4.2.1: About CMDv, Activities (ALT-O)
4.2.2: CMDv guidance (ALT-G)
4.2.3: Pharmacovigilance (ALT-P)
4.2.4: Reports for Release (ALT-T)
4.2.5:
4.2.6: Special topics (ALT-S)
4.2.7: Statistics
4.2.8: Calendar (ALT-L)
4.2.9: Frequently asked questions (ALT-Q)
- 4.2.9.1: Questions from industry and answers (ALT-N)
- 4.2.9.2: Specific issues
4.2.10: Contact Form
4.2.11: submission of translations
4.2.12: What's new Archive (6 months) (ALT-W)

CMDv Q&A (Question and answers)

Questions on regulatory matters may be asked to CMDv, via this hyperlink

CMDh list of Questions and Answers related to the submission of variations according to Commission Regulation (EC) 1234/2008 (December 2009) - click link

General questions

Q&A 130 Changes to the invented name during procedure (50.73 kb)

Q&A 123 CTD format acceptance

Q&A 063 Referring to data in another dossier

Q&A 115 Global marketing and protection period of RP

Q&A 118 ERA data submission

Q&A 133 Abridged (generic) application for an antibiotic injection

Q&A 112 Efficacy and/or safety issues in accordance with GLP principles

Q&A 111 Application under fixed combination

Q&A 87 SPC improvement of generic products

Q&A 40a Protection period of a generic

Q&A A - The same veterinary medicinal product registered by two companies with different trade names

Q&A B - Submission of a single part III for all strengths

Q&A C - MRP when two national authorisations exist

Q&A D - Change of address of the MAH

Q&A E - Extension of pharmaceutical form to a new species

Q&A F - Application for a marketing authorisation on behalf of a company outside the EEA by a Regulatory Affairs Consultant

Q&A G - Withdrawal of an application during the validation

Q&A H - Transfer of a marketing authorisation via MRP

Q&A I - Use of feedgrade antibiotics in veterinary premixes

Q&A J - Classification of products

Q&A K - Veterinary tissue adhesives

Q&A L - Change of name during procedure

Q&A 4b - Informed consent applications in a CMS

Q&A 4c - National or VMR procedure

Q&A 12 - Single generic product with two reference products

Q&A 13 - Addition of target species not included in reference product

Q&A 16 - Independent national registration with different protection period

Q&A 18 - Data requirements - experts report

Q&A 19 - Can the MAH of an originator product apply for a generic of its own product

Q&A 21 - Release of information

Q&A 24 - Diagnostic kits

Q&A 28 - National transfer of MAH

Q&A 29 - Repeat use - clarification on BPG-003

Q&A 30 - Trade names

Q&A 61 - Informed consent application

Q&A 62 - Transfer of product name from originator to generic