Regulation 4 Amendment of the Product Licences Regulations 1993

In the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993 M1—

(a)

in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and

(b)

in Schedule 1 (information, documents etc. required in respect of applications)—

(i)

in paragraph 17, for “Part 3, paragraph 1.1, second sub-paragraph of the Annex I to the 2001 Directive” substitute “ paragraph (9) of the Introduction and general principles of Annex I to the 2001 Directive ”, and

(ii)

in paragraph 18, for “Part 4, paragraph B.2 of the Annex I to the 2001 Directive” substitute “ paragraph 5.2(a) of Part I of Annex I to the 2001 Directive ”.

Annotations

Marginal citations

M1: S.I. 1993/2538; relevant amendments were made by S.I. 2002/236.