title: 2012/828/EU: Council Decision of 13 November 2012 on the conclusion of the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand

text:
               22.12.2012

               EN

               Official Journal of the European Union

               L 356/1

         COUNCIL DECISION
   of 13 November 2012
   on the conclusion of the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
   (2012/828/EU)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4), in conjunction with Article 218(6)(a)(v) thereof,
   Having regard to the proposal from the European Commission,
   Having regard to the consent of the European Parliament,
   Whereas:

               (1)

               The Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (1) entered into force on 1 January 1999 (2).

               (2)

               In accordance with Council Decision 2011/464/EU (3), the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (‘the Agreement’) was signed by the Commission on 23 February 2012, subject to its conclusion.

               (3)

               As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community.

               (4)

               The Agreement should be concluded,

         HAS ADOPTED THIS DECISION:
   Article 1
   The Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (‘the Agreement’) is hereby approved on behalf of the Union.
   The text of the Agreement is attached to this Decision.
   Article 2
   The President of the Council shall designate the person empowered to proceed, on behalf of the Union, to transmitting the diplomatic notes provided for in Article 2 of the Agreement, in order to express the consent of the Union to be bound by the Agreement (4).
   Article 3
   This Decision shall enter into force on the day of its adoption.

      Done at Brussels, 13 November 2012.

            For the Council

            The President

         V. SHIARLY

      (1)  OJ L 229, 17.8.1998, p. 62.

      (2)  OJ L 5, 9.1.1999, p. 74.

      (3)  OJ L 195, 27.7.2011, p. 1.

      (4)  The date of entry into force of the Agreement will be published in the Official Journal of the European Union by the General Secretariat of the Council.
    ---documentbreak---

               22.12.2012

               EN

               Official Journal of the European Union

               L 356/2

         AGREEMENT
   between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
   THE EUROPEAN UNION
   and
   NEW ZEALAND,
   hereinafter ‘the Parties’,
   HAVING concluded the Agreement on mutual recognition in relation to conformity assessment (1), done at Wellington on 25 June 1998 (hereinafter ‘the Agreement on Mutual Recognition’);
   NOTING the need to simplify the operation of the Agreement on Mutual Recognition;
   WHEREAS Article 3 of the Agreement on Mutual Recognition sets out the form of the Sectoral Annexes in detail, and, specifically, provides that Section II of each Sectoral Annex to the Agreement shall contain a list of the designated conformity assessment bodies;
   WHEREAS Article 4 of the Agreement on Mutual Recognition restricts the application of the Agreement to products that originate in the Parties according to non-preferential rules of origin;
   WHEREAS Article 12 of the Agreement on Mutual Recognition establishes a Joint Committee that, inter alia, gives effect to decisions on the inclusion of conformity assessment bodies in, and their removal from, the Sectoral Annexes and sets out a procedure for such inclusion and removal;
   WHEREAS Articles 8 and 12 of the Agreement on Mutual Recognition refer to the Chair of the Joint Committee;
   WHEREAS Article 12 of the Agreement on Mutual Recognition does not explicitly empower the Joint Committee to amend the Sectoral Annexes, except to give effect to the decision by a designating authority to designate or to withdraw designation of a particular conformity assessment body;
   CONSIDERING that Article 3 of the Agreement on Mutual Recognition should be amended, both to reflect the changes proposed to Article 12 thereof to limit the requirement for the Joint Committee to take action on the recognition or withdrawal of recognition of conformity assessment bodies to cases that have been contested by the other Party under Article 8 of the Agreement on Mutual Recognition, and to allow greater flexibility in the structure of Sectoral Annexes to the Agreement;
   CONSIDERING that in order that trade between the Parties is not unnecessarily restricted, the origin restriction in Article 4 of the Agreement on Mutual Recognition should be deleted;
   CONSIDERING that in order to reflect the fact that the Joint Committee is co-chaired by the Parties, the references to the Chair of the Joint Committee should be deleted from Articles 8 and 12 of the Agreement on Mutual Recognition;
   CONSIDERING that enhanced exchange of information between the Parties regarding the operation of the Agreement on Mutual Recognition will facilitate its operation;
   CONSIDERING that in order to make timely adaptations to the Sectoral Annexes so as to take account of technical progress, and other factors such as enlargement of the European Union, the Joint Committee should be explicitly empowered in Article 12 of the Agreement on Mutual Recognition to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or to withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes;
   CONSIDERING that in order to simplify the operation of the Agreement on Mutual Recognition, the need for the Joint Committee to take decisions on the recognition or withdrawal of recognition of conformity assessment bodies should be limited to cases that have been contested by the other Party under Article 8 of the Agreement on Mutual Recognition;
   CONSIDERING that in order to simplify the operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition, and suspension of conformity assessment bodies should be set up in Article 12 thereof, and the position regarding conformity assessment carried out by bodies before their designation is suspended or withdrawn should be clarified;
   CONSIDERING that the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia is identical in form to the Agreement on Mutual Recognition, and is therefore being amended in parallel in order to retain coherence between the Agreements;
   CONSIDERING that the legal references and mode of operation of the Sectoral Annexes on medicinal products GMP inspection and batch certification and on medical devices are outdated, and the opportunity has been taken to amend them to reflect the current position,
   HAVE AGREED AS FOLLOWS:
   Article 1
   Amendments to the Agreement on Mutual Recognition
   The Agreement on Mutual Recognition is hereby amended as follows:

               1.

               Article 3(2) is replaced by the following:
               ‘2.   Each Sectoral Annex shall, in general, contain the following information:

                           (a)

                           a statement of its scope and coverage;

                           (b)

                           the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures;

                           (c)

                           the designating authorities;

                           (d)

                           a set of procedures for the designation of conformity assessment bodies, and

                           (e)

                           additional provisions as required.’.

               2.

               Article 4 is replaced by the following:
               ‘Article 4
               Scope and coverage
               This Agreement shall apply to products specified in the statement of scope and coverage in each Sectoral Annex.’.

               3.

               Article 6 is replaced by the following:
               ‘Article 6
               Designating authorities
               1.   The Parties shall ensure that the designating authorities responsible for designating conformity assessment bodies have the necessary power and competence to designate, suspend, remove suspension and withdraw the designation of such bodies.
               2.   In making such designations, suspensions, removals of suspension and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.’.

               4.

               Article 7(1) is replaced by the following:
               ‘1.   The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.’.

               5.

               Article 8 is amended as follows:

                           (a)

                           paragraph 3 is replaced by the following:
                           ‘3.   Such contestation has to be justified in an objective and argued manner and in writing to the other Party and to the Joint Committee.’;

                           (b)

                           paragraph 6 is replaced by the following:
                           ‘6.   Except when decided otherwise by the Joint Committee, the contested conformity assessment body shall be suspended by the competent designating authority from the time its technical competence and compliance is contested in accordance with this Article until either agreement is reached in the Joint Committee on the status of that body or the challenging Party notifies the other Party and the Joint Committee that it is satisfied as to the technical competence and compliance of that body.’.

