Category: Medicines [EU]

Authorisation, import and manufacture of veterinary medicines Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC It sets out rules for the sale, manufacture, import, export, supply, distribution, control and use of veterinary medicinal products (VMPs), aiming to: modernise legislation; stimulate innovation in and increase the availability of VMPs; strengthen the EU’s campaign […]

Medicinal products for paediatric use This Regulation seeks to promote the production of medicinal products for paediatric use by increasing research, development and authorisation for this type of medicinal product. The lack of medicinal products specifically designed and developed for treating children* is a Europe-wide problem. Indeed, more than 50% of medicines currently prescribed for […]

Residues of veterinary medicinal products in foodstuffs of animal origin This Regulation classifies pharmacologically active substances used in veterinary medicinal products with a view to ensuring food safety. It determines permissible content in foodstuffs of animal origin and lays down maximum limits for residues of veterinary medicinal products in these foodstuffs. Regulation (EC) No 470/2009 […]

Protection of animals used for experimental purposes The European Union has established a framework to protect animals used for experimental or scientific purposes by ensuring that they are adequately cared for and that no unnecessary pain or suffering is inflicted. Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative […]

Orphan medicinal products The purpose of this Regulation is to introduce incentives to develop and market medicinal products for the prevention, diagnosis and cure of rare conditions (‘orphan medicinal products’). European Parliament and Council Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products. Summary The high cost of pharmaceutical research and development […]

Good clinical practice Under this Directive, the European Parliament and the Council are defining the principles and guidelines of good clinical practice (GCP) in line with the principles enunciated in the 1964 Helsinki Declaration. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations […]

Community code relating to veterinary medicinal products The European Union has combined in a single act all current legal provisions on production, marketing, distribution and use of veterinary medicinal products. 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 Summary The […]

Community code relating to medicinal products for human use This Directive establishes a Community code which brings together, in a single instrument, all the provisions in force governing the placing on the market, production, labelling, classification, distribution and advertising of medicinal products for human use. Directive 2001/83/EC of the European Parliament and of the Council […]

Background The European Union supports the European Pharmacopoeia, which was drawn up by the Council of Europe. The objective of this institution is to harmonise national laws on the manufacture, circulation and distribution of medicines in Europe. Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the […]

Authorisation and supervision of medicinal products European Medicines Agency This Regulation improves the operation of the authorisation procedures for the placing of medicinal products on the market in the Community and amends certain administrative aspects of the European Medicines Agency. Thanks to these measures, all innovative and safe pharmaceutical products will be placed on the […]