1. A final decision on the application shall be adopted in accordance with the procedure referred to in Article 121(2).
2. The rules of procedure of the Standing Committee established by Article 121(1) shall be adjusted to take account of the tasks incumbent upon it in accordance with this Chapter.
These adjustments shall involve the following:
- except in cases referred to in the third paragraph of Article 33, the opinion of the Standing Committee shall be obtained in writing,
- each Member State is allowed at least 28 days to forward written observations on the draft decision to the Commission,
- each Member State is able to require in writing that the draft decision be discussed by the Standing Committee, giving its reasons in detail.
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 of the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.
The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 121(2).
3. A decision as referred to in paragraph 1 shall be addressed to the Member States concerned by the matter and reported to the marketing authorization holder. The Member States shall either grant or withdraw marketing authorization, or vary the terms of a marketing authorization as necessary to comply with the decision within 30 days of its notification. They shall inform the Commission and the Agency thereof.