Rules Governing Medicinal Products in the European Union
- Volume 2 Notice to Applicants
- 2A Procedures for Marketing Authorisation
- Kapitola 1: Marketing Authorisation
- Kapitola 2: Mutual Recognition
- Kapitola 3: Community Referral
- Kapitola 4: Centralised Procedure
- Kapitola 5: Variations
- Kapitola 6: Decision Making Procedure for the Adoption of Commission Decisions
- Kapitola 7: General Information
- 2B Presentation and Content of the Dossier
- 2C Regulatory Guidelines
- 2A Procedures for Marketing Authorisation
- Volume 4 Good Manufacturing Practice
- Volume 9 Pharmacovigilance
- Volume 10 Clinical Trials
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Scientific Guidelines
- Quality Guidelines (Chemical and Herbal)
- Biologicals Guidelines
- Non-Clinical Guidelines
- Clinical Efficacy and Safety Guidelines
- Multidisciplinary Guidelines