Veterinary Medicinal Products (Amendment) Regulations, 2021 (L.N. 179 of 2021).

These regulations amend the Veterinary Medicinal Products Regulations (the principal regulations). The scope of these regulations is to add a number of essential provisions in the "principal regulations" in order to provide a more adequate and modern legal framework for the regulation and control of veterinary medicinal products. In regulation 2 a number of definitions are revised. Regulation 3 is deleted. Regulation 4 is amended in its part concerning the granting of the exemption for the veterinary medicinal products thereby referred. Immediately after regulation 4, a regulation 4A is added foreseeing that veterinary medicinal products may be obtained from any country and administered to animals for research purposes. Also a regulation 4B is added providing that Veterinary medicinal products may be exempted from the provisions of regulations 5 to 8 if it can be demonstrated that the products are veterinary samples or demonstration packs. A new regulation 4C specifies that any authorization issued under regulations 4(2), 4A and 4B, shall be deemed to be a Marketing Authorization. Finally, a regulation 4D is added providing for an exemption from the application of regulations 5 to 8 when the products are procured from a Member State of the European Union or imported from a Third country. Regulation 7 is amended and a new regulation 7A is added providing that, in order to be allowed to market, the products under regulation 7, shall make the object of an application to the Veterinary Services. Regulation 10 is amended and a new regulation 10A is added which concerns the possibility, for veterinary surgeons, to build up a case and expound it to the Veterinary Services when there is no suitable veterinary medicinal product available. In these cases the Veterinary Services may, where the disease is such that the veterinary medicinal product is likely to be needed as a matter of urgency, allow the importation of a veterinary medicinal product authorized for any non-food producing species, from any third country under any conditions it may deem fit. Regulation 11 is amended. A regulation 11A is added concerning instead the importation of veterinary medicinal products for food producing animals by veterinary surgeons. Further on, regulation 30 is revised and so are regulations from 38 to 50, concerning manufacturing and importation regulations; manufacturing authorization for veterinary medicinal products and active substances;Renewal of a manufacturing and import Authorization; Issuing of manufacturing and import Authorization; Variation of a manufacturing and import Authorization; Suspension of a manufacturing and import Authorization; Obligations of the holder of manufacturing authorization and manufacturer of active substance; Additional information pursuant to the application of a manufacturing and import Authorization; The obligation for the holder of the Authorization, to have permanently and continuously at his disposal the services of at least one qualified person; the qualifications of the qualified person and of the qualified person already engaged in the activities of the qualified person; the Responsibilities and duties of the qualified person. A new regulation 50A concerns the confirmation of a qualified person by the competent authority and a new regulation 50B concerns the registration of active substances importers, exporters, distributors and manufacturers. A new regulation 50C covers the issue of importation for re-export.A new regulation 50D, finally, concerns other licences that may be required apart from a manufacturing and import Authorization. Also regulation 58 is amended and, after it, there shall be added a new title VII " Retail supply of veterinary medical products" and a new regulation 58A on the management of retail supply of veterinary medicinal products. Following this a new title "Dispensing regulations" is added and regulation 59 concerning the dispensing of veterinary medicinal products by pharmacists, veterinary surgeons and suitably qualified persons is substituted. After regulation 59 there shall be added the new Title "Prescribing regulations" and a new regulation 59A, establishing that, in the territory of Malta, veterinary surgeons can only prescribe veterinary medicinal products in accordance with the provisions of this regulation. Regulations 60, 62, 64 and 72 are amended. A new regulation 77A is added on advertising of veterinary medicinal products regulations. Regulation 79 is amended and regulation 77A is added to regulate the administration of veterinary medicinal products and medicinal products to animals. Regulation 87 on the disposal of veterinary medicinal products waste is substituted and new regulations (from 88 to 93) are added to provide for offences and penalties.