Law on veterinary medicinal products.

This Law regulates and establishes the necessary procedure for testing and marketing, production, labelling, wholesale and retail trade, pharmacovigilance, quality control, advertising and surveillance of all recognized veterinary medicinal products. This Law sets out rules and methods aimed at ensuring the quality, safety and effectiveness of such products, intended for the protection of animal health and thus the protection of human health from veterinary medicinal product residues that can be found in food of animal origin and in animal feed. Veterinary medicinal products are divided into two different types: veterinary medicinal products issued by veterinary prescription; and those that can be issued without such prescription. The conditions for classifying, prescribing and issuing of veterinary medicinal products shall be laid down by the national Minister in charge of Agriculture, Fisheries and Rural Development. This national competent authority shall also manage all activities and shall carry out pharmacovigilance monitoring task and other inspection related affairs. This Law regulates and establishes the necessary procedure for testing and marketing, production, labelling, wholesale and retail trade, pharmacovigilance, quality control, advertising and surveillance of all recognized veterinary medicinal products. This Law sets out rules and methods aimed at ensuring the quality, safety and effectiveness of such products, intended for the protection of animal health and thus the protection of human health from veterinary medicinal product residues that can be found in food of animal origin and in animal feed. Veterinary medicinal products are divided into two different types: veterinary medicinal products issued by veterinary prescription; and those that can be issued without such prescription. The conditions for classifying, prescribing and issuing of veterinary medicinal products shall be laid down by the national Minister in charge of Agriculture, Fisheries and Rural Development. This national competent authority shall also manage all activities and shall carry out pharmacovigilance monitoring task and other inspection related affairs.
Exceptions to the application are listed in article 3.
The text is divided into fourteen main Chapters and 93 articles. Titles of Chapters are as follows: (I) Basic provisions; (II) Veterinary medicinal products testing procedures; (III) Marketing of veterinary medicinal products; (IV) Production authorization; (V) Labelling and instructions on veterinary medicinal products labelling; (VI) Transport of veterinary medicinal products; (VII) Pharmacovigilance; (VIII) Quality control for veterinary medicinal products; (IX) Advertising of veterinary medicinal products; (X) Expenses; (XI) Accessories and other veterinary products; (XII) Supervision; (XIII) Penalty provisions; and (XIV) Transitional and final provisions.
Prohibition of inappropriate product presentation is defined in article 5; Authorization for placing and application for marketing authorization are laid down in articles 22 and 23. Issues on immunological veterinary medicinal products (vaccination) are provided in article 25; for verified veterinary-medical use and data protection principle see article 28; measures related to emergency situations are in article 32; Decentralized procedure and mutual Member State recognition provisions are in article 35; time limits for placing on the market of veterinary medicinal products are defined in article 39; issues on possible changes to the conditions under which the marketing authorization was granted are in article 40, meanwhile the procedures necessary for the renewal of marketing authorization and revocation of such authorization are laid down in articles 41 and 42. General veterinary medicinal products manufacturing authorization procedures are determined in articles 48, 49 and 50. For good practice issues see article 51. Types of quality control are classified in article 67.