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 37.3 is 30 September 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 54 drafts published in Pharmeuropa 37.3 are listed here.
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Drafts published in Pharmeuropa 37.3 (end of commenting period: 30 September 2025) |
Group |
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1 |
2.5.46. Phenolic antioxidants in plastic materials Reference number: PA/PH/Exp. 16/T (23) 3 ANP Text number: 20546 |
16 |
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2 |
2.6.42. Test for procoagulant activity in immunoglobulin preparations Reference number: PA/PH/Exp. 6B/T (24) 1 ANP Text number: 20642 |
6B |
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3 |
2.8.27. Determination of estragole Reference number: PA/PH/Exp. 13A/T (25) 23 ANP Text number: 20827 |
13A |
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4 |
3.1.3. Polyolefins Reference number: PA/PH/Exp. 16/T (24) 27 ANP Text number: 30103 |
16 |
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5 |
3.1.5. Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations Reference number: PA/PH/Exp. 16/T (24) 28 ANP Text number: 30105 |
16 |
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6 |
3.1.6. Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations Reference number: PA/PH/Exp. 16/T (24) 29 ANP Text number: 30106 |
16 |
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7 |
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations Reference number: PA/PH/Exp. 16/T (24) 30 ANP Text number: 30107 |
16 |
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8 |
3.2.1. Glass containers for pharmaceutical use Reference number: PA/PH/Exp. GLS/T (20) 12 ANP Text number: 30201 |
GLS |
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9 |
5.2.14. Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines Reference number: PA/PH/Exp. 15/T (25) 2 ANP Text number: 50214 |
15 |
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10 |
5.34. Additional information on gene therapy medicinal products for human use Reference number: PA/PH/Exp. GTP/T (24) 8 ANP Text number: 53400 |
GTP |
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11 |
Adalimumab concentrated solution Reference number: PA/PH/Exp. MAB/T (24) 4 ANP Text number: 3147 |
MAB |
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12 |
Alectinib hydrochloride Reference number: PA/PH/Exp. P4/T (23) 38 ANP Text number: 3219 |
P4 |
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13 |
Alectinib hydrochloride capsules Reference number: PA/PH/Exp. P4/T (23) 39 ANP Text number: 3220 |
P4 |
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14 |
Belladonna for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (23) 12 ANP Text number: 2489 |
HOM |
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15 |
Bluetongue vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (19) 46 ANP Text number: 2899 |
15V |
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16 |
Bosentan monohydrate Reference number: PA/PH/Exp. 10D/T (25) 13 ANP Text number: 3250 |
10D |
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17 |
Calcium hydroxide Reference number: PA/PH/Exp. 9/T (25) 12 ANP Text number: 1078 |
9 |
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18 |
Carmellose calcium Reference number: PA/PH/Exp. EXP/T (25) 9 ANP Text number: 0886 |
CEL |
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19 |
Daptomycin Reference number: PA/PH/Exp. 7/T (22) 2 ANP Text number: 3034 |
7 |
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20 |
Fluorescein sodium Reference number: PA/PH/Exp. 10D/T (23) 45 ANP Text number: 1213 |
10D |
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21 |
Fritillaria cirrhosa bulb Reference number: PA/PH/Exp. TCM/T (19) 36 ANP Text number: 2586 |
TCM |
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22 |
Glutamic acid Reference number: PA/PH/Exp. 10D/T (23) 31 ANP Text number: 0750 |
10D |
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23 |
Glycerol dibehenate Reference number: PA/PH/Exp. EXP/T (25) 7 ANP Text number: 1427 |
13H |
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24 |
Glycerol distearate Reference number: PA/PH/Exp. EXP/T (25) 8 ANP Text number: 1428 |
13H |
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25 |
Human normal immunoglobulin for intravenous administration Reference number: PA/PH/Exp. 6B/T (24) 11 ANP Text number: 0918 |
6B |
