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European Medicines Agency (EMA)
Article 9

Article 9

1.

The Agency shall forthwith inform the applicant if the opinion of the Committee for Medicinal Products for Human Use is that:

(a)

the application does not satisfy the criteria for authorisation set out in this Regulation;

(b)

the summary of the product characteristics proposed by the applicant needs to be amended;

(c)

the labelling or package leaflet of the product is not in compliance with Title V of Directive 2001/83/EC;

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(d)

the authorisation needs to be granted subject to the conditions provided for in Article 14(8) and Article 14-a.

▼B
2.
Within 15 days after receipt of the opinion referred to in paragraph 1, the applicant may give written notice to the Agency that he wishes to request a re-examination of the opinion. In that case, the applicant shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion.

Within 60 days following receipt of the grounds for the request, the said Committee shall re-examine its opinion in accordance with the conditions laid down in the fourth subparagraph of Article 62(1). The reasons for the conclusion reached shall be annexed to the final opinion.

3.
Within 15 days after its adoption, the Agency shall send the final opinion of the said Committee to the Commission, to the Member States and to the applicant, together with a report describing the assessment of the medicinal product by the Committee and stating the reasons for its conclusions.
4.

If an opinion is favourable to the granting of the relevant authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion:

(a)

a draft summary of the product characteristics, as referred to in Article 11 of Directive 2001/83/EC;

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(aa)

a recommendation on the frequency of submission of periodic safety update reports;

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(b)

details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, in accordance with the criteria laid down in Title VI of Directive 2001/83/EC;

(c)

details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product;

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(ca)

details of any recommended measures for ensuring the safe use of the medicinal product to be included in the risk management system;

(cb)

if appropriate, details of any recommended obligation to conduct post-authorisation safety studies or to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Chapter 3;

(cc)

if appropriate, details of any recommended obligation to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 10b while taking into account the scientific guidance referred to in Article 108a of Directive 2001/83/EC;

▼B
(d)

the draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Title V of Directive 2001/83/EC;

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(e)

the assessment report as regards the results of the pharmaceutical and pre-clinical tests and of the clinical trials, and as regards the risk management system and the pharmacovigilance system for the medicinal product concerned.

▼B