Explanatory Note
(This note is not part of the Order)
This Order amends the Medicines (Exemptions from Licences and Animal Test Certificates) Order 1986 as follows—
(1) applicants for an exemption to carry out medicinal tests on animals were formerly notified by the licensing authority within 35 days that it was acceptable to carry out the tests; now applicants must apply for an animal lest (confirmation of exemption) certificate which will be issued by the licensing authority within the 35 days or such further period as the licensing authority determines (article 4);
(2) the exemption from the need for a licence did not apply to the sale, supply or importation of an immunological veterinary drug: for that type of drug there has been substituted an unlicensed live immunological drug. The request for an exemption from the need for a licence for a veterinary drug containing an active ingredient being a substance which is not contained in any licensed veterinary drug must now be accompanied by sufficient toxicological information for the licensing authority to be able to assess the adequacy of the proposed withdrawal period (article 5);
(3) an applicant for an animal test (confirmation of exemption) certificate has to provide the licensing authority with specified items of information. The information required includes: in respect of immunological veterinary drugs, the designation or description of each active ingredient and specified detailed information according to whether it is or is not a licensed medicinal product; in respect of all veterinary drugs, details of the shelf-life and a draft of the product literature; the address of all sites of testing, the number of animals involved and notification of the withdrawal period to be observed (article 6).