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 36.4 is 31 December 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;
- while 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 52 drafts published in Pharmeuropa 36.4 are listed here.
|
|
Drafts published in Pharmeuropa 36.4 (end of commenting period: 31 December 2024) |
Group |
|
1 |
2.8.25. High-performance thin-layer chromatography of herbal products Reference number: PA/PH/Exp. 13B/T (24) 29 ANP Text number: 20825 |
13B |
|
2 |
5.2.6. Evaluation of safety of veterinary vaccines and immunosera Reference number: PA/PH/Exp. 15V/T (24) 9 ANP Text number: 50206 |
15V |
|
3 |
5.38. Quality of data Reference number: PA/PH/Exp. SDA/T (23) 5 ANP Text number: 53800 |
SDA |
|
4 |
Almond oil, refined Reference number: PA/PH/Exp. 13H/T (24) 69 ANP Text number: 1064 |
13H |
|
5 |
Amoxicillin sodium Reference number: PA/PH/Exp. 7/T (12) 34 ANP R4 Text number: 0577 |
7 |
|
6 |
Amoxicillin trihydrate Reference number: PA/PH/Exp. 7/T (12) 13 ANP R4 Text number: 0260 |
7 |
|
7 |
Arachis oil, hydrogenated Reference number: PA/PH/Exp. 13H/T (24) 94 ANP Text number: 1171 |
13H |
|
8 |
Arachis oil, refined Reference number: PA/PH/Exp. 13H/T (24) 81 ANP Text number: 0263 |
13H |
|
9 |
Beeswax, white Reference number: PA/PH/Exp. 13H/T (24) 29 ANP Text number: 0069 |
13H |
|
10 |
Beeswax, yellow Reference number: PA/PH/Exp. 13H/T (24) 30 ANP Text number: 0070 |
13H |
|
11 |
Betacarotene Reference number: PA/PH/Exp. VIT/T (21) 17 ANP Text number: 1069 |
VIT |
|
12 |
Borage (starflower) oil, refined Reference number: PA/PH/Exp. 13H/T (24) 92 ANP Text number: 2105 |
13H |
|
13 |
Cabergoline Reference number: PA/PH/Exp. 11/T (24) 80 ANP Text number: 1773 |
11 |
|
14 |
Carnauba wax Reference number: PA/PH/Exp. 13H/T (24) 102 ANP Text number: 0597 |
13H |
|
15 |
Castor oil, refined Reference number: PA/PH/Exp. 13H/T (24) 93 ANP Text number: 2367 |
13H |
|
16 |
Chinese date Reference number: PA/PH/Exp. TCM/T (24) 20 ANP Text number: 3163 |
TCM |
|
17 |
Chlorhexidine diacetate Reference number: PA/PH/Exp. SIT/T (24) 21 ANP Text number: 0657 |
10B |
|
18 |
Chlorhexidine digluconate solution Reference number: PA/PH/Exp. 10B/T (24) 67 ANP Text number: 0658 |
10B |
|
19 |
Chlorhexidine dihydrochloride Reference number: PA/PH/Exp. SIT/T (24) 22 ANP Text number: 0659 |
10B |
|
20 |
Citalopram hydrobromide Reference number: PA/PH/Exp. 10B/T (24) 66 ANP Text number: 2288 |
10B |
|
21 |
Clenbuterol hydrochloride Reference number: PA/PH/Exp. 11/T (24) 66 ANP Text number: 1409 |
11 |
|
22 |
Coconut oil, refined Reference number: PA/PH/Exp. 13H/T (24) 89 ANP Text number: 1410 |
13H |
|
23 |
Cottonseed oil, hydrogenated Reference number: PA/PH/Exp. 13H/T (24) 84 ANP Text number: 1305 |
13H |
|
24 |
Dihydrocodeine hydrogen tartrate Reference number: PA/PH/Exp. 11/T (24) 67 ANP Text number: 1776 |
11 |
|
