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 34.1 is 31 March 2022.
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 48 drafts published in Pharmeuropa 34.1 are listed here.
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Drafts published in Pharmeuropa 34.1 (end of commenting period: 31 March 2022) |
Group |
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1 |
2.7.28. Colony-forming cell assay for human haematopoietic progenitor cells Reference number: PA/PH/Exp. CTP/T (21) 18 ANP Text number: 20728 |
CTP |
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2 |
2.7.29. Nucleated cell count and viability Reference number: PA/PH/Exp. CTP/T (21) 17 ANP Text number: 20729 |
CTP |
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3 |
3.1.17. Cyclo-olefin copolymers Reference number: PA/PH/Exp. 16/T (19) 17 ANP R3 Text number: 30117 |
16 |
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4 |
Agnus castus fruit Reference number: PA/PH/Exp. 13B/T (21) 34 ANP Text number: 2147 |
13B |
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5 |
Bismuth subcarbonate Reference number: PA/PH/Exp. 9/T (21) 31 ANP Text number: 0012 |
9 |
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6 |
Bismuth subgallate Reference number: PA/PH/Exp. 9/T (21) 32 ANP Text number: 1493 |
9 |
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7 |
Bismuth subnitrate, heavy Reference number: PA/PH/Exp. 9/T (21) 33 ANP Text number: 1494 |
9 |
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8 |
Bismuth subsalicylate Reference number: PA/PH/Exp. 9/T (21) 34 ANP Text number: 1495 |
9 |
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9 |
Black horehound Reference number: PA/PH/Exp. 13B/T (19) 31 ANP Text number: 1858 |
13B |
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10 |
Bogbean leaf Reference number: PA/PH/Exp. 13B/T (21) 32 ANP Text number: 1605 |
13B |
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11 |
Burdock root Reference number: PA/PH/Exp. 13B/T (20) 13 ANP Text number: 2943 |
13B |
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12 |
Caspofungin acetate Reference number: PA/PH/Exp. 7/T (17) 7 ANP R2 Text number: 3029 |
7 |
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13 |
Centaury Reference number: PA/PH/Exp. 13B/T (21) 47 ANP Text number: 1301 |
13B |
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14 |
Donepezil hydrochloride Reference number: PA/PH/Exp. 10A/T (21) 113 ANP Text number: 2582 |
10A |
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15 |
Eclipta herb with root Reference number: PA/PH/Exp. 13B/T (15) 19 ANP Text number: 2852 |
13B |
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16 |
Edotreotide acetate for radiopharmaceutical preparations Reference number: PA/PH/Exp. PRP/T (15) 5 ANP Text number: 2544 |
PRP |
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17 |
Fenbendazole for veterinary use Reference number: PA/PH/Exp. 10A/T (18) 78 ANP R1 Text number: 1208 |
10A |
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18 |
Gallium (68Ga) DOTANOC injection Reference number: PA/PH/Exp. 14/T (21) 39 ANP Text number: 3051 |
14 |
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19 |
Gallium (68Ga) oxodotreotide injection Reference number: PA/PH/Exp. 14/T (21) 38 ANP Text number: 3050 |
14 |
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20 |
Gozetotide for radiopharmaceutical preparations Reference number: PA/PH/Exp. PRP/T (16) 19 ANP Text number: 3042 |
PRP |
|
21 |
Halofantrine hydrochloride Reference number: PA/PH/Exp. 10B/T (20) 66 ANP R1 Text number: 1979 |
10B |
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22 |
Horse-chestnut bark Reference number: PA/PH/Exp. 13B/T (20) 16 ANP Text number: 2945 |
13B |
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23 |
Immortelle flower Reference number: PA/PH/Exp. 13B/T (19) 24 ANP Text number: 3089 |
13B |
|
24 |
Ispaghula husk Reference number: PA/PH/Exp. 13B/T (21) 52 ANP Text number: 1334 |
13B |
|
25 |
Mepyramine maleate Reference number: PA/PH/Exp. 10C/T (21) 33 ANP Text number: 0278 |
10C |
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26 |
Mercaptopurine monohydrate Reference number: PA/PH/Exp. 10B/T (20) 69 ANP R1 Text number: 0096 |
10B |
|
27 |
Milk thistle fruit Reference number: PA/PH/Exp. 13B/T (21) 39 ANP Text number: 1860 |
13B |
|
28 |
Norgestrel Reference number: PA/PH/Exp. 10B/T (17) 93 ANP Text number: 0940 |
10B |
|
29 |
Oak bark Reference number: PA/PH/Exp. 13B/T (21) 45 ANP Text number: 1887 |
13B |
|
30 |
Oxodotreotide acetate for radiopharmaceutical preparations Reference number: PA/PH/Exp. PRP/T (20) 19 ANP Text number: 3157 |
PRP |
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31 |
Pelargonium root Reference number: PA/PH/Exp. 13B/T (21) 41 ANP Text number: 2264 |
13B |
|
32 |
Pimozide Reference number: PA/PH/Exp. 10B/T (21) 83 ANP Text number: 1254 |
10B |
|
33 |
Potassium acetate Reference number: PA/PH/Exp. 9/T (21) 29 ANP Text number: 1139 |
9 |
|
34 |
Psyllium seed Reference number: PA/PH/Exp. 13B/T (21) 53 ANP Text number: 0858 |
13B |
|
35 |
Rabeprazole sodium Reference number: PA/PH/Exp. 10C/T (18) 53 ANP R1 Text number: 2868 |
10C |
|
36 |
Salbutamol Reference number: PA/PH/Exp. 10A/T (13) 109 ANP R3 Text number: 0529 |
10A |
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37 |
Salbutamol sulfate Reference number: PA/PH/Exp. 10A/T (13) 108 ANP R3 Text number: 0687 |
10A |
|
38 |
Sotalol hydrochloride Reference number: PA/PH/Exp. 10A/T (21) 114 ANP Text number: 2004 |
10A |
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39 |
Sulfobutylbetadex sodium Reference number: PA/PH/Exp. CRB/T (21) 6 ANP Text number: 2804 |
CRB |
|
40 |
Tormentil Reference number: PA/PH/Exp. 13B/T (21) 51 ANP Text number: 1478 |
13B |
|
41 |
Valerian dry aqueous extract Reference number: PA/PH/Exp. 13B/T (21) 57 ANP Text number: 2400 |
13B |
|
42 |
Valerian dry hydroalcoholic extract Reference number: PA/PH/Exp. 13B/T (21) 56 ANP Text number: 1898 |
13B |
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43 |
Valerian root Reference number: PA/PH/Exp. 13B/T (21) 54 ANP Text number: 0453 |
13B |
|
44 |
Valerian root, cut Reference number: PA/PH/Exp. 13B/T (21) 55 ANP Text number: 2526 |
13B |
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45 |
Valerian tincture Reference number: PA/PH/Exp. 13B/T (21) 58 ANP Text number: 1899 |
13B |
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46 |
Xanthan gum Reference number: PA/PH/Exp. CRB/T (21) 35 ANP Text number: 1277 |
CRB |
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47 |
Xylose Reference number: PA/PH/Exp. CRB/T (21) 12 ANP Text number: 1278 |
CRB |
|
48 |
Zinc acetate dihydrate Reference number: PA/PH/Exp. 9/T (21) 30 ANP Text number: 1482 |
9 |