The Human Medicines Regulations 2012

Supply to fulfil special patient needs U.K.

167.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product (a “special medicinal product”) if—

(a) the medicinal product is supplied in response to an unsolicited order;

(b) the medicinal product is manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;

(c) the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and

(d) the following conditions are met.

(2) Condition A is that the medicinal product is supplied—

(a) to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or

(b) for use under the supervision of a pharmacist in a registered pharmacy, a hospital or a health centre.

(3) Condition B is that no advertisement relating to the medicinal product is published by any person.

(4) Condition C is that—

(a) the manufacture and assembly of the medicinal product are carried out under such supervision; and

(b) such precautions are taken,

as are adequate to ensure that the medicinal product meets the specification of the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber who requires it.

(5) Condition D is that written records of the manufacture or assembly of the medicinal product in accordance with condition C are maintained and are available to the licensing authority or to the enforcement authority on request.

(6) Condition E is that if the medicinal product is manufactured or assembled in the United Kingdom or imported into the United Kingdom from a country other than an EEA State—

(a) it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products; or

(b) it is manufactured, assembled or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the licensing authority for the purposes of regulation 36 of the Clinical Trials Regulations.

(7) Condition F is that if the product is imported from an EEA State—

(a) it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State; or

(b) it is manufactured or assembled as an investigational medicinal product in that State by the holder of an authorisation in relation to its manufacture or assembly in accordance with Article 13 of the Clinical Trials Directive as implemented in that State[F1 ,]

[F2 and it is imported by the holder of a wholesale dealer’s licence in relation to the product in question.]

(8) Condition G is that if the product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product in accordance with paragraph (6)(a) or (7)(a), P must be the holder of a wholesale dealer's licence in relation to the product in question.

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Textual Amendments

F1 Punctuation in reg. 167(7)(b) substituted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 5(2)(a) and punctuation in reg. 167(7)(b) substituted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 5(2)(a)

F2 Words in reg. 167(7)(b) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 5(2)(b) and words in reg. 167(7)(b) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 5(2)(b)