The Human Medicines Regulations 2012

[F1 EAMS medicinal products: manufacture, assembly, importation, distribution and supply U.K.

167E.— (1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an EAMS 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 the EAMS medicinal product) 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 that relate to the advantage identified in the EAMS scientific opinion in respect of the product;

(d) the EAMS scientific opinion issued in respect of the product and has not ceased to have effect in respect of it in accordance with regulation 167D; and

(e) the conditions in paragraphs (2) to (4) are met.

(2) If the EAMS medicinal product is—

(a) manufactured or assembled (wholly or partly) in the United Kingdom, that manufacture or assembly must be—

(i) by the holder of a manufacturer’s licence (which need not relate specifically to the manufacture of special medicinal products) or, if the licensing authority agrees, a manufacturing authorisation (within the meaning given in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004) that relates to the manufacture or assembly of investigational medicinal products, and

(ii) a function permitted by that manufacturer’s licence or manufacturing authorisation;

(b) manufactured or assembled (wholly or partly) in an EEA State and imported into Northern Ireland (whether it is for sale or supply in Northern Ireland or Great Britain), that manufacture or assembly must be—

(i) by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions of the 2001 Directive as implemented in that State, or

(ii) if the medicinal product was manufactured or assembled as an investigational medicinal product in that State, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions of the EU Clinical Trials Regulation;

(c) manufactured or assembled (wholly or partly) in an approved country for import and imported into Great Britain, that manufacture or assembly must be—

(i) by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions applicable in that country, or

(ii) if the medicinal product was manufactured or assembled as an investigational medicinal product in that country, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions applicable in that country,

and that importation must be by the holder of a wholesale dealer’s licence that permits importation into Great Britain of the product in question; or

(d) manufactured or assembled (wholly or partly) outside the United Kingdom but sub-paragraph (b) or (c) does not apply to the importation of that product, the importation of that product must be—

(i) by the holder of a manufacturer’s licence that relates to the importation of special medicinal products or, if the licensing authority agrees, investigational medicinal products, and

(ii) a function permitted by that licence.

(3) Written records of the manufacture or assembly of the EAMS medicinal product must be maintained by the manufacturer or assembler and be available to the licensing authority or to the enforcement authority on request.

(4) If the EAMS medicinal 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 as mentioned in paragraph (2), P must be the holder of a wholesale dealer’s licence that permits distribution of the product in question.

(5) Where, with the agreement of the licensing authority, to ensure the ongoing availability of an EAMS medicinal product, an authorised product is assembled as that EAMS medicinal product and is supplied as part of the Scheme—

(a) that authorised product is to be treated—

(i) as an unauthorised product for the purposes of Part 13, and

(ii) as that EAMS product for the purposes regulations 167G and 167H and Part 11; and

(b) in any circumstances where that supply would not be an off label supply to which the prohibitions in regulation 46(2) did not apply (by operation of the common law), that supply is to be treated as an off label supply to which those prohibitions do not apply.]

Textual Amendments

F1 Regs. 167C-167H inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 8 (with reg. 19)