1.

The text of the introductory part of Chapter XIII of Annex II to the Agreement shall be replaced as of the fourth paragraph by the following: ‘When decisions on approval of medicinal products are taken according to the Community procedures laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council, Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council, and Directive 2001/82/EC of the European Parliament and of the Council, as amended by Directive 2004/28/EC of the European Parliament and of the Council, the EFTA States shall simultaneously and within 30 days of the Community Decision, take corresponding decisions on the basis of the relevant acts. The EEA Joint Committee shall be informed and shall periodically publish lists of such decisions in the EEA Supplement to the Official Journal. The EFTA Surveillance Authority shall monitor the application of the decisions taken by the EFTA States as provided for in Article 109 of the Agreement. Where any of the relevant acts provide for Community procedures on the granting, suspension and withdrawal of a marketing authorisation as well as supervision, including pharmacovigilance, and inspections and sanctions, these and similar tasks shall be carried out by the competent authorities in the EFTA States, on the basis of the same obligations as those of the competent authorities of EC Member States. Should any disagreement between the contracting parties arise as to the administration of these provisions, Part VII of the Agreement shall apply mutatis mutandis. The EFTA States shall participate in the work of the European Medicines Agency, hereinafter referred to as “the Agency”, as set up by Regulation (EC) No 726/2004 of the European Parliament and of the Council. The financial provisions of Title IV, Chapter 2, of Regulation (EC) No 726/2004 of the European Parliament and of the Council shall apply to the participation of the EFTA States in the work of the Agency. The EFTA States shall therefore participate in the Community contribution referred to in Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council. For this purpose the procedures laid down in Article 82(1)(a) and Protocol 32 of the Agreement shall apply mutatis mutandis with regard to the financial contribution of the EFTA States to the above mentioned Community contribution. The EFTA States may send observers to meetings of the Agency's Management Board. The EFTA States shall be fully associated with the work of the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Committee on Orphan Medicinal Products (COMP) and the Committee on Herbal Medicinal Products (HMPC). The detailed arrangements of participation for the representatives of EFTA States shall be in accordance with the provisions of Title IV, chapter 1, of Regulation (EC) No 726/2004 of the European Parliament and of the Council. Such representatives shall, however, not participate in the voting and their positions shall be recorded separately. The position of Chairman shall be reserved for a member nominated by an EC Member State. The EFTA States shall be fully associated with the work of the Coordination Group as set up by Article 27 of Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council, and Article 31 of Directive 2001/82/EC of the European Parliament and of the Council, as amended by Directive 2004/28/EC of the European Parliament and of the Council. The representatives of the EFTA States shall, however, not participate in the voting and their positions shall be recorded separately. The position of Chairman shall be reserved for a member nominated by an EC Member State. An EFTA State may request the Agency to initiate an arbitration procedure according to Title III, Chapter 4 of Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council, and according to Title III, Chapter 4 of Directive 2001/82/EC of the European Parliament and of the Council, as amended by Directive 2004/28/EC of the European Parliament and of the Council. Such a request shall, in the first place, be addressed to the Commission which shall, where it considers that the request is of common interest, forward it to the Agency for further processing. The EFTA States shall fully participate in the Telematic Exchange of Information on Medicinal Products (IMP) programme. Iceland and Norway shall provide their national competent authorities and the marketing authorisation holders with the linguistic version of the marketing authorisations required to access their own market. A marketing authorisation granted for a medicinal product following an opinion adopted by the competent EMEA scientific Committee in accordance with Article 9 or Article 34 of Regulation (EC) No 726/2004 of the European Parliament and of the Council shall not be subject to any fees other than those referred to in Article 67(3) and Article 70 of Regulation (EC) No 726/2004 of the European Parliament and of the Council. The Agency having legal personality shall enjoy in all the States of the Contracting Parties the most extensive legal capacity accorded to legal persons under their laws. The EFTA States shall apply to the Agency the Protocol of Privileges and Immunities of the European Communities. Regulation (EC) No 1049/2001 of the European Parliament and the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents shall, for the application of Regulation (EC) No 726/2004 of the European Parliament and of the Council, apply to any documents of the Agency regarding the EFTA States as well. By way of derogation from Article 12(2)(a) of the Conditions of employment of other servants of the European Communities, nationals of the EFTA States enjoying their full rights as citizens may be engaged under contract by the Executive Director of the Agency.’