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Regulation (EC) No 726/2004 of the European Parliament and of the CouncilShow full title
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
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- Revised 30/03/20190.64 MB
- Revised 28/01/20190.52 MB
- Revised 05/06/20130.92 MB
- Revised 04/12/20120.92 MB
- Revised 02/07/20120.92 MB
- Revised 06/07/20090.20 MB
- Revised 20/04/20090.20 MB
- Revised 30/12/20080.20 MB
- Revised 26/01/20070.20 MB
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Changes over time for: Article 35
Version Superseded: 31/12/2020
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Article 35U.K.
1.Within 15 days after receipt of the opinion referred to in Article 30(2), the Commission shall prepare a draft of the decision to be taken in respect of the application.
Where a draft decision envisages the granting of marketing authorisation, it shall include or make reference to the documents mentioned in Article 34(4)(a) to (e).
Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.
The draft decision shall be forwarded to Member States and the applicant.
2.The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 87(3).
3.The Standing Committee for Veterinary Medicinal Products referred to in Article 87(1) shall adjust its rules of procedure so as to take account of the tasks assigned to it by this Regulation.
The adjustments shall provide that:
(a)the opinion of the said Standing Committee is to be given in writing;
(b)Member States shall have 22 days to forward their written observations on the draft decision to the Commission; however, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days;
(c)Member States may request in writing that the draft decision referred to in paragraph 1 be discussed at a plenary meeting of the said Standing Committee, stating their reasons in detail.
4.Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion delivered by the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.
5.The provisions necessary for the implementation of paragraph 4 shall be adopted by the Commission in accordance with the procedure referred to in Article 87(2).
6.The Agency shall disseminate the documents referred to in Article 34(4) (a) to (e).
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