EDQM/EUROPE

EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES AND HEALTHCARE (EDQM)

http://www.edqm.eu/en/edqm-homepage-628.html

EDQM

EP

CEP

EMA

EudraLex The Rules Governing Medicinal Products in the European Union

http://pharmeuropa.edqm.eu/home/

Authorities Europe (EU)

EMA Documentation Service

EMA history and description

EMA NEWS

EMA: Concept Paper on Storage Conditions during Transport

EU GMP Guide, Chapter 6, Quality Control – Concept Paper

EU-GMP-Guidelines

EU-Pharmacopeia (Ph.Eur.) – online-Version

European Commission Enterprise DG Pharmaceuticals

World Health Organization (WHO) Regional Office for Europe

Organisations Europe (EU)

APIC ‘the Active Pharmac. Ingredients Committee’, division CEFIG (European Chemical Industry Council)

Drug Information Association for Europe, DIA

EDQM – European Department for the Quality of Medicines Council of Europe

ISPE – European Office

Medicines and Healthcare products Regulatory Agency (MCA) – (GB)

MEGRA e.V. (Mid-European Group of Regulatory Affairs Professionals) (german)

PDA European Office

PIC/S – Pharmaceutical Inspection Co-operation Scheme

Organisations European Countries Middle

BAH – Bundesfachverband der Arzneimittel-Hersteller e.V.

Bundesverband der Pharmazeutischen Industrie e.V. (BPI)

BV Med Bundesfachverband Medizintechnologie e.V.

DECHEMA e.V.

Deutsche Pharmazeutische Gesellschaft (DPhG)

Germany: Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik (APV)

Interpharma

Österreichische Pharmazeutische Gesellschaft

Verband der Chemischen Industrie e.V. (VCI)

Verband Forschender Arzneimittelhersteller e.V. (VFA)

Organisations European Countries South
Italy: A.F.I. Associazione Farmaceutici Industria
Organisations European Countries West
Organsisation For Professionals In Regulatory Affairs

EU Legislation – Eudralex

• Vol 1: Legislation Human
• Vol 2: Notice to Applicants Human
• Vol 3: Guidelines Human
• Vol 4: GMP Human & Veterinary
• Vol 5: Legislation Veterinary
• Vol 6: Notice to Applicants Veterinary
• Vol 8: MRL Veterinary
• Vol 9: Pharmacovigilance Human & Veterinary
• Vol 10: Clinical Trials
• EudraLex on CD Version 22 – April 2010
  • EudraLex on CD : Update

Advertisement