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 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 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.
6. 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.