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 34.3 is 30 September 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 55 drafts published in Pharmeuropa 34.3 are listed here.
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Drafts published in Pharmeuropa 34.2 (end of commenting period: 30 September 2022) |
Group |
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1 |
2.2.42. Density of solids |
POW |
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2 |
2.9.9. Measurement of consistency by penetrometry |
12 |
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3 |
5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products |
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4 |
5.34. Additional information on gene therapy medicinal products for human use |
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5 |
Alfadex |
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6 |
Alpinia oxyphylla fruit |
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7 |
Betadex |
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8 |
Cabazitaxel acetone |
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9 |
Cabazitaxel acetone concentrate for infusion |
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10 |
Calcium sulfate dihydrate |
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11 |
Cannabidiol |
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12 |
Carbasalate calcium |
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13 |
Defluorotrimethylaminium-PSMA-1007 for radiopharmaceutical preparations |
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14 |
Doxazosin mesilate |
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15 |
Fludrocortisone acetate |
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16 |
Gammadex |
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17 |
Gene therapy medicinal products for human use |
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18 |
Green bean pod |
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19 |
Gumweed herb |
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20 |
Haloperidol decanoate |
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21 |
Hedge mustard |
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22 |
Heparin calcium |
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23 |
Heparin sodium |
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24 |
Human normal immunoglobulin for intramuscular administration |
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25 |
Human normal immunoglobulin for intravenous administration |
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26 |
Human normal immunoglobulin for subcutaneous administration |
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27 |
Ioflupane (123I) injection |
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28 |
Isopropyl palmitate |
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29 |
Isosorbide dinitrate, diluted |
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30 |
Isosorbide mononitrate, diluted |
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31 |
Morphine hemisulfate 2.5-hydrate |
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32 |
Morphine hydrochloride trihydrate |
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33 |
Nadroparin calcium |
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34 |
Oxytetracycline dihydrate |
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35 |
Oxytetracycline hydrochloride |
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36 |
Pentaerythrityl tetranitrate, diluted |
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37 |
Pirfenidone capsules |
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38 |
Pirfenidone tablets |
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39 |
Polysorbate 40 |
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40 |
Polysorbate 20 |
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41 |
Polysorbate 60 |
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42 |
Polysorbate 80 |
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43 |
Rhodiola root and rhizome |
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44 |
Ribwort plantain |
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45 |
Rose flower |
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46 |
Simvastatin |
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47 |
Sodium lauroylsarcosinate |
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48 |
Sorbitol, liquid, partially dehydrated |
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49 |
Suxibuzone for veterinary use |
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50 |
Tamoxifen citrate |
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51 |
Temazepam |
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52 |
Tetracosactide |
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53 |
Veterinary semi-solid preparations for oral use |
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54 |
Water for injections |
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55 |
Water, purified |
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