               6.

               Article 9 is replaced by the following:
               ‘Article 9
               Exchange of information
               1.   The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes and shall maintain an accurate list of conformity assessment bodies designated in accordance with this Agreement.
               2.   Consistent with their obligations under the World Trade Organization Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except as provided for in paragraph 3 of this Article, notify the other Party of the new provisions at least 60 calendar days before their entry into force.
               3.   Where a Party takes urgent measures that it considers warranted by considerations of safety, health or protection of the environment in order to manage a risk posed by a product covered by a Sectoral Annex, it shall notify immediately the other Party of the measures, with a brief indication of their objective and rationale, or as otherwise specified in the Sectoral Annex.’.

               7.

               Paragraphs 3 to 7 of Article 12 are replaced by the following:
               ‘3.   The Joint Committee shall meet at least once a year unless the Joint Committee or the Parties decide otherwise. If required for the effective functioning of this Agreement, or at the request of either Party, an additional meeting or meetings shall be held.
               4.   The Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for:

                           (a)

                           amending the Sectoral Annexes in accordance with this Agreement;

                           (b)

                           exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies maintain the necessary level of competence;

                           (c)

                           in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements;

                           (d)

                           exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes including those which require modification of the Sectoral Annexes;

                           (e)

                           resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and

                           (f)

                           adopting new Sectoral Annexes in accordance with this Agreement.

                     5.   Any amendments to the Sectoral Annexes made in accordance with this Agreement and any new Sectoral Annexes adopted in accordance with this Agreement shall be notified promptly in writing by the Joint Committee to each Party, and shall come into effect as determined by the Joint Committee.
               6.   The following procedure shall apply in relation to the designation of a conformity assessment body:

                           (a)

                           a Party wishing to designate a conformity assessment body shall forward its proposal to that effect to the other Party in writing, adding supporting documentation, as may be defined by the Joint Committee;

                           (b)

                           in the event that the other Party consents to the proposal or upon the expiry of 60 calendar days without an objection having been lodged, in accordance with any applicable procedures established by the Joint Committee, the conformity assessment body shall be considered to be a designated conformity assessment body under the terms of Article 5;

                           (c)

                           in the event that, under Article 8, the other Party contests the technical competence or compliance of the proposed conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8;

                           (d)

                           in the case of the designation of a new conformity assessment body, conformity assessment carried out by such a body shall be valid from the date on which it becomes a designated conformity assessment body in accordance with this Agreement;

                           (e)

                           either Party may suspend, remove the suspension of, or withdraw the designation of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party and the Joint Committee of its decision in writing, together with the date of such decision. The suspension, removal of suspension or withdrawal of the designation shall take effect from the date of the Party’s decision;

                           (f)

                           in accordance with Article 8, either Party may, in exceptional circumstances, contest the technical competence of a designated conformity assessment body under the jurisdiction of the other Party. In this case the Joint Committee may decide to carry out a verification of the body concerned, in accordance with Article 8.

                     7.   In the event that the designation of a conformity assessment body is suspended or withdrawn, conformity assessment carried out by that body before the date of effect of the suspension or withdrawal shall remain valid unless either the responsible Party has limited or cancelled that validity, or the Joint Committee determines otherwise. The Party under whose jurisdiction the suspended or withdrawn conformity assessment body was operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity.’.

               8.

               Article 15 is amended as follows:

                           (a)

                           paragraph 3 is replaced by the following:
                           ‘3.   The Joint Committee may adopt Sectoral Annexes to which Article 2 applies and which will provide the implementing arrangements for this Agreement.’;

                           (b)

                           paragraph 4 is replaced by the following:
                           ‘4.   Amendments to the Sectoral Annexes, and the adoption of new Sectoral Annexes, shall be determined by the Joint Committee.’.

               9.

               The Annex is hereby amended as follows:

                           (a)

                           paragraph 9 is replaced by the following:

                                       ‘9.

                                       Designating authorities shall inform their Party’s representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be designated, suspended or withdrawn. The designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with this Agreement and the rules of procedure of the Joint Committee.’;

                           (b)

                           paragraph 10 is replaced by the following:

                                       ‘10.

                                       When advising their Party’s representative on the Joint Committee established under this Agreement, of the conformity assessment bodies to be designated, the designating authority shall provide the following details in respect of each conformity assessment body:

                                                   (a)

                                                   the name;

                                                   (b)

                                                   the postal address;

                                                   (c)

                                                   the facsimile (fax) number and e-mail address;

                                                   (d)

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

                                                   (e)

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

                                                   (f)

                                                   the designation procedure used to determine competence.’.

               10.

               The Sectoral Annex on medicinal products GMP inspection and batch certification, including Appendix 1 and Appendix 2, is replaced by the following:

                  ‘SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY – NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT
                  SCOPE AND COVERAGE

                              1.

                              The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in New Zealand and in the European Union, and to which Good Manufacturing Practice (GMP) requirements apply.
                              For medicinal products covered by this Sectoral Annex, each Party will recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.
                              In addition, the manufacturer’s certification of the conformity of each batch to its specifications will be recognised by the other Party without re-control at import.
                              ‘Medicinal products’ means all products regulated by the pharmaceutical legislation in the European Union and New Zealand referred to in Section I. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs, and, where appropriate, vitamins, minerals, herbal remedies and homoeopathic medicinal products.
                              ‘GMP’ is that part of quality assurance which ensures that products are consistently produced and controlled during manufacture to the quality standards appropriate to their intended use and as required by the marketing authorisation granted by the importing Party. For the purpose of this Sectoral Annex it includes the system whereby the manufacturer receives the specification of the product and/or process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification (equivalent to Qualified Person certification in the European Union).

                              2.

                              With respect to medicinal products covered by the legislation of one Party (‘regulating Party’) but not the other, the manufacturing company may request the authority nominated by the relevant contact point of the regulating Party listed in point 12 of Section III, for the purpose of this Agreement, that an inspection be made by the locally competent inspection service. This provision will apply, inter alia, to the manufacture of active pharmaceutical ingredients and intermediate products and products intended for use in clinical trials, as well as jointly determined pre-marketing inspections. Operational arrangements are detailed under point 3(b) of Section III.

                     Certification of manufacturers

                              3.

                              At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products will certify that the manufacturer:

                                          —

                                          is appropriately authorised to manufacture the relevant medicinal product or to carry out the relevant specified manufacturing operation;

                                          —

                                          is regularly inspected by the authorities, and

                                          —

                                          complies with the national GMP requirements recognised as equivalent by the two Parties, referred to in Section I. Where different GMP requirements are used as a reference (in line with the provisions in point 3(b) of Section III), this is to be mentioned in the certificate.

                                    The certificates will also identify the site(s) of manufacture (and contract testing laboratories, if any). The format of the certificate will be decided by the Joint Sectoral Group.
                              Certificates will be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, such as when a new inspection has to be carried out, this period may be extended to 60 calendar days.

