Medicines products

Committee For Proprietary Medicinal Products, Xotes to Applicants for Marketing Authorisations on the Production and Quality Control of Monoclonal... [Pg.539]

Committee for Proprietary Medicinal Product (1993) Note for Guidance Investigation of Chiral Active Substances III/3501/91. [Pg.282]

Generic applications for chiral medicinal products should be supported by bioequivalence studies using enantiospecific bioanalytical methods unless both products contain the same, stable, single enantiomer or both products contain a racemate where both enantiomers show linear pharmacokinetics. [Pg.327]

The guideline concludes with a note that there is no intention to require further data on established medicinal products which contain a racemic drug unless new evidence emerges concerning the safety or efficacy of one enantiomer. If new claims related to the chiral nature of the active substance are made, then supporting studies on the individual enantiomers will be required. [Pg.327]

Fig. 13-2. Establishing procedures for chiral new drug substances and new medicinal products containing new chiral drug substances.

The guideline on impurities in new medicinal products parallels the drug substance text, but the designated thresholds concern only degradation products. The thresholds should be applied to the product at the end of its shelf-life, as that is when the greatest level of degradation is expected to have occurred. [Pg.336]

A. G. Rauws, K. Groen, Current regulatory (draft) guidance on chiral medicinal products Canada, EEC, Japan, United States, Chirality, 1994, 6, 72-75. [Pg.341]

Eudralex The rules governing medicinal products in the European Union, Vols. 1-9, Office for Official Publications of the European Communities, Luxembourg, 1998. [Pg.341]

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. [Pg.7]

Title VI Possession, distribution and dis- Tide VI Classification of medicinal products Tide VII Wholesale distribution of medic-... [Pg.8]

Title VIII Supervision and sanctions Tide X Special provisions on medicinal products derived from human blood and plasma Tide XI Supervision and sanctions... [Pg.8]

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... [Pg.9]

Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004... [Pg.9]

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products... [Pg.12]

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. [Pg.12]

Commission Regulation (EC) No. 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State... [Pg.12]

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 ... [Pg.12]

Council Regulation (EEC) No. 2377/90 of 26 June 1990 laying down a Commrmity procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal origin. [Pg.12]

Council Regulation (EEC) No. 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products... [Pg.12]

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