Pharmafile offers tailored solutions in the area of global quality management to international standards. Our Regulatory registration process has its origins in the 1965 EC Medicines Directive, which laid down the criteria of safety, quality and efficacy. In 1981 two EC Directives were published with the intention of improving and harmonising the registration process for medicinal products within the European Union.
In the 1990’s, controls were further harmonised and tightened with the introduction of legislation covering residues in food, a centralised registration procedure and the rules for Good Manufacturing Practice.
The Veterinary Medicines Regulations 2013 SI 2033 came into force on 1 October 2013.
EU Veterinary Medicines Directives:
Directive 2001/82/EC – Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (Official Journal L 311, 28/11/2001 p. 1 – 66). (consolidated version : 18/7/2009)
Directive 2004/28/EC – Amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Official Journal L 136, 30/4/2004 p. 58 – 84)
Consolidated Directive – Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended by Directive 2004/28/EC
Directive 2009/53/EC – amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (Official Journal L 168, 30/6/2009, p. 33 – 34)
Directive 2009/9/EC – Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Official Journal L 44, 14/2/2009 p. 10 – 61).
The objectives of registration are to ensure:
the product is safe for the animal itself, the consumer of food derived from treated animals, those handling the product, and the environment
the product is of consistent high quality, does not deteriorate and has the stability to last at least until the expiry date, and the product’s efficacy conforms with the claims made on its information leaflet and label.
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