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26 |
Human normal immunoglobulin for subcutaneous administration Reference number: PA/PH/Exp. 6B/T (24) 12 ANP Text number: 2788 |
6B |
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27 |
Influenza vaccine (split virion, inactivated) Reference number: PA/PH/Exp. 15/T (25) 14 ANP Text number: 0158 |
15 |
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28 |
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Reference number: PA/PH/Exp. 15/T (25) 18 ANP Text number: 2149 |
15 |
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29 |
Influenza vaccine (surface antigen, inactivated, virosome) Reference number: PA/PH/Exp. 15/T (25) 17 ANP Text number: 2053 |
15 |
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30 |
Influenza vaccine (surface antigen, inactivated) Reference number: PA/PH/Exp. 15/T (25) 16 ANP Text number: 0869 |
15 |
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31 |
Influenza vaccine (whole virion, inactivated) Reference number: PA/PH/Exp. 15/T (25) 15 ANP Text number: 0159 |
15 |
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32 |
Iopamidol Reference number: PA/PH/Exp. 11/T (25) 34 ANP Text number: 1115 |
11 |
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33 |
Iron sucrose concentrated solution Reference number: PA/PH/Exp. NBC/T (14) 11 ANP Text number: 2753 |
NANO |
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34 |
Lauromacrogol 400 Reference number: PA/PH/Exp. 13H/T (22) 9 ANP R2 Text number: 2046 |
13H |
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35 |
Lemon verbena leaf Reference number: PA/PH/Exp. 13A/T (20) 35 ANP Text number: 1834 |
13A |
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36 |
Neotame Reference number: PA/PH/Exp. 10D/T (23) 25 ANP Text number: 3218 |
10D |
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37 |
Octyldodecanol Reference number: PA/PH/Exp. 13H/T (24) 112 ANP Text number: 1136 |
13H |
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38 |
Polyoxypropylene stearyl ether Reference number: PA/PH/Exp. 13H/T (24) 57 ANP Text number: 2602 |
13H |
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39 |
Primula flower Reference number: PA/PH/Exp. 13A/T (22) 8 ANP Text number: 2540 |
13A |
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40 |
Ropivacaine hydrochloride Reference number: PA/PH/Exp. 10A/T (16) 64 ANP Text number: 2800 |
10A |
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41 |
Sage leaf (Salvia officinalis) Reference number: PA/PH/Exp. 13A/T (24) 93 ANP Text number: 1370 |
13A |
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42 |
Sage leaf (salvia officinalis), cut Reference number: PA/PH/Exp. 13A/T (25) 28 ANP Text number: 3201 |
13A |
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43 |
Saw palmetto fruit Reference number: PA/PH/Exp. 13A/T (24) 92 ANP Text number: 1848 |
13A |
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44 |
Sorbic acid Reference number: PA/PH/Exp. SIT/T (25) 22 ANP Text number: 0592 |
10D |
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45 |
Spine date seed Reference number: PA/PH/Exp. TCM/T (09) 67 ANP Text number: 2613 |
TCM |
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46 |
Sulfadiazine Reference number: PA/PH/Exp. SIT/T (25) 20 ANP Text number: 0294 |
7 |
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47 |
Sulfamethoxazole Reference number: PA/PH/Exp. SIT/T (25) 21 ANP Text number: 0108 |
7 |
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48 |
Sulfanilamide Reference number: PA/PH/Exp. SIT/T (25) 18 ANP Text number: 1571 |
7 |
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49 |
Suppression of Ephedrine Reference number: PA/PH/Exp. 10A/T (25) 26 ANP Text number: 0488 |
10A |
|
50 |
Suppression of Ephedrine hemihydrate Reference number: PA/PH/Exp. 10A/T (25) 27 ANP Text number: 0489 |
10A |
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51 |
Suppression of Ephedrine hydrochloride, racemic Reference number: PA/PH/Exp. 10A/T (25) 28 ANP Text number: 0715 |
10A |
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52 |
Suppression of Ouabain Reference number: PA/PH/Exp. 11/T (25) 15 ANP Text number: 0048 |
11 |
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53 |
Testosterone isocaproate Reference number: PA/PH/Exp. 10B/T (25) 6 ANP Text number: 1737 |
10B |
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54 |
Verbena herb Reference number: PA/PH/Exp. 13A/T (20) 34 ANP Text number: 1854 |
13A |