Commission Regulation (EC) No 1234/2008Show full title

CHAPTER II VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC

Article 8 Notification procedure for minor variations of type IA

1. Where a minor variation of type IA is made, the holder shall submit simultaneously to all relevant authorities 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 11 shall be taken.

Article 9 Notification procedure for minor variations of type IB

1. The holder shall submit simultaneously to all relevant authorities a notification containing the elements listed in Annex IV.

If the notification fulfils the requirement laid down in the first subparagraph, the competent authority of the reference Member State shall, after consulting the other Member States concerned, acknowledge receipt of a valid notification.

2. If within 30 days following the acknowledgement of receipt of a valid notification, the competent authority of the reference Member State has not sent the holder an unfavourable opinion, the notification shall be deemed accepted by all relevant authorities.

Where the notification is accepted by the competent authority of the reference Member State, the measures provided for in Article 11 shall be taken.

3. Where the competent authority of the reference Member State is of the opinion that the notification cannot be accepted, it shall inform the holder and the other relevant authorities, 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 all relevant authorities 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 by all relevant authorities and the measures provided for in Article 11 shall be taken.

4. Where an amended notification has been submitted, the competent authority of the reference Member State shall assess it within 30 days following its receipt and the measures provided for in Article 11 shall be taken.

Article 10 ‘Prior Approval’ procedure for major variations of type II

1. The holder shall submit simultaneously to all relevant authorities an application containing the elements listed in Annex IV.

If the application fulfils the requirements laid down in the first subparagraph, the competent authority of the reference Member State shall acknowledge receipt of a valid application and inform the holder and the other relevant authorities that the procedure starts from the date of such acknowledgement.

2. Within 60 days following the acknowledgement of receipt of a valid application, the competent authority of the reference Member State shall prepare an assessment report and a decision on the application, which shall be communicated to the other relevant authorities.

The competent authority of the reference Member State 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 competent authority of the reference Member State may request the holder to provide supplementary information within a time limit set by that competent authority. In this case:

(a) the competent authority of the reference Member State shall inform the other competent authorities concerned of its request for supplementary information;

(b) the procedure shall be suspended until such supplementary information has been provided;

(c) the competent authority of the reference Member State may extend the period referred to in paragraph 2.

4. Without prejudice to Article 13 and within 30 days following receipt of the decision and of the assessment report referred to in paragraph 2, the relevant authorities shall recognise the decision and inform the competent authority of the reference Member State accordingly.

If, within the period referred to in the first subparagraph, a relevant authority has not expressed its disagreement in accordance with Article 13, the decision shall be deemed recognised by that relevant authority.

5. Where the decision referred to in paragraph 2 has been recognised by all relevant authorities in accordance with paragraph 4, the measures provided for in Article 11 shall be taken.

Article 11 Measures to close the procedures of Articles 8 to 10

1. Where reference is made to this Article, the competent authority of the reference Member State shall take the following measures:

(a) it shall inform the holder and the other relevant authorities as to whether the variation is accepted or rejected;

(b) where the variation is rejected, it shall inform the holder and the other relevant authorities of the grounds for the rejection;

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

2. Where reference is made to this Article, each relevant authority shall, where necessary and within the time limit laid down in paragraph 1 of Article 23, amend the decision granting the marketing authorisation in accordance with the accepted variation.

Article 12 Human influenza vaccines

1. By way of derogation from Article 10, the procedure laid down in paragraphs 2 to 6 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 simultaneously to all relevant authorities an application containing the elements listed in Annex IV.

If the application fulfils the requirements laid down in the first subparagraph, the competent authority of the reference Member State shall acknowledge receipt of a valid application and inform the holder and the other relevant authorities that the procedure starts from the date of such acknowledgement.

3. Within 30 days following the acknowledgement of receipt of a valid application, the competent authority of the reference Member State shall prepare an assessment report and a decision on the application, which shall be communicated to the other relevant authorities.

4. Within the period referred to in paragraph 3, the competent authority of the reference Member State may request the holder to provide supplementary information. It shall inform the other relevant authorities accordingly.

5. Within 12 days from the date of receipt of the decision and of the assessment report referred to in paragraph 3, the relevant authorities shall recognise the decision and inform the competent authority of the reference Member State accordingly.

6. Where requested by the competent authority of the reference Member State, the clinical data and data concerning the stability of the medicinal product shall be submitted by the holder to all relevant authorities within 12 days from the expiry of the period referred to in paragraph 5.

The competent authority of the reference Member State shall evaluate the data referred to in the first subparagraph and draft a final decision within seven days following receipt of the data. The other relevant authorities shall, within seven days following its receipt, recognise that final decision and adopt a decision in accordance with the final decision.

Article 13 Coordination group and arbitration

1. Where recognition of a decision in accordance with Article 10(4) or approval of an opinion in accordance with point (b) of Article 20(8) is not possible on grounds of a potential serious risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, on grounds of a potential serious risk to human or animal health or to the environment, a relevant authority shall request that the matter of disagreement be forthwith referred to the coordination group.

The party in disagreement shall give a detailed statement of the reasons for its position to all Member States concerned and to the applicant.

2. Article 33(3), (4) and (5) of Directive 2001/82/EC or Article 29(3), (4) and (5) of Directive 2001/83/EC shall apply to the matter of disagreement referred to in paragraph 1.