Proposal for a Council Decision on the conclusion of an additional Protocol to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, and the State of Israel on an Agreement between the European Community and the state of Israel on Conformity Assessment and Acceptance of Industrial Products (ACAA)
Date: 2009-10-22
Institutions: European Commission
Subjects: Israel, Protocol (EU), agreement (EU), approval, industrial product

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.10.2009 
COM(2009)559 final 

2009/0155 (ACC) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of an additional Protocol to the Euro-Mediterranean Agreement 
establishing an Association between the European Communities and their Member 
States, and the State of Israel on an Agreement between the European Community and 
the state of Israel on Conformity Assessment and Acceptance of Industrial Products 
(ACAA) 

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EXPLANATORY MEMORANDUM 

I. 

1. 

THE PROTOCOL 

BACKGROUND 

Article  2.3.1.4:  Facilitate  market  access  of 
the  European 
Neighbourhood  Action  Plan  between  the  EU  and  Israel  commits  the  Parties  to  “accelerate 
progress towards bilateral negotiations leading to an ACAA, taking into account the specific 
nature of the Israeli economy and building upon the Palermo Action Plan”. 

industrial  products,  of 

On the basis of the above, and negotiating directives included in the specific decision of the 
Council of 21 September1992 authorizing the Commission to negotiate agreements between 
the European Economic Community and certain third countries on mutual recognition relating 
to conformity assessment, as amended by the specific decisions adopted by the Council on 26 
May  1997  and  on  8  July  2002,  the  Commission  has  negotiated  and  initialled  an  additional 
Protocol  to  the  Euro-Mediterranean  Agreement  with  Israel  on  Conformity  Assessment  and 
Acceptance of industrial products (hereinafter referred to as “the Protocol”).  

The text of the Protocol is attached to this Memorandum. The Commission proposes that the 
Council  authorises  the  signature  of  the  additional  Protocol  to  the  Euro-Mediterranean 
Agreement on behalf of the Community.  

2. 

ASSESSMENT OF THE PROTOCOL 

The  Protocol  follows  the  general  principles  laid  down  in  the  Commission's  Communication 
on  Community  External  Trade  Policy  in  the  field  of  standards  and  conformity  assessment 
(COM(96) 564 final. of 13.11.1996). 

It  has  been  decided,  in  consultation  with  the  133  Committee,  to  adopt  this  agreement  as  a 
Protocol  to  the  Euro-Mediterranean  Agreement  establishing  an  association  between  the 
European Communities and their Member States, of the one part, and the State of Israel, of 
the other part, signed on 20 November 1995 (OJ L 147, 21.06.2000, p.3) rather than as a stand 
alone Agreement. 

The  ACAA  provides  for  an  extension  of  certain  benefits  of  the  Internal  Market  in  sectors 
already aligned. The ACAA thus facilitates market access by eliminating technical barriers to 
trade with respect to industrial products. Each ACAA consists of a framework agreement and 
one or more annexes, setting out the products covered, and the means adopted to extend the 
benefit of trade in that sector. 

To this end, the ACAA provides for two mechanisms, first, for the recognition of equivalence 
in  technical  regulation,  standardization  and  conformity  assessment  for  industrial  products 
subject  to  equivalent  regulation  in  Community  law  and  the  national  law  of  the  partner 
country,  and  second,  for  the  mutual  acceptance  of  industrial  products  that  fulfil  the 
requirements to be lawfully placed on the market in one of the Parties.  

Under the first mechanism, mutual recognition of products operates on the basis of the acquis 
communautaire that has been transposed by the partner country, in the same way as it would 
apply  to  products  placed  on  the  market  of  a  Member  State.  It  allows  industrial  products 
covered by it and attested as compliant according to the procedures of the European Union to 

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be  placed  on  the  Israeli  market  without  having  to  undergo  any  further  approval  procedures, 
and  vice  versa.  At  present  one  sector  is  included:  good  manufacturing  practice  (GMP)  for 
pharmaceutical  products.  Israel  has  taken  over  the  Community  technical  legislation  in  the 
sector covered by the Annex to the Protocol and participates in the European organisations in 
the sector covered by it. 

The  second  mechanism,  i.e.,  the  mutual  acceptance  of  industrial  products  not  commonly 
regulated, confirms that Articles 16 and 17 of the Euro-Mediterranean Agreement with Israel 
apply without other restriction in the product sectors covered by it. That is, Annexes applying 
this  mechanism  will  provide  that  where  no  European  technical  regulations  exist,  industrial 
products listed under such Annexes lawfully traded in the market of either Party (i.e., on the 
territory of Israel or that of one of the Member States of the EU) may be lawfully traded in the 
other. No annexes making this mechanism operational are at present included.  

3. THE FRAMEWORK AGREEMENT 

Article 1: Purpose and means. This article establishes the purpose of the ACAA, namely the 
elimination of technical barriers to trade in respect to industrial products. The ACAA provides 
for two mechanisms, as described above. 

Article 2: Definitions. This is self-explanatory.  

Article 3: Alignment of legislation. This contains a commitment for Israel to take appropriate 
measures to take over and maintain measures to align with and maintain Community law, as it 
applies  to  products  covered  by  the  Agreement.  For  New  Approach  sectors  (which  will  be 
explicitly identified as such in the Annexes that relate to them) there is also an obligation on 
Israel  to  maintain  relevant  transposed  standards,  in  the  same  way  as  a  Member  State  of  the 
EU. 

Article 4: Infrastructure. This commits Israel to establish and maintain a quality infrastructure 
equivalent to that of the EU for sectors covered by the Protocol.  

Article  5:  Mutual  acceptance  of  industrial  products.  The  principles  of  the  two  mechanisms 
underlying the mutual acceptance of products onto the market of the other Party, as described 
above, are detailed in this Article. There is also a provision that, unless otherwise agreed, the 
ACAA does not entail any obligation, for one Party, to accept product attested as compliant 
by bodies other than those of the Parties. 

Article 6: Safeguard clause. This sets up the right of each Party to deny market access when 
that Party is able to demonstrate that a product might endanger legitimate concerns covered 
by  legislation  applicable  to  the  products  covered  by  an  Annex  (mainly  to  do  with  safety  or 
public health). The Annexes will provide for the detailed procedures to be used in such cases. 

Article  7:  Extension  of  coverage.  This  sets  out  that  the  Parties  may  modify  the  scope  and 
coverage of this Protocol through amendment of the Annexes or by the addition of new ones. 

Article  8:  Obligations  of  Parties  as  regards  their  Responsible  Authorities  and  Notified 
Bodies. This article obliges the Parties to ensure that their reponsible authorities monitor the 
technical competence and compliance of their respective notified bodies and have power and 
expertise for designating, suspending, and withdrawing such bodies. In addition, it obliges the 
Parties to ensure that their notified bodies comply with the requirements of Community and 

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aligned national law, and maintain their technical competence to carry out the tasks for which 
they have been notified. 