25 |
Dihydroergocristine mesilate Reference number: PA/PH/Exp. 11/T (24) 68 ANP Text number: 1416 |
11 |
|
26 |
Evening primrose oil, refined Reference number: PA/PH/Exp. 13H/T (24) 91 ANP Text number: 2104 |
13H |
|
27 |
Geranium oil Reference number: PA/PH/Exp. 13A/T (17) 7 ANP Text number: 3005 |
13A |
|
28 |
Hexylaminolevulinate hydrochloride Reference number: PA/PH/Exp. 10D/T (17) 16 ANP Text number: 3062 |
10D |
|
29 |
Histamine dihydrochloride Reference number: PA/PH/Exp. SIT/T (24) 25 ANP Text number: 0143 |
11 |
|
30 |
Hydrocortisone Reference number: PA/PH/Exp. 10B/T (24) 65 ANP Text number: 0335 |
10B |
|
31 |
Insulin glargine injection Reference number: PA/PH/Exp. 6/T (20) 15 ANP Text number: 3129 |
6 |
|
32 |
Maize oil, refined Reference number: PA/PH/Exp. 13H/T (24) 85 ANP Text number: 1342 |
13H |
|
33 |
Malic acid Reference number: PA/PH/Exp. 10D/T (24) 28 ANP Text number: 2080 |
10D |
|
34 |
Methods of preparation of homoeopathic stocks and potentisation Reference number: PA/PH/Exp. HMM/T (24) 5 ANP Text number: 2371 |
HMM |
|
35 |
Methylthioninium chloride hydrate Reference number: PA/PH/Exp. 10A/T (24) 49 ANP Text number: 1132 |
10A |
|
36 |
Olive oil, refined Reference number: PA/PH/Exp. 13H/T (24) 68 ANP Text number: 1456 |
13H |
|
37 |
Oxalic acid dihydrate Reference number: PA/PH/Exp. 10D/T (19) 30 ANP R4 Text number: 2963 |
10D |
|
38 |
Penicillamine Reference number: PA/PH/Exp. 11/T (24) 75 ANP Text number: 0566 |
11 |
|
39 |
Pergolide mesilate Reference number: PA/PH/Exp. 11/T (24) 70 ANP Text number: 1555 |
11 |
|
40 |
Pilocarpine hydrochloride Reference number: PA/PH/Exp. 11/T (24) 71 ANP Text number: 0633 |
11 |
|
41 |
Pilocarpine nitrate Reference number: PA/PH/Exp. 11/T (24) 72 ANP Text number: 0104 |
11 |
|
42 |
Rapeseed oil, refined Reference number: PA/PH/Exp. 13H/T (24) 86 ANP Text number: 1369 |
13H |
|
43 |
Ropinirole hydrochloride Reference number: PA/PH/Exp. 10D/T (21) 59 ANP R3 Text number: 2604 |
10D |
|
44 |
Safflower oil, refined Reference number: PA/PH/Exp. 13H/T (24) 90 ANP Text number: 2088 |
13H |
|
45 |
Sesame oil, refined Reference number: PA/PH/Exp. 13H/T (24) 82 ANP Text number: 0433 |
13H |
|
46 |
Soya-bean oil, hydrogenated Reference number: PA/PH/Exp. 13H/T (24) 83 ANP Text number: 1265 |
13H |
|
47 |
Soya-bean oil, refined Reference number: PA/PH/Exp. 13H/T (24) 70 ANP Text number: 1473 |
13H |
|
48 |
Sultamicillin Reference number: PA/PH/Exp. 7/T (24) 29 ANP Text number: 2211 |
7 |
|
49 |
Sunflower oil, refined Reference number: PA/PH/Exp. 13H/T (24) 87 ANP Text number: 1371 |
13H |
|
50 |
Tryptophan Reference number: PA/PH/Exp. 10/T (24) 36 ANP Text number: 1272 |
10D |
|
51 |
Virgate wormwood herb Reference number: PA/PH/Exp. TCM/T (24) 73 ANP Text number: 2633 |
TCM |
|
52 |
Wheat-germ oil, refined Reference number: PA/PH/Exp. 13H/T (24) 88 ANP Text number: 1379 |
13H |