Regulation 2 Advertisements relating to medicinal products for which there is a product licence of right

(1)

Subject to the following provisions of these regulations, no advertisement, other than a reference advertisement or trade advertisement, relating to a medicinal product in respect of which there is a product licence being a licence of right, shall be issued by a commercially interested party or by any person at the request or with the consent of a commercially interested party unless one or more of the conditions specified in paragraph (2) of this regulation are satisfied.

(2)

The conditions referred to in the preceding paragraph are that—

(i)

such product licence is deemed, by virtue of section 47(4) and (5) of the Act, to have incorporated therein the standard provisions contained in paragraphs 9 to 11 of Part I of Schedule 1 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971^f1 as amended^f2 (which paragraphs were added by the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1974^f3, or

(ii)

such product licence has been varied under section 30 of the Act so as to include provisions identical or equivalent to the standard provisions contained in the said paragraphs 9 to 11, or

(iii)

the licensing authority have consented in writing to the issue of the advertisement in question or, in the case of a particular advertisement, the licensing authority have been notified in writing that it is intended to issue the advertisement and have not, during the period of 42 days from being so notified, signified in writing that, for any of the purposes referred to in section 95(4) of the Act, that particular advertisement ought not to be issued.

(3)

Where such product licence relates to a medicinal product in respect of which an exemption from the restrictions imposed by section 7 of the Act would have applied by virtue of Article 2(1) of the Medicines (Exemption from Licences) (Foods and Cosmetics) Order 1971^f4 as amended^f5 were it not for the provisions of Article 2(3) of that order, the condition contained in paragraph (2)(ii) of this regulation shall be deemed to be satisfied—

(i)

in the case of an advertisement relating to such medicinal product directed to the public, if such product licence has been varied so as to include a provision identical or equivalent to the standard provision contained in the said paragraph 10, or

(ii)

in the case of an advertisement relating to such medicinal product directed to practitioners, if such product licence has been varied so as to include a provision identical or equivalent to the standard provision contained in the said paragraph 10 and provisions equivalent to the standard provisions contained in the said paragraphs 9 and 11 but limited so as to apply only to advertisements directed to practitioners.

Annotations

Footnotes

f1: (1971 II, p. 2809).
f2: S.I. 1972/1226 (1972 II, p. 3708).
f3: (1974 III, p. 5811).
f4: (1971 II, p. 3945).
f5: S.I. 1973/2079(1973 III, p. 7182).