Article 9: Notified bodies. This describes the procedure for the notification of bodies to assess 
conformity in relation to the legal requirements specified in the corresponding annexes. The 
procedure is similar to the one applied within the Community. It also sets out the procedure 
for the withdrawal of notified bodies. 

Article 10: Verification of notified bodies. This article gives the right to one Party to request a 
verification of a body notified by the other Party. The verification may be done either by the 
authorities which have designated the body or together by the authorities of both Parties. The 
notified body would be suspended until a final decision is taken. 

Article 11: Exchange of information. This transparency provision ensures uniform application 
and interpretation of the Protocol. It also provides for the Parties to encourage their notified 
bodies to co-operate to establish mutual recognition agreements in the voluntary sphere. 

Article 12: Confidentiality. This standard provision prohibits disclosing information acquired 
under this Protocol. 

Article 13: Management of the Agreement. This article provides that the Committee (defined 
in  Art.  2  as  the  Association  Committee  set  up  under  the  Association  Agreement,  or  any 
working group (subcommittee "Industry, trade and services") set up and designated for trade 
purposes  under  Article  73  of  the  Association  Agreement)  shall  manage  the  Agreement, 
including  adding  and  amending  Annexes,  appointing  experts  for  verifications,  considering 
new  arrangements,  and  resolving  questions  related  to  the  Protocol.  It  also  provides  for 
ultimate recourse to the disputes settlement procedure set out in Article 75 of the Association 
Agreement. 

Article  14:  Technical  co-operation  and  assistance.  This  confirms  the  Community  policy  on 
technical co-operation and assistance with a view to properly implementing this Protocol. 

Article 15: Agreements with other countries. Provides that the agreement can be extended to 
other  countries  by  explicit  agreement,  and  encourages  -  but  does  not  force  -  Israel  to  make 
agreements similar to the Protocol, and covering the same products, that the EU might make 
with another country.  

Article 16: Entry into force. A standard provision that provides the arrangement for the entry 
into force.  

Article  18:  Status  of  the  Agreement.  A  standard  provision  establishing  the  status  of  the 
different language versions of the text. 

4. 

THE ANNEXES  

4.1 

Annex on Mutual Acceptance of Industrial Products  

There  is  one  Annex,  covering  good  manufacturing  practice  (GMP)  for  pharmaceutical 
products.  It  operates  by  the  mechanism  described  above  whereby  mutual  recognition  of 
products  operates  on  the  basis  of  the  acquis  communautaire  that  has  been  transposed  by 
Israel.  

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Coverage  is  determined  by  the  relevant  Community  or  Israeli  national  law,  which  will  be 
notified by each Party to the other under Section I.  

Section  II  deals  with  the  scope.  It  lists  the  coverage  and  exclusions,  and  provides  for  an 
exchange of letters listing types of products to be covered. It also specifies that it applies to 
products covered by it irrespective of their origin. The ACAA will cover good manufacturing 
practice (GMP) for all products in the pharmaceutical field, with the exception of advanced 
therapy products, special medicinal products based on tissues and cells of human origin, and 
medicinal products that include blood products. The inclusion of these fields may be agreed 
between the Parties if the Israeli legislation governing them is brought into alignment. 

Section  III  states  that  the  Parties  shall  notify  the  identity  of  their  responsible  authorities  to 
each  other.  Responsible  Authorities  are  responsible  for  the  GMP  cetification  process  in  the 
Parties (Notified Bodies are not relevant to GMP).  

Section  IV  provides  for  the  specific  arrangements  for  these  products.  Clause  1  provides 
definitions.  Clause  2  describes  the  mutual  obligations  of  the  Parties,  to  recognise  the 
conclusions  of  compliance  of  manufacturers  and  importers  with  EU  GMP  and  its  Israeli 
equivalent.  Clause  3  provides  for  an  exchange  of  information  on  the  authorisation  status  of 
manufacturers  and  importers  and  on  the  outcome  of  inspections.  Clause  4  provides  for  an 
exchange  of  inspection  reports.  Clause  5  deals  with  the  exchange  of  laboratory  testing  on 
reasoned  request.  Clause  6  makes  similar  provisions  for  exchange  of  information  on  batch 
release of products. Clause 7 fixes the format for information exchange. Clause 8 provides a 
safeguard  mechanism,  giving  either  Party  the  right  to  ask  for  a  full  inspection  or  testing 
report.  Clause  9  commits  Israel  to  participate  in  the  Community  alert  system.  Clause  10 
provides for information exchange. Clause 11 provides for the notification of contact points 
who will monitor the implementation and operation of the Annex. 

4.2 

Annexes on Mutual Acceptance of Industrial Products no commonly regulated 

No such annexes have been negotiated for the moment. The ACAA provides nevertheless the 
basis for such acceptance of products. 

5. 

RELATIONS WITH EFTA /EEA MEMBER COUNTRIES 

In  accordance  with  the  information  and  consultation  procedures  set  out  in  the  European 
Economic Area-Agreement and Protocol 12 of that Agreement, the Commission has informed 
EFTA/EEA Member Countries on the progress of the negotiations and the final result.  

6. 

IMPACT 

The Commission considers that the proposed ACAA creates an acceptable balance of benefits 
for  all  parties.  In  the  sector  covered  the  Community  has  secured  effective  market  access  in 
terms  of  access  to  procedures  of  the  other  party.  The  ACAA  confirms  that  Israel  has  taken 
over the Community legislation. Commercial benefits will be achieved with the ACAA. 

The  Protocol  will  allow  Community  exporters,  if  they  so  choose,  to  test  and  certify  their 
industrial  products  to  the  same  (aligned)  requirements  prior  to  export,  and  then  access  that 
market without any further conformity assessment requirements. The certification procedures 
will  only  need  to  be  carried  out  one  time  for  both  markets  and  against  the  same  aligned 

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requirements or standards. The recognition of certification will permit savings and stimulate 
exports.  

It has not always been possible to quantify the costs or time taken to obtain batch clearance 
for pharmaceutical products in Israel. The precise extent of savings in time, cost and market 
opportunity of this Protocol is therefore not feasible in every case to determine. This may only 
be possible once the Protocol has been in operation for some time.  

See table I, attached, for figures for trade in pharmaceutical products between Israel and the 
EU.  They  have  been  supplied  by  the  European  Federation  of  Pharmaceutical  Industries  and 
Associations (EFPIA). It will be noted that the total trade in such products between the Parties 
to the proposed ACAA amounted in 2007 to close to €1bn. 

In fact, most benefits are clearly not quantifiable, such as reduced time for accessing markets, 
better  predictability,  less  protectionism,  and  harmonisation  of  systems.  What  can  be 
ascertained  is  that  any  agreement  provides  reciprocal  levels  of  market  access,  in  terms  of 
conformity assessment.  

In terms of the benefits to Israel, the ACAA will facilitate access to the Community market. 
Israel  regards  the  ACAA  as  a  means  to  develop  closer  industrial  relations  with  the  EU  and 
fully to integrate certain sectors with the Single Market. 

