All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 35.3 is 30 September 2023.
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 27 drafts published in Pharmeuropa 35.3 are listed here.
|
|
Drafts published in Pharmeuropa 35.3 (end of commenting period: 30 September 2023) |
Group |
|
1 |
2.2.47. Capillary electrophoresis Reference number: PA/PH/Exp. CE/T (16) 1 ANP Text number: 20247 |
CE |
|
2 |
Amiodarone hydrochloride Reference number: PA/PH/Exp. 11/T (20) 40 ANP R1 Text number: 0803 |
11 |
|
3 |
Baclofen Reference number: PA/PH/Exp. 11/T (17) 63 ANP R2 Text number: 0653 |
11 |
|
4 |
Brivaracetam Reference number: PA/PH/Exp. P4/T (23) 9 ANP Text number: 3139 |
P4 |
|
5 |
Burdock root Reference number: PA/PH/Exp. 13B/T (23) 21 ANP Text number: 2943 |
13B |
|
6 |
Charcoal, activated Reference number: PA/PH/Exp. 9/T (23) 20 ANP Text number: 0313 |
9 |
|
7 |
Cinnarizine Reference number: PA/PH/Exp. 10B/T (23) 7 ANP Text number: 0816 |
10B |
|
8 |
Dextromethorphan hydrobromide monohydrate Reference number: PA/PH/Exp. 11/T (23) 32 ANP Text number: 0020 |
11 |
|
9 |
Doxylamine hydrogen succinate Reference number: PA/PH/Exp. 10C/T (23) 17 ANP Text number: 1589 |
10C |
|
10 |
Eleutherococcus Reference number: PA/PH/Exp. 13A/T (20) 25 ANP Text number: 1419 |
13A |
|
11 |
Etravirine tablets Reference number: PA/PH/Exp. P4/T (21) 36 ANP Text number: 3122 |
P4 |
|
12 |
Narrow-leaved coneflower root Reference number: PA/PH/Exp. 13A/T (23) 1 ANP Text number: 1821 |
13A |
|
13 |
Orodispersible films Reference number: PA/PH/Exp. 12/T (22) 3 ANP Text number: 3195 |
12 |
|
14 |
Oromucosal preparations Reference number: PA/PH/Exp. 12/T (21) 11 ANP Text number: 1807 |
12 |
|
15 |
Pale coneflower root Reference number: PA/PH/Exp. 13A/T (23) 2 ANP Text number: 1822 |
13A |
|
16 |
Pharmaceutical preparations Reference number: PA/PH/Exp. 13A/T (23) 21 ANP Text number: 2619 |
PHP |
|
17 |
Phyllanthus fruit Reference number: PA/PH/Exp. TCM/T (20) 43 ANP Text number: 3160 |
TCM |
|
18 |
Pirfenidone tablets Reference number: PA/PH/Exp. P4/T (20) 9 ANP R1 Text number: 3155 |
P4 |
|
19 |
Purple coneflower herb Reference number: PA/PH/Exp. 13A/T (23) 3 ANP Text number: 1823 |
13A |
|
20 |
Purple coneflower root Reference number: PA/PH/Exp. 13A/T (23) 4 ANP Text number: 1824 |
13A |
|
21 |
Revision of the titles of monographs on medicinal products containing a chemically defined active substance present as a salt Reference number: PA/PH/SG (23) 6 ANP Text number: 80003 |
SG |
|
22 |
Rosuvastatin zinc tetrahydrate Reference number: PA/PH/Exp. 10B/T (23) 19 ANP Text number: 3135 |
10B |
|
23 |
Sodium calcium edetate hydrate Reference number: PA/PH/Exp. 10D/T (16) 26 ANP R1 Text number: 0231 |
10D |
|
24 |
Sorafenib tosilate Reference number: PA/PH/Exp. 17/T (22) 10 ANP Text number: 2931 |
17 |
|
25 |
Sorbitol, liquid, partially dehydrated Reference number: PA/PH/Exp. CRB/T (23) 24 ANP Text number: 2048 |
CRB |
|
26 |
Topiramate Reference number: PA/PH/Exp. 10D/T (22) 40 ANP Text number: 2616 |
10D |
|
27 |
Trimetazidine dihydrochloride Reference number: PA/PH/Exp. 10B/T (23) 9 ANP Text number: 1741 |
10B |