The Medicines (Products for Human Use—Fees) Amendment Regulations 1994

Explanatory Note

(This note is not part of the Order)

These Regulations further amend the Medicines (Products for Human Use Fees) Regulations 1991 (“the principal Regulations”), which prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 and periodic fees in connection with the holding of such licences, insofar as they apply to medicinal products for human use only.

These Regulations (regulation 2 and the Schedule) vary most of the fees payable for applications for the grant of product licences, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates; for variations of such licences or certificates; for the renewal of certain manufacturers' licences and clinical trial certificates; and periodic fees in connection with the holding of licences. They also vary the fees payable in respect of inspections of sites carried out in connection with applications for, or during the currency of, such licences. The result of these variations is that capital fees have been reduced by an overall average of 10% and periodic fees have been increased by an overall average of 13%. A copy of the Compliance Cost Assessment can be obtained from the House of Commons Library.

These Regulations also make a number of miscellaneous amendments:

• they provide for fees to be payable in relation to inspection of sites used in the preparation of biological intermediate prducts (regulations 4, 5 and 8(2));

• they provide for a concessionary fee where applications for product licences are received within three months of the expiry of a product licence for the same product and ensure that liability for a periodic fee remains as if the original licence had not expired (regulations 6 and 7(2)(c));

• they amend the definition of “active ingredient” (regulation 7(2)(a)) and insert new categories in the definition of “complex application” in Part I of Schedule 1 to the principal Regulations (regulation 7(2)(b));

• they amend paragraph 4 of Part II of Schedule 1 to the principal Regulations in respect of the charging of fees relating to applications for product licences which form a joint development between two or more applicants (regulation 7(3)(b));

• they increase the concessionary rate (in paragraph 7(2) of Part II of Schedule 1 and paragraph 8(2)(a) of Part III of Schedule 3 to the principal Regulations) applying to certain applicants for and holders of wholesale dealer’s licences (regulations 7(3)(c) and 9(3)(b));

• they substitute for references to Council Directive 75/318/EEC (OJ No. L147, 9.6.1975, p.1), references to the Medicines (Applications for the Grant of Product Licences Products for Human Use) Regulations 1993 (S. I.1993/2538) and make consequential amendments (regulations 3(a), 7(3)(a), 7(4)(a)(ii) and 9(2)); they also disapply paragraph 2 of Part III of Schedule 1 to the principal Regulations which required the levying of a higher fee for an application for the variation of a licence granted under this provision in specified circumstances (regulation 7(4)(a)(i) and (b));

• they clarify paragraph 4 of Part III of Schedule 3 to the principal Regulations (liability for periodic fees for product licences relating to new active substances) (regulation 9(3)(a));

• they reduce the liability for the standard charge on withdrawal of an application for a product licence in specified circumstances (regulation 10);

• they revoke Part IIIA of, and paragraph 2A of Schedule 4 to, the principal Regulations (fees to be payable on renewal of certain product licences) and make consequential amendments (regulations 3(b) and 11);

• they effect a drafting improvement in Schedule 2 to the principal Regulations (regulation 8(3)).