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Table I. Trade in pharmaceutical products between EU and Israel, the West Bank and Gaza 

Notes.  

1. “Imports” denotes imports from Israel, the West Bank and Gaza to the EU-27 for the period stated. “Exports” denotes exports from the EU-27 to 
Israel, the West Bank and Gaza for the period stated. 

2. Amounts are given in millions of Euro. 

3. The full point is used as the decimal marker. 

4. Source: EFPIA. 

Part 1 of 2: 2000 and 2005 

PRODUCT 

2000 

- 

2936 - Provitamins 
2937 - Hormones 
2938 - Heterosides 
2939 - Alkaloids 
2941 - Antibiotics 
3001 
- 
Products 
3002 
Products 
3003 
Products 
3004 
Products 
3005 
Products 
3006 
Products 
Total (2936-3006)  
Total (3001-3006) 

- 

- 

- 

- 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

Import 

Export 

7.371
467
1.728
3.806
1.278

6.679
1.517
121
1.075
7.552

Trade 
Balance 

-691 
1.050 
-1.607 
-2.732 
6.274 

2005  

Import 

Export 

7.796
3.008
1.129
512
8.735

2.697
3.173
256
955
19.696

2

1.260

1.258 

20

159

Trade 
Balance 

-5.099
166
-873
444
10.962

140

348.092

38.732

-309.359 

134.778

52.921

-81.858

1.925

17.192

15.268 

122.469

8.278

-114.191

45.949

275.486

229.537 

230.340

321.602

91.261

5.283

5.378

96 

6.172

3.501

-2.671

4.092
419.992
405.342

9.571
364.563
347.620

5.478 
-55.429 
-57.723 

4.868
519.826
498.648

22.160
435.399
408.621

17.292
-84.428
-90.027

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Table I continued 

Part 2 of 2: 2007 

PRODUCT 

- 

2936 - Provitamins 
2937 - Hormones 
2938 - Heterosides 
2939 - Alkaloids 
2941 - Antibiotics 
3001 
- 
Products 
3002 
Products 
3003 
Products 
3004 
Products 
3005 
Products 
3006 
Products 
Total (2936-3006)  
Total (3001-3006) 

- 

- 

- 

- 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

Pharmaceutical 

2007  

Import 

Export 

5.735
1.075
149
5.180
1.242

4.609
1.474
300
1.418
6.959

54

340

Trade 
Balance 

-1.126
399
152
-3.762
5.717

286

8.465

53.419

44.954

68.847

12.338

-56.509

400.290

344.611

-55.679

4.463

5.025

562

5.483
500.982
487.602

27.137
457.632
442.871

21.654
-43.350
-44.731

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II. 

THE DRAFT COUNCIL DECISION 

A proposal for a Council Decision is attached.  

It is concerned with the signature and adoption of the ACAA. Signature is required by Israel 
for the adoption of this Protocol. It is accordingly proposed that the President of the Council 
be  authorised  to  designate  the  person  empowered  to  sign  the  Protocol  on  behalf  of  the 
Community, on the basis of Articles 133 and 300 of the Treaty. In this context, the Council 
should,  in  line  with  previous  Council  Decisions  on  the  conclusion  of  ACAAs  and  mutual 
recognition  agreements,  establish 
the 
implementation and management of the Protocol. 

the  appropriate  Community  procedures 

for 

In particular, the Council should confer on the Commission, in consultation with the special 
committee  appointed  by  the  Council,  the  necessary  powers  for  the  management  and 
implementation  of  the  Protocol.  Moreover,  the  Council  should  delegate  to  the  Commission, 
acting  in  consultation  with  the  special  committee,  the  necessary  powers  to  determine  the 
Community position with regard to this Protocol in the Association Committee, or, where the 
Association  Council  has  in  accordance  with  Article  73  of  the  Association  Agreement 
delegated powers to a working group designated to cover trade issues, in that working group.  

The delegation of powers to the Commission includes delegation of the power to add –after 
appropriate  consultation  with  Member  States  in  the  framework  of  the  133  Committee-  new 
Annexes,  since,  as  indicated  in  the  Preamble,  the  commitments  in  the  Euro-Mediterranean 
Agreement include the use of best endeavours to approximate the laws of the Parties. 

The  Commission  therefore  proposes  that  the  Council  adopt  the  attached  Decision  on  the 
signature and conclusion of the ACAA. 

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2009/0155 (ACC) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of an additional Protocol to the Euro-Mediterranean Agreement 
establishing an Association between the European Communities and their Member 
States and the State of Israel on an Agreement between the European Community and 
the state of Israel on Conformity Assessment and Acceptance of Industrial Products 
(ACAA) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 133  in  conjunction  the  first  sentence  of  the  first  subparagraph  of  Article  300(2) 
thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

The Euro-Mediterranean Agreement establishing an association between the European 
Communities and their Member States, of the one part, and the State of Israel of the 
other  part  (hereinafter  “the  Association  Agreement”),1  entered  into  force  on  20 
November 1995; 

Article  47  of  the  Association  Agreement  provides,  where  appropriate,  for  the 
conclusion  of  a  European  conformity  assessment  agreement,  and  Article  55  of  the 
same  Agreement provides  for the use of best endeavours to approximate the laws of 
the Parties; 

The  Protocol  to  the  Association  Agreement  on  Conformity  Assessment  and 
Acceptance of Industrial Products (hereinafter “the Protocol”) initialled in Brussels on 
24 June 2009 should be signed;  

Article 70(2) of the Association Agreement provides that the Association Council may 
delegate to the Association Committee any of its powers, and Article 73 provides that 
the Association Council may decide to set up any working group or body necessary for 
the implementation of the Agreement; 

(5) 

The  appropriate  internal  procedures  should  be  established  to  ensure  the  proper 
functioning of the Protocol; 

1 

OJ L 147, 21.6.2000, p. 3. 

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(6) 

It  is  necessary  to  empower  the  Commission  to  make  technical  amendments  to  this 
Protocol and to take decisions for its implementation; 

HAS DECIDED AS FOLLOWS: 

Article 1 

The  Protocol  to  the  Euro-Mediterranean  Agreement  with  the  State  of  Israel  on  Conformity 
Assessment and Acceptance of Industrial Products (hereinafter referred to as “the Protocol”), 
is hereby approved on behalf of the European Community. 

The text of the Protocol is attached to this Decision.  

Article 2 

The President of the Council is hereby authorised to designate the person empowered to sign 
the Protocol, on behalf of the Community. The President of the Council shall, on behalf of the 
Community, transmit the diplomatic note provided for in Article 16 of the Protocol. 

1. 

