title: 2013/1/EU: Council Decision of 20 November 2012 on the conclusion of 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, on Conformity Assessment and Acceptance of Industrial Products (CAA)

text:
               4.1.2013

               EN

               Official Journal of the European Union

               L 1/1

      COUNCIL DECISION

   of 20 November 2012
   on the conclusion of 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, on Conformity Assessment and Acceptance of Industrial Products (CAA)
   (2013/1/EU)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the functioning of the European Union, and in particular Article 207 in conjunction with Article 218(6)(a)(v) and Article 218(7) thereof,
   Having regard to the proposal from the European Commission,
   Having regard to the consent of the European Parliament,
   Whereas:

               (1)

               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 (1) (‘the Association Agreement’), entered into force on 20 November 1995.

               (2)

               Article 47 of the Association Agreement provides for the conclusion, where appropriate, of agreements on mutual recognition in the field of conformity assessment, and Article 55 of the Agreement provides for the use of best endeavours to approximate the laws of the Parties in order to facilitate the implementation of the Agreement.

               (3)

               The Protocol to the Association Agreement on Conformity Assessment and Acceptance of Industrial Products (CAA) (‘the Protocol’) was signed on behalf of the Union on 6 May 2010.

               (4)

               The Protocol should be approved.

               (5)

               The Commission is responsible for ensuring the Union’s external representation in connection with the Protocol, including information and notification functions, and forwarding replies to requests in accordance with the Annexes. The Protocol will be implemented on the basis of the relevant Union legislation on accreditation, market surveillance and the marketing of products.

               (6)

               It is necessary to empower the Commission to make technical amendments to the Protocol,

         HAS ADOPTED THIS DECISION:
   Article 1
   The 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) is hereby approved on behalf of the Union.
   The text of the Protocol is attached to this Decision.
   Article 2
   The President of the Council shall transmit, on behalf of the Union, the diplomatic note provided for in Article 16 of the Protocol.
   Article 3
   The Commission shall be authorised to approve amendments pursuant to Articles 7, 13 and 15 of the Protocol, after consultation with the special committee appointed by the Council in accordance with Article 218(4) of the Treaty.
   Article 4
   This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

      Done at Brussels, 20 November 2012.

            For the Council

            The President

         A. D. MAVROYIANNIS

      (1)  OJ L 147, 21.6.2000, p. 3.

         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
      Purpose and means
      1.   The purpose of this Protocol 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 Protocol, which form an integral part of this Protocol.
      2.   The purpose set out in paragraph 1 shall be met through:

                  (a)

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

                  (b)

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

                  (c)

                  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 EU law and to the equivalent Israeli national law;

                  (d)

                  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 EU, on conditions analogous to those applying to trade in goods between the Member States of the EU.

            Article 2
      Definitions
      For the purpose of this Protocol,

                  (a)

                  "Industrial products" means products, as defined by the scope of the Annexes to this Protocol;

                  (b)

                  "Relevant EU 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 Protocol;

                  (c)

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

                  (d)

                  "Responsible Authority" means a body under the jurisdiction 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 Notified Bodies;

                  (e)

                  "Notified Body" means a body notified, by a Responsible Authority under the respective jurisdiction of one of the Parties to this Protocol, to the other Party, as competent to assess conformity in relation to requirements of EU or national law;

                  (f)

                  "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 Protocol shall have the meaning given in relevant EU law and Israel's national law.
      Article 3
      Alignment of legislation
      For the purpose of this Protocol, Israel agrees to take appropriate measures, in consultation with the European Commission, to align with and maintain relevant EU law as it applies to the placing on the market of products covered by 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 "New Approach" sectors) Israel agrees to take appropriate measures, in consultation with the European Commission, to align with and maintain relevant EU 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 Protocol, 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 Protocol where relevant EU 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 EU.
      Article 5
      Mutual acceptance of industrial products including their conformity assessment
      1.   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.

            2   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 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 this Protocol.
      3.   Where products are subject to obligatory conformity assessment procedures to be carried out in accordance with the EU 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.
      4   Notwithstanding paragraphs 1, 2 and 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 Protocol 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 Protocol, 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.
      Article 7
      Extension of coverage
      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 in Article 13.
      Article 8
      Obligations of parties as regards their responsible authorities and notified bodies

                  1.

                              (a)

                              The Parties shall ensure that Responsible Authorities under their jurisdiction which are responsible for the effective implementation of EU 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 EU 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.

                  2.

                              (a)

                              The Parties shall ensure that Notified Bodies, notified under their respective jurisdiction to assess conformity in relation to requirements of EU or national law specified in the Annexes, continuously comply with the requirements of such EU 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 EU and national law, to ensure the conformity of industrial products with EU 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 Protocol 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 that Annex;

                  (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 EU 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 Protocol under which the Notified Body is competent to assess conformity, and as appropriate any limitations to such competence within the scope of that 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.

            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 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
      1.   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.
      2.   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.   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 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 Protocol, and to encourage trade in industrial goods between them, the Parties, shall:

                  (a)

                  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;

                  (b)

                  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 Protocol 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 Protocol 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 Protocol.
      Article 13
      Management of this Protocol
      1.   Responsibility for the effective functioning of this Protocol 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);

                  (d)

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

                  (e)

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

                  (f)

                  resolving any questions relating to the application of this Protocol;

                  (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.   The Committee may delegate the above responsibilities set out under this Protocol.
      3.   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 Protocol.
      Article 15
      Agreements with other countries
      1.   This Protocol 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 EU has concluded an Agreement similar to this Protocol in corresponding sectors.
      2.   Where the EU notifies Israel that it has concluded an Agreement similar to this Protocol with a third country or party, that covers the acceptance of industrial products in corresponding sectors, Israel shall consider concluding an Agreement with the third country or party that provides for such an extension.
      Article 16
      Entry into force
      This Protocol 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 Protocol have been fulfilled.
      Article 17
      Duration
      This Protocol is concluded for an unlimited period. Each of the Parties may denounce this Protocol by notifying the other Party. This Protocol shall cease to apply twelve months after the date of such notification.
      During the period between the denunciation of this Protocol by one Party and its ceasing to apply, the termination of this Protocol 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 Protocol prior to the effective date of such termination.
      Article 18
      Languages
      This Protocol is drawn up in two originals in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish, Swedish and Hebrew languages, each text being equally authentic.

