The Medicines (Products for Animal Use — Fees) (Amendment) Regulations 1996

• Citation: S.I. 1996/2196
• Sections: 8

Section 1 Title and commencement

These Regulations may be cited as the Medicines (Products for Animal Use — Fees) (Amendment) Regulations 1996 and shall come into force on 13th September 1996.

Section 2 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995

The Medicines (Products for Animal Use — Fees) Regulations 1995 shall be amended in accordance with regulations 3 to 7 below.

Section 3 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995

In regulation 2(1) (Interpretation) in the definition of “complex application”for the words “a marketing authorisation, product licence or animal test certificate”there shall be substituted the words “a marketing authorisation or product licence”.

Section 4 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995

In Schedule 1, in Part I (Interpretation), after the definition of “category III application”there shall be inserted the following definition:

“food-producing animals”means animals whose flesh or products are intended for human consumption;.

Section 5 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995

In Schedule 1, Part II, for paragraph 6 (fees for applications for animal test certificates), there shall be substituted the following paragraph:

(6) The fee for an application for an animal test certificate in relation to a medicinal product, other than a biological product, which is for administration to food-producing animals shall be £600, and in any other case shall be £250..

Section 6 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995

In Schedule 1, Part IV, for paragraph 6 (fees for an application for the variation of an animal test certificate), there shall be substituted the following paragraph:

(6)

(1) The fee for an application for the variation of an animal test certificate shall be £200..

Section 7 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995

In Schedule 1, Part V, paragraph 3 (fee for an application for renewal of an animal test certificate), for the figure “£525”there shall be substituted the figure “£90”.

Section 8 Transitional provision

Nothing in these Regulations shall apply to an application made before the date these Regulations come into force.