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Explanatory note

Original text. Later amendments are not shown.

(This note is not part of the Regulations)

These Regulations, which replace the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1994 (S.I. 1994/1554), prescribe fees in connection with applications and inspections relating to:

(a)

marketing authorisations granted under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142); and

(b)

licences and certificates granted under the Medicines Act 1968 insofar as they apply to medicinal products for animal use.

Where fees are increased, the previous fees are specified in the Regulations. Where no previous fees are specified in the Regulations, then the fees remain the same as those prescribed by the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1994, except in the case of fees for applications for assistance in connection with mutual recognition applications (regulation 4 and Part III of Schedule 1) which are prescribed for the first time.

A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament and copies can be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3NB.