         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 šestého května dva tisíce deset.
         Udfærdiget i Bruxelles den sjette maj to tusind og ti.
         Geschehen zu Brüssel am sechsten Mai zweitausendzehn.
         Kahe tuhande kümnenda aasta maikuu kuuendal päeval Brüsselis.
         Έγινε στις Βρυξέλλες, στις έξι Μαΐου δύο χιλιάδες δέκα.
         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 tūkstoši desmitā gada sestajā maijā.
         Priimta du tūkstančiai dešimtų metų gegužės šeštą dieną Briuselyje.
         Kelt Brüsszelben, a kétezer-tizedik év május havának hatodik napján.
         Magħmul fi Brussell, fis-sitt jum ta' Mejju tas-sena elfejn u għaxra.
         Gedaan te Brussel, de zesde mei tweeduizend tien.
         Sporządzono w Brukseli dnia szóstego maja roku dwa tysiące dziesiątego.
         Feito em Bruxelas, em seis de Maio de dois mil e dez.
         Întocmit la Bruxelles, la șase mai două mii zece.
         V Bruseli šiesteho mája dvetisícdesať.
         V Bruslju, dne šestega maja leta dva tisoč deset.
         Tehty Brysselissä kuudentena päivänä toukokuuta vuonna kaksituhattakymmenen.
         Som skedde i Bryssel den sjätte maj tjugohundratio.
         2010

            За Европейския съюз
            Por la Unión Europea
            Za Evropskou unii
            For Den Europæiske Union
            Für die Europäische Union
            Euroopa Liidu nimel
            Για την Ευρωπαϊκή Ένωση
            For the European Union
            Pour l'Union européenne
            Per l'Unione europea
            Eiropas Savienības vārdā –
            Europos Sąjungos vardu
            Az Európai Unió részéről
            Għall-Unjoni Ewropea
            Voor de Europese Unie
            W imieniu Unii Europejskiej
            Pela União Europeia
            Pentru Uniunea Europeană
            Za Európsku úniu
            Za Evropsko unijo
            Euroopan unionin puolesta
            På Europeiska unionens vägnar

            За Държавата Израел
            Por el Estado de Israel
            Za Stát Izrael
            For Staten Israel
            Für den Staat Israel
            Iisraeli Riigi nimel
            Για το Κράτος του Ισραήλ
            For the State of Israel
            Pour l'État d'Israël
            Per lo Stato d'Israele
            Izraēlas Valsts vārdā
            Izraelio Valstybės vardu
            Izrael Állam részéről
            Għall-Istat tal-Iżrael
            Voor de Staat Israël
            W imieniu Państwa Izrael
            Pelo Estado de Israel
            Pentru Statul Israel
            Za Izraelský štát
            Za Državo Izrael
            Israelin valtion puolesta
            För Staten Israel

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

         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 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
         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.
         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.

               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.
         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 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 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.


Important legal notice

|

32006D0997

2006/997/EC: Council Decision of 23 October 2006 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and Uruguay

Official Journal L 406 , 23/10/2006 P. 0010 - 0010 Official Journal L 406 , 30/12/2006 P. 0010 - 0010

		Council Decisionof 23 October 2006on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and Uruguay(2006/997/EC)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 133 in conjunction with the first sentence of the first subparagraph of Article 300(2) thereof,Having regard to the proposal from the Commission,Whereas:(1) On 22 March 2004 the Council authorised the Commission to open negotiations with certain other Members of the WTO under Article XXIV.6 of the General Agreement on Tariffs and Trade (GATT) 1994, in the course of the accessions to the European Union of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic.(2) Negotiations have been conducted by the Commission in consultation with the Committee established by Article 133 of the Treaty and within the framework of the negotiating directives issued by the Council.(3) The Commission has finalised negotiations for an Agreement in the form of an Exchange of Letters between the European Community and Uruguay. The Agreement should be approved,HAS DECIDED AS FOLLOWS:Article 1The Agreement in the form of an Exchange of Letters between the European Community and Uruguay relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of the accession to the European Community is hereby approved on behalf of the Community.The text of the Agreement in the form of an Exchange of Letters is attached to this Decision.Article 2The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement in the form of an Exchange of Letters in order to bind the Community.Done at Luxembourg, 23 October 2006.For the CouncilThe PresidentJ.-E Enestam--------------------------------------------------


title: 2008/37/EC: Commission Decision of 14 December 2007 setting up the European Research Council Executive Agency for the management of the specific Community programme Ideas in the field of frontier research in application of Council Regulation (EC) No 58/2003 (Text with EEA relevance)

text:
               12.1.2008

               EN

               Official Journal of the European Union

               L 9/15

      COMMISSION DECISION

   of 14 December 2007
   setting up the ‘European Research Council Executive Agency’ for the management of the specific Community programme ‘Ideas’ in the field of frontier research in application of Council Regulation (EC) No 58/2003
   (Text with EEA relevance)
   (2008/37/EC)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Regulation (EC) No 58/2003 of 19 December 2002 laying down the statute for executive agencies to be entrusted with certain tasks in the management of Community programmes (1), and in particular Article 3(1) thereof,
   Whereas:

               (1)

               Regulation (EC) No 58/2003 empowers the Commission to set up executive agencies in accordance with the general statute laid down by that Regulation and to entrust them with certain management tasks relating to one or more Community programmes.

