HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 1/2
EN
Official Journal of the European Union
4.1.2013
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 Conformity Assessment and Acceptance of Industrial Products (CAA)
THE EUROPEAN UNION,
hereinafter referred to as "EU"
and
THE STATE OF ISRAEL,
hereinafter referred to as "Israel",
hereinafter 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" ( 1 ),
RECOGNISING that the adoption and implementation of relevant EU law by Israel provides the opportunity to extend
certain benefits of the internal market and to ensure its effective operation in certain sectors,
CONSIDERING the shared commitment of the Parties 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 a Protocol to the Association Agreement on Conformity Assessment and Acceptance of Industrial
Products (hereafter referred to as "this Protocol") 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 Association Agreement provides for the use of best
endeavours to approximate the laws of the Parties,
CONSIDERING that, in the sectors covered by this Protocol, Israel's national law is substantially aligned with relevant EU
law,
NOTING the close relationship between the European Union and Iceland, Liechtenstein and Norway under 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 those countries equivalent to this Protocol,
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:
Article 1
industrial products, listed in the Annexes to this Protocol, which
form an integral part of this Protocol.
Purpose and means
1.
The purpose of this Protocol is to facilitate the elimination
2. The
purpose
set
out
in
paragraph
1
shall
be
met
through:
by the Parties of technical barriers to trade in respect of certain
(a) the adoption and implementation by Israel of national
technical regulations, standards and conformity assessment
( 1 ) OJ L 147 of 21.6.2000, p. 3 and "Kitvei Amana" (Israel Official
procedures which are equivalent to those of relevant EU
Publication Journal), 1034.
law;

---

EN
4.1.2013 Official
Journal
of
the
European
Union
L
1/3
(b) the implementation by Israel of a regulatory and technical
The terms used in this Protocol shall have the meaning given in
infrastructure which is equivalent to that in place in the
relevant EU law and Israel's national law.
Member States of the EU;
Article 3
(c) the mutual acceptance on their markets by both Parties of
industrial products which fulfil the requirements for being
Alignment of legislation
lawfully placed on the market in one of the Parties,
including where appropriate the mutual recognition of the
For the purpose of this Protocol, Israel agrees to take appro
results of obligatory conformity assessment of industrial
priate measures, in consultation with the European
products subject to relevant EU law and to the equivalent
Commission, to align with and maintain relevant EU law as it
Israeli national law;
applies to the placing on the market of products covered by this
Protocol.
(d) the acceptance on their markets by both Parties of industrial
products which fulfil the requirements for being lawfully
In sectors covered by this Protocol where relevant EU law is
placed on the market in Israel and any one of the
based upon the use of technical standards giving presumption
Member States of the EU, on conditions analogous to
of conformity with essential safety requirements (known as
those applying to trade in goods between the Member
"New Approach" sectors) Israel agrees to take appropriate
States of the EU.
measures, in consultation with the European Commission, to
align with and maintain relevant EU practice in the fields of
standardisation, metrology, accreditation, conformity
Article 2
assessment, market surveillance, general safety of products,
and producers’ liability. "New Approach" sectors are indicated
Definitions
as such in the Sectoral Annexes.
For the purpose of this Protocol,
Article 4
(a) "Industrial products" means products, as defined by the
Technical infrastructure
scope of the Annexes to this Protocol;
For the purpose of this Protocol, Israel agrees to take appro
priate measures, in consultation with the European
Commission, to establish and maintain appropriate Responsible
(b) "Relevant EU law" means any legal act and implementing
Authorities in accordance with Article 9.
practice of the European Union applicable to a particular
situation, risk or category of industrial products, referenced
in the Annexes to this Protocol;
In sectors covered by this Protocol where relevant EU law is
based upon the use of technical standards giving presumption
of conformity with essential safety requirements (known as
(c) "National law" means any legal act and implementing
"New Approach" sectors) Israel agrees to establish and
practice by which Israel has aligned its legislation with
maintain bodies that are capable of sustaining the functions
relevant EU law applicable to a particular situation, risk or
of standardisation, metrology, accreditation, market surveillance,
category of industrial products;
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
(d) "Responsible Authority" means a body under the juris
the EU.
diction of one of the Member States of the EU or of
Israel which is responsible for the effective implementation
of EU and national law in a specified industrial sector, and
which where appropriate has the responsibility for notifying
Article 5
Notified Bodies;
Mutual acceptance of industrial products including their
conformity assessment
(e) "Notified Body" means a body notified, by a Responsible
1. The
Parties
agree
that,
for
the
purpose
of
mutual
Authority under the respective jurisdiction of one of the
acceptance, industrial products listed in the Annexes on
Parties to this Protocol, to the other Party, as competent
Acceptance of Regulated Products, fulfilling the requirements
to assess conformity in relation to requirements of EU or
for being lawfully placed on the market of a Party, may be
national law;
placed on the market of the other party, if, in particular, they
fulfil:
(f) "Committee" means the Association Committee set up
under Article 70 of the Association Agreement or a body
(a) the requirements of applicable legislative provisions related
set up by the Association Council under Article 73 of the
to the location in either of the Parties of the persons
Association Agreement and designated to cover trade issues.
responsible for placing of products on the market; and