The  Commission,  after  consultation  with  the  special  committee  appointed  by  the 
Council, shall:  

Article 3 

(a) 

(b) 

carry  into  effect  the  information,  co-operation,  notification,  amendment, 
verification and management functions provided for in Articles 6, 7, 8, 9, 10, 
11, 13, 14 and 15 of the Protocol; 

carry  into  effect  the  information,  co-operation,  notification,  amendment, 
verification  and  management  functions  provided  for  in  the  Annexes  to  the 
Protocol; 

(c) 

if necessary, reply to requests in accordance with the Annexes to the Protocol. 

2. 

The  position  to  be  taken  by  the  Community  with  regard  to  the  Protocol  in  the 
Association  Committee  and,  where  applicable,  in  a  body  set  up  by  the  Association 
Council under Article 73 of the Association Agreement and designated to cover trade 
issues, shall be determined by the Commission, following consultation of the special 
committee referred to in paragraph 1 of this Article. 

Done at Brussels,  

For the Council 
The President 

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PROTOCOL TO THE EURO-MEDITERRANEAN AGREEMENT ESTABLISHING AN 
ASSOCIATION BETWEEN THE EUROPEAN COMMUNITIES AND THEIR MEMBER 
STATES, OF THE ONE PART, AND THE STATE OF ISRAEL, OF THE OTHER PART, 
ON AN AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE STATE 
OF ISRAEL ON CONFORMITY ASSESSMENT AND ACCEPTANCE OF INDUSTRIAL 
PRODUCTS (ACAA) 

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THE EUROPEAN COMMUNITY 

AND 

THE STATE OF ISRAEL  

Hereinafter referred to as “Israel” 

Both together referred to as “the Parties”, 

WHEREAS Israel is a party to the EURO-MEDITERRANEAN AGREEMENT ESTABLISHING 
AN  ASSOCIATION  BETWEEN  THE  EUROPEAN  COMMUNITIES  AND  THEIR  MEMBER 
STATES,  OF  THE  ONE  PART,  AND  THE  STATE  OF  ISRAEL,  OF  THE  OTHER  PART, 
Hereinafter referred to as “the Association Agreement”2, 

RECOGNISING  that  the  adoption  and  implementation  of  relevant  Community  law  by  Israel 
provides the opportunity to extend certain benefits of the internal market and to ensure its effective 
operation in certain sectors, 

CONSIDERING that, in the sectors covered by this Agreement, Israel's national law is substantially 
aligned with relevant Community law, 

CONSIDERING  their  shared  commitment  to  the  principles  of  free  movement  of  goods  and  to 
promoting product quality, so as to ensure the health and safety of their citizens and the protection 
of the environment, including through technical assistance and other forms of cooperation between 
them, 

DESIRING to conclude as a Protocol to the Association Agreement an Agreement on Conformity 
Assessment  and  Acceptance  of  Industrial  Products  (hereafter  referred  to  as  “this  Agreement”) 
providing  for  the  application  of  the  mutual  acceptance  of  industrial  products  which  fulfil  the 
requirements  for  being  lawfully  placed  on  the  market  in  one  of  the  Parties,  including  where 
appropriate the mutual recognition of the results of obligatory conformity assessment of industrial 
products, noting that Article 47 of the Association Agreement provides, where appropriate, for the 
conclusion  of  a  European  conformity  assessment  agreement  and  that  Article  55  of  the  same 
Agreement provides for the use of best endeavours to approximate the laws of the Parties, 

NOTING  the  close  relationship  between  the  European  Union  and  Iceland,  Liechtenstein  and 
Norway  through  the  Agreement  on  the  European  Economic  Area,  which  makes  it  appropriate  to 
consider the conclusion of a parallel European Conformity Assessment Agreement between Israel 
and these countries equivalent to this Agreement, 

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

HAVE AGREED AS FOLLOWS: 

2 

OJ L 147 of 21.6.2000, p. 3 and “Kitvei Amana” (Israel Official Publication Journal), 1034. 

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Article 1 

Purpose and means 

1. 

The  purpose  of  this  Agreement  is  to  facilitate  the  elimination  by  the  Parties  of  technical 
barriers  to  trade  in  respect  of  certain  industrial  products,  listed  in  the  Annexes  to  this 
Agreement, which form an integral part of this Agreement. 

2. 

The means to this end are:  

(a) 

(b) 

(c) 

(d) 

the  adoption  and  implementation  by  Israel  of  national  technical  regulations, 
standards  and  conformity  assessment  procedures  which  are  equivalent  to  those  of 
relevant Community law; 

the  implementation  by  Israel  of  a  regulatory  and  technical  infrastructure  which  is 
equivalent to that in place in the Member States of the European Union;  

the mutual acceptance on their markets by both Parties of industrial products which 
fulfil the requirements for being lawfully placed on the market in one of the Parties, 
including  where  appropriate  the  mutual  recognition  of  the  results  of  obligatory 
conformity assessment of industrial products subject to relevant Community law and 
to the equivalent Israeli national law. 

the acceptance on their markets by both Parties of industrial products which fulfil the 
requirements  for  being  lawfully  placed  on  the  market  in  Israel  and  any  one  of  the 
Member States of the European Union, on conditions analogous to those applying to 
trade in goods between the Member States of the European Union. 

Article 2 

Definitions 

For the purpose of this Agreement,  

(a) 

(b) 

(c) 

(d) 

“Industrial  products”  means  products,  as  defined  by  the  scope  of  the  Annexes  to  the 
present Agreement; 

“Relevant  Community  law”  means  any  legal  act  and  implementing  practice  of  the 
European Union applicable to a particular situation, risk or category of industrial products, 
referenced in the Annexes to this Agreement; 

“National law” means any legal act and implementing practice by which Israel has aligned 
its  legislation  with  relevant  Community  law  applicable  to  a  particular  situation,  risk  or 
category of industrial products; 

“Responsible Authority” means a body under the jurisdiction of one of the Member States 
of the European Union or of Israel which is responsible for the effective implementation of 

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(e) 

(f) 

Community and national law in a specified industrial sector, and which where appropriate 
has the responsibility for notifying Notified Bodies;  

“Notified Body” means a body notified, by a Responsible Authority under the respective 
jurisdiction  of  one  of  the  Parties  to  this  Agreement,  to  the  other  Party,  as  competent  to 
assess conformity in relation to requirements of Community or national law. 

"Committee" means the Association Committee set up under Article 70 of the Association 
Agreement or a body set up by the Association Council under Article 73 of the Association 
Agreement and designated to cover trade issues. 

The  terms  used  in  this  Agreement  shall  have  the  meaning  given  in  relevant  Community  law  and 
Israel's national law. 

Article 3 

Alignment of legislation 

For the purpose of this Agreement, Israel agrees to take appropriate measures, in consultation with 
the European Commission, to align with and maintain relevant Community law as it applies to the 
placing on the market of products covered by this Agreement,  

In  sectors  covered  by  this  Agreement  where  relevant  Community  law  is  based  upon  the  use  of 
technical standards giving presumption of conformity with essential safety requirements (known as 
“New  Approach”  sectors)  Israel  agrees  to  take  appropriate  measures,  in  consultation  with  the 
European  Commission,  to  align  with  and  maintain  relevant  Community  practice  in  the  fields  of 
standardisation,  metrology,  accreditation,  conformity  assessment,  market  surveillance,  general 
safety  of  products,  and  producers’  liability.  “New  Approach”  sectors  are  indicated  as  such  in  the 
Sectoral Annexes. 