                     Batch certification

                              4.

                              Each batch exported will be accompanied by a batch certificate prepared by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate will attest that the batch meets its specifications and will be kept by the importer of the batch. It will be made available upon request of the competent authority.
                              When issuing a certificate, the manufacturer will take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It will contain a statement that the batch processing and packaging records were reviewed and found to be in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union the ‘qualified person’ as referred to in relevant European Union legislation. In New Zealand, the responsible person is named on the licence to manufacture issued under the relevant New Zealand legislation.

                     SECTION I

                     LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS

                  Subject to Section III, general GMP inspections will be carried out against the GMP requirements of the exporting Party. The applicable legislative, regulatory and administrative provisions related to this Sectoral Annex are set out in the Table.
                  However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, will be those of the relevant product marketing authorisation granted by the importing Party.

                              Applicable legislative, regulatory and administrative provisions for the European Union

                              Applicable legislative, regulatory and administrative provisions for New Zealand

                                          —

                                          Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products, as amended

                                          —

                                          Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended

                                          —

                                          Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended

                                          —

                                          Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as amended

                                          —

                                          Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended

                                          —

                                          Guide to Good Distribution Practice (94/C 63/03)

                                          —

                                          Volume 4 — Guidelines for good manufacturing practices for medicinal products for human and veterinary use

                                          —

                                          Medicines Act, 1981

                                          —

                                          Medicines Regulations, 1984

                                          —

                                          New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Parts 1, 2, 4 and 5

                                          —

                                          Agricultural Compounds and Veterinary Medicines Act, 1997

                                          —

                                          Agricultural Compounds and Veterinary Medicines Regulations, 2001

                                          —

                                          Agricultural Compounds and Veterinary Medicines (ACVM) Standard for Good Manufacturing Practice

                                          —

                                          Agricultural Compounds and Veterinary Medicines (ACVM) Guideline for Good Manufacturing Practice

                                          —

                                          and any legislation adopted on the basis of, or that amends, the above legislation

                     SECTION II

                     OFFICIAL INSPECTION SERVICES

                  The lists of official inspection services related to this Sectoral Annex have been jointly determined by the Parties and will be maintained by them. If a Party requests from the other Party a copy of its latest lists of official inspection services, the requested Party will provide the requesting Party with a copy of those lists within 30 calendar days of the date of receipt of the request.

                     SECTION III

                     OPERATIONAL PROVISIONS

                  1.   Transmission of inspection reports

                  Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing or control site, in the case where analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see point (2). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin.
                  If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.
                  2.   Inspection reports

                  A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party.
                  3.   Reference GMP

                              (a)

                              Manufacturers will be inspected against the applicable GMP of the exporting Party (see Section I).

                              (b)

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

                        Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) will be determined according to a procedure established by the Joint Sectoral Group.
                  4.   Nature of inspections

                              (a)

                              Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections).

                              (b)

                              ‘Product- or process-oriented’ inspections (which may be ‘pre-marketing’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.

                        5.   Inspection/establishment fees

                  The regime of inspection/establishment fees is determined by the manufacturer’s location. Inspection/establishment fees will not be charged to manufacturers located on the territory of the other Party for products covered by this Sectoral Annex.
                  6.   Safeguard clause for inspections

                  Each Party reserves the right to conduct its own inspection for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the option of joining the inspection. Recourse to this safeguard clause should be an exception. Should such an inspection take place, inspection costs may be recovered.
                  7.   Exchange of information between authorities and approximation of quality requirements

                  In accordance with the general provisions of this Agreement, the Parties will exchange any relevant information necessary for the ongoing mutual recognition of inspections. For the purposes of demonstration of capability in cases of significant changes to regulatory systems in either of the Parties, additional specific information may be requested by either Party in relation to an official inspection service. Such specific requests may cover information on training, inspection procedures, general information and document exchange, and transparency of agency audits of official inspection services relevant to the operation of this Sectoral Annex. Such requests should be made through and managed by the Joint Sectoral Group as part of an ongoing maintenance programme.
                  In addition, the relevant authorities in New Zealand and in the European Union will keep each other informed of any new technical guidance or changes to inspection procedures. Each Party will consult the other before their adoption.
                  8.   Official batch release

                  The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement does not encompass this mutual recognition of official batch releases. However, when an official batch release procedure applies, the manufacturer will provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party.
                  For the European Union, the official batch release procedure for medicinal products for human use is published by the European Directorate for the Quality of Medicines & HealthCare. For New Zealand, the official batch release procedure is specified in document ‘WHO Technical Report Series, No 822, 1992’.
                  9.   Inspectors’ training

                  In accordance with the general provisions of this Agreement, training sessions for inspectors, organised by the authorities, will be accessible to inspectors of the other Party. The Parties will keep each other informed of these sessions.
                  10.   Joint inspections

                  In accordance with the general provisions of this Agreement, and by mutual arrangement between the Parties, joint inspections may be authorised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form will be established through procedures approved by the Joint Sectoral Group.
                  11.   Alert system

                  Contact points will be designated by the Parties to permit competent authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defects, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure will be jointly established.
                  The Parties will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, is communicated to the other Party with the appropriate degree of urgency.
                  12.   Contact points

                  For the purpose of this Sectoral Annex, the contact points for any technical question, such as exchange of inspection reports, inspector training sessions, technical requirements, will be:

                              FOR NEW ZEALAND:

                                 For medicinal products for human use:

                                          Group Manager

                                          Medicines and Medical Devices Safety Authority (Medsafe)

                                          PO Box 5013

                                          Wellington

                                          New Zealand

                                          Tel. 64-4-819 6874

                                          Fax 64-4-819 6806

                                 For medicinal products for use in animals:

                                          Director, Approvals and ACVM Standards

                                          Ministry of Agriculture and Forestry

                                          (MAF) PO Box 2526

                                          Wellington 6140

                                          New Zealand

                                          Tel. 64-4-894 2541

                                          Fax 64-4-894 2501

                              FOR THE EUROPEAN UNION:

                                          The Director of the European Medicines Agency

                                          7 Westferry Circus

                                          Canary Wharf

                                          London E14 4HB

                                          United Kingdom

                                          Tel. 44-171-418 8400

                                          Fax 44-171-418 8416

                        13.   Joint Sectoral Group

                  A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint Committee as the Joint Committee will determine.
                  The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.
                  14.   Divergence of views

                  Both Parties will use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.

                     SECTION IV

                     CHANGES TO THE LIST OF OFFICIAL INSPECTION SERVICES

                  The Parties recognise the need for this Sectoral Annex to accommodate change, particularly with regard to the entry of new official inspection services or changes in the nature or role of established competent authorities. Where significant changes have occurred with regard to official inspection services, the Joint Sectoral Group will consider what, if any, additional information is required to verify programmes and establish or maintain mutual recognition of inspections, in accordance with point 7 of Section III.’.

