S.L. 437.47 Art. 34Situation when the matter has to be referred to the Committee before reaching a decision.

Malta or the European Commission or the applicant or marketing authorisation holder shall, in specific cases where the interests of the European Community are involved, refer the matter to the Committee for the application of the procedure laid down in Articles 36, 37 and 38 of European Union Council Directive 2004/

28/EC before a decision is reached on a request for a marketing authorization or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appear necessary, so as to take account in particular of the information collected in accordance with Title VII. Malta or the European Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder.

Malta and the applicant or the marketing authorisation holder shall forward to the Committee all available information relating to the matter in question.