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 34.4 is 31 December 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 34 drafts published in Pharmeuropa 34.4 are listed here.
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Drafts published in Pharmeuropa 34.4 (end of commenting period: 31 December 2022) |
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1 |
2.6.27. Microbiological examination of cell-based preparations Reference number: PA/PH/Exp. CTP/T (22) 10 ANP Text number: 20627 |
CTP |
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2 |
5.33. Design of experiments Reference number: PA/PH/Exp. SDA/T (22) 4 ANP Text number: 53300 |
SDA |
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3 |
Acamprosate calcium Reference number: PA/PH/Exp. 10A/T (22) 34 ANP Text number: 1585 |
10A |
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4 |
Aluminium magnesium silicate Reference number: PA/PH/Exp. 9/T (22) 27 ANP Text number: 1388 |
9 |
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5 |
Aluminium oxide, hydrated Reference number: PA/PH/Exp. 9/T (22) 25 ANP Text number: 0311 |
9 |
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6 |
Aluminium sodium silicate Reference number: PA/PH/Exp. 9/T (22) 29 ANP Text number: 1676 |
9 |
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7 |
Amomum fruit Reference number: PA/PH/Exp. TCM/T (16) 147 ANP Text number: 2554 |
TCM |
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8 |
Calcitriol Reference number: PA/PH/Exp. VIT/T (22) 16 ANP Text number: 0883 |
VIT |
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9 |
Cannabis flower Reference number: PA/PH/Exp. 13B/T (20) 4 ANP Text number: 3028 |
13B |
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10 |
Ethylcellulose Reference number: PA/PH/Exp. EXP/T (22) 20 ANP Text number: 0822 |
EXP |
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11 |
Eye preparations Reference number: PA/PH/Exp. 12/T (22) 34 ANP Text number: 1163 |
12 |
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12 |
Grapevine leaf Reference number: PA/PH/Exp. 13A/T (15) 42 ANP Text number: 2667 |
13A |
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13 |
Homoeopathic pillules, coated Reference number: PA/PH/Exp. HMM/T (22) 3 ANP Text number: 2786 |
HMM |
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14 |
Homoeopathic preparations Reference number: PA/PH/Exp. HMM/T (22) 6 ANP Text number: 1038 |
HOM |
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15 |
Hydroxypropylcellulose Reference number: PA/PH/Exp. EXP/T (22) 21 ANP Text number: 0337 |
EXP |
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16 |
L-Malic acid Reference number: PA/PH/Exp. 10D/T (22) 23 ANP Text number: 3143 |
10D |
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17 |
Lauromacrogol 400 Reference number: PA/PH/Exp. 13H/T (22) 9 ANP Text number: 2046 |
13H |
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18 |
Magnesium peroxide Reference number: PA/PH/Exp. 9/T (22) 28 ANP Text number: 1540 |
9 |
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19 |
Magnesium trisilicate hydrate Reference number: PA/PH/Exp. 9/T (22) 26 ANP Text number: 0403 |
9 |
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20 |
Meadowsweet Reference number: PA/PH/Exp. 13A/T (20) 24 ANP Text number: 1868 |
13A |
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21 |
Mefloquine hydrochloride Reference number: PA/PH/Exp. 10D/T (22) 24 ANP Text number: 1241 |
10D |
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22 |
Memantine hydrochloride Reference number: PA/PH/Exp. 10B/T (22) 102 ANP Text number: 2773 |
10B |
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23 |
Methods of preparation of homoeopathic stocks and potentisation Reference number: PA/PH/Exp. HMM/T (22) 5 ANP Text number: 2371 |
HMM |
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24 |
Oxygen (98 per cent) Reference number: PA/PH/Exp. 9G/T (18) 2 ANP R8 Text number: 3098 |
9G |
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25 |
Oxytetracycline dihydrate Reference number: PA/PH/Exp. 7/T (22) 52 ANP Text number: 0199 |
7 |
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26 |
Polygonum multiflorum stem Reference number: PA/PH/Exp. TCM/T (11) 33 ANP Text number: 2725 |
TCM |
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27 |
Preparations for irrigation Reference number: PA/PH/Exp. 12/T (22) 33 ANP Text number: 1116 |
12 |
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28 |
Quillaia bark Reference number: PA/PH/Exp. 13A/T (20) 31 ANP Text number: 1843 |
13A |
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29 |
Round amomum fruit Reference number: PA/PH/Exp. TCM/T (16) 148 ANP Text number: 2555 |
TCM |
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30 |
Solutions for organ preservation Reference number: PA/PH/Exp. 12/T (22) 35 ANP Text number: 1264 |
12 |
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31 |
Suxamethonium chloride dihydrate Reference number: PA/PH/Exp. 10A/T (17) 118 ANP Text number: 0248 |
10A |
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32 |
Szechwan lovage rhizome Reference number: PA/PH/Exp. TCM/T (22) 39 ANP Text number: 2634 |
TCM |
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33 |
Ursodoxicoltaurine dihydrate Reference number: PA/PH/Exp. 11/T (22) 34 ANP Text number: 3150 |
11 |
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34 |
Walnut Leaf Reference number: PA/PH/Exp. 13B/T (20) 6 ANP Text number: 2946 |
13B |
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