Article 13c: ‘Prior Approval’ procedure for major variations of type II

Location:

Chapter IIA

Source:

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 may extend it to 90 days for variations listed in Annex V or for grouping of variations in accordance with Article 13d(2), first subparagraph, point (c).

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.