1. When reference is made to the procedure described in this Article, the Committee shall consider the matter concerned and issue a reasoned opinion within 90 days of the date on which the matter was referred to it.
However, in cases submitted to the Committee in accordance with Articles 30 and 31, this period may be extended by 90 days.
In case of urgency, on a proposal from its Chairman, the Committee may agree to a shorter deadline.
2. In order to consider the matter, the Committee may appoint one of its members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks.
3. In the cases referred to in Articles 29 and 30, before issuing its opinion, the Committee shall provide the marketing authorization holder with an opportunity to present written or oral explanations.
In the case referred to in Article 31, the marketing authorization holder may be asked to explain himself orally or in writing.
If it considers it appropriate, the Committee may invite any other person to provide information relating to the matter before it.
The Committee may suspend the time limit referred to in paragraph 1 in order to allow the marketing authorization holder to prepare explanations.
4. The Agency shall forthwith inform the marketing authorization holder where the opinion of the Committee is that:
- the application does not satisfy the criteria for authorization, or
- the summary of the product characteristics proposed by the applicant in accordance with Article 11 should be amended, or
- the authorization should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the medicinal product including pharmacovigilance, or
- a marketing authorization should be suspended, varied or withdrawn.
Within 15 days of the receipt of the opinion, the marketing authorization holder may notify the Agency in writing of his intention to appeal. In that case, he shall forward the detailed grounds for appeal to the Agency within 60 days of receipt of the opinion. Within 60 days of receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised, and the conclusions reached on the appeal shall be annexed to the assessment report referred to in paragraph 5.
5. Within 30 days of its adoption, the Agency shall forward the final opinion of the Committee to the Member States, the Commission and the marketing authorization holder together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions.
In the event of an opinion in favour of granting or maintaining an authorization 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;
(b) any conditions affecting the authorization within the meaning of paragraph 4.