Order No. 78 of the National Sanitary Veterinary and Food Safety Authority validating the Guidance on the legal framework governing parallel imports of veterinary medicinal products for which a marketing authorization has already been granted and the Simplified Procedure for obtaining marketing authorizations for veterinary medicinal products.

Guidance on the legal framework governing parallel imports of veterinary medicinal products for which a marketing authorization has already been granted and the Simplified Procedure for obtaining marketing authorizations for veterinary medicinal products is an information document designed to help national authorities and economic operators involved in parallel imports of veterinary medicinal products to understand the main points of reference. Parallel imports of veterinary medicinal products shall be intended those in parallel with the distribution network that the original manufacturers or suppliers have established for their products in a Member State and refers to veterinary medicinal products which are similar in all respects to those marketed by the distribution networks of the original manufacturers or suppliers. A veterinary medicinal product may be imported in parallel on the basis of an authorization issued under a "simplified" procedure, in which the applicant must provide less information than is necessary for an application for a marketing authorization. In general, a veterinary medicinal product cannot be placed on the market of a Member State of the European Union, including Romania, without a marketing authorization, the primary purpose of which is to protect human and animal health. Marketing authorizations are granted either at national or Community level. The fact that a veterinary medicinal product sufficiently similar for parallel importation had a marketing authorization in Romania does not necessarily imply that this marketing authorization, "reference", must still be valid at the time of parallel import. The marketing authorization may be renewed after 5 years on the basis of a reassessment of the risk-benefit balance by the Institute for the Control of Biological Products and Veterinary Medicinal Products, if it has issued the authorization. The holder of an industrial or commercial property right protected by the law of a Member State may not rely on that law to oppose the importation of a veterinary medicinal product which has been lawfully placed on the market of another Member State by or with the consent of the holder of that right. The right shall be deemed to have been exhausted once the veterinary medicinal product has been placed on the market somewhere in the European Union. The trade mark proprietor must be notified in advance of the sale of the repackaged veterinary medicinal product.