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

Location:

Chapter III

Source:

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 may extend it to 90 days for variations listed in Annex V or for grouping of variations in accordance with Article 7(2), first subparagraph, point (c).

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) 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.

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.