skip to main content
European Commission Logo
en English
Newsroom

EUDRALEX : The rules governing medicinal products in the European Union

date:  30/03/1999

author:  European Commission

--- Medicinal products for human use ---

volume 1 : Pharmaceuticals legislation

volume 2 : Notice to applicants

vol. 2 A : Procedures for marketing authorisation

vol. 2 B : Presentation and content of the dossier

volume 3 : Guidelines

vol. 3 A : Quality and biotechnology

vol. 3 B : Safety, environment and information

vol. 3 C : Efficacy

--- Medicinal products for human and veterinary use ---

volume 4 : Good manufacturing practices

--- Veterinary medicinal products ---

volume 5 : Pharmaceuticals legislation

volume 6 : Notice to applicants

vol. 6 A : Procedures for marketing authorisation

vol. 6 B : Presentation and content of the dossier

volume 7 : Guidelines

vol. 7 A : General, efficacy, environmental risk assessment

vol. 7 B : Immunologicals, quality

volume 8 : Maximum residue limits (not yet published)

volume 9 : Pharmacovigilance (not yet published)

Luxembourg: Eur-Op, 1998- - 9 vol. vol. 1 - Eur-Op catalogue n° CO-08-97-856-**-C, 300 p., price 44.50 euro vol. 2 (A+B) - Eur-Op catalogue n° CO-41-97-001(+002)-**-C, price 70 euro vol. 3 (A+B+C) - Eur-Op catalogue n° CO-54-97-001(+002+003)-**-C, price 122 euro vol. 4 - Eur-Op catalogue n° CO-08-97-977-**-C, price 22 euro vol. 5 - Eur-Op catalogue n° CO-08-97-864-**-C, price 40 euro vol. 6 (A+B) - Eur-Op catalogue n° CO-05-98-001(+002)-**-C, price 52 euro vol. 7 (A+B) - Eur-Op catalogue n° CO-30-98-001(+002)-**-C, price 70 euro DE, EN, ES, FR, IT

Related Growth Website