               11.

               The Sectoral Annex on medical devices is replaced by the following:‘
                  SECTORAL ANNEX ON MEDICAL DEVICES TO THE EUROPEAN COMMUNITY — NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT
                  SCOPE AND COVERAGE
                  The provisions of this Sectoral Annex will apply to the following products:

                              Products for export to the European Union

                              Products for export to New Zealand

                                          (1)

                                          All medical devices:

                                                      (a)

                                                      manufactured in New Zealand; and

                                                      (b)

                                                      subject to third party conformity assessment procedures, both product and quality systems-related; and

                                                      (c)

                                                      provided for in Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; and

                                                      (d)

                                                      provided for in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended.

                                          (1)

                                          All medical devices:

                                                      (a)

                                                      manufactured in the European Union; and

                                                      (b)

                                                      subject to third party conformity assessment procedures, both product and quality systems-related, or subject to other requirements under the legislation listed in Section I, as amended.

                                          (2)

                                          For the purposes of paragraph 1:

                                                      (a)

                                                      medical devices provided for in the Appendix are excluded; and

                                                      (b)

                                                      unless otherwise provided for or by mutual arrangement by the Parties, ‘manufacture’ of a medical device does not include:

                                                                  (i)

                                                                  restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or

                                                                  (ii)

                                                                  operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or

                                                                  (iii)

                                                                  quality control inspections alone; or

                                                                  (iv)

                                                                  sterilisation alone.

                                          (2)

                                          For the purposes of paragraph 1:

                                                      (a)

                                                      medical devices provided for in the Appendix are excluded; and

                                                      (b)

                                                      unless otherwise provided for or by mutual arrangement by the Parties, ‘manufacture’ of a medical device does not include:

                                                                  (i)

                                                                  restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or

                                                                  (ii)

                                                                  operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or

                                                                  (iii)

                                                                  quality control inspections alone; or

                                                                  (iv)

                                                                  sterilisation alone.

                     SECTION I

                     LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS

                              The legislative, regulatory and administrative requirements of the European Union with which New Zealand-designated conformity assessment bodies will assess compliance

                              The legislative, regulatory and administrative requirements of New Zealand with which European Union-designated conformity assessment bodies will assess compliance

                                          —

                                          Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended

                                          —

                                          Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended

                                          —

                                          and any European Union legislation adopted on the basis of these Directives

                                          —

                                          Radiocommunications Act 1989 and Regulations made pursuant to that Act

                                          —

                                          Electricity Act 1992 and Regulations made pursuant to that Act

                                          —

                                          Medicines Act 1981

                                          —

                                          Medicines Regulations 1984

                                          —

                                          Medicines (Database of Medical Devices) Regulations 2003

                                          —

                                          and any legislation adopted on the basis of, or that amends, the above legislation

                     SECTION II

                     THE AUTHORITIES RESPONSIBLE FOR DESIGNATING CONFORMITY ASSESSMENT BODIES UNDER THIS SECTORAL ANNEX

                              For the conformity assessment bodies designated by New Zealand

                              For the conformity assessment bodies designated by the European Union

                                          —

                                          Ministry of Health

                                          —

                                             Belgium

                                                      —

                                                      Ministère de la Santé publique, de l’Environnement et de l’Intégration sociale

                                                      —

                                                      Ministerie van Volksgezondheid, Leefmilieu en Sociale Integratie

                                                      —

                                                      Agence Fédérale des Médicaments et des Produits de Santé – Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten

                                          —

                                             Bulgaria

                                          Държавна агенция за метрологичен и технически надзор

                                          —

                                             Czech Republic

                                          Úřad pro technickou normalizaci, metrologii a státní zkušebnictví

                                          —

                                             Denmark

                                                      —

                                                      Indenrigs- og Sundhedsministeriet

                                                      —

                                                      Lægemiddelstyrelsen

                                          —

                                             Germany

                                                      —

                                                      ZLG — Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Bonn

                                                      —

                                                      ZLS — Zentralstelle der Länder für Sicherheitstechnik, München

                                          —

                                             Estonia

                                          Majandus- ja Kommunikatsiooniministeerium

                                          —

                                             Ireland

                                                      —

                                                      Department of Health

                                                      —

                                                      Irish Medicines Board

                                          —

                                             Greece

                                                      —

                                                      Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης

                                                      —

                                                      Εθνικός Οργανισμός Φαρμάκων

                                          —

                                             Spain

                                                      —

                                                      Ministerio de Sanidad, Política Social e Igualdad

                                                      —

                                                      Agencia Española de Medicamentos y Productos Sanitarios

                                          —

                                             France

                                                      —

                                                      Ministère de la Santé

                                                      —

                                                      Agence Française de Sécurité Sanitaire des produits de Santé

                                                      —

                                                      Agence Nationale du Médicament Vétérinaire

                                          —

                                             Italy

                                          Ministero della Salute – Dipartimento dell’ Innovazione – Direzione Generale Farmaci e Dispositivi Medici

                                          —

                                             Cyprus

                                                      —

                                                      The Drugs Council, Pharmaceutical Services (Ministry of Health)

                                                      —

                                                      Veterinary Services (Ministry of Agriculture)

                                          —

                                             Latvia

                                                      —

                                                      Zāļu valsts aģentūra

                                                      —

                                                      Veselības ministrija

                                          —

                                             Lithuania

                                          Lietuvos Respublikos sveikatos apsaugos ministerija

                                          —

                                             Luxembourg

                                                      —

                                                      Ministère de la Santé

                                                      —

                                                      Division de la Pharmacie et des Médicaments

                                          —

                                             Hungary

                                          Országos Gyógyszerészeti Intézet

                                          —

                                             Malta

                                          Direttorat tal-Affarijiet Regolatorji, Awtorità Maltija dwar l-iStandards

                                          —

                                             Netherlands

                                                      —

                                                      Ministerie van Volksgezondheid, Welzijn en Sport

                                                      —

                                                      Inspectie voor de Gezondheidszorg

                                          —

                                             Austria

                                                      —

                                                      Bundesministerium für Gesundheit

                                                      —

                                                      Bundesamt für Sicherheit im Gesundheitswesen

                                          —

                                             Poland

                                                      —

                                                      Ministerstwo Zdrowia

                                                      —

                                                      Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

                                          —

                                             Portugal

                                          INFARMED:I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.)

