Where, in the opinion of the Commission, written comments put forward by a Member State under the procedure laid down in Article 3 raise important new questions of a scientific or technical nature which have not been dealt with in the opinion delivered by the European Agency for the Evaluation of Medicinal Products, the chariman shall suspend the procedure and the Commission shall refer the matter to the Agency for further examination. The chairman shall inform the members of the Committee thereof.

A new procedure shall be initiated in the 30 days following reception by the Commission of the Agency's reply.