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

• Citation: S.I. 1991/2063
• Sections: 6

Section 1 Citation and commencement

These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Animal Use) (Amendment) Regulations 1991 and shall come into force on 4th October 1991.

Section 2 Amendments

(1) The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991 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” shall be deleted.

Section 1 Product licences

The fee payable under regulation 5(a) in connection with an application for variation of a product licence—

(a) in the case of a complex application, shall be £1,050;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment–

(aa) for a variation, shall be £315;

(bb) for any other consequential variation to other licences, in identical terms, shall be £105;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £105 in respect of each variation;

(iii) where the variation applied for involves the reissue of the product licence in the new name of the company, shall be £105;

(iv) where the product licence relates solely to an emergency vaccine, shall be £30.

Section 2 Manufacturers' licences

The fee payable under regulation 5(a) in connection with an application for variation of a manufacturer’s licence—

(a) in the case of a manufacturer’s licence referred to in paragraph 5(2) of Part II of this Schedule, shall be £85;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £325;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.

Section 3 Wholesale dealers' licences

The fee payable under regulation 5(a) in connection with an application for variation of a wholesale dealer’s licence—

(a) requiring veterinary, scientific or pharmaceutical assessment, shall be £325;

(b) not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.

Section 4 Animal Test Certificates

The fee payable under regulation 5(a) in connection with an application for variation of—

(a) an animal test certificate—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £315;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £105;

(iii) where the variation applied for involves the reissue of the animal test certificate in the new name of the company, shall be £105; or

(b) an animal test (confirmation of exemption) certificate—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £300;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £85;

(iii) where the variation applied for involves the reissue of the animal test (confirmation of exemption) certificate in the new name of the company, shall be £85.