2. At the latest 90 days after receipt of the notification, the competent authority shall either:

(a) forward the dossier to the Commission with a favourable opinion, or

(b) inform the notifier that the proposed release does not fulfil the conditions of this Directive and that it is therefore rejected.

3. In the case referred to in paragraph 2 (a), the dossier forwarded to the Commission shall include a summary of the notification together with a statement of the conditions under which the competent authority proposes to consent to the placing on the market of the product.

The format of this summary shall be established by the Commission in accordance with the procedure laid down in Article 21.

In particular where the competent authority has acceded to the request of the notifier, under the terms of the last subparagraph of Article 11 (1), not to comply with some of the requirements of Annex III B, it shall at the same time inform the Commission thereof.

4. If the competent authority receives additional information pursuant to Article 11 (6), it shall immediately inform the Commission and the other Member States.

5. For the purpose of calculating the 90-day period referred to in paragraph 2, any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier shall not be taken into account.