Commission Regulation (EC) No 1234/2008Dangos y teitl llawn

CHAPTER III VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS

Article 14 Notification procedure for minor variations of type IA

1. Where a minor variation of type IA is made, the holder shall submit to the Agency a notification containing the elements listed in Annex IV. This notification shall be submitted within 12 months following 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 17 shall be taken.

Article 15 Notification procedure for minor variations of type IB

1. The holder shall submit to the Agency a notification containing the elements listed in Annex IV.

If the notification fulfils the requirement laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid notification.

2. If within 30 days following the acknowledgement of receipt of a valid notification the Agency has not sent the holder an unfavourable opinion, its opinion shall be deemed favourable.

Where the opinion of the Agency on the notification is favourable, the measures provided for in Article 17 shall be taken.

3. Where the Agency 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 of receipt of the unfavourable opinion, the holder may submit to the Agency 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 and the measures provided for in Article 17 shall be taken.

4. Where an amended notification has been submitted, the Agency shall assess it within 30 days following its receipt and the measures provided for in Article 17 shall be taken.

Article 16 ‘Prior Approval’ procedure for major variations of type II

1. The holder shall submit to the Agency an application containing the elements listed in Annex IV.

If the application fulfils the requirements laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid application.

2. The Agency shall issue an opinion on the valid application referred to in paragraph 1 within 60 days following its receipt.

The Agency 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.

The period referred to in the first subparagraph shall be 90 days for variations listed in Part 2 of Annex V.

3. Within the period referred to in paragraph 2, the Agency may request the holder to provide supplementary information within a time limit set by the Agency. The procedure shall be suspended until such time as the supplementary information has been provided. In this case the Agency may extend the period referred to in paragraph 2.

4. Article 9(1) and (2) and Article 34(1) and (2) of Regulation (EC) No 726/2004 shall apply to the opinion on the valid application.

Within 15 days from the adoption of the final opinion on the valid application, the measures provided for in Article 17 shall be taken.

Article 17 Measures to close the procedures of Articles 14 to 16

1. Where reference is made to this Article, the Agency shall take the following measures:

(a) it shall inform the holder and the Commission as to whether its opinion on the variation is favourable or unfavourable;

(b) where its opinion on the variation is unfavourable, it shall inform the holder and the Commission of the grounds for that opinion;

(c) it shall inform the holder and the Commission as to whether the variation requires any amendment to the decision granting the marketing authorisation.

2. Where reference is made to this Article, the Commission shall, where necessary, based on a proposal from the Agency and within the time limit laid down in paragraph 1 of Article 23, amend the decision granting the marketing authorisation and update the Community Register of Medicinal Products provided for in Article 13(1) and Article 38(1) of Regulation (EC) No 726/2004 accordingly.

Article 18 Human influenza vaccines

1. By way of derogation from Article 16, the procedure laid down in paragraphs 2 to 7 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 Agency an application containing the elements listed in Annex IV.

If the application fulfils the requirements laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid application and inform the holder that the procedure starts from the date of such acknowledgement.

3. Within 45 days following the acknowledgement of receipt of a valid application, the Agency shall give its opinion on the application.

4. Within the period referred to in paragraph 3, the Agency may request the holder to provide supplementary information.

5. The Agency shall submit forthwith its opinion to the Commission.

The Commission shall, where necessary and on the basis of that opinion, adopt a decision on the variation to the terms of the marketing authorisation and inform the holder accordingly.

6. Where requested, the holder shall submit the clinical data and the data concerning the stability of the medicinal product to the Agency within 12 days from the expiry of the period referred to in paragraph 3.

The Agency shall evaluate the data referred to in the first subparagraph and shall give its final opinion within 10 days following receipt of the data. The Agency shall communicate its final opinion to the Commission and to the holder within three days from the date of issue of its final opinion.

7. Where necessary and based on the final opinion of the Agency, the Commission shall amend the decision granting the marketing authorisation and update the Community Register of Medicinal Products provided for in Article 13(1) of Regulation (EC) No 726/2004 accordingly.