UK Offence Report

The Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999

UK Statutory Instrument 1999 No. 267 — creates 3 criminal offences.

3offences created
0recorded in force
0revoked
Made
5 February 1999
In force from
5 April 1999
Extent
Not stated
Subject
Drugs and medicines
Made under
European Communities Act 1972, Medicines Act 1968

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations amend the Medicines (Advertising) Regulations 1994 (“the Advertising Regulations”) and the Medicines (Monitoring of Advertising) Regulations 1994 (“the Monitoring of Advertising Regulations”). Those Regulations contain the legislative measures necessary for implementing Council Directive 92/28/EEC concerning the advertising of medicinal products for human use (“the Advertising Directive”), and these Regulations make further provision relating to the implementation of that Directive. Regulation 2 amends the interpretation provision of the Advertising Regulations, adding new definitions of “persons qualified to prescribe or supply” medicinal products and of “the Health Ministers”, and clarifying the scope of the existing definition of “relevant medicinal products”. Regulation 3 inserts a new regulation 3A into the Advertising Regulations which sets out general principles relating to the advertising of relevant medicinal products. These principles are based on article 2(2) and (3) of the Advertising Directive. Regulation 4 amends regulation 4 of the Advertising Regulations, including amongst the duties of holders of marketing authorizations responsibilities based on the first and fourth indents of article 13(2) of the Advertising Directive. These relate to samples of advertisements which must be kept available for the Health Ministers, and, to information and assistance which must be supplied to them to enable them to carry out their functions under the Advertising Regulations and the Monitoring of Advertising Regulations. Regulation 5 contains a revised version of regulation 12 of the Advertising Regulations, extending the prohibition (based on article 3(6) of the Advertising Directive) on sale or supply to the public of relevant medicinal products for promotional purposes. Regulations 6 and 9 change two of the headings in the Advertising Regulations to reflect more accurately the provisions to which they relate. Regulation 7 extends the application of regulation 20 of the Advertising Regulations to cover the activities of medical sales representatives who promote relevant medicinal products to persons qualified to supply such products. Regulation 8 contains technical amendments to the offences provision of the Advertising Regulations, making regulations 3A and 12 offences for the purposes of those Regulations and clarifying the applicability of the enforcement provisions of the Medicines Act 1968 to breaches of the Advertising Regulations. Regulation 10 contains a minor modification to the definition of “publication” for the purposes of the Monitoring of Advertising Regulations, and regulation 11 contains a minor modification of regulation 3 of the Monitoring of Advertising Regulations which arises as a consequence of the new Schedule to those Regulations inserted by virtue of these Regulations. Regulation 12 inserts two regulations into the Monitoring of Advertising Regulations: a regulation applying the enforcement provisions of the Medicines Act 1968 to breaches of the Monitoring of Advertising Regulations, and a regulation giving effect to the new Schedule inserted by virtue of these Regulations. Regulation 13 inserts a new Schedule into the Monitoring of Advertising Regulations. The Schedule contains a new notices procedure relating to the scrutiny of published or proposed advertisements for relevant medicinal products. This procedure is to be used by the Health Ministers for determining whether or not the advertisements, if published, would be in breach of the Advertising Regulations. There is an opportunity for written representations to be made to the Health Ministers before they reach their decision or determination. Breaches of the notices will, in certain circumstances, be offences.

Offences created by this instrument

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

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