---

L 1/4
EN
Official Journal of the European Union
4.1.2013
(b) where appropriate, applicable provisions related to the
effective implementation of EU and national law shall
location of the bodies that are responsible for assessing
continuously apply it. Further, they shall ensure that
compliance.
these Responsible Authorities are able to ensure the
conformity of industrial products with EU or national
law or to require their withdrawal from the market
2 The
Parties
agree
that,
for
the
purpose
of
mutual
and, where appropriate, to notify, suspend, remove
acceptance, industrial products listed in the Annexes on
suspension and withdraw the notification of Notified
Acceptance of Products Not Commonly Regulated, and for
Bodies.
which no European technical regulations exist, may be traded
between Israel and the EU 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
(b) The Parties shall notify each other of the names and
this Protocol.
addresses of their Responsible Authorities, and shall
maintain a list of such bodies.
3. Where products are subject to obligatory conformity
assessment procedures to be carried out in accordance with
2. (a)
The
Parties
shall
ensure
that
Notified
Bodies,
notified
the EU and national laws listed in the Annexes, the Parties
under their respective jurisdiction to assess conformity
further agree to recognise the results of such procedures
in relation to requirements of EU or national law
without requiring them to be repeated, nor with the imposition
specified in the Annexes, continuously comply with
of any additional requirements for the purposes of accepting
the requirements of such EU or national law.
such conformity assessment.
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
4 Notwithstanding
paragraphs
1,
2
and
3,
neither
Party
shall
are notified.
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 Protocol
(b) The Parties shall notify each other of the names and
between either Party and a third country or party, or by virtue
addresses of their Notified Bodies, and shall maintain a
of a unilateral concession by either Party to a third country or
list of such bodies.
party.
Article 6
Article 9
Safeguard clause
Procedures for the recognition of responsible authorities
and the notification of notified bodies
Where a Party finds that an industrial product placed on the
market on its territory by virtue of this Protocol, and used in
1. The
following
procedure
shall
apply
for
the
recognition
of
accordance with its intended use, may compromise the safety or
Responsible Authorities which are responsible for the effective
health of users or other persons, or any other legitimate
implementation of EU and national law, to ensure the
concern protected by legislation identified in the Annexes, it
conformity of industrial products with EU or national law or
may take appropriate measures to withdraw such a product
to require their withdrawal from the market and, where appro
from the market, to prohibit its placing on the market,
priate, are able to notify, suspend, remove suspension and
putting into service or use, or to restrict its free movement.
withdraw the notification of Notified Bodies:
The Annexes shall provide for the procedure to be applied in
(a) a Party shall forward its nomination to the other Party in
such cases.
writing, stating the territory and title of the Annex to this
Protocol under which the Responsible Authority is
competent to carry out the tasks listed in Article 8(1),
Article 7
including as appropriate any limitations to such competence
Extension of coverage
within the territory or the scope of that Annex;
If Israel adopts and implements further national law aligning
with relevant EU law, the Parties may amend the Annexes or
conclude new ones, in accordance with the procedure laid down
(b) on the acknowledgement of the other Party, given in
in Article 13.
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
Article 8
from that date.
Obligations of parties as regards their responsible
authorities and notified bodies
2. The
following
procedure
shall
apply
for
the
notification
of
1. (a)
The
Parties
shall
ensure
that
Responsible
Authorities Notified Bodies to assess conformity in relation to the
under their jurisdiction which are responsible for the
requirements of EU or national law specified in the Annexes:

