What changed between the plenary report and the adopted text

Added:3. A marketing authorisation granted under the purely national marketing authorisation procedure shall be valid only in the Member State of the competent authority that granted it.

Added:Section 3 Marketing authorisations valid in several Member States

Added:Article 33 Scope of decentralised procedure for national marketing authorisations

Added:1. An application for marketing authorisation under the decentralised procedure for national marketing authorisation in several Member States in respect of the same medicinal product shall be submitted to the competent authorities in those Member States in which the marketing authorisation is applied.

Added:2. The competent authorities in the Member State concerned shall examine the applications in accordance with Articles 29, 30 and 34 and grant a marketing authorisation in accordance with Articles 43 to 45.

Added:3. Where a competent authority of the Member State notes that another marketing authorisation application for the same medicinal product is being examined by the competent authority in another Member State, the competent authorities of the Member States concerned shall decline to examine the application and shall advise the applicant that the provisions referred to in Articles 35 and 36 apply.

Added:4. Where the competent authorities of the Member States are informed that another Member State has authorised a medicinal product that is the subject of a marketing authorisation application in the Member State concerned, they shall reject the application unless it was submitted in compliance with the provisions referred to in Articles 35 and 36.

Added:5. Marketing authorisations granted under decentralised procedure for national marketing authorisation shall be valid only in those Member States of the competent authority that granted it.

Added:Article 34 Decentralised procedure for national marketing authorisations

Added:1. With a view to obtain a national marketing authorisation for a medicinal product in several Member States in respect of the same medicinal product under the decentralised procedure for national marketing authorisation, an applicant shall submit a marketing authorisation application based on an identical dossier to the competent authority of the Member State chosen by the applicant, to prepare an assessment report on the medicinal product in accordance with Article 43(5) and to act in accordance with this Section (‘reference Member State for the decentralised procedure’), and to the competent authorities in the other Member States concerned.

Added:2. The application for marketing authorisation shall contain:

Added:(a) the particulars and documentations referred to Articles 6, 9 to 14 and 62;

Added:(b) a list of Member States concerned by the application.

Added:3. The applicantcompetent authority of the reference Member State for the decentralised procedure shall inform allthe Coordination group for decentralised and mutual recognition procedures of an application, which shall thereafter notify the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay. [Am. 150]

Added:4. In cases where on examination of an application for a marketing authorisation the competent authority of the reference Member State for the decentralised procedure considers that the submitted data are not of sufficient quality or maturity for the completion of the examination of the application, the examination can be terminated within 90 days of the validation of the application.

Added:The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn by default. [Am. 151]

Added:The competent authority of the reference Member State for the decentralised procedure shall inform the competent authorities of the Member States concerned and the applicant accordingly.

Added:5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant.

Added:6. Within 60 days of receipt of the assessment report, the competent authorities of the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the competent authority of the reference Member State for the decentralised procedure accordingly. The competent authority of the reference Member State for the decentralised procedure shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

Added:7. Within 30 days after acknowledgement of the agreement, the competent authorities of all Member States concerned in which an application has been submitted in accordance with paragraph 1 shall adopt a decision according to Articles 43 to 45 and in conformity with the approved assessment report, the summary of product characteristics and the labelling and package leaflet as approved.

Added:Section 4 Mutual recognition of national marketing authorisations

Added:Article 35 Scope of mutual recognition procedure for national marketing authorisations

Added:An application for marketing authorisation for mutual recognition procedure for national marketing authorisation, granted under Articles 43 to 45 and in accordance with Article 32, shall be submitted to the competent authorities of other Member States in accordance with the procedure laid down in Article 36.

Added:Article 36 Mutual recognition procedure for national marketing authorisations

Added:1. An application for mutual recognition of a marketing authorisation, granted under Articles 43 to 45 and in accordance with Article 32, in several Member States in respect of the same medicinal product shall be submitted to the competent authority of the Member State that granted the marketing authorisation (‘reference Member State for the mutual recognition procedure’) and to the competent authorities of the Member States concerned where the applicant seeks to obtain a national marketing authorisation.

Added:2. Application shall include a list of Member States concerned by the application.

Added:3. The competent authority of the reference Member State for the mutual recognition procedure shall reject an application for mutual recognition of marketing authorisation of medicinal product within a year from the granting of that marketing authorisation, unless the competent authority of the Member State informs the competent authority of the reference Member State for the mutual recognition procedure of its interest in this medicinal product.

Added:4. The applicantcompetent authority of the reference Member State for the decentralised procedure shall inform the Coordination group for decentralised and mutual recognition procedures of an application, which shall thereafter notify the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay. [Am. 152]

Added:5. If the competent authorities of the Member States concerned so require, the marketing authorisation holder shall request the competent authority of the reference Member State for the mutual recognition procedure to update the assessment report drawn on the medicinal concerned by the application. In that case, the reference Member State shall update the assessment report within 90 days after validation of the application. If the competent authorities of the Member States concerned do not require the update of the assessment report, the reference Member State shall provide the assessment report within 30 days.

Added:6. Within 60 days of receipt of the assessment report, the competent authorities of the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and package leaflet and shall inform the competent authority of the reference Member State accordingly.