               (2)

               The purpose of empowering the Commission to set up executive agencies is to allow it to focus on core activities and functions which cannot be outsourced, without relinquishing control over, or ultimate responsibility for, activities managed by the said executive agencies.

               (3)

               Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (2) provides for the establishment of the European Research Council as a means of implementing the ‘Ideas’ (3) Specific Programme. The European Research Council shall consist of an independent Scientific Council supported by a dedicated implementation structure.

               (4)

               By Decision 2007/134/EC of 2 February 2007 establishing the European Research Council (4) the Commission, in addition to setting up the European Research Council (ERC) and the Scientific Council, announced the setting-up of the dedicated implementation structure as an executive agency, to be established by a separate act in compliance with Regulation (EC) No 58/2003.

               (5)

               Management of the ‘Ideas’ Specific Programme involves implementation of research projects which does not entail political decision-making and requires a high level of scientific and financial expertise throughout the project cycle.

               (6)

               The delegation, to an executive agency, of tasks related to programme execution is possible with a clear separation between the programming stage, this being established by the Scientific Council and adopted by the Commission, and implementation, which would be entrusted to the executive agency, according to the principles and methodology established by the Scientific Council.

               (7)

               A cost-benefit analysis carried out for that purpose showed that using an executive agency to manage the activities of the European Research Council would be advantageous both in financial and non-financial terms.

               (8)

               The Agency should implement its operating budget in accordance with Commission Regulation (EC) No 1653/2004 of 21 September 2004 which establishes a standard financial regulation for the executive agencies pursuant to Council Regulation (EC) No 58/2003 laying down the statute for executive agencies to be entrusted with certain tasks in the management of Community programmes (5).

               (9)

               The measures provided for by this Decision are in accordance with the opinion of the Committee for Executive Agencies,

         HAS DECIDED AS FOLLOWS:
   Article 1
   Establishment of the Agency
   1.   An executive agency (hereinafter referred to as the Agency) is hereby established for the management of Community activity in the field of research, its statute being governed by Council Regulation (EC) No 58/2003.
   2.   The name of the Agency shall be ‘The European Research Council Executive Agency’.
   Article 2
   Location
   The Agency shall be located in Brussels.
   Article 3
   Term
   The Agency is hereby established for a period beginning on 1 January 2008 and ending on 31 December 2017.
   Article 4
   Objectives and tasks
   1.   The Agency is hereby entrusted, within the framework of the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) established by Decision No 1982/2006/EC, with the following tasks:

               —

               management of phases in the lifetime of specific projects — as set out in the decision delegating powers to this Agency — in the context of implementing the Ideas Specific Programme, on the basis of Council Decision No 2006/972/EC (6) and the work programme established by the Scientific Council and adopted by the Commission, as well as the necessary checks to that end, adopting the relevant decisions where the Commission has empowered it to do so,

               —

               adoption of the instruments of budget execution for revenue and expenditure and carrying out, where the Commission has empowered it to do so, all the operations necessary for the management of the ‘Ideas’ Specific Programme and, in particular, those linked to the award of grants and contracts,

               —

               gathering, analysing and passing on to the Commission and the Scientific Council all the information needed to guide the implementation of the Community programme.

         2.   The Commission decision delegating authority to the Agency shall set out in detail all the tasks entrusted to it and shall be amended should any additional tasks be entrusted to the Agency. It shall be forwarded, for information purposes, to the Committee for Executive Agencies.
   Article 5
   Organisational structure
   1.   The Agency shall be managed by a Steering Committee and a Director appointed by the Commission.
   2.   The members of the Steering Committee shall be appointed for two years.
   3.   The Director of the Agency shall be appointed for four years.
   4.   The appointments of members of the Steering Committee and the Director may be renewed.
   Article 6
   Grants
   The Agency shall receive grants entered in the general budget of the European Communities taken from the funds allocated to the ‘Ideas’ Specific Programme.
   Article 7
   Supervision and reporting
   The Agency shall be subject to supervision by the Commission and shall report regularly on progress in implementing the programme for which it is responsible in accordance with the arrangements and at the intervals stipulated in the instrument of delegation.
   Article 8
   Implementation of the operating budget
   The Agency shall implement its operating budget in accordance with the provisions of Regulation (EC) No 1653/2004.

      Done at Brussels, 14 December 2007.

            For the Commission

         Janez POTOČNIK

            Member of the Commission

      (1)  OJ L 11, 16.1.2003, p. 1.

      (2)  OJ L 412, 30.12.2006, p. 1.

      (3)  OJ L 54, 22.2.2007, p. 81.

      (4)  OJ L 57, 24.2.2007, p. 14.

      (5)  OJ L 297, 22.9.2004, p. 6. Regulation as amended by Regulation (EC) No 1821/2005 (OJ L 293, 9.11.2005, p. 10).

