Order No. 16 of the National Sanitary Veterinary and Food Safety Authority validating Veterinary Sanitary Regulation regarding the conditions for the organization and operation of veterinary pharmaceutical units and units intended for the commercialization of pet animals.

Veterinary Sanitary Regulation establishes the conditions for the organization and operation of veterinary pharmaceutical units and units intended for the commercialization of pet animals. It applies to veterinary pharmaceutical units - veterinary pharmacies, veterinary pharmaceutical points and veterinary pharmaceutical warehouses, as well as units intended for the commercialization of companion animals, which carry out their activity on the basis of veterinary sanitary registration or of the veterinary sanitary operating authorization issued by the competent veterinary sanitary authority. Veterinary pharmacy shall be intended veterinary sanitary unit that owns and markets veterinary medicinal products, hygiene and cosmetic products for veterinary use, instruments, medicinal plant products, combined feed, medicated feed, complementary feed and other products intended for animals, in compliance with the legal provisions in force. Veterinary pharmaceutical units can only be established in compliance with the conditions related to the fields of competence in which the veterinary profession has exclusivity. On order to obtain veterinary sanitary registration/authorization pharmaceutical units must exercise one of the following activities: (a) wholesale trade of pharmaceutical products for veterinary use; (b) retail trade of pharmaceutical products for veterinary use; and (c) management of warehouses. After the veterinary sanitary registration, respectively after the issuance of the veterinary sanitary authorization for operation, the veterinary pharmaceutical units that are the subject of this sanitary regulation, are registered in the national record register drawn up by the Directorate for control and coordination of veterinary pharmaceutical activity within the National Veterinary Sanitary and Food Safety Authority. In veterinary pharmaceutical units, the products must be placed by action groups. In veterinary pharmaceutical units, it is prohibited to carry out other activities other than those provided for in the veterinary sanitary registration/veterinary sanitary authorization for operation. All veterinary pharmaceutical units must have a contract with a specialized commercial company for the destruction and denaturation of expired or damaged products. In veterinary pharmaceutical units, keeping and selling pets is prohibited. Issuance of veterinary medicinal products, as well as other products for veterinary use, is done only at retail, self-service being prohibited. In veterinary pharmacies, as well as in veterinary pharmaceutical points, the possession and sale of veterinary biological products are prohibited. In veterinary pharmacies, the sale of combined feed, complementary feed and medicated feed is allowed, only if they have a place specifically intended for this purpose, so that there is no interference with the other products from the veterinary pharmacy. Veterinary pharmacies are obliged to have in the technical library, on paper or in electronic format: (a) the Romanian Pharmacopoeia, the edition in force; (b) the nomenclature of veterinary medicinal products in force; and (c) veterinary sanitary legislation in force and, in particular, that relating to veterinary medicinal products. In the veterinary pharmacy it is mandatory to have, in original or in copy, the following categories of documents: (a) documents certifying the origin and quality of veterinary medicinal products, invoices or transfer notes, batch analysis bulletins, quality certificates; in the documents for the purchase of veterinary medicinal products and other products for veterinary use, both the name and the manufacturing series, as well as the validity of each product must be recorded; (b) record register of master and officinal preparations and record register of prescriptions that are not retained in the pharmacy, prescriptions that are marked on the back with the date of issue of the veterinary medicinal products and the stamp of the veterinary pharmacy, prescription copy register master, which includes the date of preparation and the number of the prescription, the ingredients, the method of preparation, the pharmaceutical form and the quantity prepared, the method of administration, as well as the name of the doctor who issued the prescription, the voucher/receipt/invoice number issued/issued, the date of issuance of the master prescription, observations; c) the list of suppliers; d) documents certifying the qualitative reception of pharmaceutical substances and the quality of distilled water, sheets for their identification reactions, according to the Romanian Pharmacopoeia, the edition in force; e) documents certifying, in accordance with the provisions the legislation in force, the release of toxic, narcotic, psychotropic substances and other therapeutic groups that are released on the basis of a medical prescription and that are retained in the veterinary pharmacy.