---

EN
4.1.2013 Official
Journal
of
the
European
Union
L
1/5
(a) a Party shall forward its notification to the other Party in
(a) notify each other of relevant proposed and actual legislative
writing, stating the title of the Annex to this Protocol under
amendments, and exchange information concerning the
which the Notified Body is competent to assess conformity,
implementation of law and practice, including in particular
and as appropriate any limitations to such competence
on procedures to ensure the compliance of Notified Bodies
within the scope of that Annex;
on their territory with the rules applicable to them;
(b) on the acknowledgement of the other Party, given in
(b) invite each other to take part in their relevant mechanisms
writing, the body shall be considered as notified and as
of information exchange, in regards to mechanisms dealing
competent to assess conformity in relation to the said
with sectors covered by the Annexes to this Protocol unless
requirements specified in the Annexes from that date.
specified otherwise in the Annexes. The EU will explore the
possibility of inviting Israel to participate in relevant
European networks and bodies;
3. 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
(c) encourage their Notified Bodies to cooperate with a view to
conformity in relation to the said requirements specified in
establishing mutual recognition arrangements in the
the Annexes from the date of its withdrawal at the latest. Never
voluntary sphere.
theless, conformity assessment carried out before that date shall
remain valid, unless otherwise decided by the Committee.
Article 12
Article 10
Confidentiality
Verification of notified bodies
Representatives, experts and other agents of the Parties shall be
1. Each Party may request the other Party to verify the
required, even after their duties have ceased, not to disclose
technical competence and compliance of a notified body, or a
information acquired under this Protocol which is of the kind
candidate notified body, under its jurisdiction. Such request shall
covered by the obligation of professional secrecy. This
be justified, in an objective and reasoned manner, in order to
information may not be used for purposes other than those
allow the Party responsible for the notification to carry out the
envisaged by this Protocol.
requested verification and report speedily to the other Party. The
Parties may also jointly examine the body, with the partici
pation of the relevant responsible authorities. To this end, the
Article 13
Parties shall ensure the full cooperation of bodies under their
jurisdiction. The Parties shall take all appropriate steps, and use
Management of this Protocol
whatever available means may be necessary, with a view to
1. Responsibility
for
the
effective
functioning
of
this
Protocol
resolving any problems which are detected.
shall be borne by the Committee. In particular, it shall have the
power to take decisions regarding:
2. If
the
problems
cannot
be
resolved
to
the
satisfaction
of
both Parties, they may notify the Committee of their
(a) amending and withdrawing Annexes;
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
(b) adding new Annexes;
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.
(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);
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 EU or
national law specified in the Annexes shall be suspended in part
(d) exchanging information on proposed and actual
or totally from the date on which the disagreement of the
amendments to the EU law and national law referred to
Parties has been notified to the Committee.
in the Annexes;
Article 11
(e) considering new or additional conformity assessment
procedures affecting a sector covered by an Annex;
Exchange of information and cooperation
In order to ensure a correct and uniform application and inter
pretation of this Protocol, and to encourage trade in industrial
(f) resolving any questions relating to the application of this
goods between them, the Parties, shall:
Protocol;

---

L 1/6
EN
Official Journal of the European Union
4.1.2013
(g) referring questions for decision to the disputes settlement
Article 16
mechanism set out in Article 75 of the Association
Agreement or any other relevant dispute settlement
Entry into force
mechanism set up by agreement between the Parties
This Protocol shall enter into force 30 days after the date of the
pursuant to the Association Agreement.
later written communication, through diplomatic channels, by
which the parties have notified each other that their respective
2. The
Committee
may
delegate
the
above
responsibilities
set internal legal requirements for the entry into force of this
out under this Protocol.
Protocol have been fulfilled.
3. Amendments
to
the
annexes
shall
enter
into
force
as
the
Article 17
Committee shall decide.
Duration
Article 14
This Protocol is concluded for an unlimited period. Each of the
Parties may denounce this Protocol by notifying the other Party.
Technical cooperation
This Protocol shall cease to apply twelve months after the date
of such notification.
The Parties shall cooperate where necessary in order to support
the effective implementation and application of this Protocol.
During the period between the denunciation of this Protocol by
Article 15
one Party and its ceasing to apply, the termination of this
Protocol shall not adversely effect or in any way prejudice
Agreements with other countries
any right or obligation accrued to or to be incurred by virtue
1. This
Protocol
may,
by
explicit
agreement
between
the of the application of this Protocol prior to the effective date of
Parties, including by a decision of the Committee, be
such termination.
extended to cover the acceptance of industrial products from
third countries or parties with which the EU has concluded an
Article 18
Agreement similar to this Protocol in corresponding sectors.
Languages
2. Where
the
EU
notifies
Israel
that
it
has
concluded
an
This Protocol is drawn up in two originals in the Bulgarian,
Agreement similar to this Protocol with a third country or
Czech, Danish, Dutch, English, Estonian, Finnish, French,
party, that covers the acceptance of industrial products in
German, Greek, Hungarian, Italian, Latvian, Lithuanian,
corresponding sectors, Israel shall consider concluding an
Maltese, Polish, Portuguese, Romanian, Slovak, Slovene,
Agreement with the third country or party that provides for
Spanish, Swedish and Hebrew languages, each text being
such an extension.
equally authentic.

