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 36.2 is 30 June 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;
- 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 61 drafts published in Pharmeuropa 36.2 are listed here.
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Drafts published in Pharmeuropa 36.2 (end of commenting period: 30 June 2024) |
Group |
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1 |
2.5.25. Carbon monoxide in gases Reference number: PA/PH/Exp. 9G/T (23) 12 ANP Text number: 20525 |
9G |
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2 |
2.6.41. High-throughput sequencing for the detection of viral extraneous agents Reference number: PA/PH/Exp. 15/T (21) 27 ANP Text number: 20641 |
HTS |
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3 |
2.9.17. Test for extractable volume of parenteral preparations Reference number: PA/PH/Exp. 12/T (20) 47 ANP Text number: 20917 |
12 |
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4 |
2.9.54. Uniformity of delivered dose of inhalation and nasal preparations Reference number: PA/PH/Exp. INH/T (18) 3 ANP Text number: 20954 |
INH |
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5 |
5.32. Cell-based preparations for human use Reference number: PA/PH/Exp. CTP/T (21) 10 ANP Text number: 53200 |
CTP |
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6 |
5.36. mRNA vaccines for human use Reference number: PA/PH/Exp. mRNAVAC/T (23) 9 ANP Text number: 53600 |
mRNAVAC |
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7 |
5.37. Recombinant viral vectored vaccines for human use Reference number: PA/PH/Exp. 15/T (23) 56 ANP Text number: 53700 |
15V |
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8 |
5.39. mRNA substances for the production of mRNA vaccines for human use Reference number: PA/PH/Exp. mRNAVAC/T (23) 8 ANP Text number: 53900 |
mRNAVAC |
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9 |
5.40. DNA template for the preparation of mRNA substances Reference number: PA/PH/Exp. mRNAVAC/T (23) 7 ANP Text number: 54000 |
mRNAVAC |
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10 |
Amlodipine besilate Reference number: PA/PH/Exp. 11/T (24) 3 ANP Text number: 1491 |
11 |
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11 |
Aprotinin Reference number: PA/PH/Exp. 6/T (23) 41 ANP Text number: 0580 |
6 |
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12 |
Aprotinin concentrated solution Reference number: PA/PH/Exp. 6/T (23) 39 ANP Text number: 0579 |
6 |
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13 |
Bromperidol decanoate Reference number: PA/PH/Exp. 10B/T (21) 88 ANP R1 Text number: 1397 |
10B |
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14 |
Calendula for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (08) 30 ANP Text number: 2492 |
HOM |
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15 |
Cefixime trihydrate Reference number: PA/PH/Exp. 7/T (13) 138 ANP Text number: 1188 |
7 |
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16 |
Cellulose acetate butyrate Reference number: PA/PH/Exp. EXP/T (24) 8 ANP Text number: 1406 |
CEL |
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17 |
Chamomilla for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (08) 29 ANP Text number: 2493 |
HOM |
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18 |
Cholesterol Reference number: PA/PH/Exp. SIT/T (23) 37 ANP Text number: 0993 |
VIT |
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19 |
Chymotrypsin Reference number: PA/PH/Exp. 6/T (23) 38 ANP Text number: 0476 |
6 |
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20 |
Clonazepam Reference number: PA/PH/Exp. 10B/T (24) 6 ANP Text number: 0890 |
10B |
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21 |
Clopidogrel besilate Reference number: PA/PH/Exp. 10C/T (23) 43 ANP Text number: 2790 |
10C |
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22 |
Codergocrine mesilate Reference number: PA/PH/Exp. 11/T (23) 97 ANP Text number: 2060 |
11 |
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23 |
Danaparoid sodium Reference number: PA/PH/Exp. 6/T (23) 40 ANP Text number: 2090 |
6 |
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24 |
Daunorubicin hydrochloride Reference number: PA/PH/Exp. 7/T (23) 66 ANP Text number: 0662 |
7 |
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25 |
Ear preparations Reference number: PA/PH/Exp. 12/T (23) 37 ANP Text number: 0652 |
12 |
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26 |
Felodipine Reference number: PA/PH/Exp. SIT/T (23) 36 ANP Text number: 1013 |
11 |
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27 |
Fleeceflower root Reference number: PA/PH/Exp. TCM/T (23) 93 ANP Text number: 2433 |
TCM |
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28 |
Foot-and-mouth disease (ruminants) vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (23) 38 ANP Text number: 0063 |
15V |
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29 |
