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 37.4 is 31 December 2025.
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 38 drafts published in Pharmeuropa 37.4 are listed here.
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Drafts published in Pharmeuropa 37.4 (end of commenting period: 31 December 2025) |
Group |
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1 |
2.4.24. Identification and control of residual solvents Reference number: PA/PH/Exp. MG/T (25) 2 ANP Text number: 20424 |
MG |
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2 |
2.8.23. Microscopic examination of herbal drugs Reference number: PA/PH/Exp. 13A/T (24) 82 ANP Text number: 20823 |
13A |
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3 |
2.8.28. Determination of thujone Reference number: PA/PH/Exp. 13A/T (25) 57 ANP Text number: 20828 |
13A |
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4 |
3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders Reference number: PA/PH/Exp. 16/T (24) 18 ANP Text number: 30209 |
16 |
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5 |
Aloes dry extract, standardised Reference number: PA/PH/Exp. 13B/T (24) 69 ANP Text number: 0259 |
13B |
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6 |
Aloes, Cape Reference number: PA/PH/Exp. 13B/T (24) 68 ANP Text number: 0258 |
13B |
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7 |
Ascorbyl palmitate Reference number: PA/PH/Exp. VIT/T (21) 24 ANP Text number: 0807 |
VIT |
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8 |
Azelaic acid Reference number: PA/PH/Exp. 11/T (24) 19 ANP Text number: 3244 |
11 |
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9 |
Cannabis flower Reference number: PA/PH/Exp. 13B/T (25) 40 ANP Text number: 3028 |
13B |
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10 |
Cetylpyridinium chloride monohydrate Reference number: PA/PH/Exp. 10B/T (25) 45 ANP Text number: 0379 |
10B |
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11 |
Chloroquine phosphate Reference number: PA/PH/Exp. SIT/T (25) 41 ANP Text number: 0544 |
11 |
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12 |
Chloroquine sulfate monohydrate Reference number: PA/PH/Exp. SIT/T (25) 40 ANP Text number: 0545 |
11 |
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13 |
Cineole Reference number: PA/PH/Exp. 11/T (24) 100 ANP Text number: 1973 |
11 |
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14 |
Clarithromycin Reference number: PA/PH/Exp. 7/T (25) 23 ANP Text number: 1651 |
7 |
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15 |
Clindamycin phosphate Reference number: PA/PH/Exp. 7/T (25) 25 ANP Text number: 0996 |
7 |
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16 |
Cochinchinese asparagus root Reference number: PA/PH/Exp. TCM/T (25) 74 ANP Text number: 3221 |
TCM |
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17 |
Croscarmellose sodium Reference number: PA/PH/Exp. CEL/T (21) 28 ANP R1 Text number: 0985 |
CEL |
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18 |
Econazole Reference number: PA/PH/Exp. SIT/T (25) 43 ANP Text number: 2049 |
10B |
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19 |
Ibandronate sodium monohydrate Reference number: PA/PH/Exp. 11/T (25) 53 ANP Text number: 2771 |
11 |
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20 |
Iomeprol Reference number: PA/PH/Exp. 10B/T (25) 46 ANP Text number: 2925 |
10B |
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21 |
Levocetirizine dihydrochloride Reference number: PA/PH/Exp. 10C/T (25) 31 ANP Text number: 3115 |
10C |
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22 |
Liquid preparations for oral use Reference number: PA/PH/Exp. 12/T (25) 22 ANP Text number: 0672 |
12 |
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23 |
Maltitol, liquid Reference number: PA/PH/Exp. CRB/T (25) 6 ANP Text number: 1236 |
CRB |
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24 |
Mitoxantrone hydrochloride Reference number: PA/PH/Exp. 11/T (24) 99 ANP R1 Text number: 1243 |
11 |
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25 |
Mupirocin Reference number: PA/PH/Exp. 7/T (13) 15 ANP Text number: 1450 |
7 |
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26 |
Mupirocin calcium dihydrate Reference number: PA/PH/Exp. 7/T (13) 16 ANP Text number: 1451 |
7 |
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27 |
Naproxen Reference number: PA/PH/Exp. SIT/T (25) 34 ANP Text number: 0731 |
10A |
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28 |
Naproxen sodium Reference number: PA/PH/Exp. SIT/T (25) 35 ANP Text number: 1702 |
10A |
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29 |
Nikethamide Reference number: PA/PH/Exp. 10A/T (18) 187 ANP Text number: 0233 |
10A |
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30 |
Noscapine Reference number: PA/PH/Exp. 11/T (25) 4 ANP Text number: 0516 |
11 |
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31 |
Olaparib Reference number: PA/PH/Exp. P4/T (24) 1 ANP Text number: 3238 |
P4 |
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32 |
Olaparib tablets Reference number: PA/PH/Exp. P4/T (24) 4 ANP Text number: 3239 |
P4 |
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33 |
Parenteral preparations Reference number: PA/PH/Exp. 12/T (25) 23 ANP Text number: 0520 |
12 |
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34 |
Procainamide hydrochloride Reference number: PA/PH/Exp. SIT/T (25) 42 ANP Text number: 0567 |
11 |
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35 |
Sorbitol, liquid (crystallising) Reference number: PA/PH/Exp. CRB/T (24) 34 ANP Text number: 0436 |
CRB |
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36 |
Sorbitol, liquid (non-crystallising) Reference number: PA/PH/Exp. CRB/T (25) 8 ANP Text number: 0437 |
CRB |
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37 |
Sorbitol, liquid, partially dehydrated Reference number: PA/PH/Exp. CRB/T (25) 7 ANP Text number: 2048 |
CRB |
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38 |
Tioguanine Reference number: PA/PH/Exp. 11/T (25) 67 ANP Text number: 3260 |
11 |