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)
3.2.5: CMDh-Referrals
3.2.6: Product Information (ALT-T)
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-G)
3.2.10: Paediatric Regulation (ALT-N)
3.2.11: Questions & Answers (ALT-Q)
- 3.2.11.1: Applications for MA
- 3.2.11.2: CMDh Referrals
- 3.2.11.3: Variations
- 3.2.11.4: Post referral phase
- 3.2.11.5: PSURs & Renewals (ALT-W)
- 3.2.11.6: Product Information / Information on medicinal products
- 3.2.11.7: Generics & Usage Patents
- 3.2.11.8: Biologicals
- 3.2.11.9: Homeopathics
- 3.2.11.10: Advice from CMDh
- 3.2.11.11: EU-Enlargement
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-Y)

FAQ

Introduction:

This Question and answers section gives advice on regulatory issues in connection with the Mutual Recognition and Decentralised Procedures. Reference is made, where additional information is available from CMDh guidance documents.

For general regulatory guidance on the interpretation and implementation of the new pharmaceutical legislation, please refer to the Notice to Applicants, where updated guidance will be published by the European Commission.
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm

Index Q&As:

- Applications for MA
- CMDh Referrals
- Variations
- Post referral phase
- PSURs & Renewals
- Product Information/Information on Medicinal Products
- Generics & Usage Patents
- Biologicals
- Homeopathics
- Advice from CMDh
- EU enlargement