---

EN
4.1.2013 Official
Journal
of
the
European
Union
L
1/7
Съставено в Брюксел на шести май две хиляди и десета година.
Hecho en Bruselas, el seis de mayo de dos mil diez.
V Bruselu dne estého května dva tisíce deset.
Udfrdiget i Bruxelles den sjette maj to tusind og ti.
Geschehen zu Brüssel am sechsten Mai zweitausendzehn.
Kahe tuhande kümnenda aasta maikuu kuuendal peval Brüsselis.
γινε στι Βρυξλλε, στι ξι Μαου δο χιλιδε δκα.
Done at Brussels on the sixth day of May in the year two thousand and ten.
Fait à Bruxelles, le six mai deux mille dix.
Fatto a Bruxelles, addì sei maggio duemiladieci.
Briselē, divi tūkstoi desmitā gada sestajā maijā.
Priimta du tūkstaniai deimt met gegus et dien Briuselyje.
Kelt Brüsszelben, a kétezer-tizedik év május havának hatodik napján.
Magmul fi Brussell, fis-sitt jum ta' Mejju tas-sena elfejn u gaxra.
Gedaan te Brussel, de zesde mei tweeduizend tien.
Sporzdzono w Brukseli dnia szóstego maja roku dwa tysice dziesitego.
Feito em Bruxelas, em seis de Maio de dois mil e dez.
ntocmit la Bruxelles, la ase mai dou mii zece.
V Bruseli iesteho mája dvetisícdesa.
V Bruslju, dne estega maja leta dva tiso deset.
Tehty Brysseliss kuudentena pivn toukokuuta vuonna kaksituhattakymmenen.
Som skedde i Bryssel den sjtte maj tjugohundratio.
2010

---

L 1/8
EN
Official Journal of the European Union
4.1.2013
За Европейския съюз
Por la Unión Europea
Za Evropskou unii
For Den Europiske Union
Für die Europische Union
Euroopa Liidu nimel
Για την Ευρωπακ νωση
For the European Union
Pour l'Union européenne
Per l'Unione europea
Eiropas Savienības vārdā –
Europos Sjungos vardu
Az Európai Unió részérl
Gall-Unjoni Ewropea
Voor de Europese Unie
W imieniu Unii Europejskiej
Pela Unio Europeia
Pentru Uniunea European
Za Európsku úniu
Za Evropsko unijo
Euroopan unionin puolesta
P Europeiska unionens vgnar
За Държавата Израел
Por el Estado de Israel
Za Stát Izrael
For Staten Israel
Für den Staat Israel
Iisraeli Riigi nimel
Για το Κρτο του Ισραλ
For the State of Israel
Pour l'tat d'Isral
Per lo Stato d'Israele
Izraēlas Valsts vārdā
Izraelio Valstybs vardu
Izrael llam részérl
Gall-Istat tal-Irael
Voor de Staat Isral
W imieniu Pastwa Izrael
Pelo Estado de Israel
Pentru Statul Israel
Za Izraelsk tát
Za Dravo Izrael
Israelin valtion puolesta
Fr Staten Israel

---

EN
4.1.2013 Official
Journal
of
the
European
Union
L
1/9
ANNEX
ON MUTUAL ACCEPTANCE OF INDUSTRIAL PRODUCTS
Pharmaceutical Good Manufacturing Practice (GMP)
SECTION I
EU and national law
EU law:
EU legislation and provisions that the European Commission has notified to Israel and published in
connection with this Annex.
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 phar
maceutical 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
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 Protocol in relation to this Annex, the Parties agree to inform
each other about Agreements similar in effect to this Protocol, 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 EU law set out 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 Protocol 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
EU
Bodies which have been designated by the Member States of the EU in accordance with EU law set out in Section I,
notified to Israel in accordance with Article 9 of this Protocol and which have been made public by the European
Commission.

---

L 1/10
EN
Official Journal of the European Union
4.1.2013
Israel
Bodies which have been designated by Israel in accordance with Israeli national law set out in Section I, notified to the EU
in accordance with Article 9 of this Protocol and which have been made public by Israel.
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 EU or Israel as referred to
and regulated by pharmaceutical legislation and guidelines of the EU, 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 EU, 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) 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.
(b) 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.
(c) 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 EU and Israeli national laws set out in Section I.
(d) The provisions in points (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.
(e) However, the provisions in points (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 Protocol, 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.
(f) 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.
(g) 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.

---

EN
4.1.2013 Official
Journal
of
the
European
Union L
1/11
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
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 EU 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 EU.
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 EU.
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 Protocol, 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 EU.
10. Information and Cooperation
The Parties to the Protocol 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.

---

L 1/12
EN
Official Journal of the European Union
4.1.2013
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 EU 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 EU, 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 manu
facturing 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 EU and Israeli national law.
Requests for cooperation 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 EU 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.

---

Document Outline

• �

---