OpenLegislation

Regulation 8 General exceptions

Original text. Later amendments are not shown.

(1)

The prohibitions, restrictions and requirements imposed by any provision of these regulations do not apply to any advertisement relating to a medicinal product where the holder of the product licence which relates to the medicinal product has sent or delivered a copy of the advertisement to the licensing authority and the authority have not within the period of 42 days commencing with the date of receipt of the advertisement by the authority notified the holder of the product licence that the advertisement ought not to be issued.

(2)

The prohibitions, restrictions and requirements imposed by any provision of these regulations do not apply to—

(a)

any letter written to a person in reply to a specific inquiry made by or on behalf of that person in relation to a medicinal product of a particular description;

(b)

any letter or other communication specifically addressed to a member of either House of Parliament or of the Northern Ireland Assembly;

(c)

any representation made by a commercially interested person or any advertisement sent or supplied exclusively, or any advertisement included in a journal or other publication supplied or directed mainly or exclusively to, or any cinematographic film or sound recording played to—

(i)

persons who in the usual course of their business or profession may lawfully prescribe, sell, supply, manufacture, assemble or administer the medicinal product or other substance or article to which that advertisement relates, or

(ii)

persons who in the course of such business or profession provide training or instruction to persons undergoing training with a view to obtaining a qualification in such business or profession, or

(iii)

persons who in the course of such business or profession as aforesaid are engaged in the preparation or publication of printed matter, cinematograph film, sound recording or matter intended for sound broadcasting or television in relation to the medicinal product or other substance or article to which that advertisement relates or in relation to the treatment or prevention of any disease to which any provision of these regulations applies, or

(iv)

a Minister of the Crown, a Government Department, a local authority, or a charitable, educational or scientific body, in relation to any of the functions of any of such bodies relating to medicinal products or other substances or articles, or the treatment, prevention or diagnosis of any of the diseases specified in Schedule 1 or Schedule 2 to these regulations;

(d)

any reference to a medicinal product of a description or falling within a class specified in regulation 3 of these regulations where such reference is contained in a statutory report circulated to members of a company formed and registered under the Companies Act 1948 or the Companies Act (Northern Ireland) 1960 or formed and registered under or incorporated by or under any other Act of Parliament or any other report, circular, notice or announcement prepared solely for the purpose of providing information about a company's affairs;

(e)

any printed matter, photograph, cinematograph film, sound recording, sound broadcasting, television broadcast or sound or television programme transmitted to subscribers to a diffusion service (in this paragraph referred to as “the material”), if—

(i)

the material has not been prepared or issued by or on behalf of or at the request of a commercially interested party, and

(ii)

the material has not been prepared or issued for the purposes of inducing any person to purchase, or to request a doctor or dentist to prescribe, a medicinal product or other substance or article;

(f)

any notice displayed for the purpose of encouraging employees to participate in a health care programme.

(3)

The prohibitions, restrictions and requirements imposed by any provision of these regulations do not apply for the period up to and including the 1st January 1981 to the use of the name of a medicinal product where such name is that shown in the product licence issued in respect of such product.