The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 43 (obligations of licence holder)

33.—(1) Regulation 43(1) is amended as follows.

(2) In paragraph (1), for “by the European Commission in accordance with Article 84 of the 2001 Directive” substitute “under, or that apply by virtue of, regulation C17”.

(3) In paragraph (5)(a) and 7(b)(ii), for “marketing authorisation, Article 126a authorisation”, substitute “UK marketing authorisation”.

(4) In paragraph (6)—

(a) in sub-paragraph (a), insert at the end “in the United Kingdom”; and

(b) for sub-paragraph (b), substitute—

“(b) the export to an approved country for import, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that country without—

(i) a marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the 2001 Directive, by virtue of legislation adopted by that country under Article 5(1) of that Directive, where the approved country for import is an EEA State, or

(ii) such equivalent authorisation, certificate or registration in the approved country for import, under legislation in that country that makes provision that is equivalent to Article 5(1) of the 2001 Directive, where the approved country for import is not an EEA State.”.

(5) In paragraph (7)—

(a) in sub-paragraph (b)—

(i) in sub-paragraph (i), for “the competent authority of any EEA State” substitute “an appropriate authority for the licensing of medicinal products in an approved country for import”, and

(ii) in sub-paragraph (ii), for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”; and

(b) omit sub-paragraph (c)(vii).

(6) For paragraph (8) substitute—

“(8) Paragraph (8A) applies to a person (“P”) who—

(a) imports a medicinal product, other than for the sole purpose of wholesale distribution of that product to a person in a country other than the United Kingdom; but

(b) is not the holder of a UK marketing authorisation, certificate of registration or traditional herbal registration in respect of that product.

(8A) Where this paragraph applies, P must—

(a) notify—

(i) the holder of any authorisation, certificate or registration, granted by an authority in the country from which the product is exported, to sell or supply that product in that country, and

(ii) the licensing authority,

of the intention to import that product; and

(b) pay a fee to the licensing authority in accordance with the Fees Regulations.”.

(7) Omit paragraphs (10) and (11).

(8) In paragraph (13), insert “UK” before “marketing authorisation holder”.

(9) Omit paragraph (15).

(1)

Regulation 43 was amended by S.I. 2013/1855 and 2016/186.