The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024

Amendment to regulation 60A

49.  In regulation 60A (condition as to the submitting of samples and other information to the appropriate authority)(1)—

(a) in paragraph (1), for the definition of “the batch testing exemption”, substitute—

““the batch testing exemption” means that—

(a)

in the case of a medicinal product for sale or supply in Northern Ireland only and authorised under a UKMA(NI) or a UKMA(UK)(Category 2), a certificate—

(i)

has been issued by a laboratory in an EEA State, and

(ii)

in the case of a product of a kind listed in Article 114(1) of the 2001 Directive, was issued in the same EEA State as that in which the batch was manufactured, and

the appropriate authority is satisfied that the certificate provides confirmation of conformity with the approved specifications in the UKMA(NI) or UKMA(UK)(Category 2), as applicable, or

(b)

in the absence of such a certificate, or in the case of a medicinal product authorised for sale or supply under a UKMA(GB) or a UKMA(UK)(Category 1)—

(i)

a certificate has been issued by a laboratory in a country other than the United Kingdom,

(ii)

an agreement has been made between that country and the United Kingdom (whether or not the agreement is solely with that country, a group of countries or an organisation of which that country is a part), and

(iii)

that agreement is to the effect that the appropriate authority will recognise that certificate in respect of the batch of the medicinal product, in place of the appropriate authority’s own examination of a sample from the batch, the appropriate documentation or both.”;

(b) in paragraph (5), omit “and regulation 60B(5)”;

(c) in paragraph (9)(a) and (b), omit “or regulation 60B”;

(d) in paragraph (10), for “Where” substitute “Subject to paragraph (10A), where”;

(e) after paragraph (10), insert—

“(10A) Where a holder of a UK marketing authorisation intends to rely on paragraph (a) of the batch testing exemption in relation to a batch of a medicinal product, that holder must not sell or supply, or offer to sell or supply, in Northern Ireland, a medicinal product that forms part of that batch until the appropriate authority has confirmed that it is satisfied as set out in that paragraph.”.

(1)

Regulation 60A was inserted by S.I. 2019/775 as amended by S.I. 2020/1488.