Memorandum by the Ministry of Agriculture, Fisheries
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.
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.
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