Article 4 

Technical infrastructure 

For the purpose of this Agreement, Israel agrees to take appropriate measures, in consultation with 
the  European  Commission,  to  establish  and  maintain  appropriate  Responsible  Authorities  in 
accordance with Article 9. 

In  sectors  covered  by  this  Agreement  where  relevant  Community  law  is  based  upon  the  use  of 
technical standards giving presumption of conformity with essential safety requirements (known as 
“New  Approach”  sectors)  Israel  agrees  to  establish  and  maintain  bodies  that  are  capable  of 
sustaining  the  functions  of  standardisation,  metrology,  accreditation,  market  surveillance, 
assessment of general safety of products, and assessment and enforcement of producer liability on 
its territory at a level broadly equivalent to those in place in the Member States of the Union.  

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1. 

2 

3. 

4 

Article 5 

Mutual acceptance of industrial products including their conformity assessment 

The Parties agree that, for the purpose of mutual acceptance, industrial products listed in 
the  Annexes  on  Acceptance  of  Regulated  Products,  fulfilling  the  requirements  for  being 
lawfully placed on the market of a Party, may be placed on the market of the other party, 
if, in particular, they fulfil:  

(a) 

the requirements of applicable legislative provisions related to the location in either 
of the Parties of the persons responsible for placing of products on the market; and 

(b)  where appropriate, applicable provisions related to the location of the bodies that are

 responsible for assessing compliance.  

The Parties agree that, for the purpose of mutual acceptance, industrial products listed in 
the  Annexes  on  Acceptance  of  Products  Not  Commonly  Regulated,  and  for  which  no 
European  technical  regulations  exist,  may  be  traded  between  Israel  and  the  European 
Union on the basis that a product lawfully traded in the market of Israel or of one of the 
Member  States  of  the  EU  may  be  lawfully  traded  upon  that  of  the  other  Party  to  this 
Agreement.  

Where products are subject to obligatory conformity assessment procedures to be carried 
out in accordance with the Community and national laws listed in the Annexes, the Parties 
further  agree  to  recognise  the  results  of  such  procedures  without  requiring  them  to  be 
repeated,  nor  with  the  imposition  of  any  additional  requirements  for  the  purposes  of 
accepting such conformity assessment.  

Notwithstanding  Paragraphs  5.1,  5.2  and  5.3,  neither  Party  shall  be  obliged  to  accept 
products on to its market that have been lawfully placed on the market of the other Party as 
a  consequence  of  an  agreement  similar  in  effect  to  this  Agreement  between  either  Party 
and a third country or party, or by virtue of a unilateral concession by either Party to a third 
country or party.  

Article 6 

Safeguard clause 

Where a Party finds that an industrial product placed on the market on its territory by virtue of this 
Agreement, and used in accordance with its intended use, may compromise the safety or health of 
users  or  other  persons,  or  any  other  legitimate  concern  protected  by  legislation  identified  in  the 
Annexes, it may take appropriate measures to withdraw such a product from the market, to prohibit 
its placing on the market, putting into service or use, or to restrict its free movement.  

The Annexes shall provide for the procedure to be applied in such cases. 

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Article 7 

Extension of coverage 

If  Israel  adopts  and  implements  further  national  law  aligning  with  relevant  Community  law,  the 
Parties may amend the Annexes or conclude new ones, in accordance with the procedure laid down 
in Article 13.  

Article 8 

1. 

2. 

Obligations of Parties as regards their Responsible Authorities and Notified Bodies 

(a) The Parties shall ensure that Responsible Authorities under their jurisdiction which are 
responsible  for  the  effective  implementation  of  Community  and  national  law  shall 
continuously apply it. Further, they shall ensure that these Responsible Authorities are able 
to  ensure  the  conformity  of  industrial  products  with  Community  or  national  law  or  to 
require  their  withdrawal  from  the  market  and,  where  appropriate,  to  notify,  suspend, 
remove suspension and withdraw the notification of Notified Bodies. 

(b)  The  Parties  shall  notify  each  other  of  the  names  and  addresses  of  their  Responsible 
Authorities, and shall maintain a list of such bodies. 

(a) The Parties shall ensure that Notified Bodies, notified under their respective jurisdiction 
to assess conformity in relation to requirements of Community or national law specified in 
the Annexes, continuously comply with the requirements of such Community or national 
law. Further, they shall take all necessary steps to ensure that such notified bodies maintain 
the necessary competence to carry out the tasks for which they are notified. 

(b) The Parties shall notify each other of the names and addresses of their Notified Bodies, 
and shall maintain a list of such bodies. 

Article 9 

Procedures for the recognition of Responsible Authorities and the notification of Notified Bodies 

1. 

The following procedure shall apply for the recognition of Responsible Authorities which 
are responsible for the effective implementation of Community and national law, to ensure 
the conformity of industrial products  with Community or  national law  or to require their 
withdrawal  from  the  market  and,  where  appropriate,  are  able  to  notify,  suspend,  remove 
suspension and withdraw the notification of Notified Bodies: 

(a) 
a Party shall forward its nomination to the other Party in writing, stating the territory 
and  title  of  the  Annex  to  this  Agreement  under  which  the  Responsible  Authority  is 
competent  to  carry  out  the  tasks  listed  in  Article  8.1,  including  as  appropriate  any 
limitations to such competence within the territory or the scope of the Annex; 

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(b)  on  the  acknowledgement  of  the  other  Party,  given  in  writing,  the  Responsible 
Authority  shall  be  considered  as  competent  to  carry  out  the  tasks  listed  in  Article  8.1  in 
relation to the Annexes for which it has been recognised from that date. 

2. 

The  following  procedure  shall  apply  for  the  notification  of  Notified  Bodies  to  assess 
conformity in relation to the requirements of Community or national law specified in the 
Annexes: 

(a) 
a Party shall forward its notification to the other Party in writing, stating the title of 
the  Annex  to  this  Agreement  under  which  the  Notified  Body  is  competent  to  assess 
conformity, and as appropriate any limitations to such competence within the scope of the 
Annex; 

(b)  on  the  acknowledgement  of  the  other  Party,  given  in  writing,  the  body  shall  be 
considered  as  notified  and  as  competent  to  assess  conformity  in  relation  to  the  said 
requirements specified in the Annexes from that date. 

If a Party decides to withdraw the notification of a Notified Body under its jurisdiction, it 
shall inform the other Party in writing. The Notified Body will cease to assess conformity 
in  relation  to  the  said  requirements  specified  in  the  Annexes  from  the  date  of  its 
withdrawal at the latest. Nevertheless, conformity assessment carried out before that date 
shall remain valid, unless otherwise decided by the Committee. 

