  Industry  and  Trade,  that  lays  down  ranges  of  nominal
quantities and nominal capacities permitted for certain types of
prepackaged products.

DECREE No. 331/2000 Coll. (91/26.09.2000), of the Ministry
of  Industry  and  Trade,  that  lays  down  the  requirements  for
bottles used as measuring containers for prepackages.

43

SECTION II
SPECIFIC ARRANGEMENTS

Safeguard Clauses

A.

Safeguard clause relating to industrial products.

1. Where a Party has taken a measure to deny free access to its market for industrial
products  subject  to  this  Annex,  it  shall  immediately  inform  the  other  Party,
indicating the reasons for its decision and how non-compliance has been assessed.

2.

3.

4.

The Parties shall consider the matter and the evidence brought to their knowledge,
and shall report to each other the results of their investigations.

In  case  of  agreement,  the  Parties  shall  take  appropriate  measures  to  ensure  that
such products are not placed on the market.

In case of disagreement on the outcome of such investigations the matter shall be
forwarded to the Association Council who may decide to have an expertise carried
out.

5. Where the Association Council finds that the measure is:

(a)

(b)

unjustified,  the  national  authority  of  the  Party  who  has  taken  the  measure
shall withdraw it;

justified,  the  Parties  shall  take  appropriate  measures  to  ensure  that  such
products are not placed on the market.

44