      (6)  OJ L 400, 30.12.2006, p. 243.


title: 75/80/EEC: Council Decision of 2 December 1974 on the conclusion of the Agreement between the European Economic Community and the United Nations Children's Fund (UNICEF) on the supply of skimmed-milk powder as food aid

text:
No L 32/ 10                        Official Journal of the European Communities                    5 . 2. 75
                                                 COUNCIL DECISION
                                                   of 2 December 1974
              on the conclusion of the Agreement between the European Economic Community
              and the United Nations Children's Fund (UNICEF) on the supply of skimmed-milk
                                                    powder as food aid
                                                       (75 /80/EEC)
              THE COUNCIL OF THE EUROPEAN COMMUNITIES,
              Having regard to the Treaty establishing the European Economic Community, and
              in particular Articles 113 , 114 and 228 thereof;
              Having regard to the proposal of the Commission ;
            ' Whereas the United Nations Children's Fund (UNICEF) has made known its require
              ments in skimmed-milk powder;
              Whereas, by Regulation (EEC) No 1827/74 (*), the Council has placed 2 250 metric
              tons of this product at the disposal of UNICEF;
              Whereas concerning emergency actions to be decided upon in implementation of the
              Agreement referred to in Article 2, the Community's approval should be given to
               UNICEF as quickly as possible, and whereas it may prove necessary to reply very
              rapidly to any requests for modifications which might be made by UNICEF during
              the implementation of the said Agreement,
              HAS DECIDED AS FOLLOWS :
                                                         Article 1
              The Agreement between the European Economic Community and the United Nations
              Children's Fund ( UNICEF) on the supply of skimmed-milk powder as food aid is
              hereby concluded on behalf of the European Economic Community.
              The text of the Agreement is annexed to this Decision.
                                                         Article 2
              The approval of the Community provided for in Articles II, III and VIII of the
              Agreement will be given by the Commission.
                                                         Article 3
              The President of the Council is hereby authorized to designate the persons entitled
              to sign the Agreement and confer on them the powers necessary to bind the Community.
              Done at Brussels, 2 December 1974.
                                                                         For the Council
                                                                          The President
                                                                       I SAUVAGNARGUES
              (») OJ No L 190, 13. 7. 1974, p. 22.


Avis juridique important

|

32003D0508

2003/508/EC: Commission Decision of 7 July 2003 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decisions 2000/657/EC and 2001/852/EC (Text with EEA relevance)

