Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001

• Citation: S.I. 2001/3751
• Sections: 6

Section 1 Title, commencement and interpretation

(1) These Regulations may be cited as the Medicines (Products of Animal Use—Fees) (Amendment No. 2) Regulations 2001 and shall come into force on 15th December 2001.

(2) In these Regulations “the Principal Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 1998 .

Section 2 Amendment of fees specified in the principal Regulations

(1) In respect of each provision of the principal Regulations specified in the entries in column (1) (the subject matter of which is described in column (2)) of Part I of the Schedule to these Regulations, where a fee is specified opposite that provision in column (3) there shall be substituted the fee specified opposite that provision in column (4).

(2) Paragraphs 1 and 2 of Part IV of the principal Regulations shall be replaced with the provisions of Part II of the Schedule to these Regulations.

(3) In Schedule 3 to the principal Regulations—

(a) in Part II, paragraph 1 (calculation of annual fees) there shall be substituted the figure “£275” for the figure “ £269 ” , the figure “£19,600” for the figure “ £18,956 ” , and the figure “0.46%” for the figure “ 0.451%. ” ;

(b) in Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure “0.7%” for the figure “ 0.677% ” ; and

(c) in Part III (calculation of annual fee—emergency vaccines) there shall be substituted the figure “0.7%” for the figure “ 0.677% ” .

Section 3 Transitional provisions

(1) Subject to paragraphs (2) and (3) below, these Regulations shall not apply in respect of any application made before the date these Regulations come into force.

(2) These Regulations shall apply in relation to any fee payable in respect of any inspection made after these Regulations come into force in connection with any application made before they come into force.

(3) Where, in connection with an application to renew a marketing authorisation, licence or certificate made before these Regulations come into force, the authorisation, licence or certificate is due to expire on or after the date these Regulations come into force, regulation 17(4) and (5) of the principal Regulations shall apply to that application on the basis that the fee payable for the application following the coming into force of these Regulations is the appropriate fee payable.

(4) Nothing in these Regulations shall have effect in relation to an annual fee relating to a calendar year earlier than 2000.

Section 1

The application fee for a minor variation (Type 1) to a marketing authorisation (other than a mutually recognised marketing authorisation) as referred to in Annex 1 to Commission Regulation (EC) No. 541/95 (concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a member State ) shall be as follows:—

Section 2

The application fee for any other variation to a marketing authorisation (other than a mutually recognised marketing authorisation), or for any variation to a product licence, shall be £2,220 except in the following cases, where the fee shall be the amount specified:—

Section 2A

Notwithstanding the above, the fee for a variation where the licence relates solely to an emergency vaccine shall be £40 for each variation.