                                          —

                                             Romania

                                          Ministerul Sănătății – Departament Dispozitive Medicale

                                          —

                                             Slovenia

                                                      —

                                                      Ministrstvo za zdravje

                                                      —

                                                      Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

                                          —

                                             Slovakia

                                          Úrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky

                                          —

                                             Finland

                                                      —

                                                      Sosiaali- ja terveysministeriö

                                                      —

                                                      Sosiaali- ja terveysalan lupa- ja valvontavirasto (Valvira)

                                          —

                                             Sweden

                                          Styrelsen för ackreditering och teknisk kontroll (SWEDAC)

                                          —

                                             United Kingdom

                                          Medicines and Healthcare products Regulatory Agency

                     SECTION III

                     PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES

                              The procedures to be followed by New Zealand in designating conformity assessment bodies to assess products against the European Union’s requirements

                              The procedures to be followed by the European Union in designating conformity assessment bodies to assess products against New Zealand’s requirements

                              Conformity assessment bodies to be designated for the purposes of this Sectoral Annex will meet the requirements of the Directives listed in Section I, taking into account Annex II to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, and be designated on the basis of the procedures defined in the Annex to this Agreement. This may be demonstrated through:

                                          (a)

                                          Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either:

                                                      —

                                                      accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), or

                                                      —

                                                      able to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.

                                          (b)

                                          Quality System certification bodies operating according to the requirements of EN 45012 or ISO Guide 62, and either:

                                                      —

                                                      accredited by JAS-ANZ, or

                                                      —

                                                      able to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.

                                          (c)

                                          Inspection bodies operating according to the requirements of ISO/IEC 17020, and either:

                                                      —

                                                      accredited by the Testing Laboratory Registration Council of New Zealand or any other body established by law in New Zealand which replaces it and which has the same functions, or

                                                      —

                                                      able to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.

                                    Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.

                                          1.

                                          The procedures for designating conformity assessment bodies will be consistent with the principles and procedures set out in the Annex to this Agreement.

                                          2.

                                          The following procedures are deemed to be consistent with those set out in the Annex to this Agreement:

                                                      (a)

                                                      Certification bodies:

                                                                  —

                                                                  accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement (MLA) for certification of products,

                                                                  —

                                                                  members of the Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE) CB Scheme,

                                                                  —

                                                                  accredited by an accreditation body with which JAS-ANZ has a mutual recognition agreement, or

                                                                  —

                                                                  able to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.

                                                      (b)

                                                      Testing laboratories:

                                                                  —

                                                                  accredited by accreditation bodies which are signatories to the EA MLA for calibration and testing laboratories,

                                                                  —

                                                                  recognised within the IECEE CB Scheme, or

                                                                  —

                                                                  able to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.

                                    Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.

                     SECTION IV

                     ADDITIONAL PROVISIONS

                  1.   New legislation

                  The Parties note New Zealand’s intention to introduce new legislation concerning medical devices, and jointly decide that the provisions of this Sectoral Annex will apply to this legislation upon its entry into force in New Zealand.
                  The Parties jointly declare their intention to extend the scope of this Sectoral Annex to in vitro diagnostic devices as soon as New Zealand’s new legislation concerning medical devices is in place.
                  2.   Exchange of information

                  The Parties will inform each other of incidents in the context of the medical device vigilance procedure, or with regard to matters concerning product safety. The Parties will also inform each other of:

                              —

                              certificates withdrawn, suspended, restricted or revoked, and

                              —

                              any legislation or amendment to existing legislation adopted on the basis of the legal texts listed in Section I.

                        The contact points through which the information can be passed are:

                              New Zealand:

                                          The Manager

                                          Medicines and Medical Devices Safety Authority (Medsafe)

                                          PO Box 5013

                                          Wellington

                                          New Zealand

                                          Tel. 64-4-819 6874

                                          Fax 64-4-819 6806

                                    and

                                          Group Manager

                                          Energy Safety and Radio Spectrum Management

                                          Ministry of Economic Development (MED)

                                          P.O. Box 1473

                                          Wellington

                                          New Zealand

                                          Tel. 64-4-472-0030

                                          Fax 64-4-471-0500

                              European Union

                                          European Commission

                                          Directorate-General for Health and Consumers

                                          Rue de la Loi/Wetstraat 200

                                          B-1049 Brussels

                                          Tel. 32-2-299 11 11

                        The Parties may exchange information on the consequences of the establishment of the European Database on Medical Devices (Eudamed).
                  In addition, the Medicines and Medical Devices Safety Authority will advise of any certificates issued.
                  3.   Subcontracting

                  Where required by New Zealand legislative, regulatory and administrative provisions, European Union conformity assessment bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with point 2 of Section III.
                  4.   Recording of approvals granted

                  In addition to the requirements imposed by the Annex to this Agreement on the designation of a conformity assessment body, the relevant European Union designating authority will provide to New Zealand, in respect of each designated conformity assessment body, details of the method that such conformity assessment body intends to adopt to record the fact that an approval required by the Secretary under the Electricity Act 1992 (and Regulations made pursuant to that Act) for fittings or appliances to be sold or offered for sale in New Zealand has been granted.
                  5.   Confidence-building with respect to high-risk devices

                              5.1.

                              A confidence-building process for the purpose of strengthening confidence in the designating systems of each of the Parties will apply for the following medical devices:

                                          —

                                          active implantable devices as defined in the legislation referred to in Section I;

                                          —

                                          devices that are classified as class III devices under the legislation referred to in Section I;

                                          —

                                          medical devices that are implantable intra-ocular lenses;

                                          —

                                          medical devices that are intra-ocular visco elastic fluids, and

                                          —

                                          medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease.

                              5.2.

                              The Parties will establish a detailed programme to this effect involving the Medicines and Medical Devices Safety Authority and the European Union’s competent authorities.

                              5.3.

                              The confidence-building period will be reviewed after two years commencing from the date this Sectoral Annex, as amended, becomes effective.

                              5.4.

                              Additional specific requirements for regulatory progress:

                                          5.4.1.

                                          In pursuance of Articles 2, 7(1), 8(1) and 9(1) of this Agreement, either Party may request additional specific requirements in relation to the conformity assessment bodies for the purposes of demonstration of experience in the evolving regulatory systems.

                                          5.4.2.

                                          These specific requirements may include training, observed conformity assessment body audits, visits and information and document exchange, including audit reports.

                                          5.4.3.

                                          These requirements may likewise be applicable in relation to the designation of a conformity assessment body in accordance with this Agreement.

                        6.   Joint Sectoral Group

                  A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint Committee as the latter will determine.
                  The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.
                  7.   Divergence of views

                  Both Parties will use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of conformity assessment reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.

                  Appendix
                  The provisions of this Sectoral Annex will not apply to the following devices:

                              —

                              medical devices that contain or are manufactured using cells, tissues or tissue derivatives of animal origin that have been rendered non-viable, where the safety with regard to viruses or other transferable agents requires validated methods for elimination or viral inactivation in the course of the manufacturing process;

                              —

                              medical devices that contain tissues, cells or substances of microbial, bacterial or recombinant origin and are intended for use in or on the human body;

                              —

                              medical devices incorporating tissues or tissue derivatives of human origin;

                              —

                              medical devices incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;

                              —

                              medical devices that incorporate, or intend to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device, and

                              —

                              medical devices that are intended by the manufacturer specifically to be used for chemical disinfection of another medical device, except for sterilisers using dry heat, moist heat or ethylene oxide.