Official Journal L 174 , 12/07/2003 P. 0010 - 0039

Commission Decisionof 7 July 2003adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decisions 2000/657/EC and 2001/852/EC(Text with EEA relevance)(2003/508/EC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals(1), and in particular Article 12(1) thereof,Whereas:(1) Under Regulation (EC) No 304/2003, the Commission is to decide on behalf of the Community whether or not to permit the import into the Community of each chemical subject to the prior informed consent (PIC) procedure.(2) The United Nations Environment Programme (UNEP) and the Food and Agriculture Organization (FAO) have been appointed to provide secretariat services for the operation of the interim PIC procedure established by the Final Act of the Conference of Plenipotentiaries on the Rotterdam Convention on the Prior Informed Consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade, in particular the Resolution on interim arrangements laid down therein; the Convention was signed on 11 September 1998 and approved by the Community by Council Decision 2003/106/EC(2).(3) The Commission, acting as common designated authority, is required to forward decisions on chemicals to the Secretariat of the interim PIC procedure, hereinafter "the interim Secretariat", on behalf of the Community and its Member States.(4) The interim Secretariat has requested that participants in the PIC procedure use the special Importing Country Response form when reporting their import decisions.(5) The chemical monocrotophos has been added to the list of chemicals subject to the interim PIC procedure, as a pesticide, for which the Commission has received information from the interim Secretariat in the form of a Decision Guidance Document. Monocrotophos is already subject to the interim PIC procedure to the extent that certain severely hazardous pesticide formulations containing monocrotophos are listed in Annex III to the Rotterdam Convention. Pending a Community evaluation of monocrotophos within the framework of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 806/2003(4), an interim response concerning those pesticide formulations was given in Commission Decision 2000/657/EC of 16 October 2000 adopting Community import decisions for certain chemicals pursuant to Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals(5), as amended by Decision 2001/852/EC(6). Pursuant to Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisation for plant protection products containing these substances(7), monocrotophos was excluded from Annex I to Directive 91/414/EEC and authorisations for plant protection products containing it were to be withdrawn by 25 July 2003. The interim response set out in Decision 2000/657/EC should therefore be replaced by a final import decision.(6) The chemicals 2,4,5-T, chlorobenzilate and phosphamidon fall within the scope of Directive 91/414/EEC, which provides for a transitional period during which Member States may, pending a Community decision, take a decision on substances and products falling within the scope of that Directive. By Regulation (EC) No 2076/2002, those substances were excluded from Annex I to Directive 91/414/EEC and authorisations for plant protection products containing the substances were to be withdrawn by 25 July 2003. The import decisions for the pesticide formulations 2,4,5-T, chlorobenzilate and phosphamidon set out in Decision 2000/657/EC, which were submitted as interim responses pending a Community decision, should therefore be replaced by final decisions.(7) The chemicals parathion and methyl parathion also fall within the scope of Directive 91/414/EEC. By Commission Decision 2001/520/EC of 9 July 2001 concerning the non-inclusion of parathion in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance(8) and Commission Decision 2003/166/EC of 10 March 2003 concerning the non-inclusion of methyl parathion in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance(9), those substances have now been excluded from Annex I to Directive 91/414/EEC and authorisations for plant protection products containing them have been withdrawn. Consequently, the import decisions for the pesticide formulations parathion and methyl parathion, as set out in Commission Decision 2001/852/EC of 19 November 2001 on adopting Community import decisions pursuant to Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals and amending Decision 2000/657/EC and Decision 2000/657/EC, respectively, which were submitted as interim responses pending a Community decision, should be replaced by final decisions.(8) The chemical ethylene oxide is covered by Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances(10), as last amended by Regulation (EC) No 807/2003(11). This was reflected in a final decision on import contained in Decision 2001/852/EC. However, ethylene oxide has recently been notified under the Community programme for the evaluation of existing substances under Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(12), which provides for a transitional period during which Member States may, pending a Community decision, take a decision on substances and products falling within its scope. The import decision set out in Decision 2001/852/EC should therefore be replaced.(9) The chemicals polybrominated biphenyls (PBBs) were made subject to severe restrictions at Community level by Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(13), as last amended by Directive 2003/11/EC of the European Parliament and of the Council(14). This was reflected in a Community import decision that was published in PIC Circular V reporting the situation as at 30 June 1995. However, that Decision did not take into account a complete ban on PBBs in Austria dating from 1993. It is therefore necessary to replace that import Decision.(10) The measures provided for in this Decision are in accordance with the opinion of the Committee set up pursuant to Article 29 of Council Directive 67/548/EEC(15), as last amended by Regulation (EC) No 807/2003,HAS DECIDED AS FOLLOWS:Article 1The interim responses on the import of the chemicals 2,4,5-T, chlorobenzilate, methyl parathion, monocrotophos and phosphamidon, as set out in the Annex to Decision 2000/657/EEC, are replaced by the import response forms set out in Annex I to this Decision.Article 2The final decision on the import of ethylene oxide and the interim response on the import of parathion, as set out in the Annex to Decision 2001/852/EC, are replaced by the import response forms set out in Annex II to this Decision.Article 3The final decision on the import of polybrominated biphenyls (PBBs), published in PIC Circular V, is replaced by the import response form set out in Annex III to this Decision.Done at Brussels, 7 July 2003.For the CommissionMargot WallströmMember of the Commission(1) OJ L 63, 6.3.2003, p. 1.(2) OJ L 63, 6.3.2003, p. 27.(3) OJ L 230, 19.8.1991, p. 1.(4) OJ L 122, 16.5.2003, p. 1.(5) OJ L 275, 27.10.2000, p. 44.(6) OJ L 318, 4.12.2001, p. 28.(7) OJ L 319, 23.11.2002, p. 3.(8) OJ L 187, 10.7.2001, p. 47.(9) OJ L 67, 12.3.2003, p. 18.(10) OJ L 33, 8.2.1979, p. 36.(11) OJ L 122, 16.5.2003, p. 36.(12) OJ L 123, 24.4.1998, p. 1.(13) OJ L 262, 27.9.1976, p. 201.(14) OJ L 42, 15.2.2003, p. 45.(15) OJ 196, 16.8.1967, p. 1.ANNEX IRevised import decisions for the chemical substances 2,4,5-T, chlorobenzilate, methyl parathion, monocrotophos and phosphamidon replacing the previous import decisions set out in Decision 2000/657/EC>PIC FILE= "L_2003174EN.001302.TIF">>PIC FILE= "L_2003174EN.001401.TIF">>PIC FILE= "L_2003174EN.001501.TIF">>PIC FILE= "L_2003174EN.001601.TIF">>PIC FILE= "L_2003174EN.001701.TIF">>PIC FILE= "L_2003174EN.001801.TIF">>PIC FILE= "L_2003174EN.001901.TIF">>PIC FILE= "L_2003174EN.002001.TIF">>PIC FILE= "L_2003174EN.002101.TIF">>PIC FILE= "L_2003174EN.002201.TIF">>PIC FILE= "L_2003174EN.002301.TIF">>PIC FILE= "L_2003174EN.002401.TIF">>PIC FILE= "L_2003174EN.002501.TIF">>PIC FILE= "L_2003174EN.002601.TIF">>PIC FILE= "L_2003174EN.002701.TIF">>PIC FILE= "L_2003174EN.002801.TIF">ANNEX IIRevised import decisions for the chemical substances ethylene oxide and parathion replacing the previous import decisions set out in Decision 2001/852/EC>PIC FILE= "L_2003174EN.002902.TIF">>PIC FILE= "L_2003174EN.003001.TIF">>PIC FILE= "L_2003174EN.003101.TIF">>PIC FILE= "L_2003174EN.003201.TIF">>PIC FILE= "L_2003174EN.003301.TIF">>PIC FILE= "L_2003174EN.003401.TIF">>PIC FILE= "L_2003174EN.003501.TIF">ANNEX IIIRevised import decision for the chemical substance PBB (polybrominated biphenyls) replacing the previous 1995 import decision>PIC FILE= "L_2003174EN.003602.TIF">>PIC FILE= "L_2003174EN.003701.TIF">>PIC FILE= "L_2003174EN.003801.TIF">>PIC FILE= "L_2003174EN.003901.TIF">


title: 2008/823/EC: Commission Decision of 22 October 2008 amending Decision 95/319/EC setting up a Committee of Senior Labour Inspectors (Text with EEA relevance)

text:
               30.10.2008

               EN

               Official Journal of the European Union

               L 288/5

      COMMISSION DECISION

   of 22 October 2008
   amending Decision 95/319/EC setting up a Committee of Senior Labour Inspectors
   (Text with EEA relevance)
   (2008/823/EC)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Whereas:

               (1)

               By Decision 95/319/EC (1) the Commission set up a Committee of Senior Labour Inspectors, hereinafter referred to as ‘the Committee’.

               (2)

               Recent enlargements of the European Union have effectively doubled the size of the Committee. The plenary meetings now comprise 54 Committee members. In the event of new enlargements this number will increase still further.

               (3)

               To enable the Committee to fulfil its tasks and allow the members of the Committee to engage in a practical, interactive exchange of experience and opinion, which is not feasible with such a large Committee, the number of members per Member State should be reduced from two to one. The Member States should be able to appoint an alternate member to attend meetings where the full member cannot be present.

               (4)

               To guarantee the quality of the Committee's work, nominees for membership should be the senior representatives of the national labour inspection services with a mandate to carry out the tasks of the Committee.

               (5)

               Provision should be made for each member or alternate member to be able to be accompanied by an expert at Committee meetings. For practical reasons relating to meeting organisation, notification of such experts' attendance should be given at least one month before the Committee meeting concerned.

               (6)

               To facilitate the way working groups operate, it should be possible for them to be chaired by an expert from a national labour inspection service who is not a member of the Committee.

