(This note is not part of the Regulations)
These Regulations which replace the Medicines (Fees) Regulations 1978 (as amended) prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 in so far as they apply to medicinal products for animal use only.
The Regulations provide for increased fees to be payable for applications for the grant of product licences, manufacturers' licences, wholesale dealers' licences, animal test certificates and export certificates (Part II).
The Regulations also provide for increased fees to be payable for applications for variations of such licences or certificates (Part III) and for renewal thereof (Part IV). The Regulations provide for increased fees to be payable in respect of inspections of sites carried out in connection with such applications for such licences or certificates and during the currency thereof (Part V).
In addition the Regulations provide for increased annual fees to be payable, calculated on the basis of annual turnover, in connection with applications for the grant or renewal of any product licence (Part VII).
Administrative provisions (Part VIII) deal with time of payment and waiver or refund of fees in specified circumstances.
Part IX of the Regulations deals with revocations, savings and transitional provisions.
The only change of substance is the introduction of a fee to be payable in respect of the testing of samples where batch control sample testing is a condition of the licence (Part VI).