                        Both Parties may decide by common arrangement to extend the application of this Sectoral Annex to the aforementioned medical devices.
               ’.
         Article 2
   Entry into force
   This Agreement shall enter into force on the first day of the second month following the date on which the Parties have exchanged diplomatic notes confirming the completion of their respective procedures for entry into force of this Agreement

      Done at Brussels, in duplicate, on 23 February 2012 in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages, each text being equally authentic.

         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
         För Europeiska unionen

         За Нοва Зeлaндия
         Por Nueva Zelanda
         Za Nový Zéland
         For New Zealand
         Für Neuseeland
         Uus-Meremaa nimel
         Για τη Nέα Ζηλανδία
         For New Zealand
         Pour la Nouvelle-Zélande
         Per la Nuova Zelanda
         Jaunzēlandes vārdā –
         Naujosios Zelandijos vardu
         Uj-Zéland részéről
         Gћal New Zealand
         Voor Nieuw-Zeeland
         W imieniu Nowej Zelandii
         Pela Nova Zelândia
         Pentru Noua Zeelandă
         Za Nový Zéland
         Za Novo Zelandijo
         Unden-Seelannin puolesta
         För Nya Zeeland

      (1)  OJ L 229, 17.8.1998, p. 62.


Avis juridique important

|

31996D0172

96/172/EC: Decision No 160 of 28 November 1995 concerning the scope of Article 71 (1) (b) (ii) of Council Regulation (EEC) No 1408/71 relating to the right to unemployment benefits of workers, other than frontier workers, who, during their last employment, were residing in the territory of a Member State other than the competent State

Official Journal L 049 , 28/02/1996 P. 0031 - 0033

DECISION No 160 of 28 November 1995 concerning the scope of Article 71 (1) (b) (ii) of Council Regulation (EEC) No 1408/71 relating to the right to unemployment benefits of workers, other than frontier workers, who, during their last employment, were residing in the territory of a Member State other than the competent State (96/172/EC)THE ADMINISTRATIVE COMMISSION OF THE EUROPEAN COMMUNITIES ON SOCIAL SECURITY FOR MIGRANT WORKERS,Having regard to Article 81 (a) of Council Regulation (EEC) No 1408/71, under which it is made responsible for dealing with all matters of interpretation arising from Regulations (EEC) No 1408/71 and (EEC) No 574/72,Having been requested to decide which workers are referred to in Article 71 (1) (b) (ii) of Regulation (EEC) No 1408/71,Whereas the categories of workers expressly referred to by Decision No 131 of 3 December 1985 should be extended and this Decision amended accordingly;Whereas Article 71 of the said Regulation lays down special rules concerning the granting and the payment of unemployment benefits to unemployed persons who, during their last employment, resided in a Member State other than the competent State;Whereas the determining factor for the application of Article 71 in its entirety is the fact that the person concerned resided during his last employment in a Member State other than the one to the legislation of which he was subject, which does not necessarily correspond to the one in which he was employed;Whereas according to the definition given in Article 1 (h) of Regulation (EEC) No 1408/71, the term 'residence` means habitual residence, 'stay` being defined as temporary residence in subparagraph (i) of that Article;Whereas the workers referred to in Articles 14 (1) and 14 (b) (1) of Regulation (EEC) No 1408/71 are presumed in the absence of proof to the contrary to reside in the competent State;Whereas it ensues from the provisions of Article 1 (b) and (c) of Regulation (EEC) No 1408/71 that frontier workers and seasonal workers have their place of residence in a country other than the country of employment, which, by virtue of Article 13 (2) (a) of the said Regulation is the competent country and that there is therefore no doubt that such workers are covered by Article 71 of the same Regulation;Whereas the categories of workers referred to by Articles 13 (2) (c), 14 (2) (a) and (b) and (3) and Article 16 (2) of Regulation (EEC) No 1408/71 and the workers to whom an agreement as referred to in Article 17 of that Regulation applies are likely to reside, in certain cases, in a Member State other than the State determined as being competent under that Article;Whereas for the categories of workers referred to by Article 13 (2) (c), Article 14 (2) (a) and (b) and 3 and Article 16 (2) above and the workers to whom an agreement as referred to in Article 17 of that Regulation applies, determining in what State such workers have their place of residence must be examined on a case by case basis and whereas this must be done for workers referred to in Article 14 (2) (a) and (b) for the purposes of their affiliation;Whereas, under Article 71 (1) (a) (ii) and (b) (ii), responsibility for the payment of benefits is transferred from the competent State to the country of residence where the person concerned puts himself at the disposal of the employment services of the latter country;Whereas, although this is acceptable in the case of frontier workers and of seasonal workers and of certain other categories who likewise retain close links with their country of origin, it would no longer be acceptable if, by too broad an interpretation of the concept of 'residence`, the field of application of Article 71 of Regulation (EEC) No 1408/71 were to be extended to include all migrant workers who have fairly stable employment in a Member State and who have left their families in their country of origin;Acting in accordance with the provisions of Article 80 (3) of Regulation (EEC) No 1408/71,HAS DECIDED AS FOLLOWS:1. In addition to seasonal workers, Article 71 (1) (b) (ii) of Regulation (EEC) No 1408/71 shall apply in particular to the following categories of workers:(a) Workers referred to in Article 13 (2) (c) of the said Regulation;(b) Workers employed in international transport as referred to in Article 14 (2) (a) of the said Regulation;(c) Workers other than workers employed in international transport who normally pursue their occupation in several Member States as referred to in Article 14 (2) (b);(d) Workers employed by an undertaking straddling a common frontier as referred to in Article 14 (3);(e) Workers employed by diplomatic missions and consular posts and the private domestic staff of agents of such missions or posts as referred to in Article 16 (2) of the said Regulation;(f) To workers to whom an agreement as referred to in Article 17 of that Regulation applies,where they resided during their last employment in a Member State other than the competent State.2. Workers referred to in paragraph 1, who during their last employment were subject to the legislation of a Member State other than the State of the place of employment shall be eligible for benefits to the provisions of the legislation of the State of residence, as if they had previously been subject to that legislation.3. Workers referred to in Article 14 (1) and 14 (b) (1) shall be presumed, in the absence of proof to the contrary, to reside in the competent State.4. This Decision, which replaces Decision No 131 of 3 December 1985, shall enter into force on the first day of the month following its publication in the Official Journal of the European Communities.The Chairman of the Administrative CommissionCarlos GARCÍA DE CORTÁZAR Y NEBREDA


title: Council Decision (EU, Euratom) 2016/981 of 16 June 2016 appointing a member of the Court of Auditors

text:
               18.6.2016

               EN

               Official Journal of the European Union

               L 161/39

         COUNCIL DECISION (EU, Euratom) 2016/981
   of 16 June 2016
   appointing a member of the Court of Auditors
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 286(2) thereof,
   Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof,
   Having regard to the proposal by the Republic of Lithuania,
   Having regard to the opinion of the European Parliament (1),
   Whereas:

               (1)

               The term of office of Ms Rasa BUDBERGYTĖ expired on 6 May 2016.

