S.L. 437.47 Art. 4Non-inactivated immunological veterinary medicinal products.

(1) The Director may provide that these regulations shall not apply to non-inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality.

(2) In the case of veterinary medicinal products intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept exclusively as pets, Malta may permit exemptions from the provisions in regulations 5 to 8, provided that such products do not contain substances the use of which requires veterinary control and that all possible measures are taken to prevent unauthorised use of the products for other animals.

(3) In order to be granted the exemption for the veterinary medicinal product referred to in this sub-regulation applicants shall submit an application with the Veterinary Services.

(4) In order to qualify under the exemption described in this sub-regulation (2) the product must be manufactured by:

(a) the holder of a manufacturing authorisation if manufactured in Malta or in another Member State of the European Union;

(b) the holder of a relevant licence conferring authorisation to manufacture veterinary medicinal products if the product is manufactured in a Third country.

(5) The product must not be classified as requiring a veterinary prescription.

(6) The manufacturer, importer, wholesale dealer or retailer of a veterinary medicinal product shall declare that he will notify the Veterinary Services within fifteen (15) days of learning of any serious adverse reactions in accordance with sub-regulations (2) and (3) of regulation 68. A record of each adverse reaction and serious adverse reaction must be maintained on becoming aware of it. The records shall be kept for five (5) years.

(7) The Veterinary Services shall prepare and publish a list of active substances that can be used in veterinary medicinal products authorised under sub-regulation (2), specifying the species of non-food producing animals for which it is approved and may specify how the active substance or a product containing the active substances to be administered.

(8) The Veterinary Services may decide not to apply the provisions of this Regulation to a previously exempted product if any one or more of the following occur:

(a) serious adverse reactions are reported;

(b) it is demonstrated, at any time after authorisation, that the substance is carcinogenic, genotoxic or that it shows developmental toxicity (including teratogenicity);

(c) the product contain active substances that are re-classified as narcotic or psychotropic substances;

(d) any one of the ingredient/s in the product is/are not included anymore in the list mentioned in paragraph

(d) of sub-regulation (3);

(e) it is reported and is verified by the Veterinary Services that the product is not being used on the animals mentioned in sub-regulation (2);

(9) The product authorised under sub-regulation (2) shall be clearly labelled as being exempt from the requirements of regulations 5, 6, 7 and 8 in relation to a Marketing Authorisation. The information obtainable from the whole pack must at least show the following details:

(a) the name of the veterinary medicinal product;

(b) the pharmaceutical dosage form;

(c) the name and strength of each active substance;

(d) the route of administration;

(e) the batch number;

(f) the expiry date;

(g) a sentence to the effect of "For administration on non-food producing animals only" authorised in accordance to regulation 4(2) of these regulations;

(h) the target species;

(i) storage instructions;

(j) the shelf-life after the immediate packaging has been opened for the first time;

(k) therapeutic indications;

(l) contra-indications;

(m) interaction with other medicines and other forms of interaction;

(n) dosage instructions.

(10) If there is sufficient room on the label, the information may be present only on it without the need of a package leaflet. The information must be conveyed in a clear and legible manner.

(11) The provisions of sub-regulation 5 shall come into force on the 1st November 2021.