Joint Committee on Statutory Instruments Eighth Report


APPENDIX VII


Memorandum by the Ministry of Agriculture, Fisheries and Food


MEDICINES (PRODUCTS FOR ANIMAL USE - FEES) REGULATIONS 1997 (S.I. 1997/1469)

  The Joint Committee by letter dated 9 July 1997 requested a memorandum on the following points:

    (1)  Indicate, in accordance with paragraph 2.101(a) of the Statutory Instruments Practice what Community obligations are being implemented by this instrument; and explain why this information does not appear in the Explanatory Note.

Response

  Insofar as the regulations relate to marketing authorisations they supplement the Marketing Authorisations for Veterinary Products Regulations 1994 (S.I. 1994/3142) in implementing Council Directive 93/40/EEC amending Directive 81/85/EEC and 81/852/EEC. It is only those provisions that relate to product licences and animal test certificates under the Medicines Act 1968 that do not relate to Community obligations and these provisions rely on the powers cited under the Medicines Act 1971. The Ministry accepts that a reference to Directive 93/40/EEC in the Explanatory Note to these regulations should have been included.

    (2)   Regulations 16 and 17 make different provision about the time for payment of fees. Are the fees covered by regulation 16 all those payable under the regulations except those covered by regulation 17? If so explain how this result is achieved.

Response

  Regulation 16 provides (inter alia) that any fee payable under the regulations shall be payable within 30 days from the due date, as defined in regulation 18(6)(a). Regulation 17(1) provides that fees (other than fees for inspections) shall be payable at the time of application. It is accepted that these provisions are inconsistent and an amendment will be made to correct the position at the next available opportunity. In practical terms, regulation 17(1) will not be sought to be enforced; it is proposed that fees should be payable in accordance with regulation 16.

15th July 1997


 
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