The Medicines (Products for Human Use—Fees) Amendment Regulations 2000

Explanatory Note

(This note is not part of the Regulations)

These Regulations make further amendments to the Medicines (Products for Human Use—Fees) Regulations 1995 (“the principal Regulations”). The principal Regulations make provision for the fees payable relating to marketing authorizations, licences and certificates in respect of medicines for human use.

Regulation 2 inserts new definitions into the principal Regulations that are relevant to the other new provisions being inserted. Regulation 3 inserts a new Part IIA into the principal Regulations. This contains provisions relating to the setting of new capital fees for assistance in obtaining marketing authorizations in other countries that are contracting parties to the Agreement on the European Economic Area (“EEA States”). The fees relate to a procedure laid down in Chapter III of Council Directive 75/319/EEC whereby companies that have obtained a marketing authorization in one EEA State can apply to have the authorization recognised in other EEA states, with assistance from the country that granted the original authorization.

Regulation 3 makes a consequential amendment to a provision in the principal regulations relating to the time at which capital fees under the Regulations are to be paid. Regulation 4 inserts a new Part IIA into Schedule 1 of the principal Regulations, which sets out the different amounts for the new fees. Regulation 5 contains a provision relating to the times at which small companies have to pay the new fees, allowing them to delay payment of part of the fee in prescribed circumstances.

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.