The Human Medicines Regulations 2012

Product licences

2.—(1) This paragraph applies to a marketing authorisation that—

(a) became a marketing authorisation on 1st January 1995 by virtue of paragraph 1 of Schedule 6(1) to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (conversion of existing product licences); and

(b) by virtue of paragraph 1 of this Schedule, has effect from the coming into force of these Regulations as a marketing authorisation granted under these Regulations.

(2) The following provisions do not apply in relation to the marketing authorisation—

(a) regulation 68(7) (revocation etc of marketing authorisation because the holder has ceased to be established in the EU); and

(b) regulation 258 (packaging requirements: specific provisions).

(3) Paragraph (4) applies if the marketing authorisation has not been renewed in the period beginning with 1st January 1995 and ending when these Regulations come into force.

(4) The Medicines (Labelling) Regulations 1976(2) and the Medicines (Leaflets) Regulations 1977(3) (and subsequent regulations amending those regulations) in so far as they relate to medicinal products continue to have effect in relation to the product to which the marketing authorisation relates until the marketing authorisation is renewed.

(1)

S.I. 1994/3144, as amended by S.I. 2004/3224 and S.I. 2005/2759. There are other amendments to those regulations that are not relevant to this paragraph..

(2)

S.I. 1976/1726, as amended by S.I. 1977/996 and 2168, S.I. 1978/41 and 1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558 and 2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 and 3144, S.I. 2002/236, S.I. 2004/1031 and S.I. 2005/2745 and 2753.

(3)

S.I. 1977/1055, as amended by S.I. 1992/3274, 1994/104 and 3144, and 2005/2753..