Article 10 

Verification of notified bodies 

Each Party may request the other Party to verify the technical competence and compliance 
of a notified body, or a candidate notified body, under its jurisdiction. Such request shall be 
justified, in an objective and reasoned manner, in order to allow the Party responsible for 
the  notification  to  carry  out  the  requested  verification  and  report  speedily  to  the  other 
Party. The Parties may also jointly examine the body, with the participation of the relevant 
responsible authorities. To this end, the Parties shall ensure the full cooperation of bodies 
under  their  jurisdiction.  The  Parties  shall  take  all  appropriate  steps,  and  use  whatever 
available  means  may  be  necessary,  with  a  view  to  resolving  any  problems  which  are 
detected.  

If the problems cannot be resolved to the satisfaction of both Parties, they may notify the 
Committee  of  their  disagreement,  giving  (a)  the  reasons  for  the  request  supported  by 
relevant evidence to verify the technical competence and compliance of the notified body; 
(b) the reasons why the problems cannot be resolved to the satisfaction of both Parties and 
(c) evidence showing there exists an imminent and real threat to human health and safety 
when relevant. The Committee may decide on appropriate action. 

3. 

1. 

2. 

3. 

Unless and until decided otherwise by the Committee, the notification of the body and the 
recognition  of  its  competence  to  assess  conformity  in  relation  to  the  requirements  of 

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Community or national law specified in the Annexes shall be suspended in part or totally 
from the date on which the disagreement of the Parties has been notified to the Committee. 

Article 11 

Exchange of information and cooperation 

In  order  to  ensure  a  correct  and  uniform  application  and  interpretation  of  this  Agreement,  and  to 
encourage trade in industrial goods between them, the Parties, shall:  

(a) 

(b) 

notify  each  other  of  relevant  proposed  and  actual  legislative  amendments,  and  exchange 
information concerning the implementation of law and practice, including in particular on 
procedures  to  ensure  the  compliance  of  Notified  Bodies  on  their  territory  with  the  rules 
applicable to them;  

invite  each  other  to  take  part  in  their  relevant  mechanisms  of  information  exchange,  in 
regards  to  mechanisms  dealing  with  sectors  covered  by  the  Annexes  to  this  Agreement 
unless specified otherwise in the Annexes. The EU will explore the possibility of inviting 
Israel to participate in relevant European networks and bodies;  

c) 

encourage  their  Notified  Bodies  to  cooperate  with  a  view  to  establishing  mutual 
recognition arrangements in the voluntary sphere. 

Article 12 

Confidentiality 

Representatives,  experts  and  other  agents  of  the  Parties  shall  be  required,  even  after  their  duties 
have  ceased,  not  to  disclose  information  acquired  under  this  Agreement  which  is  of  the  kind 
covered by the obligation of professional secrecy. This information may not be used for purposes 
other than those envisaged by this Agreement. 

Article 13 

Management of the Agreement 

1. 

Responsibility  for  the  effective  functioning  of  this  Agreement  shall  be  borne  by  the 
Committee. In particular, it shall have the power to take decisions regarding: 

(a) 

amending and withdrawing Annexes; 

(b) 

adding new Annexes; 

(c) 

appointing  experts  to  verify  the  technical  competence  of  a  notified  body  and  its 
compliance  with  the  requirements  applicable  to  them,  in  accordance  with  Article 
10.1; 

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(d) 

(e) 

exchanging information on proposed and actual amendments to the Community law 
and national law referred to in the Annexes;  

considering  new  or  additional  conformity  assessment  procedures  affecting  a  sector 
covered by an Annex; 

(f) 

resolving any questions relating to the application of this Agreement; 

(g) 

referring  questions  for  decision  to  the  disputes  settlement  mechanism  set  out  in 
Article  75  of  the  Association  Agreement  or  any  other  relevant  dispute  settlement 
mechanism  set  up  by  agreement  between  the  Parties  pursuant  to  the  Association 
Agreement. 

2. 

3. 

The Committee may delegate the above responsibilities set out under this Agreement. 

Amendments to the annexes shall enter into force as the Committee shall decide.  

Article 14 

Technical cooperation  

The  Parties  shall  cooperate  where  necessary  in  order  to  support  the  effective  implementation  and 
application of this Agreement. 

Article 15 

Agreements with other countries 

1. 

2. 

This Agreement may, by explicit agreement between the Parties, including by a decision of 
the  Committee,  be  extended  to  cover  the  acceptance  of  industrial  products  from  third 
countries or parties with which the European Union has concluded an Agreement similar to 
this Agreement in corresponding sectors.  

Where  the  European  Union  notifies  Israel  that  it  has  made  an  Agreement  similar  to  this 
Agreement with a third country or party, that covers the acceptance of industrial products 
in corresponding sectors, Israel shall consider making an Agreement with the third country 
or party that provides for such an extension. 

Article 16 

Entry into force 

This  Agreement  shall  enter  into  force  30  days  after  the  date  of  the  later  written  communication, 
through  diplomatic  channels,  by  which  the  parties  have  notified  each  other  that  their  respective 
internal legal requirements for the entry into force of this agreement have been fulfilled. 

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Article 17 

Duration 

The  Agreement  is  concluded  for  an  unlimited  period.  Each  of  the  Parties  may  denounce  the 
Agreement  by  notifying  the  other  Party.  The  Agreement shall  cease to apply  twelve  months after 
the date of such notification. 

During the period between the denunciation of the Agreement by one Party and its ceasing to apply, 
the  termination  of  this  Agreement  shall  not  adversely  effect  or  in  any  way  prejudice  any  right  or 
obligation accrued to or to be incurred by virtue of the application of this Agreement prior to the 
effective date of such termination. 

Article 18 

Status of the Agreement 

This  Agreement  is  drawn  up  in  two  originals  in  the  Bulgarian,  Czech,  Danish,  Dutch,  English, 
Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, 
Polish, Portuguese, Romanian, Slovak, Slovene, Spanish, Swedish and Hebrew languages, each text 
being equally authentic. 

Done at 

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ANNEX ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS 

Pharmaceutical Good Manufacturing Practice (GMP) 

SECTION I 

COMMUNITY AND NATIONAL LAW 

Community law: 

legislation  and  provisions 

Community 
the  European 
Commission  has  notified  to  Israel  and  published  in  connection 
with this Annex. 

that 

Israeli National law: 

Israeli  legislation  that  Israel  has  notified  to  the  European 
Commission and published in connection with this Annex. 

SECTION II 

SCOPE AND COVERAGE  

1. Scope 

Except  as  provided  for  in  clause  2,  Exclusions,  the  provisions  of  this  Annex  cover  medicinal 
products,  active  pharmaceutical  ingredients,  pharmaceutical  excipients  or  mixtures  thereof,  for 
human  or  veterinary  use,  to  which  Good  Manufacturing  Practice  (GMP)  requirements  apply  and 
that  are  governed  by  the  requirements  of  relevant  legislation  notified  by  each  party  to  the  other 
under Section I of this Annex directly distributed by the manufacturer or importer of one Party to 
the importer of the other party.  

