The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

Explanatory Note

(This note is not part of the Regulations)

These Regulations make amendments to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the principal Regulations”), which implemented in respect of the United Kingdom a range of European Community measures relating to the marketing of medicinal products for human use.

Regulation 2 amends the definition of “the relevant Community provisions” in the principal Regulations, updating the reference to Council Directive 75/318/EEC on the approximation of the laws of member States relating to analytical, pharmacotoxological and clinical standards and protocols in respect of the testing of medicinal products. As a result, it now refers to that Directive as amended by Commission Directives 1999/82/EC and 1999/83/EC. Commission Directive 1999/82/EC relates to compliance with the European Commission’s “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicial Products” which is applied to new applications for marketing authorizations for medicinal products from 1st July 2000 and to all marketing authorizations from 1st March 2001. The principal Regulations are also amended so that, from the latter date, a holder of a marketing authorization who fails to introduce any changes or make any amendments that may be required to demonstrate compliance with that Guideline may be guilty of an offence (regulation 4(2)).

Regulation 3 inserts a new regulation 3A into the principal Regulations. It contains a new statutory procedure for determinations by the licensing authority as defined in the Medicines Act 1968(1), as to whether or not a product is a “relevant medicinal product”. The procedure allows for representations to be made against provisional determinations, and for those representations to be considered by a review panel appointed by the licensing authority. Once a final determination has been made, the licensing authority may serve a notice requiring a person not to place a product determined to be a relevant medicinal product on the market, or to stop marketing it from a date specified, unless or until a marketing authorization has been granted in respect of the product. A new provision is inserted into Schedule 3 of the principal Regulations making breach of such a notice an offence in respect of relevant medicinal products (regulation 4(1)).

Regulation 5 makes a minor amendment to the special warnings which must be included on the packaging of medicinal products containing paracetamol on the general sale list, other than products prepared or dispensed in accordance with a prescription given by a medical practitioner.

(1)

1968 c. 67; see section 6 of that Act.