All new texts of the European Pharmacopoeia and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.1 is 31 March 2021.
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 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 28 drafts published in Pharmeuropa 33.1 are:
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Drafts published in Pharmeuropa 33.1 |
Group |
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1 |
2.6.39. Microbiological examination of human tissues |
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2 |
2.9.2. Disintegration test for solid rectal and vaginal dosage forms |
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3 |
2.9.5. Uniformity of mass of single-dose preparations |
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4 |
Adrenaline |
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5 |
Amiodarone hydrochloride |
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6 |
Bupivacaine |
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7 |
Calcium chloride hexahydrate |
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8 |
Cetyl palmitate |
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9 |
Cholecalciferol concentrate (powder form) |
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10 |
Ciprofloxacin hydrochloride hydrate |
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11 |
Clostridium botulinum vaccine for veterinary use |
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12 |
Enoxolone |
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13 |
Ferrum metallicum for homoeopathic preparations |
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14 |
Fish oil, rich in omega-3 acids |
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15 |
Follitropin |
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16 |
Follitropin concentrated solution |
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17 |
Gallium (68Ga) chloride (accelerator-produced) solution for radiolabelling |
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18 |
Halofantrine hydrochloride |
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19 |
Levomepromazine hydrochloride |
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20 |
Magnesium chloride 4.5-hydrate |
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21 |
Mycoplasma gallisepticum vaccine (live) for chickens |
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22 |
Oxytocin |
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23 |
Quinine hydrochloride dihydrate |
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24 |
Shepherd’s purse |
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25 |
Simvastatin |
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26 |
Thioridazine hydrochloride |
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27 |
Toadflax herb |
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28 |
Vaginal preparations |
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