This  includes  chemical  and  biological  pharmaceuticals,  immunologicals,  radio-pharmaceuticals, 
and herbal medicinal products. 

The provisions of this Annex shall apply to products covered by it irrespective of their origin. 

2. Exclusions 

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Medicinal  products  derived  from  human  blood  or  human  plasma,  advanced  therapy  medicinal 
products,  investigational  medicinal  products,  homoeopathic  medicinal  products,  medicinal  gases 
and veterinary immunologicals are excluded from the coverage of this Annex. 

The possibility of extending the coverage of this Annex to medicinal products derived from human 
blood or human plasma, investigational medicinal products and veterinary immunologicals shall be 
discussed by the Parties two years from the entry into force of this Annex.  

3. Maintenance, publication and extension of coverage and exclusion  

Upon entry into force of this Annex, the Parties shall establish by exchange of letters a list of types 
of products and activities that it covers, and may also specify products to be excluded.  

In addition, for the implementation of Article 5.4 of this Agreement in relation to this Annex, the 
Parties  agree  to  inform  each  other  about  agreements  similar  in  effect  to  this  Agreement,  and  any 
unilateral  concessions  to  a  third  country  or  party  having  a  similar  effect  to  an  agreement  of  this 
type, the scope of products and procedures covered therein, and their intention as to whether or not 
to  accept  products  onto  their  markets  while  derogating  from  certain  obligations  (notably  those  in 
Section IV.2) in relation to such agreements and unilateral concessions. 

The  Parties  may,  through  the  contact  points  specified  in  clause  11  of  Section  IV,  following  an 
assessment of legal and implementing provisions and practices in compliance with Community law 
specified  in  Section  I,  add  or  exclude  further  types  of  products  and  activities.  Following  such 
procedure the list may be amended as appropriate by exchange of letters between the Parties. 

The Parties will make publicly available: (1) the list of types of products and activities covered by 
this Annex, (2) a list of any agreements similar in effect to this Agreement for which the derogation 
in  Section  IV  clause  2(e)  has  been  applied  by  the  other  Party  and  (3)  a  list  of  any  unilateral 
concessions to a third country or party having a similar effect to an agreement of this type for which 
the derogation in Section IV clause 2(e) has been applied by the other Party. 

SECTION III 

RESPONSIBLE AUTHORITIES  

European Union 

Bodies  which  have  been  designated  by  the  Member  States  of  the  European  Union  in  accordance 
with Community law of Section I, notified to Israel in accordance with Article 9 of this Agreement 
and which have been made public by the European Commission. 

Israel 

Bodies which have been designated by Israel in accordance with Israeli National law of Section I, 
notified to the European Union in accordance with Article 9 of this Agreement and which have been 
made public by Israel. 

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SECTION IV 

SPECIFIC ARRANGEMENTS 

1. Definitions 

For the purpose of this Annex the following definitions apply: 

Official Medicines Control Laboratory (OMCL): Laboratory designated by a Member State of the 
European Union or Israel as referred to and regulated by pharmaceutical legislation and guidelines 
of the Community, the Council of Europe and Israel to perform laboratory testing for a competent 
authority,  independently  from  the  manufacturer,  for  medicinal  products  prior  to  and/or  after 
marketing  for  the  general  surveillance  of  medicines  in  relation  to  the  safety  of  human  patients 
and/or animals. 

Official  Control  Authority  Batch  Release  (OCABR):  Requirement  by  a  Party,  as  referred  to  and 
regulated  by  pharmaceutical  legislation  and  guidelines  of  the  Community  and  the  Council  of 
Europe  and  Israel,  that  an  Official  Medicines  Control  Laboratory  determines  the  conformity  of  a 
batch  with  the  approved  specifications  as  laid  down  in  the  marketing  authorisation  before  the 
competent  authority  of  the  Party  will  allow  that  batch  to  be  marketed.  The  examination  includes 
testing on a schedule as defined in the guidelines referred to above. 

Re-control:  Testing  of  medicinal  products  imported  from  a  third  country  or  the  other  Party 
including a full qualitative analysis, a quantitative analysis of at least all the active substances and 
all the other tests or checks necessary to ensure the quality of medicinal products in accordance with 
the requirements of the marketing authorisation.  

2. Obligations of the Parties 

(a) 

(b) 

(c) 

For  products  covered  by  this  Annex,  each  Party  shall  recognise  the  conclusions  of 
inspections  of  compliance  of  manufacturers  and  importers  with  the  principles  and 
guidelines of EU GMP and equivalent Israeli GMP carried out by the relevant inspection 
services  of  the  other  Party  on  its  own  territory  or  in  a  third  country  in  compliance  with 
provisions on inspections  as  documented through the granting or refusal to grant a GMP 
certificate. The relevant provisions are listed in Section I. 

For  medicinal  products  covered  by  this  Annex,  each  Party  shall  recognise  the  relevant 
manufacturing  and  import  authorisations  confirming  compliance  with  legislation  on 
manufacture  and  importation  and  with  the  principles  and  guidelines  on  EU  GMP  and 
equivalent Israeli GMP. 

Certification  of  the  conformity  of  each  batch  to  its  specifications  by  either  the 
manufacturer established in one of the Parties, or the importer, shall be recognised by the 
other  Party  without  re-control  at  import  from  one  Party  to  the  other.  However,  the 
additional  responsibilities  of  the  qualified  person  or  the  responsible  pharmacist  of  the 
importer in each Party, with respect to the certification of each batch as set out in Section I 
above,  remain  in  accordance  with  the  provisions  of  the  Community  and  Israeli  National 
laws set out in Section I. 

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(d) 

(e) 

(f) 

(g) 

The  provisions  in  paragraph  (a),  (b)  and  (c)  shall  apply  to  finished  or  intermediate 
medicinal  product  imported  from  a  third  country  and  further  exported  to  the  other  Party, 
only (1) if each batch of the medicinal product has been subject to re-control by either the 
importer from a third country or a manufacturer located in one of the Parties and (2) if the 
manufacturer  in  the  third  country  has  been  subject  to  an  inspection  by  the  competent 
authority  of  either  Party  of  which  the  outcome  has  been  that  for  the  product  or  product 
category the manufacturer complies with Good Manufacturing Practice. 

However, the provisions in paragraphs (a), (b) and (c) do not apply to products imported 
from  a  third  country,  that  have  exclusively  been  tested  in  and  inspected  by  a  competent 
authority of that or another third country. Any derogation from this provision on the basis 
of  an  agreement  by  one  Party  similar  in  effect  to  this  Agreement,  or  any  unilateral 
concessions by one Party to a third country or party having a similar effect to an agreement 
of this type shall be subject to the consent of the other Party.  