               (2)

               A new appointment should therefore be made,

         HAS ADOPTED THIS DECISION:
   Article 1
   Mr Rimantas ŠADŽIUS is hereby appointed member of the Court of Auditors for the period from 16 June 2016 to 15 June 2022.
   Article 2
   This Decision shall enter into force on the date of its adoption.

      Done at Luxembourg, 16 June 2016.

            For the Council

            The President

         L.F. ASSCHER

      (1)  Opinion of 7 June 2016 (not yet published in the Official Journal).


title: 2014/152/CFSP: Political and Security Committee Decision Atalanta/1/2014 of 18 March 2014 on the appointment of the EU Force Commander for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) and repealing Decision Atalanta/3/2013

text:
               21.3.2014

               EN

               Official Journal of the European Union

               L 85/8

      POLITICAL AND SECURITY COMMITTEE DECISION ATALANTA/1/2014
   of 18 March 2014
   on the appointment of the EU Force Commander for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) and repealing Decision Atalanta/3/2013
   (2014/152/CFSP)
   THE POLITICAL AND SECURITY COMMITTEE,
   Having regard to the Treaty on European Union, and in particular Article 38 thereof,
   Having regard to Council Joint Action 2008/851/CFSP of 10 November 2008 on a European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (1), and in particular Article 6 thereof,
   Whereas:

               (1)

               Pursuant to Article 6(1) of Joint Action 2008/851/CFSP, the Council authorised the Political and Security Committee (‘PSC’) to take decisions on the appointment of the EU Force Commander for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (‘EU Force Commander’).

               (2)

               On 2 December 2013, the PSC adopted Decision Atalanta/3/2013 (2) appointing Rear Admiral Hervé BLEJEAN as EU Force Commander.

               (3)

               The EU Operation Commander has recommended the appointment of Rear Admiral (LH) Jürgen zur MÜHLEN as the new EU Force Commander to succeed Rear Admiral Hervé BLEJEAN.

               (4)

               The EU Military Committee supports that recommendation.

               (5)

               Decision Atalanta/3/2013 should therefore be repealed.

               (6)

               In accordance with Article 5 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and the implementation of decisions and actions of the Union which have defence implications,

         HAS ADOPTED THIS DECISION:
   Article 1
   Rear Admiral (LH) Jürgen zur MÜHLEN is hereby appointed EU Force Commander for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) as from 6 April 2014.
   Article 2
   Decision Atalanta/3/2013 is hereby repealed.
   Article 3
   This Decision shall enter into force on 6 April 2014.

      Done at Brussels, 18 March 2014.

            For the Political and Security Committee

            The Chairperson

         W. STEVENS

      (1)  OJ L 301, 12.11.2008, p. 33.

      (2)  Political and Security Committee Decision Atalanta/3/2013 of 2 December 2013 on the appointment of an EU Force Commander for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) (OJ L 324, 5.12.2013, p. 7).


title: 2005/157/EC: Council Decision of 17 February 2005 appointing two German members and two German alternate members of the Committee of the Regions

text:
               25.2.2005

               EN

               Official Journal of the European Union

               L 52/37

      COUNCIL DECISION

   of 17 February 2005
   appointing two German members and two German alternate members of the Committee of the Regions
   (2005/157/EC)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 263 thereof,
   Having regard to the proposal from the German Government,
   Whereas:

               (1)

               On 22 January 2002 the Council adopted Decision 2002/60/EC (1) appointing the members and alternate members of the Committee of the Regions.

               (2)

               Two seats as members of the Committee of the Regions have become vacant following the expiry of the mandates of Ms Barbara RICHSTEIN and Mr Manfred LENZ, notified to the Council on 12 January 2005, one seat as an alternate member of the Committee of the Regions has become vacant following the expiry of the mandate of Mr Wolfgang KLEIN, notified to the Council on 7 December 2004, and one seat as an alternate member of the Committee of the Regions has become vacant following the resignation of Mr Hans-Georg KLUGE, notified to the Council on 21 December 2004,

         HAS DECIDED AS FOLLOWS:
   Sole Article
   The following are hereby appointed to the Committee of the Regions

               (a)

               as members:

                           Mr Gerd HARMS
                           Bevollmächtigter des Landes Brandenburg für Bundes- und Europaangelegenheiten,
                           Staatssekretär in der Staatskanzlei
                           in place of Ms Barbara RICHSTEIN

                           Ms Barbara RICHSTEIN
                           Abgeordnete des Landtages Brandenburg
                           in place of Mr Manfred LENZ

               (b)

               as alternate members:

                           Mr Markus KARP
                           Staatssekretär im Ministerium für Wissenschaft, Forschung und Kultur
                           in place of Mr Hans-Georg KLUGE

                           Mr Steffen REICHE
                           Mitglied des Landtages
                           in place of Mr Wolfgang KLEIN

         for the remainder of their term of office, which runs until 25 January 2006.

      Done at Brussels, 17 February 2005.

            For the Council

            The President

         J.-C. JUNCKER

      (1)  OJ L 24, 26.1.2002, p. 38.


title: 2010/810/EU: Decision of the European Parliament and of the Council of 15 December 2010 on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 28 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (application EGF/2010/016 ES/Aragón Retail trade from Spain)

text:
               28.12.2010

               EN

               Official Journal of the European Union

               L 342/22

         DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 15 December 2010
   on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 28 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (application EGF/2010/016 ES/Aragón Retail trade from Spain)
   (2010/810/EU)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (1), and in particular point 28 thereof,
   Having regard to Regulation (EC) No 1927/2006 of the European Parliament and of the Council of 20 December 2006 establishing the European Globalisation Adjustment Fund (2), and in particular Article 12(3) thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               The European Globalisation Adjustment Fund (EGF) was established to provide additional support for workers made redundant as a result of major structural changes in world trade patterns due to globalisation and to assist them with their reintegration into the labour market.

               (2)

               The scope of the EGF was broadened for applications submitted from 1 May 2009 to include support for workers made redundant as a direct result of the global financial and economic crisis.

               (3)

               The Interinstitutional Agreement of 17 May 2006 allows the mobilisation of the EGF within the annual ceiling of EUR 500 million.

               (4)

               Spain submitted an application on 6 May 2010 to mobilise the EGF in respect of redundancies in 593 enterprises operating in the NACE Revision 2 Division 47 (Retail trade, except for motor vehicles and motorcycles) in the NUTS II region of Aragón (ES24) and supplemented it with additional information up to 1 July 2010. This application complies with the requirements for determining the financial contributions as laid down in Article 10 of Regulation (EC) No 1927/2006. The Commission therefore proposes to mobilise an amount of EUR 1 560 000.

