The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020

New regulation 3A

4.  After regulation 3 (scope of these Regulations: special provisions), insert—

“Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products

3A.— (1) Regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) do not apply in circumstances where a medicinal product used for vaccination or immunisation against coronavirus is manufactured, prepared or assembled by or under the supervision of a doctor, a registered nurse or a pharmacist—

(a) who is acting in the course of his or her profession; and

(b) for the purposes of the supply or administration of the medicinal product to a patient under relevant arrangements.

(2) Regulation 46 does not apply in respect of a medicinal product—

(a) which is the result of the assembly of an authorised medicinal product;

(b) which is used for the reformulation of a medicinal product used for vaccination or immunisation against coronavirus; and

(c) the assembly of which (as mentioned in sub-paragraph (a)) is—

(i) in accordance with a manufacturer’s licence, or

(ii) undertaken in circumstances where regulation 17(1) does not apply by virtue of regulation 3 (scope of these regulations: special provisions) or regulation 4 (special provisions for pharmacies etc.).

(3) Regulation 17(1) does not apply in circumstances where a medicinal product used for vaccination or immunisation against coronavirus is labelled by a holder of a wholesale dealer’s licence to take account of a change to the shelf life of the product because of the thawing of the product.

(4) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products)—

(a) does not apply to a medicinal product that is the result of a process of manufacture, preparation or assembly in accordance with paragraph (1) or (2); and

(b) is to be construed as permitting labelling in accordance with paragraph (3), in the case of a product which is otherwise labelled in accordance with that Part.

(5) For the purposes of this regulation—

“authorised” has the meaning given in regulation 3(15)(1); and

“relevant arrangements” has the meaning given in regulation 19(4C)(2) (exemptions from requirement for wholesale dealer’s licence).

(6) This regulation ceases to have effect on 1st April 2022.”.

(1)

Regulation 3(15) is to be amended by S.I. 2019/775 as amended by S.I. 2020/1488.

(2)

Paragraph (4C) was inserted by S.I. 2020/1125.