All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.4 is 31 December 2020.
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 European Pharmacopoeia (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 42 drafts published in Pharmeuropa 32.4 are:
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Drafts published in Pharmeuropa 32.4 (end of commenting period: 31 December 2020) |
Group |
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1 |
2.9.12. Sieve testReference number: PA/PH/Exp. POW/T (20) 15 ANP Text number: 20912 |
POW |
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2 |
2.9.7. Friability of uncoated tabletsReference number: PA/PH/Exp. 12/T (20) 32 ANP Text number: 20907 |
12 |
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3 |
5.26. Implementation of pharmacopoeial proceduresReference number: PA/PH/Exp. MG/T (18) 9 ANP Text number: 52600 |
MG |
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4 |
AcitretinReference number: PA/PH/Exp. SIT/T (20) 24 ANP Text number: 1385 |
VIT |
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5 |
Air, medicinalReference number: PA/PH/Exp. 9G/T (20) 4 ANP Text number: 1238 |
9G |
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6 |
Ammonia (13N) injectionReference number: PA/PH/Exp. 14/T (16) 29 ANP Text number: 1492 |
14 |
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7 |
ArgonReference number: PA/PH/Exp. 9G/T (20) 8 ANP Text number: 2407 |
9G |
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8 |
Betiatide for radiopharmaceutical preparationsReference number: PA/PH/Exp. PRP/T (20) 8 ANP Text number: 2551 |
PRP |
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9 |
BromazepamReference number: PA/PH/Exp. 10B/T (20) 28 ANP Text number: 0879 |
10B |
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10 |
Calcium gluconate for injectionReference number: PA/PH/Exp. 9/T (19) 4 ANP Text number: 0979 |
9 |
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11 |
Carbon monoxide (15O)Reference number: PA/PH/Exp. 14/T (19) 12 ANP Text number: 1607 |
14 |
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12 |
Cefoxitin sodiumReference number: PA/PH/Exp. 7/T (15) 86 ANP Text number: 0990 |
7 |
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13 |
Chinese motherwortReference number: PA/PH/Exp. TCM/T (12) 20 ANP Text number: 2785 |
TCM |
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14 |
ColchicineReference number: PA/PH/Exp. SIT/T (20) 22 ANP Text number: 0758 |
11 |
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15 |
Copper tetramibi tetrafluoroborate for radiopharmaceutical preparationsReference number: PA/PH/Exp. PRP/T (20) 5 ANP Text number: 2547 |
PRP |
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16 |
CrotamitonReference number: PA/PH/Exp. 11/T (20) 22 ANP Text number: 1194 |
11 |
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17 |
Dronedarone hydrochlorideReference number: PA/PH/Exp. P4/T (20) 19 ANP Text number: 3039 |
P4 |
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18 |
DydrogesteroneReference number: PA/PH/Exp. 10B/T (20) 70 ANP Text number: 2357 |
10B |
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19 |
FelodipineReference number: PA/PH/Exp. 11/T (20) 41 ANP Text number: 1013 |
11 |
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20 |
Flumazenil (N-[11C]methyl) injectionReference number: PA/PH/Exp. 14/T (19) 14 ANP Text number: 1917 |
14 |
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21 |
Hydroxyethyl salicylateReference number: PA/PH/Exp. 10D/T (20) 17 ANP Text number: 1225 |
10D |
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22 |
Influenza vaccine (split virion, inactivated)Reference number: PA/PH/Exp. 15/T (20) 33 ANP Text number: 0158 |
15 |
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23 |
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)Reference number: PA/PH/Exp. 15/T (20) 32 ANP Text number: 2149 |
15 |
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24 |
Influenza vaccine (surface antigen, inactivated)Reference number: PA/PH/Exp. 15/T (20) 31 ANP Text number: 0869 |
15 |
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25 |
l-Methionine ([11C]methyl) injectionReference number: PA/PH/Exp. 14/T (19) 13 ANP Text number: 1617 |
14 |
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26 |
LevocarnitineReference number: PA/PH/Exp. 10D/T (20) 36 ANP Text number: 1339 |
10D |
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27 |
Manganese sulfate monohydrateReference number: PA/PH/Exp. 9/T (20) 51 ANP Text number: 1543 |
9 |
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28 |
Mebeverine hydrochlorideReference number: PA/PH/Exp. 10D/T (20) 33 ANP Text number: 2097 |
10D |
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29 |
Mercaptopurine monohydrateReference number: PA/PH/Exp. 10B/T (20) 69 ANP Text number: 0096 |
10B |
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30 |
Mullein flowerReference number: PA/PH/Exp. 13A/T (20) 28 ANP Text number: 1853 |
13A |
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31 |
NitrogenReference number: PA/PH/Exp. 9G/T (20) 3 ANP Text number: 1247 |
9G |
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32 |
Oxygen (15O)Reference number: PA/PH/Exp. 14/T (19) 10 ANP Text number: 1620 |
14 |
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33 |
Purple coneflower herb expressed juice, stabilised with ethanolReference number: PA/PH/Exp. 13A/T (13) 76 ANP R2 Text number: 2282 |
13A |
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34 |
Purple coneflower herb expressed juice, stabilised without ethanolReference number: PA/PH/Exp. 13A/T (13) 77 ANP R2 Text number: 2894 |
13A |
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35 |
Raclopride ([11C]methoxy) injectionReference number: PA/PH/Exp. 14/T (19) 15 ANP Text number: 1924 |
14 |
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36 |
Radiopharmaceutical preparationsReference number: PA/PH/Exp. 14/T (19) 41 ANP Text number: 0125 |
14 |
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37 |
Rectal preparationsReference number: PA/PH/Exp. 12/T (15) 38 ANP Text number: 1145 |
12 |
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38 |
Risedronate sodium 2.5-hydrateReference number: PA/PH/Exp. 11/T (20) 29 ANP Text number: 2572 |
11 |
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39 |
Saw palmetto fruitReference number: PA/PH/Exp. 13A/T (20) 57 ANP Text number: 1848 |
13A |
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40 |
Sodium acetate ([1-11C]) injectionReference number: PA/PH/Exp. 14/T (19) 16 ANP Text number: 1920 |
14 |
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41 |
TretinoinReference number: PA/PH/Exp. SIT/T (20) 23 ANP Text number: 0693 |
VIT |
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42 |
Water (15O) injectionReference number: PA/PH/Exp. 14/T (19) 11 ANP Text number: 1582 |
14 |