Ecolex Logo
The gateway to
environmental law
Search results » Legislation

Order No. 66 of the National Sanitary Veterinary and Food Safety Authority validating the Guidance on the legal framework governing the parallel import of veterinary medicinal products for which a marketing authorization has already been granted and the Simplified Procedure for obtaining the parallel import authorization for veterinary medicinal products.

Country/Territory
Romania
Document type
Regulation
Date
2012
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Intellectual property rights/patents Authorization/permit Packaging/labelling Internal trade International trade Access-to-information
Geographical area
Black Sea, Eastern Europe, Europe, Europe and Central Asia, European Union Countries
Abstract

This Guidance is an information document designed to help national authorities and economic operators involved in the parallel import of veterinary medicinal products to understand the main legal benchmarks governing this type of activity. It refers to the practical applications of the principle of free movement of goods in the field of parallel import from a Member State of the European Union into Romania of patented veterinary medicinal products for which a marketing authorization has already been granted in Romania. A patented medicinal product is a finished drug placed on the market under a special name and in a special package. The Institute for the Control of Biological Products and Veterinary Medicines manages the parallel import for veterinary medicinal products authorized in Romania through a national or decentralized/mutual recognition procedure. The parallel import of centrally authorized veterinary medicinal products is managed by the European Medicines Agency (EMA). The parallel import of a veterinary medicinal product represents a lawful form of trade within the EU internal market. Parallel trade is a lawful form of economic activity with goods between the Member States of the European Union. It is known as "parallel" insofar as it takes place outside and - in most cases - in parallel with the distribution network that the original manufacturers or suppliers have in a Member State of the European Union and refers to medicinal products, which are similar 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 a parallel import authorization issued under the 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. National authorities may not obstruct the parallel importation of veterinary medicinal products by requiring importers to apply the same requirements to manufacturers who apply for the first time for a marketing authorization for a veterinary medicinal product, provided that this exception does not undermine the protection of human and animal health. When the information necessary for the protection of human and animal health is already available to the Institute for the Control of Biological Products and Veterinary Medicines, as a result of the first placing on the market of a veterinary medicinal product in Romania, the product, imported in parallel, is subject to authorization granted on the basis of the simplified procedure, provided that: (a) the imported veterinary medicinal product has been granted a marketing authorization in the Member State of export; and (b) the imported veterinary medicinal product is sufficiently similar to a veterinary medicinal product that has already received a marketing authorization in Romania, even if there are differences regarding excipients.

Full text
Romanian
Website
www.icbmv.ro