European perspectives in the field of medicinal products

Authors: Simona Sturzu, Mirela Marinescu
Affiliation: Institute for Control of Veterinary Biological Products and Medicines Bucharest

European legislation governing veterinary medicinal product is under review by the European Commission. The new legislation will cover areas for research, development and authorization of new medicinal products and determine how it will perform distribution of veterinary medicinal products for both farm animals and pets. Revision of this legislative project is expected to be posted for public consultation in this year, the final form to be adopted in 2014.

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New legislation on the marketing and use of feed: status of nutritional supplements

Authors: Simona Sturzu, Luminita Paraschiv                                                                                   Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti

The term “nutritional supplements” for animals is found first in the “Proposal for the European Parliament and of the Board amending Directive 93/74/EEC on feeding stuffs intended for particular nutritional purposes and amending Directives 74/63/EEC, 79/373/EEC and 82/471/EEC”, submitted by the European Commission to the European Parliament and Council Director for approval on July 28, 1997. The proposal was not approved, for the reasons it hat this category of “supplements for animal nutrition” is already regulated at EU level on legislation to feed, supplementary feed, feed premixes, food for particular nutritional purposes. In order to harmonize the conditions for the marketing and use of feed, to clarify of divergences and uncertainties due existing legislative vacuum, in order to ensure a high level of protection of public health and to provide adequate information to users and consumers, The Regulation (EC) No 767/2009 of the European Parliament and the Council on the marketing and use of feed, amending Regulation (EC) No 1831/2003 and repealing Council Directive 79 / 373/EEC, Council Directive 80/511/EEC, Directives 82 / 471/CEE, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217 / EC (1) approved. The new regulation simplifies and clarifies the existing procedures and renewal the legislation for the marketing and use of feed materials, compound feed and bio proteins, including dietary feed.

full text (in Romanian)