3.2.1: About CMDh (ALT-O)
3.2.2: Statistics (ALT-S)
3.2.3: Press Releases (ALT-P)
3.2.4: Procedural Guidance (ALT-L)
- 3.2.4.1: General Info (ALT-G)
- 3.2.4.2: Application for MA (ALT-T)
- 3.2.4.3: eSubmissions (ALT-N)
- 3.2.4.4: Generics
- 3.2.4.5: Applicant´s Responses
- 3.2.4.6: Renewal (ALT-W)
- 3.2.4.7: Variation
- 3.2.4.8: USR
- 3.2.4.9: Art 61.3 Procedure (ALT-6)
- 3.2.4.10: Consultation with target patient groups
- 3.2.4.11: Post Referral Phase
- 3.2.4.12: Pandemic Plan
3.2.5: CMDh-Referrals
3.2.6: Product Information
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-K)
3.2.10: Paediatric Regulation
3.2.11: Questions & Answers (ALT-Q)
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-Y)

Procedural Guidance

General Information Click here

Application for Marketing Authorisation Click here

eSubmissions Click here

Generics Click here

Applicants' responses Click here

Renewal Click here

Variation Click here

USR Click here

Article 61.3 Procedure Click here

Consultation with target patient groups Click here

Post-referral phase Click here

Pandemic Plan Click here