When  one  party  requires  a  competent  authority  or  an  Official  Medicines  Control 
Laboratory to carry out an Official Control Authority Batch Release, such checks carried 
out  by  an  authority  of  a  Party  will  be  recognised  as  valid  by  the  other  Party  through 
certificates  documenting  compliance  with  specifications  laid  down  in  the  marketing 
authorisation.  

Each  Party  will  ensure  that  each  product  batch  exported  to  the  other  Party  will  be 
accompanied by a batch certificate. Batch certificates for medicinal products will be duly 
signed by the qualified person or responsible pharmacist of the manufacturer or importer of 
the appropriate Party. 

3. Exchange of manufacturing/import authorisations and GMP compliance information 

The Parties shall exchange information on the authorisation status of manufacturers and importers 
and  on  the  outcome  of  inspections,  in  particular  by  entering  authorisations,  GMP  certificates  and 
information  on  GMP  non-compliance  into  the  database  on  GMP  managed  by  the  European 
Medicines Agency (EMEA). 

4. Exchange of inspection reports 

Upon reasoned request by a Party, the relevant inspection services of the other Party shall forward a 
copy  of  the  last  inspection  report  of  the  manufacturing  or  importing  site  or,  in  case  analytical 
operations  are  contracted  out,  also  of  the  contract  site.  This  shall  in  particular  apply  when  the 
inspection included an assessment of compliance of manufacture and control tests for a medicinal 
product in accordance with the particulars and documents submitted for a marketing authorisation 
or  when  the  inspection  was  performed  in  response  to  a  quality  defect.  Each  Party  shall  deal  with 
these inspection reports with the degree of confidentiality requested by the providing Party. Parties 
will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being 
extended to 60 days should a new inspection or re-control be carried out. 

5. Exchange of results of laboratory testing performed by OMCLs 

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Upon reasoned request by a Party, the relevant authorities of the other Party shall forward a copy of 
the  results  of  laboratory  testing  performed  as  part  of  market  surveillance  activities.  This  shall  in 
particular  apply  when  such  testing  is  performed  in  relation  to  a  quality  defect  or  when  there  is  a 
suspicion that the product could be falsely represented as an authorised product with respect to its 
identity, history or source. 

6. Exchange of results of Official Control Authority Batch Release (OCABR) 

When an OCABR procedure is applied, the results of such procedures carried out by a competent 
authority of the exporting Party shall be accepted as valid by the other party under the conditions 
defined  in  Community  legislation  and  implementing  provisions.  The  competent  authority  of  the 
exporting Party shall on request make the certificate or the results of non-compliance available to 
the importing Party. 

7. Format of Information exchange 

Authorisations, inspection reports, GMP certificates and information on GMP non-compliance shall 
follow the format in accordance with the procedures published by the Community. 

Certificates on OCABR as well as notices of non-compliance shall follow the format in accordance 
with the procedures on OCABR published by the Council of Europe. 

Batch certificates for medicinal products that accompany each batch shall document at least the date 
of manufacture, the date of expiry, results of the qualitative and quantitative analysis and the name 
and  address  of  the  laboratory  where  such  analysis  was  performed,  the  name  and  address  of  the 
manufacturer(s) and, where applicable, the importer. They shall also include a reference to the GMP 
certificate issued for the manufacturer and, where applicable, the importer. Batch certificates shall 
follow the provisions in accordance with the procedures published by the Community. 

8. Safeguard clause 

Each Party shall have the right to ask for the full inspection report or the full testing report by an 
OMCL  and  conduct  its  own  inspection  and  its  own  OCABR.  Except  for  situations  mentioned  in 
clause  4,  recourse  to  this  provision  should  be  an  exception,  and  the  cause  identified  to  the  other 
Party in an objective and reasoned manner. Such requests shall be notified in advance to the other 
Party, which shall have the option of joining the activity.  

9. Alert System 

On  the  entry  into  force  of  the  present  Agreement,  Israel  shall  participate  in  and  contribute  to  the 
Community information and rapid alert system related to quality defects, counterfeiting and batch 
recalls. 

The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing or 
import authorisation, based on non-compliance with GMP, are communicated to each other with the 
appropriate degree of urgency as laid down in the procedures published by the Community. 

10. Information and Cooperation 

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The  Parties  to  the  Agreement  shall  regularly  exchange  information  on  the  implementation  and 
operation of this Annex. 

They shall keep each other informed on training sessions for inspectors and scientists from Official 
Medicines Control Laboratories. Such sessions, organised by one Party, shall where practicable be 
made accessible to the other Party. 

Representatives  of  Israel  are  encouraged  to  participate  regularly  in  the  discussions  on  GMP  and 
quality  related  topics  of  working  groups  coordinated  by  the  European  Medicines  Agency  and  the 
network  of  OMCLs  coordinated  by  the  European  Directorate  for  the  Quality  of  Medicines  and 
Healthcare (EDQM) under the auspices of the Council of Europe. In addition, Israel is encouraged 
to participate in coordinated inspection activities in third countries. 

As part of its implementation of relevant Community law, Israel shall participate in the operation of 
the Community database on GMP managed by the European Medicines Agency.  

For  the  purposes  of  demonstration  of  capability  and  compliance  of  GMP  inspection  systems  and 
OMCLs with European standards and requirements in the evolving regulatory systems, the parties 
shall  participate  in  the  Joint  Audit  Programme  of  the  Member  States  of  the  European  Union,  as 
published by the EMEA, and the Mutual Joint Audit Programme, as established by the EDQM and 
any future comparable audit programme.  

Additional  specific  information  shall  on  request  be  supplied  by  a  Party  in  relation  to  its  official 
inspection  service  and  Official  Medicines  Control  Laboratories.  Such  specific  information  may 
include  training,  observed  audits,  general  information  and  document  exchange,  transparency  of 
agency audits, exchanges of external assessments and review reports relating to official inspection 
services. 

Parties  agree  to  facilitate  information  exchange  and  interdisciplinary  cooperation  in  cases  when 
actors in the manufacturing and distribution chain are suspected of contravening the legislation.. 

With  respect  to  medicinal  products  covered  by  the  scope  of  this  Annex,  but  not  covered  under 
Section II.3, the Parties may cooperate in planning and performing inspections and in exchanging 
information on such inspections. 

The  Parties  will  agree  to  meet  upon  reasonable  request  of  either  party  to  discuss  issues  of 
preparation, implementation of and compliance with relevant Community and Israeli National law.  

Requests for co-operation under this clause should be made through the contact points referred to in 
clause 11. 

11. Contact points 

Each Party shall notify to the other Party its contact points for the purposes set out in this Annex. 

The  contact  points  shall  jointly  monitor  the  implementation  and  operation  of  this  Annex,  in 
particular  the  assessment  of  relevant  Community  and  Israeli  National  law  and  implementing 
provisions and practices, and shall agree on the list of types of products and activities specified in 
clause 3 of Section II.  

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