The Human Medicines Regulations 2012

Immunity from civil liability

345.—(1) This regulation applies where the licensing authority makes a recommendation or requirement to which paragraph (2) applies in response to the suspected or confirmed spread of—

(a) pathogenic agents;

(b) toxins;

(c) chemical agents; or

(d) nuclear radiation,

which may cause harm to human beings.

(2) This paragraph applies to a recommendation or requirement—

(a) for the use of a medicinal product without an authorisation; or

(b) for the use of a medicinal product with an authorisation, but for a therapeutic indication that is not permitted under the authorisation.

(3) None of the following are to be subject to any civil liability for any loss or damage resulting from the use of the product in accordance with the recommendation or requirement—

(a) any holder of an authorisation for the product;

(b) any manufacturer of the product;

(c) any officer, servant, employee or agent of a person within paragraph (a) or (b); or

(d) any health care professional.

(4) This regulation does not apply in relation to liability under section 2 (liability for defective products) of the Consumer Protection Act 1987(1) or article 5 of the Consumer Protection (Northern Ireland) Order 1987(2).

(5) In this regulation “authorisation” means a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation.

(1)

1987 c.43. Section 2(4) was repealed in relation to England and Wales by S.I. 2000/2771 article 2(1) and (3) and in relation to Scotland by S.S.I. 2001/265 article 2(1) and (3).

(2)

S.I. 1987/2049 (N.I. 20), as amended by 2001 c.13 (NI).