Added:7. The competent authority of reference Member State for the mutual recognition procedure shall record the agreement of all parties, close the procedure and inform the applicant accordingly. The assessment report together with the summary of product characteristics, labelling and package leaflet approved by the competent authority of the reference Member State for the mutual recognition procedure shall be sent to the Member States concerned and to the applicant.

Added:8. Within 30 days after acknowledgement of the agreement, the competent authorities of all Member States concerned in which an application has been submitted in accordance with paragraph 1 shall adopt a decision according to Articles 43 to 45 in conformity with the approved assessment report, the summary of product characteristics, the labelling and package leaflet as approved.

Added:Section 5 Coordination of national marketing authorisation

Added:Article 37 Coordination group for decentralised and mutual recognition procedures

Added:1. A coordination group for decentralised and mutual recognition procedures (‘coordination group’) shall be set up for the following purposes:

Added:(a) the examination of any question relating to a national marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Sections 3, 4 and 5 of this Chapter, and Article 95;

Added:(b) the examination of questions related to the pharmacovigilance of medicinal products covered by national marketing authorisations, in accordance with Articles 108, 110, 112, 116 and 121;

Added:(c) the examination of questions relating to variations of national marketing authorisations, in accordance with Article 93(1).

Added:For the fulfilment of its pharmacovigilance tasks contemplated under first subparagraph, point (b), including approving risk management systems and monitoring their effectiveness, the coordination group shall rely on the scientific assessment and the recommendations of the Pharmacovigilance Risk Assessment Committee referred to in Article 149 of [revised Regulation (EC) No 726/2004].

Added:2. The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Member States may appoint an alternateAlternates may be appointed for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts. [Am. 153]

Added:Members of the coordination group and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to competent authorities of the Member States. Each competent authority of the Member State shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts.

Added:Article 147 of [revised Regulation (EC) No 726/2004] shall apply to the coordination group as regards transparency and the independence of its members.

Added:3. The Agency shall provide the secretariat of this coordination group. The coordination group shall draw up its own Rules of Procedure, which shall enter into force after a favourable opinion has been given by the Commission. These Rules of Procedure shall be made publicly available.

Added:4. The Executive Director of the Agency or the representative of the Executive Director and representatives of the Commission shall be entitled to attend all meetings of the coordination group.

Added:5. The members of the coordination group shall ensure that there is appropriate coordination between the tasks of that group and the work of competent authorities of the Member States, including the consultative bodies concerned with the marketing authorisation.

Added:6. Where otherwise provided for in this Directive, within the coordination group, all Member States representatives shall use their best endeavours to reach a position by consensus on the action to be taken. If such a consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall prevail.

Added:7. Members of the coordination group shall be required, even after their duties have ceased, not to disclose information of the kind covered by the obligation of professional secrecy.

Added:Article 38 Divergent positions of Member States in decentralised or mutual recognition procedure

Added:1. If, at the end of the period laid down in Articles 34(6) or 36(6), there is disagreement between Member States on whether the marketing authorisation can be issued, on the grounds of potential serious risk to public health, the disagreeing Member State concerned shall give a detailed explanation of the points of disagreement and the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be referred to the coordination group without undue delay.

Added:2. Guidelines to be adopted by the Commission shall define a potential serious risk to public health.

Added:3. Within the coordination group, all disagreeing Member States concerned shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known orally or in writing. If, within 60 days of the communication of the points of disagreement, the Member States reach an agreement by consensus, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. The procedure laid down in Articles 34(7) or 36(8) shall apply.

Added:4. If within the 60-day period laid down in paragraph 3, an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 41 and 42.

Added:5. In the circumstances referred to in paragraph 4, Member States that have approved the assessment report, the summary of product characteristics, the labelling and package leaflet of the reference Member State may, at the request of the applicant, authorise the medicinal product without waiting for the outcome of the procedure laid down in Article 41. In that event, the national marketing authorisation granted shall be without prejudice to the outcome of that procedure.

Added:Article 39 Referral procedure of divergent decisions of Member States

Added:If applications for a national marketing authorisation have been submitted in accordance with Articles 6 and 9 to 14 for a particular medicinal product, and if Member States have adopted divergent decisions concerning the national marketing authorisation, its variation, suspension or revocation or the summary of product characteristics, the competent authority of the Member State, the Commission or the marketing authorisation holder may refer the matter to the Committee for Medicinal Products for Human Use for the application of the procedure laid down in Articles 41 and 42.

Added:Article 40 Harmonisation of summary of product characteristics

Added:1. In order to promote the harmonisation of national marketing authorisations for medicinal products throughout the Union, the competent authorities of the Member States shall, each year, forward to the coordination group referred to in Article 37 a list of medicinal products for which a harmonised summary of product characteristics is to be drawn up.

Added:2. The coordination group shall lay down a list of medicinal products for which a harmonised summary of product characteristics is to be drawn up, taking into account the proposals from the competent authorities of all Member States, and shall forward that list to the Commission.

Added:3. The Commission or the competent authority of a Member State, in agreement with the Agency and taking into account the views of interested parties, may refer the matter concerning the harmonisation of summary of products characteristics of those medicinal products to the Committee for Medicinal Products for Human Use for the application of the procedure laid down in Articles 41 and 42.

Added:Article 41 Scientific evaluation by the Committee for Medicinal Products for Human Use in a referral procedure