Citation, interpretation and commencement

1.  These Regulations, which may be cited as the Medicines (Fees) Amendment Regulations 1987, amend the Medicines (Fees) Regulations 1978(4) (hereinafter referred to as "the principal Regulations") and shall come into force on 1st September 1987.

Insertion in the principal Regulations of regulation 4A

2.  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(5), the National Health Service (Scotland) Act 1978(6) or the Health and Personal Social Services (Northern Ireland) Order 1972(7)".

Amendment of regulation 14 of the principal Regulations

3.  In regulation 14 of the principal Regulations (time for payment of capital fees) there is inserted after the word "grant" the words ",or as the case may be, the variation,".

Amendment to Table A of Part I of Schedule 1 to the principal Regulations

4.-(1) Table A of Part I of Schedule 1 to the principal Regulations (types and levels of fees), is amended in accordance with the following provisions of this regulation.

(2) For each entry in Column 2 (Capital Fees), of the sum "£2,500" there is substituted the sum "£4,000".

(3) For each entry in Column 2 of the sum "£150" there is substituted the sum "£250".

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Fees) Regulations 1978 ("the principal Regulations") which provide for the fees payable in connection with licences granted and certificates issued under the Medicines Act 1968.

Regulation 2 introduces a capital fee of £75 for the variation of a product licence granted under Part II of the Medicines Act 1968. Only one fee is payable for an application to vary one or more of the provisions of a licence made on one occasion. Certain public bodies exempt from having to pay fees for the grant of a product licence under the principal Regulations are likewise exempted from having to pay this fee.

Regulation 3 provides that this fee be paid on the application for variation.

Regulation 4 amends Column 2 of Part I of Schedule 1 to the principal Regulations by increasing the amount of capital fees payable for the grant of product licences for medicinal products for human and veterinary use. The standard amount of capital fees payable is increased from £150 to £250 and the higher alternative amount (payable in circumstances specified in the principal Regulations) is increased from £2,500 to £4,000.