Regulation 2 Insertion in the principal Regulations of regulation 4A

After regulation 4 of the principal Regulations there is inserted the following regulation—

“Capital fees for variations

4A

(1)

Subject to the following provisions of this regulation a capital fee of £75 shall be payable by the applicant in connection with each application for the variation of one or more of the provisions of a product licence granted under Part II of the Act unless such application is made at the specific invitation of the licensing authority.

(2)

The provisions of paragraph (1) shall not apply in the case of an application for variation which is made by an authority or board constituted under the National Health Service Act 1977^f1, the National Health Service (Scotland) Act 1978^f2 or the Health and Personal Social Services (Northern Ireland) Order 1972^f3”.