               (5)

               The EGF should, therefore, be mobilised in order to provide a financial contribution for the application submitted by Spain,

         HAVE ADOPTED THIS DECISION:
   Article 1
   For the general budget of the European Union for the financial year 2010, the European Globalisation Adjustment Fund shall be mobilised to provide the sum of EUR 1 560 000 in commitment and payment appropriations.
   Article 2
   This Decision shall be published in the Official Journal of the European Union.

      Done at Strasbourg, 15 December 2010.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         O. CHASTEL

      (1)  OJ C 139, 14.6.2006, p. 1.

      (2)  OJ L 406, 30.12.2006, p. 1.


title: 2014/716/EU, Euratom: Council Decision, taken by common accord with the President-elect of the Commission, of 15 October 2014 adopting the list of the other persons whom the Council proposes for appointment as Members of the Commission, repealing and replacing Decision 2014/648/EU, Euratom

text:
               17.10.2014

               EN

               Official Journal of the European Union

               L 299/29

         COUNCIL DECISION,
   taken by common accord with the President-elect of the Commission,
   of 15 October 2014
   adopting the list of the other persons whom the Council proposes for appointment as Members of the Commission, repealing and replacing Decision 2014/648/EU, Euratom

      (2014/716/EU, Euratom)

   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on European Union, and in particular Article 17(3) and (5) and the second subparagraph of Article 17(7) thereof,
   Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof,
   Having regard to European Council Decision 2013/272/EU of 22 May 2013 concerning the number of members of the European Commission (1),
   Whereas:

               (1)

               The mandate of the Commission appointed by European Council Decision 2010/80/EU (2) comes to an end on 31 October 2014.

               (2)

               A new Commission, consisting of one national of each Member State, including its President and the High Representative of the Union for Foreign Affairs and Security Policy, should be appointed until 31 October 2019.

               (3)

               The European Council nominated Mr Jean-Claude JUNCKER as the person put forward to the European Parliament as President of the Commission, and the European Parliament elected him as President of the Commission at its Plenary Session of 15 July 2014.

               (4)

               On 30 August 2014, the European Council, in agreement with the President-elect of the Commission, appointed Ms Federica MOGHERINI as High Representative of the Union for Foreign Affairs and Security Policy in accordance with Article 18(1) of the Treaty on European Union.

               (5)

               By Decision 2014/648/EU, Euratom (3), the Council adopted by common accord with the President-elect of the Commission the list of the other persons whom it proposes for appointment as Members of the Commission until 31 October 2019.

               (6)

               By common accord with the President-elect of the Commission, Decision 2014/648/EU, Euratom should be repealed before the list contained in it is subject to the vote of consent of the European Parliament and should be replaced by this Decision.

               (7)

               In accordance with Article 17(7), third subparagraph, of the Treaty on European Union, the President, the High Representative of the Union for Foreign Affairs and Security Policy and the other Members of the Commission are subject as a body to a vote of consent by the European Parliament,

         HAS ADOPTED THIS DECISION:
   Article 1
   By common accord with Mr Jean-Claude JUNCKER, President-elect of the Commission, the Council proposes the following persons for appointment as Members of the Commission until 31 October 2019:

               Mr Vytenis Povilas ANDRIUKAITIS

               Mr Andrus ANSIP

               Mr Miguel ARIAS CAÑETE

               Mr Dimitris AVRAMOPOULOS

               Ms Elżbieta BIEŃKOWSKA

               Ms Violeta BULC

               Ms Corina CREȚU

               Mr Valdis DOMBROVSKIS

               Ms Kristalina GEORGIEVA

               Mr Johannes HAHN

               Mr Jonathan HILL

               Mr Phil HOGAN

               Ms Věra JOUROVÁ

               Mr Jyrki KATAINEN

               Ms Cecilia MALMSTRÖM

               Mr Neven MIMICA

               Mr Carlos MOEDAS

               Mr Pierre MOSCOVICI

               Mr Tibor NAVRACSICS

               Mr Günther OETTINGER

               Mr Maroš ŠEFČOVIČ

               Mr Christos STYLIANIDES

               Ms Marianne THYSSEN

               Mr Frans TIMMERMANS

               Mr Karmenu VELLA

               Ms Margrethe VESTAGER
               in addition to:

               Ms Federica MOGHERINI, appointed High Representative of the Union for Foreign Affairs and Security Policy.

         Article 2
   Decision 2014/648/EU, Euratom is hereby repealed.
   Article 3
   This Decision shall be forwarded to the European Parliament.
   It shall be published in the Official Journal of the European Union.

      Done at Brussels, 15 October 2014.

            For the Council

            The President

         S. GOZI

      (1)  OJ L 165, 18.6.2013, p. 98.

      (2)  European Council Decision 2010/80/EU of 9 February 2010 appointing the European Commission (OJ L 38, 11.2.2010, p. 7).

      (3)  Council Decision, taken by common accord with the President-elect of the Commission, of 5 September 2014 adopting the list of the other persons whom the Council proposes for appointment as Members of the Commission (2014/648/EU, Euratom) (OJ L 268, 9.9.2014, p. 5).


Avis juridique important

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31991D0617

91/617/EEC: Council Decision of 28 October 1991 concerning the conclusion of an Agreement between the European Economic Community and the Principality of Liechtenstein establishing cooperation in the field of education and training within the framework of the Erasmus programme

Official Journal L 332 , 03/12/1991 P. 0061 - 0061

COUNCIL DECISION of 28 October 1991 concerning the conclusion of an Agreement between the  European Economic Community and the Principality of Liechtenstein establishing cooperation in the  field of education and training within the framework of the Erasmus programme (91/617/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  235 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas by Decision 87/327/EEC (3) as amended by Decision 89/663/EEC (4), the Council adopted the  European Community Action Scheme for the Mobility of University Students (Erasmus); Whereas on 5 November 1990, the Council authorized the Commission to negotiate with the EFTA  countries and Liechtenstein, in accordance with specific negotiating Directives, bilateral  agreements having as their objective cooperation in the field of education and training within the  framework of the Erasmus programme; Whereas a Cooperation Agreement between the European Economic Community and the Principality of  Liechtenstein, by its nature enriches the impact of the Erasmus programme so as to develop  inter-university cooperation and to strengthen the skill levels of human resources in Europe, HAS DECIDED AS FOLLOWS: Article 1 The Agreement between the European Economic Community and the Principality of Liechtenstein of  Austria establishing cooperation in the field of education and training within the framework of the  Erasmus programme is hereby approved on behalf of the Community. The text of the Agreement is attached to this Decision. Article 2 The President of the Council shall give the notification provided for in Article 13 of the  Agreement (5). Done at Luxembourg, 28 October 1991. For the Council The President J. M. M. RITZEN (1) OJ N° C 127, 17. 5. 1991, p. 3. (2) Opinion delivered on 24 October 1991 (not yet published in the Official Journal). (3) OJ N° L 166, 25. 6. 1987, p. 20. (4) OJ N° L 395, 30. 12. 1989, p. 23. (5) See page 71 of this Official Journal.