Last updated: 27 February 2023
See updates at the end of the post.
EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
Revision 1 of the above document dated 15 Feb 2023 is available here.
Source: EMA
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 – 23 February 2023
You can view the highlights from the meeting here.
Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)
You can view Rev 2 (13 Feb 2023) of the above rules here.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9 February 2023
Here is a link to the above highlights
Source: EMA
Validation checklist Type II quality variations
You can download the latest version (10 Feb 2023) of this checklist here.
Source: EMA
Updates
| Date | Update(s) |
|---|---|
| 27 Feb 2023 | Link added to updated EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 |