The Human Medicines (Amendment) Regulations 2023

• Citation: S.I. 2023/437
• Sections: 5

Section 1 Citation, commencement and extent

(1) These Regulations may be cited as the Human Medicines (Amendment) Regulations 2023 and come into force on the twenty-eighth day after the day on which they are laid before Parliament.

(2) These Regulations extend to England and Wales, Scotland and Northern Ireland.

Section 2 Amendment of the Human Medicines Regulations 2012

The Human Medicines Regulations 2012 are amended in accordance with regulations 3 to 5.

Section 3 Amendment of regulation 17 (manufacturing of medicinal products)

(1) Regulation 17 is amended as follows.

(2) In paragraph (2), for “paragraphs (3) to (5)” substitute “paragraphs (3) to (9)” .

(3) After paragraph (8) insert—

(9) Paragraph (1)(d) does not apply to the importation of a medicinal product into Northern Ireland from Great Britain by the holder of a wholesale dealer’s licence, where the following conditions are met—

(a) the medicinal product has undergone—

(i) in an EEA State, the quality control testing provided for by Article 51 of the 2001 Directive, or

(ii) in the United Kingdom, checks in accordance with these Regulations and the requirements of the marketing authorisation relating to the product and that these are appropriately certified;

(b) the batch release of the medicinal product has been undertaken—

(i) in Northern Ireland or an EEA State, by a qualified person in accordance with Article 51(1) of the 2001 Directive, and it is accompanied by the appropriate control reports, or

(ii) in Great Britain, by a qualified person applying equivalent standards;

(c) the medicinal product has a UKMA(UK) or UKMA(NI);

(d) the importation of the medicinal product is with a view to its sale or supply in Northern Ireland only; and

(e) in the case of medicinal products, other than radiopharmaceuticals, that are required to bear safety features pursuant to Article 54a of the 2001 Directive, that the features specified in paragraph 18A of Schedule 24 are affixed on the packaging.

Section 4 Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)

In regulation 49(3) —

(a) for sub-paragraph (a) substitute—

(a) a UKMA(UK) or UKMA(NI), must be established in the United Kingdom or an EEA State;

(b) in sub-paragraph (b)(ii), after “the United Kingdom” insert “or an EEA State” ; and

(c) in sub-paragraph (c), for “UKMA(UK)” substitute “parallel import licence” .

Section 5 Insertion of new regulation 345A (obligation on licensing authority to maintain list of medicinal products to which derogations have applied)

After regulation 345 insert—

Obligation on licensing authority to maintain list of medicinal products to which derogations have applied

(345A)

(1) The licensing authority must publish a list of medicinal products to which the derogations described in Articles 5a, 8(2a) and (2b), 18a, 20 (second paragraph), 40(1a) and (3a), 48(3) and 104(3) of the 2001 Directive have applied.

(2) The licensing authority must update the list referred to in paragraph (1) at least every six months.