S.L. 458.35 ст. 59Submission of draft protocol.

(1) Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State (e.g. Malta) that requests the study according to Article 22a of Directive 2001/83/EC. For such studies, the marketing authorisation holder shall submit a draft protocol to the Authority.

(2) Within sixty days of the submission of the draft protocol the Authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall issue:

(a) a letter endorsing the draft protocol;

(b) a letter of objection, which shall set out in detail the grounds for the objection, in any of the following cases:

(i) it considers that the conduct of the study promotes the use of a medicinal product;

(ii) it considers that the design of the study does not fulfil the study objectives; or

(c) a letter notifying the marketing authorisation holder that the study is a clinical trial falling under the scope of Directive 2001/20/EC.

(3) (a) The study may commence only when the written endorsement from the Authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, has been issued.

(b) Where a letter of endorsement as referred to in sub-regulation (2)(a) has been issued, the marketing authorisation holder shall forward the protocol to the competent authorities of the Member States in which the study is to be conducted and may thereafter commence the study according to the endorsed protocol.