Explanatory note

These Regulations amend the Medicines (Medicated Animal Feeding Stuffs) (No. 2) Regulations 1992 (the “principal Regulations”).

The main changes made by the Regulations are that they alter the fees payable in respect of the entry or retention in, or restoration to, the Register of manufacturers of animal feeding stuffs. From 1995 the commencement of the registration year is changed from 1st July to 1st April, and the fees which would otherwise have been charged are adjusted accordingly for the period 1st July 1994 to 31st March 1995 (regulations 3, 8 and the Schedule). Other drafting changes are made to regulation 3 of the principal Regulations.

The Regulations also clarify the requirements in respect of medicated feeding stuffs in which prescription only medicines have been incorporated which have been manufactured in the United Kingdom and those which have been imported from other member States and elsewhere, provide that such products imported from other member States should comply with Article 10.1, 1st indent, of Council Directive 90/167/EEC (OJ No. L92, 7.4.90, p.42) and amend the restriction concerning placing on the market of final medicated feeding stuffs so that it applies only to final medicated feeding stuffs in which prescription only medicines are incorporated (regulations 4, 5 and 6). They also remove in certain circumstances the requirement that a copy of a Veterinary Written Direction should be sent to the Royal Pharmaceutical Society of Great Britain (regulation 7).

A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament.