Pharmeuropa 36.1 just released
All new European Pharmacopoeia (Ph. Eur.) texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.1 is 31 March 2024.
Users and interested parties are welcome to comment on these drafts. It should be noted that:
- although draft monographs must not be regarded as official standards, they will, once adopted by the Ph. Eur. Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph. Eur. member states;
- if general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.
It is therefore extremely important that users provide feedback on such drafts.
Comments made after adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.
So don’t miss this opportunity to provide your comments. The 57 drafts published in Pharmeuropa 36.1 are listed here.
| Drafts published in Pharmeuropa 36.1 (end of commenting period: 31 March 2024) | Group | |
|---|---|---|
| 1 | 2.5.42. N-Nitrosamines in active substances and medicinal products Reference number: PA/PH/SG (20) 68 ANP Text number: 20542 Direct link | MG |
| 2 | 2.6.7. Mycoplasmas Reference number: PA/PH/Exp. MYC/T (21) 1 ANP R1 Text number: 20607 Direct link | MYC |
| 3 | 5.1.9. Guidelines for using the test for sterility Reference number: PA/PH/Exp. 1/T (23) 17 ANP Text number: 50109 Direct link | 1 |
The complete table can be found on the website: Pharmeuropa 36.1 just released – European Directorate for the Quality of Medicines & HealthCare (edqm.eu)
The deadline for comments on Pharmeuropa 36.1 is 31 March 2024. So don’t miss this opportunity to provide your comments.
Read the full article here
Source: European Directorate for the Quality of Medicines & HealthCare, Pharmeuropa 36.1 just released, website Pharmeuropa 36.1 just released – European Directorate for the Quality of Medicines & HealthCare (edqm.eu)