(10)

the following Chapter IIa is inserted after Article 13: ‘CHAPTER IIa VARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS Article 13a Notification procedure for minor variations of type IA 1. Where a minor variation of type IA is made, the holder shall submit to the competent authority a notification containing the elements listed in Annex IV. This notification shall be submitted within 12 months following the implementation of the variation. However, the notification shall be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned. 2. Within 30 days following receipt of the notification, the measures provided for in Article 13e shall be taken. Article 13b Notification procedure for minor variations of type IB 1. The holder shall submit to the competent authority a notification containing the elements listed in Annex IV. If the notification fulfils the requirement laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid notification. 2. If within 30 days following the acknowledgement of receipt of a valid notification, the competent authority has not sent the holder an unfavourable opinion, the notification shall be deemed accepted by the competent authority. Where the notification is accepted by the competent authority, the measures provided for in Article 13e shall be taken. 3. Where the competent authority is of the opinion that the notification cannot be accepted, it shall inform the holder, stating the grounds on which its unfavourable opinion is based. Within 30 days following the receipt of the unfavourable opinion, the holder may submit to the competent authority an amended notification in order to take due account of the grounds laid down in that opinion. If the holder does not amend the notification in accordance with the second subparagraph, the notification shall be deemed rejected. 4. Where an amended notification has been submitted, the competent authority shall assess it within 30 days following its receipt and the measures provided for in Article 13e shall be taken. 5. This Article shall not apply where a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension. In such case, the prior approval procedure in Article 13c shall apply. This Article shall not apply where a type IB variation request is submitted in a grouping that includes an extension. In such case, the procedure in Article 19 shall apply. Article 13c “Prior Approval” procedure for major variations of type II 1. The holder shall submit to the competent authority an application containing the elements listed in Annex IV. If the application fulfils the requirements laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid application. 2. Within 60 days following the acknowledgement of receipt of a valid application, the competent authority shall conclude the assessment. The competent authority may reduce the period referred to in the first subparagraph, having regard to the urgency of the matter, or extend it to 90 days for variations listed in Part 1 of Annex V or for grouping of variations in accordance with Article 13d(2)(c). The period referred to in the first subparagraph shall be 90 days for variations listed in Part 2 of Annex V. 3. Within the periods referred to in paragraph 2, the competent authority may request the holder to provide supplementary information within a time limit set by the competent authority. In this case the procedure shall be suspended until such supplementary information has been provided and the competent authority may extend the period referred to in paragraph 2. 4. Within 30 days after the conclusion of the assessment, the measures provided for in Article 13e shall be taken. 5. This Article shall not apply where a type II variation request is submitted in a grouping that includes an extension. In such case, the procedure in Article 19 shall apply. Article 13d Grouping of variations to purely national marketing authorisations 1. Where several variations are notified or applied for, a separate notification or application in accordance with Articles 13a, 13b, 13c, or 19 as appropriate shall be submitted to the competent authority in respect of each variation sought. 2. By way of derogation from paragraph 1 the following shall apply: (a) where the same minor variation(s) of type IA to the terms of one or more marketing authorisations owned by the same holder are notified at the same time to the same competent authority, a single notification as referred to in Article 13a may cover all such variations; (b) where several variations to the terms of the same marketing authorisation are submitted at the same time to the same competent authority, a single submission may cover all such variations provided that the variations concerned fall within one of the cases listed in Annex III; (c) where the same variation(s) to the terms of one or more marketing authorisations owned by the same holder are submitted at the same time to the same competent authority and they are not covered under subparagraph (a) or (b), a single submission may cover all such variations provided that the competent authority agrees to such single submission. The submission referred to in points (b) and (c) shall be made by means of the following: (i) a single notification in accordance with Article 13b where at least one of the variations is a minor variation of type IB and the remaining variations are minor variations; (ii) a single application in accordance with Article 13c where at least one of the variations is a major variation of type II and none of the variations is an extension; (iii) a single application in accordance with Article 19 where at least one of the variations is an extension. Article 13e Measures to close the procedures of Articles 13a to 13c Where reference is made to this Article, the competent authority shall take the following measures: (a) it shall inform the holder as to whether the variation is accepted or rejected; (b) where the variation is rejected, it shall inform the holder of the grounds for the rejection; (c) where necessary, it shall amend the decision granting the marketing authorisation in accordance with the accepted variation within the time limit laid down in paragraph 1 of Article 23. Article 13f Human influenza vaccines 1. By way of derogation from Article 13c, the procedure laid down in paragraphs 2 to 4 shall apply to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine. 2. The holder shall submit to the competent authority an application containing the elements listed in Annex IV. If the application fulfils the requirements laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid application. 3. The competent authority shall assess the application submitted. Where deemed necessary, the competent authority may request additional data to the holder in order to complete its assessment. 4. The competent authority shall adopt a decision within 45 days from the receipt of a valid application and shall take the measures provided for in Article 13e. The 45-day period referred to in the first subparagraph shall be suspended from the moment when the additional data referred to in paragraph 3 is requested until the data is submitted.’;