TITLE III

MARKETING
CHAPTER 4

Mutual recognition procedure and decentralised procedure
Article 35
1
Member States or the Commission or the applicant or marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Articles 36, 37 and 38 before a decision is reached on a request for a marketing authorisation 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.
The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder.
The Member State and the applicant or the marketing authorisation holder shall forward to the Committee all available information relating to the matter in question.
2
Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to specific parts of the authorisation.
In that case, Article 39 shall apply to those medicinal products only if they are covered by the marketing authorisation procedure referred to in this Chapter.
Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.