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 35.4 is 31 December 2023.
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 34 drafts published in Pharmeuropa 35.4 are listed here.
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Drafts published in Pharmeuropa 35.4 (end of commenting period: 31 December 2023) |
Group |
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1 |
2.5.44. Capillary isoelectric focusing for recombinant therapeutic monoclonal antibodies Reference number: PA/PH/Exp. MAB/T (21) 21 ANP Text number: 20544 |
MAB |
|
2 |
2.7.24. Flow cytometry Reference number: PA/PH/Exp. CTP/T (21) 13 ANP Text number: 20724 |
CTP |
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3 |
2.9.31. Particle size analysis by laser light diffraction Reference number: PA/PH/Exp. POW/T (16) 9 ANP Text number: 20931 |
POW |
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4 |
Amitriptyline hydrochloride Reference number: PA/PH/Exp. SIT/T (23) 23 ANP Text number: 0464 |
10A |
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5 |
Atropine sulfate monohydrate Reference number: PA/PH/Exp. 11/T (23) 47 ANP Text number: 0068 |
11 |
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6 |
Caspofungin acetate Reference number: PA/PH/Exp. 7/T (17) 7 ANP R4 Text number: 3029 |
7 |
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7 |
Chlorhexidine digluconate solution Reference number: PA/PH/Exp. 10B/T (23) 65 ANP Text number: 0658 |
10B |
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8 |
Clomipramine hydrochloride Reference number: PA/PH/Exp. SIT/T (23) 22 ANP Text number: 0889 |
10A |
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9 |
Cuprum aceticum for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (23) 25 ANP Text number: 2146 |
HOM |
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10 |
Dapagliflozin propylene glycol monohydrate Reference number: PA/PH/Exp. P4/T (19) 47 ANP Text number: 3137 |
P4 |
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11 |
Dapagliflozin propylene glycol tablets Reference number: PA/PH/Exp. P4/T (21) 29 ANP Text number: 3175 |
P4 |
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12 |
Dicloxacillin sodium monohydrate Reference number: PA/PH/Exp. 7/T (19) 45 ANP Text number: 0663 |
7 |
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13 |
Dosulepin hydrochloride Reference number: PA/PH/Exp. SIT/T (23) 21 ANP Text number: 1314 |
10A |
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14 |
Doxapram hydrochloride monohydrate Reference number: PA/PH/Exp. 11/T (23) 53 ANP Text number: 1201 |
11 |
|
15 |
Epimedium leaf Reference number: PA/PH/Exp. TCM/T (23) 38 ANP Text number: 3190 |
TCM |
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16 |
Horse-chestnut bark Reference number: PA/PH/Exp. 13B/T (23) 38 ANP Text number: 2945 |
13B |
|
17 |
Hydroxyethylcellulose Reference number: PA/PH/Exp. EXP/T (23) 19 ANP Text number: 0336 |
CEL |
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18 |
Iberis amara for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (14) 2 ANP Text number: 2838 |
HOM |
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19 |
Ivermectin Reference number: PA/PH/Exp. 7/T (22) 40 ANP Text number: 1336 |
7 |
|
20 |
Macrogols Reference number: PA/PH/Exp. EXP/T (23) 20 ANP Text number: 1444 |
13H |
|
21 |
Macrogols, high-molecular-mass Reference number: PA/PH/Exp. EXP/T (23) 21 ANP Text number: 2444 |
13H |
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22 |
Methylene chloride Reference number: PA/PH/Exp. 10D/T (23) 54 ANP Text number: 0932 |
10D |
|
23 |
Mulberry leaf Reference number: PA/PH/Exp. TCM/T (23) 26 ANP Text number: 3164 |
TCM |
|
24 |
Olodaterol hydrochloride Reference number: PA/PH/Exp. P4/T (21) 26 ANP Text number: 3174 |
P4 |
|
25 |
Patchouli herb Reference number: PA/PH/Exp. TCM/T (23) 36 ANP Text number: 3192 |
TCM |
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26 |
Pentobarbital sodium Reference number: PA/PH/Exp. SIT/T (23) 24 ANP Text number: 0419 |
10A |
|
27 |
Pinellia rhizome, prepared Reference number: PA/PH/Exp. TCM/T (23) 37 ANP Text number: 2655 |
TCM |
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28 |
Procainamide hydrochloride Reference number: PA/PH/Exp. 11/T (23) 60 ANP Text number: 0567 |
11 |
|
29 |
Pumpkin seed Reference number: PA/PH/Exp. 13B/T (23) 37 ANP Text number: 2941 |
13B |
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30 |
Ropinirole hydrochloride Reference number: PA/PH/Exp. 10D/T (21) 59 ANP R2 Text number: 2604 |
10D |
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31 |
Starches, hydroxyethyl Reference number: PA/PH/Exp. CRB/T (23) 41 ANP Text number: 1785 |
CRB |
|
32 |
Teriparatide injection Reference number: PA/PH/Exp. 6/T (21) 16 ANP Text number: 3130 |
6 |
|
33 |
Vancomycin hydrochloride Reference number: PA/PH/Exp. 7/T (23) 30 ANP Text number: 1058 |
7 |
|
34 |
Wild pansy (flowering aerial parts) Reference number: PA/PH/Exp. 13A/T (14) 61 ANP Text number: 1855 |
13A |