The Medicines (Products for Human Use– Fees) Amendment Regulations 1992

Amendment of Schedule 2 to the principal Regulations

9.—(1) Schedule 2 to the principal Regulations (fees for inspections), shall be amended in accordance with the following paragraphs of this regulation.

(2) In paragraph 2 (fees)–

(a) for “paragraphs 3 to 5,”, there shall be substituted “paragraphs 2A to 5,”;

(b) in sub-paragraph (b), after the words “such products” there shall be inserted the words–

• “except where the site inspected is concerned solely with the sterilisation of medicinal products which have been manufactured elsewhere,”.

(3) After paragraph 2, there shall be inserted the following paragraph–

“2A.— (1) Where any inspection at a site would be a supersite inspection and that site consists of two or more separate manufacturing operations on different parts of the site, an inspection may, pursuant to a request in writing from the applicant, or as the case may be, the licence holder, relate to one or more manufacturing facilities at that site.

(2) An inspection referred to in sub-paragraph (1) shall be categorised in accordance with the number of relevant persons employed in each manufacturing operation which is inspected as if that operation constituted the entire site and the fee payable for that inspection shall be the appropriate fee specified for that category in paragraph 2, or if more than one manufacturing operation is inspected, the aggregate of the appropriate fees shall be payable.”.