               (7)

               Specific categories of observers should be able to attend Committee meetings.

               (8)

               The Committee should adopt rules of procedure laying down the practical arrangements for its work.

               (9)

               Decision 95/319/EC should be amended accordingly.

               (10)

               This Decision should take effect on 1 January 2010, the date on which a new term of office starts for members of the Committee,

         HAS DECIDED AS FOLLOWS:
   Article 1
   Decision 95/319/EC is amended as follows:

               1.

               Article 5 is amended as follows:

                           (a)

                           paragraphs 1 and 2 are replaced by the following:
                           ‘1.   The Committee shall comprise one full member per Member State.
                           One alternate member may be appointed for each full member. An alternate member shall attend the Committee meetings only when the full member is unable to be present.
                           2.   Full and alternate members of the Committee shall be appointed by the Commission on a proposal by the Member State.
                           When submitting the names of their nominees to the Commission, the Member States shall ensure that these are the senior representatives of their labour inspection services with a mandate to carry out the tasks of the Committee.’;

                           (b)

                           paragraph 5 is deleted;

               2.

               Article 8 is replaced by the following:
               ‘Article 8
               1.   The Committee may, in accordance with the representative of the Commission, invite any person with particular competence in respect of an item on the agenda to take part in its work.
               2.   Each member or alternate member may be accompanied by an expert, provided that the member submits a reasoned request to the chairman at least one month before the relevant Committee meeting.’;

               3.

               in Article 9, paragraph 2 is replaced by the following:
               ‘2.   Working groups shall be chaired by a member of the Committee or an expert of the labour inspection services of the Member States, and shall consist of members of the Committee and/or experts, as the case may be. Working groups shall report to the Committee in plenary session.’;

               4.

               the following Article 9a is inserted:
               ‘Article 9a
               Neither members nor experts shall receive payment for their work.’;

               5.

               in Article 10, the following paragraph 3 is added:
               ‘3.   The following may attend meetings of the Committee as observers:

                           (a)

                           a representative of the labour inspection service of each EEA/EFTA state;

                           (b)

                           the Director of the European Agency for Safety and Health at Work;

                           (c)

                           a representative of the International Labour Organisation.’;

               6.

               the following Article 11a is inserted:
               ‘Article 11a
               The Committee shall adopt its rules of procedure, which shall lay down the practical arrangements for its work, including the convening of meetings and the organisation of working groups.’;

               7.

               in Article 12, paragraph 2 is replaced by the following:
               ‘2.   The Commission shall forward that report to the Council, the European Parliament, the European Economic and Social Committee and the Advisory Committee on Safety and Health at Work.’

         Article 2
   This Decision shall take effect on 1 January 2010.

      Done at Brussels, 22 October 2008.

            For the Commission

         Vladimír ŠPIDLA

            Member of the Commission

      (1)  OJ L 188, 9.8.1995, p. 11.


title: Decision No U1 of 12 June 2009 concerning Article 54(3) of Regulation (EC) No 987/2009 of the European Parliament and of the Council relating to increases in unemployment benefit for dependent members of the family (Text of relevance to the EEA and to the EC/Switzerland Agreement)

text:
               24.4.2010

               EN

               Official Journal of the European Union

               C 106/42

         DECISION No U1
   of 12 June 2009
   concerning Article 54(3) of Regulation (EC) No 987/2009 of the European Parliament and of the Council relating to increases in unemployment benefit for dependent members of the family
   (Text of relevance to the EEA and to the EC/Switzerland Agreement)
   2010/C 106/11
   THE ADMINISTRATIVE COMMISSION FOR THE COORDINATION OF SOCIAL SECURITY SYSTEMS,
   Having regard to Article 72(a) of Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (1), under which the Administrative Commission is responsible for dealing with all administrative questions or questions of interpretation arising from the provisions of Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (2),
   Having regard to Article 54(2) and (3) of Regulation (EC) No 987/2009,
   Whereas:

               (1)

               Pursuant to Article 54(3) of Regulation (EC) No 987/2009, if under the legislation of a Member State the amount of unemployment benefit varies with the number of members of the family, the competent institution shall also take into consideration when calculating the benefit the number of members of the family residing in the territory of a Member State other than that where the competent institution is situated.

               (2)

               Under Article 2(2) of the said Regulation, the institutions shall provide or exchange without delay all data necessary for establishing and determining the rights and obligations of persons to whom Regulation (EC) No 883/2004 applies.

               (3)

               The documents and structured electronic documents provided for under Article 4(1) of Regulation (EC) No 987/2009, are a means of proof of the rights of the person concerned, but their issue does not constitute a condition for such rights.

               (4)

               The documents relating to members of the family residing in the territory of a Member State other than that where the competent institution is situated can be communicated only after the start of the period of unemployment for which benefit is payable.

               (5)

               Payments in arrears of increases in unemployment benefits payable for family members must be made for the period preceding the date of submission of information concerning family members residing in the territory of a Member State other than the Member State in which the competent institution is situated, provided that the said persons were already dependent on the unemployed person at the start of the period of unemployment for which benefit is payable.
               Acting in accordance with the conditions laid down in Article 71(2) of Regulation (EC) No 883/2004,

         HAS DECIDED AS FOLLOWS:

               1.

               The communication of the document relating to members of the family after the start of the period of unemployment for which benefit is payable shall not have the effect of postponing the starting of the acquisition of entitlement to unemployment benefit at the increased rate for dependent members of the family, which shall be determined in accordance with the legislation of the competent State.

               2.

               Where the institution communicating the document referred to in paragraph 1 is not in a position to certify that the members of the family are not taken into consideration for the calculation of unemployment benefits due to another person under the legislation of the Member State in whose territory they reside, the person concerned shall be allowed to supplement the said document by a declaration to that effect.

