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 38.2 is 30 June 2026.
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 46 drafts published in Pharmeuropa 38.2 are listed here.
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Drafts published in Pharmeuropa 38.2 (end of commenting period: 30 June 2026) |
Group |
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1 |
2.1.4. Sieves. This chapter has undergone pharmacopoeial harmonisation. See chapter 5.8. Pharmacopoeial harmonisation. Reference number: PA/PH/Exp. POW/T (25) 26 ANP Text number: 20104 |
POW |
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2 |
2.7.13. Assay of human anti-D immunoglobulin Reference number: PA/PH/Exp. 6B/T (25) 10 ANP Text number: 20713 |
6B |
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3 |
2.9.38. Particle-size distribution analysis by analytical sieving Reference number: PA/PH/Exp. POW/T (22) 6 ANP Text number: 20938 |
POW |
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4 |
5.1.10. Guidelines for using the test for bacterial endotoxins Reference number: PA/PH/Exp. BET/T (25) 12 ANP Text number: 50110 |
BET |
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5 |
Bitter fennel, cut Reference number: PA/PH/Exp. 13A/T (25) 33 ANP Text number: 3254 |
13A |
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6 |
Chlorobutanol Reference number: PA/PH/Exp. 10A/T (25) 59 ANP Text number: 0382 |
10A |
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7 |
Chlorobutanol hemihydrate Reference number: PA/PH/Exp. 10A/T (25) 60 ANP Text number: 0383 |
10A |
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8 |
Cholecalciferol concentrate (oily form) Reference number: PA/PH/Exp. VIT/T (25) 15 ANP Text number: 0575 |
VIT |
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9 |
Cholecalciferol concentrate (powder form) Reference number: PA/PH/Exp. VIT/T (25) 45 ANP Text number: 0574 |
VIT |
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10 |
Eltrombopag olamine Reference number: PA/PH/Exp. P4/T (21) 11 ANP Text number: 3178 |
P4 |
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11 |
Empagliflozin Reference number: PA/PH/Exp. P4/T (23) 43 ANP Text number: 3234 |
P4 |
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12 |
Fennel, bitter Reference number: PA/PH/Exp. 13A/T (25) 32 ANP Text number: 0824 |
13A |
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13 |
Ferrous gluconate hydrate Reference number: PA/PH/Exp. 9/T (26) 1 ANP Text number: 0493 |
9 |
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14 |
Fish oil, rich in omega-3 acids Reference number: PA/PH/Exp. 13H/T (26) 7 ANP Text number: 1912 |
13H |
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15 |
Fludrocortisone acetate Reference number: PA/PH/Exp. SIT/T (25) 61 ANP Text number: 0767 |
10B |
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16 |
Flumetasone pivalate Reference number: PA/PH/Exp. SIT/T (25) 62 ANP Text number: 1327 |
10B |
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17 |
Flurazepam monohydrochloride Reference number: PA/PH/Exp. 10B/T (26) 4 ANP Text number: 0905 |
10B |
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18 |
Fluvastatin sodium Reference number: PA/PH/Exp. 10A/T (26) 11 ANP Text number: 2333 |
10A |
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19 |
Glycerol distearate Reference number: PA/PH/Exp. 13H/T (26) 4 ANP Text number: 1428 |
13H |
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20 |
Glycerol monostearate 40-55 Reference number: PA/PH/Exp. 13H/T (26) 2 ANP Text number: 0495 |
13H |
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21 |
Hydroxocobalamin acetate Reference number: PA/PH/Exp. VIT/T (26) 2 ANP Text number: 0913 |
VIT |
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22 |
Liothyronine sodium Reference number: PA/PH/Exp. 11/T (26) 2 ANP Text number: 0728 |
11 |
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23 |
Meldonium dihydrate Reference number: PA/PH/Exp. 10A/T (26) 10 ANP Text number: 2624 |
10A |
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24 |
Melissa leaf Reference number: PA/PH/Exp. 13A/T (24) 91 ANP Text number: 1447 |
13A |
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25 |
Metformin hydrochloride and dapagliflozin propylene glycol tablets Reference number: PA/PH/Exp. P4/T (22) 43 ANP Text number: 3207 |
P4 |
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26 |
Mycophenolate mofetil Reference number: PA/PH/Exp. 10A/T (25) 82 ANP Text number: 1700 |
10A |
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27 |
Nabilone Reference number: PA/PH/Exp. 11/T (23) 56 ANP R1 Text number: 3102 |
11 |
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28 |
Nicotine Reference number: PA/PH/Exp. 11/T (25) 112 ANP Text number: 1452 |
11 |
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29 |
Nicotine ditartrate dihydrate Reference number: PA/PH/Exp. 11/T (25) 113 ANP Text number: 2599 |
11 |
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30 |
Nicotine resinate Reference number: PA/PH/Exp. 11/T (25) 10 ANP Text number: 1792 |
11 |
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31 |
Nicotine resinate with glycerol Reference number: PA/PH/Exp. 11/T (25) 114 ANP Text number: 3292 |
11 |
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32 |
Oleyl alcohol Reference number: PA/PH/Exp. 13H/T (26) 3 ANP Text number: 2073 |
13H |
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33 |
Omega-3-acid ethyl esters 60 Reference number: PA/PH/Exp. 13H/T (26) 8 ANP Text number: 2063 |
13H |
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34 |
Omega-3-acid ethyl esters 90 Reference number: PA/PH/Exp. 13H/T (26) 5 ANP Text number: 1250 |
13H |
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35 |
Omega-3-acid triglycerides Reference number: PA/PH/Exp. 13H/T (26) 6 ANP Text number: 1352 |
13H |
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36 |
Oseltamivir phosphate Reference number: PA/PH/Exp. P4/T (25) 45 ANP Text number: 2422 |
P4 |
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37 |
Porcine influenza vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (25) 27 ANP Text number: 0963 |
15V |
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38 |
Porcine parvovirosis vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (25) 28 ANP Text number: 0965 |
15V |
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39 |
Prednisolone acetate Reference number: PA/PH/Exp. 10B/T (25) 84 ANP Text number: 0734 |
10B |
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40 |
Squalane Reference number: PA/PH/Exp. 13H/T (26) 1 ANP Text number: 1630 |
13H |
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41 |
Suppression of Belladonna, prepared Reference number: PA/PH/Exp. 13B/T (26) 7 ANP Text number: 0222 |
13B |
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42 |
Swine erysipelas vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (25) 26 ANP Text number: 0064 |
15V |
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43 |
Triamcinolone Reference number: PA/PH/Exp. 10B/T (25) 85 ANP Text number: 1376 |
10B |
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44 |
Ustekinumab concentrated solution Reference number: PA/PH/Exp. MAB/T (25) 8 ANP R2 Text number: 3165 |
MAB |
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45 |
Ustekinumab injection Reference number: PA/PH/Exp. MAB/T (26) 3 ANP R2 Text number: 3188 |
MAB |
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46 |
Vitamin A concentrate (oily form), synthetic Reference number: PA/PH/Exp. VIT/T (25) 16 ANP Text number: 0219 |
VIT |