European medicinal product

Eudralex The rules governing medicinal products in the European Union, Vols. 1-9, Office for Official Publications of the European Communities, Luxembourg, 1998. 

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. 

Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC Amended by Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use... 

Regulation (EC) No. 141/2000 ofthe European Parliament and of the Council ofl6 December 1999 on orphan medicinal products Commission Regulation (EC) No. 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts similar medicinal product and clinical superiority ... 

The Rules Governing Medicinal Products in the European Union, Volume 10, Clinical Trials. 

The CTD format has been incorporated into the E U regulations and is set out in the revised version of Annex I to directive 2001/82/EC, which was published as Commission Directive 2003/63/EC. It is also supported by detailed guidance in the Rules Governing Medicinal Products in the European Union, Volume 2B - Presentation and content of the dossier - CTD2001 edition. The relationship between the CTD format and the previous four-section format that was used in the E U is shown in Table 6.1. 

The Rules Governing Medicinal Products in the European Union, Volume 2, Notice to Applicants, Medicinal Products for Human Use. http //ec.europa.eu/enterprise/pharmaceuticals/index en.htm. 

The Community procedure for establishing MRLs of veterinary medicines in foodstuffs of animal origin is set down in Council Regulation (EEC) No. 2377/90 as amended by Council Regulation (EC) No. 1308/1999. The regulations are supported by detailed guidance contained in The Rules Governing Medicinal Products in the European Union, Volume 8 - Maximum Residue Limits. 

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

The European regulations relating to dmg GMPs are set out in two directives Directive 2003/94/EC, which lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. 

Inspectors findings and observations Relevant headings from The Rules Governing Medicinal relevant to the inspection and Products in the European Community, Good deficiencies Manufacturing Practice for Medicinal Products Vol. IV. (Guide to GMP, Basic Requirements, relevant for scope of inspection). ... 

Office for Official Publications of the European Community (1992) The Rules Governing Medicinal Products in the European Community, vol. IV, Guide to Good Manufacturing Practice for the Manufacture of Medicinal Products. 

There are specific GMP requirements, particularly for medicinal products and food additives. Both the European institutions and the FDA impose constraints and require the approval of any modification in manufacturing of the products concerned. 

Good Manufacturing Practice and certification of starting materials for the industrial manufacture of medicinal products. Concept paper on a Community regulatory framework , 1995 European Commission, Directorate General IE, Industry Consumer Goods Industries III/E/3 Pharmaceuticals, July. 

The reader may wonder why process validation is included. This is simply a matter of consideration of the content of guidelines issued in the past that relate to development pharmaceutics. The first such pan-European guideline, adopted by the Committee for Proprietary Medicinal Products (CPMP) in 1988, included advice on both development pharmaceutics and process development. Later versions of the guidelines on development pharmaceutics and on process development have addressed these topics separately, but the historical and practical perspectives suggests that both need to be discussed here. 

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