The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

Amendment of regulation 38 of the principal Regulations

This section has no associated Explanatory Memorandum

19.  In regulation 38 of the principal Regulations (application for manufacturing authorisation)—

(a)in paragraph (3), for “Every” substitute “Subject to paragraph (3A), every”; and

(b)after paragraph (3), insert the following paragraph—

(3A) No fee need accompany an application for the grant of a manufacturing authorisation where arrangements have been made with the licensing authority for the payment of the fee referred to in paragraph (3)(b) other than at the time of the application..