The Medicines (Fees Relating to Medicinal Products for Animal Use) (Amendment) Regulations 1991

Amendments

2.—(1) The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991(1) shall be amended in accordance with the following provisions of this regulation.

(2) In regulation 2(1) (interpretation) the definition of “inactive biological medicinal product” shall be deleted.

(3) For paragraph (b) in regulations 3, 5 and 8 respectively there shall be substituted the following paragraph—

“(b) in respect of any inspection specified in Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule.”.

(4) In regulation 10 (inspections of a site) for the words “paragraphs 2, 3, 4 and 6 of Schedule 2” there shall be substituted the words “paragraphs 2 to 6 of Schedule 2”.

(5) In regulation 16(1) (late payment of annual fees) for the words “one month” there shall be substituted the words “three months”.

(6) For Part III of Schedule 1 (fees for applications for variations of licences or certificates) there shall be substituted Part III as set out in the Schedule to these Regulations.

(7) In Schedule 2 (fees for inspections)—

(a) in paragraph 1(1) (interpretation) before the definition of “major inspection” there shall be inserted the following definition—

““dormant biological medicinal product” means a product which is not currently being manufactured or sold and in respect of which there is no current intention to recommence the manufacture or sale;”;

(b) in paragraph (5) for the words “an inactive biological medicinal product” there shall be substituted the words “a dormant biological medicinal product”.

(8) In Schedule 4—

(a) in Part I, paragraph 5 for the words “paragraph 5 of Part II of this Schedule” there shall be substituted the words “paragraph 4 of Part II of this Schedule”;

(b) in Part III for the words “paragraph 2 of Part I” there shall be substituted the words “the provisions of Part I of this Schedule”.

(9) In paragraph 1 of Schedule 5 the words “in accordance with paragraph 5(a) of Part I of Schedule 4”(2) shall be deleted.

(1)

S.I. 1991/632.

(2)

These words were inserted by a correction slip to S.I. 1991/632.