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Commission Regulation (EC) No 1234/2008Show full title
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)
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- Revised 02/11/20120.74 MB
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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.
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