               3.

               This Decision shall be published in the Official Journal of the European Union. It shall apply from the date of entry into force of Regulation (EC) No 987/2009.

            The Chair of the Administrative Commission

         Gabriela PIKOROVÁ

      (1)  OJ L 166, 30.4.2004, p. 1.

      (2)  OJ L 284, 30.10.2009, p. 1.


title: Decision of the European Parliament of 5 May 2010 on discharge in respect of the implementation of the budget of the Euratom Supply Agency for the financial year 2008

text:
               25.9.2010

               EN

               Official Journal of the European Union

               L 252/192

         DECISION OF THE EUROPEAN PARLIAMENT
   of 5 May 2010
   on discharge in respect of the implementation of the budget of the Euratom Supply Agency for the financial year 2008
   (2010/540/EU)
   THE EUROPEAN PARLIAMENT,
   having regard to the final annual accounts of the Euratom Supply Agency for the financial year 2008,
   having regard to the Court of Auditors’ report on the annual accounts of the Euratom Supply Agency for the financial year 2008, together with the Agency’s replies (1),
   having regard to the Council’s recommendation of 16 February 2010 (5827/2010 — C7-0061/2010),
   having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,
   having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,
   having regard to Council Decision 2008/114/EC, Euratom of 12 February 2008 establishing Statutes for the Euratom Supply Agency (3) and in particular Article 8 thereof,
   having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Regulation (EC, Euratom) No 1605/2002 (4), and in particular Article 94 thereof,
   having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,
   having regard to the report of the Committee on Budgetary Control (A7-0076/2010),

               1.

               Grants the Director-General of the Euratom Supply Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2008;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Director-General of the Euratom Supply Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Jerzy BUZEK

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 304, 15.12.2009, p. 6.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 41, 15.2.2008, p. 15.

      (4)  OJ L 357, 31.12.2002, p. 72.
    ---documentbreak---

               25.9.2010

               EN

               Official Journal of the European Union

               L 252/193

         RESOLUTION OF THE EUROPEAN PARLIAMENT
   of 5 May 2010
   with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the Euratom Supply Agency for the financial year 2008
   THE EUROPEAN PARLIAMENT,
   having regard to the final annual accounts of the Euratom Supply Agency for the financial year 2008,
   having regard to the Court of Auditors’ report on the annual accounts of the Euratom Supply Agency for the financial year 2008, together with the Agency’s replies (1),
   having regard to the Council’s recommendation of 16 February 2010 (5827/2010 — C7-0061/2010),
   having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,
   having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,
   having regard to Council Decision 2008/114/EC, Euratom of 12 February 2008 establishing Statutes for the Euratom Supply Agency (3) and in particular Article 8 thereof,
   having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Regulation (EC, Euratom) No 1605/2002 (4), and in particular Article 94 thereof,
   having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,
   having regard to the report of the Committee on Budgetary Control (A7-0076/2010),

               A.

               whereas the Court of Auditors states that it has obtained reasonable assurances that the annual accounts for the financial year 2008 are reliable, and that the underlying transactions are legal and regular,

               B.

               whereas, under Decision 2008/114/EC, Euratom, Euratom Supply Agency established in Luxembourg in 1958, has a new Statute and has become an Agency,

               1.

               Notes that in 2008 the Agency did not receive any subsidy to cover its operations and the Commission bore all expenses incurred by the Agency for the implementation of the 2008 budget; notes also that the commitments carried over from the financial year 2007 were paid with the unused part of the 2007 subsidy;

               2.

               Notes therefore that, in the absence of an autonomous budget, the Agency is de facto integrated in the Commission;

               3.

               Points out, nevertheless, that this situation raises the issue of the need to maintain the Agency in its current form and organisation; notes, however, the Agency’s reply, claiming that the present situation reflects the balance between, on the one hand, a clear relationship with the Commission (e.g. the Commission may issue directives and it appoints the Director-General of the Agency) and, on the other hand, a degree of legal and financial autonomy;

      Internal audit

               4.

               Acknowledges that, in accordance with Article 3 of its Statutes, the Agency has selected its own internal auditor, who took up his duties only on 1 July 2009;

               5.

               Refers for other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 5 May 2010 (5) on the performance, financial management and control of the agencies.

      (1)  OJ C 304, 15.12.2009, p. 6.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 41, 15.2.2008, p. 15.

      (4)  OJ L 357, 31.12.2002, p. 72.

      (5)  Texts adopted, P7_TA(2010)0139. See page 241 of this Official Journal.


title: 2011/574/EU: Decision of the European Parliament of 10 May 2011 on discharge in respect of the implementation of the budget of the European Centre for Disease Prevention and Control for the financial year 2009

text:
               27.9.2011

               EN

               Official Journal of the European Union

               L 250/145

         DECISION OF THE EUROPEAN PARLIAMENT
   of 10 May 2011
   on discharge in respect of the implementation of the budget of the European Centre for Disease Prevention and Control for the financial year 2009
   (2011/574/EU)
   THE EUROPEAN PARLIAMENT,
   having regard to the final annual accounts of the European Centre for Disease Prevention and Control for the financial year 2009,
   having regard to the Court of Auditors’ report on the annual accounts of the European Centre for Disease Prevention and Control for the financial year 2009, together with the Centre’s replies (1),
   having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),
   having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,
   having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,
   having regard to Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control (3), and in particular Article 23 thereof,
   having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,
   having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,
   having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0107/2011),

               1.

               Grants the Director of the European Centre for Disease Prevention and Control discharge in respect of the implementation of the Centre’s budget for the financial year 2009;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Director of the European Centre for Disease Prevention and Control, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Jerzy BUZEK

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 338, 14.12.2010, p. 124.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 142, 30.4.2004, p. 1.