Fourstamen stephania root Reference number: PA/PH/Exp. TCM/T (24) 9 ANP Text number: 2478 |
13A |
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30 |
Glycerol monostearate 40-55 Reference number: PA/PH/Exp. EXP/T (24) 4 ANP Text number: 0495 |
13H |
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31 |
Heparin calcium Reference number: PA/PH/Exp. 6/T (23) 36 ANP Text number: 0332 |
6 |
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32 |
Heparin sodium Reference number: PA/PH/Exp. 6/T (23) 37 ANP Text number: 0333 |
6 |
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33 |
Hydroxyzine hydrochloride Reference number: PA/PH/Exp. 10B/T (23) 62 ANP Text number: 0916 |
10B |
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34 |
Kanamycin acid sulfate Reference number: PA/PH/Exp. 7/T (23) 67 ANP Text number: 0033 |
7 |
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35 |
Kanamycin monosulfate monohydrate Reference number: PA/PH/Exp. 7/T (23) 68 ANP Text number: 0032 |
7 |
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36 |
L-Malic acid Reference number: PA/PH/Exp. 10D/T (22) 23 ANP R1 Text number: 3143 |
10D |
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37 |
Linagliptin Reference number: PA/PH/Exp. P4/T (21) 41 ANP Text number: 3173 |
P4 |
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38 |
Macrogol poly(vinyl acetate)-poly(vinylcaprolactam) grafted copolymer Reference number: PA/PH/Exp. P4/T (19) 94 ANP Text number: 3156 |
P4 |
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39 |
Macrogolglycerol hydroxystearate Reference number: PA/PH/Exp. EXP/T (24) 7 ANP Text number: 1083 |
13H |
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40 |
Macrogolglycerol ricinoleate Reference number: PA/PH/Exp. EXP/T (24) 6 ANP Text number: 1082 |
13H |
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41 |
Metronidazole benzoate Reference number: PA/PH/Exp. 10A/T (24) 8 ANP Text number: 0934 |
10A |
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42 |
Myrtle oil Reference number: PA/PH/Exp. 13A/T (13) 16 ANP Text number: 2823 |
13A |
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43 |
Nasal preparations Reference number: PA/PH/Exp. 12/T (23) 6 ANP Text number: 0676 |
12 |
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44 |
Octenidine dihydrochloride Reference number: PA/PH/Exp. 10A/T (18) 186 ANP Text number: 3075 |
10A |
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45 |
Preparations for inhalation Reference number: PA/PH/Exp. INH/T (23) 7 ANP Text number: 0671 |
INH |
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46 |
Pressurised pharmaceutical preparations Reference number: PA/PH/Exp. 12/T (23) 27 ANP Text number: 0523 |
12 |
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47 |
Procaine hydrochloride Reference number: PA/PH/Exp. 10A/T (23) 87 ANP Text number: 0050 |
10A |
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48 |
Rifamycin sodium Reference number: PA/PH/Exp. 7/T (23) 69 ANP Text number: 0432 |
7 |
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49 |
Sevelamer carbonate Reference number: PA/PH/Exp. 10A/T (18) 190 ANP Text number: 2747 |
10A |
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50 |
Sevelamer hydrochloride Reference number: PA/PH/Exp. 10A/T (18) 191 ANP Text number: 2748 |
10A |
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51 |
Streptomycin sulfate Reference number: PA/PH/Exp. 7/T (23) 70 ANP Text number: 0053 |
7 |
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52 |
Sufentanil Reference number: PA/PH/Exp. 10B/T (22) 46 ANP Text number: 1569 |
10B |
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53 |
Sufentanil citrate Reference number: PA/PH/Exp. 10B/T (22) 47 ANP Text number: 1269 |
10B |
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54 |
Suxamethonium chloride dihydrate Reference number: PA/PH/Exp. 10A/T (17) 118 ANP R1 Text number: 0248 |
10A |
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55 |
Tiabendazole for veterinary use Reference number: PA/PH/Exp. 10A/T (24) 9 ANP Text number: 0866 |
10A |
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56 |
Tobramycin Reference number: PA/PH/Exp. 7/T (23) 71 ANP Text number: 0645 |
7 |
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57 |
Trypsin Reference number: PA/PH/Exp. 6/T (23) 42 ANP Text number: 0694 |
6 |
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58 |
Urokinase Reference number: PA/PH/Exp. 6/T (23) 43 ANP Text number: 0695 |
6 |
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59 |
Ursodeoxycholic acid Reference number: PA/PH/Exp. 11/T (24) 6 ANP Text number: 1275 |
11 |
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60 |
Vaccines for human use Reference number: PA/PH/Exp. 15/T (22) 28 ANP Text number: 0153 |
15 |
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61 |
Zanamivir hydrate Reference number: PA/PH/Exp. 10C/T (23) 44 ANP Text number: 2611 |
10C |
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