The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

Transitional Provisions

19.—(1) On 1st January 1995 all existing product licences granted for veterinary medicinal products under the Medicines Act 1968, other than product licences for immunological veterinary medicinal products (except for those granted in response to an application made on or after 1st April 1993, including any application made under the Medicines (Veterinary Medicinal Products) (Renewal Applications for Product Licences Subject to Review) Regulations 1993(1) ) will be deemed to be marketing authorisations granted under these Regulations and shall be subject to the same terms and conditions, except that whenever any report of a suspected adverse reaction is required to be submitted to the Ministers within a period of less than fifteen days, that period shall be extended to fifteen days.

(2) The expiry dates of such marketing authorisations shall be the same date as the date on which the product licence would have expired.

(3) This Regulation shall apply to any licences which on 1st January 1995 continue in force pending renewal under the provisions of section 24(6) of the Medicines Act 1968.

(4) Any product licence which becomes a marketing authorisation by virtue of the operation of this regulation shall be subject to the following additional conditions—

(a) the labels of containers or packages of a veterinary medicinal product categorised under the Medicines Act 1968 as a medicinal product on a general sale list, if they are large enough, or the package insert if they are not, shall bear the words “If signs of disease persist or appear consult your veterinary surgeon or veterinary practitioner”; and

(b) the labels of containers or packages of a veterinary medicinal product not categorised under that Act as a medicinal product on the general sale list, if they are large enough, or the package insert if they are not, shall, if the product is embrocation, liniment, lotion, liquid antiseptic or other liquid preparation or gel and is for external use only, bear the words “For external use only”.

(5) In the case of a container placed on the market on or after 1st January 1995 but on or before 31st December 1996 and not labelled in conformity with these Regulations, it shall be a defence in any proceedings for a defendant to prove that the container as labelled was in conformity with the relevant legislation current before the coming into force of these Regulations; and the provisions of this paragraph shall apply to package inserts in the same way as it applies to labels.

(6) The requirement for the holder of a marketing authorisation to be established within the European Economic Community shall not apply to the holder of a product licence deemed to be a marketing authorisation under these Regulations until the authorisation is due to be renewed.

(1)

S.I. 1993/2399.