Explanatory note

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.