      (4)  OJ L 357, 31.12.2002, p. 72.
    ---documentbreak---

               27.9.2011

               EN

               Official Journal of the European Union

               L 250/146

         RESOLUTION OF THE EUROPEAN PARLIAMENT
   of 10 May 2011
   with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Centre for Disease Prevention and Control for the financial year 2009
   THE EUROPEAN PARLIAMENT,
   having regard to the final annual accounts of the European Centre for Disease Prevention and Control for the financial year 2009,
   having regard to the Court of Auditors’ report on the annual accounts of the European Centre for Disease Prevention and Control for the financial year 2009, together with the Centre’s replies (1),
   having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),
   having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,
   having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,
   having regard to Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control (3), and in particular Article 23 thereof,
   having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,
   having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,
   having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0107/2011),

               A.

               whereas the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts for the financial year 2009 are reliable and that the underlying transactions are legal and regular,

               B.

               whereas on 5 May 2010 Parliament granted the Director of the European Centre for Disease Prevention and Control discharge for implementation of the Centre’s budget for the financial year 2008 (5), and in its resolution accompanying the discharge decision, inter alia:

                           —

                           noted that the Court of Auditors pointed out that about EUR 16 200 000 (representing 40 % of the Centre’s total budget) had to be carried over,

                           —

                           was concerned that as of 31 December 2008 there was still no seat agreement between the Centre and the Swedish Government,

                           —

                           pointed out that there were still weaknesses in the planning of recruitment procedures,

                           —

                           deplored the fact that the Centre has not comprehensively fulfilled its obligation to send to the authority responsible for discharge a report drawn up by its Director summarising the number of internal audits conducted by the Internal Auditor as provided for in Article 72(5) of the framework Financial Regulation,

               C.

               whereas the budget of the Centre for the year 2009 was EUR 51 000 000, which is an increase of 25,3 % on the financial year 2008,

               1.

               Notes that the Centre’s budget increased from EUR 17 100 000 in 2006 to EUR 51 000 000 in 2009;

               2.

               Notes that EUR 51 000 000 had been made available as resources for the Centre in 2009, of which EUR 48 100 000 came from subsidies from the Union budget;

               3.

               Underlines that the implementation of payment credits slightly improved to 91 %, which represents an amount of unused credits of EUR 4 800 000; notes, however, that this under-execution is related to the fact that the Centre limited its request for payment credits in order to reduce the amount of cash in its bank account at year-end, as requested by the Court of Auditors and the Commission;

      Performance

               4.

               Calls once more on the Centre to set out, in a table to be annexed to the Court of Auditors’ next report, a comparison of the operations that were carried out during the year for which discharge is to be granted and during the previous financial year, so as to enable the discharge authority to assess more effectively the Centre’s performance from one year to the next;

               5.

               Considers, nevertheless, that the Centre is an important institution that can strengthen and develop European disease surveillance and assess and communicate current and emerging threats to human health posed by infectious diseases;

               6.

               Points to the important contributions made by the Centre to the measures to fight the H1N1 pandemic in 2009, for example by issuing preliminary guidelines on the ‘Use of specific pandemic influenza vaccines during the H1N1 2009 pandemic’;

               7.

               Takes the view that the Centre’s powers must be strengthened so that the Union has an independent capacity to assess the severity of the risk of infection should a pandemic occur and so that coordination between the Member States can be improved;

               8.

               Notes that the Centre was able to develop a considerable number of products and services in 2009 on epidemiology, surveillance, prevention and control of communicable diseases as well as publishing a variety of scientific reports;

               9.

               Requests the Court of Auditors to undertake performance audits on the Centre;

      Carry-over of appropriations

               10.

               Is concerned that already in 2006 the Court of Auditors reported a high level of carry-overs which has a negative impact on the implementation of the budget and is at odds with the principle of annuality; notes in particular that appropriations carried forward from 2008, amounting to EUR 2 200 000, had to be cancelled and in 2009 appropriations carried forward represented 42 % of Title II — Administrative expenditure, and 63 % of Title III — Operational expenditure; calls therefore on the Centre to inform the discharge authority of the measures taken to redress this deficiency;

      The Centre’s seat

               11.

               Welcomes the fact that, in the end, a Seat Agreement was signed by the Chair’s Management Board and the Swedish Minister for Public Health and Elderly Care on 30 June 2010 as well as an accompanying change in the law to enable the Centre’s staff and their families to be included in Sweden’s population register;

      Internal audit

               12.

               Is concerned about the fact that once again the Centre has not comprehensively fulfilled its obligation to send to the discharge authority a report drawn up by its Director summarising the content of the Internal Audit Service (IAS) recommendation as provided for in Article 72(5) of the framework Financial Regulation; is concerned, in particular, that, in relation to the follow-up of earlier recommendations, the Centre received one ‘very important’ recommendation and seven other ‘important’ recommendations from the IAS but that no information is given on their content; urges therefore the Director of the Centre to provide this information;

               13.

               Acknowledges that the IAS also performed an audit on financial management in 2009 which had the overall objective of obtaining reasonable assurance on the adequacy of the internal controls supporting procedures for financial management, procurement planning, budget implementation, management reporting and monitoring and controls; stresses that the IAS’ recommendations concern the need to update and reinforce financial procedures for commitments and payments to define and record more accurately the controls performed;

               14.

               Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2011 (6) on the performance, financial management and control of the agencies.

      (1)  OJ C 338, 14.12.2010, p. 124.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 142, 30.4.2004, p. 1.

      (4)  OJ L 357, 31.12.2002, p. 72.

      (5)  OJ L 252, 25.9.2010, p. 141.

      (6)  Texts adopted, P7_TA(2011)0163 (see page 269 of this Official Journal).