All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.1 is 31 March 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 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 22 drafts published in Pharmeuropa 32.1 are:
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Drafts published in Pharmeuropa 32.1 (end of commenting period: 31 March 2020) |
Group |
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1 |
2.1.7. Balances Reference number: PA/PH/Exp. MG/T (19) 14 ANP Text number: 20107 |
MG |
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2 |
2.8.26. Contaminant pyrrolizidine alkaloids Reference number: PA/PH/Exp. PA/T (18) 1 ANP Text number: 20826 |
PA |
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3 |
Allergen products Reference number: PA/PH/Exp. ALG/T (19) 12 ANP Text number: 1063 |
ALG |
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4 |
Bumetanide Reference number: PA/PH/Exp. 10B/T (19) 81 ANP Text number: 1076 |
10B |
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5 |
Calcium hydroxide Reference number: PA/PH/Exp. 9/T (19) 62 ANP Text number: 1078 |
9 |
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6 |
Calcium phosphate Reference number: PA/PH/Exp. 9/T (19) 61 ANP Text number: 1052 |
9 |
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7 |
Copper sulfate pentahydrate Reference number: PA/PH/Exp. 9/T (19) 60 ANP Text number: 0894 |
9 |
|
8 |
Dimetindene maleate Reference number: PA/PH/Exp. 10B/T (19) 80 ANP Text number: 1417 |
10B |
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9 |
Dipotassium clorazepate monohydrate Reference number: PA/PH/Exp. 10A/T (19) 123 ANP Text number: 0898 |
10A |
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10 |
Etomidate Reference number: PA/PH/Exp. 10B/T (19) 83 ANP Text number: 1514 |
10B |
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11 |
Ferrous sulfate, dried Reference number: PA/PH/Exp. 9/T (19) 66 ANP Text number: 2340 |
9 |
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12 |
Flubendazole Reference number: PA/PH/Exp. 10B/T (18) 101 ANP Text number: 1721 |
10B |
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13 |
Magnesium carbonate, light Reference number: PA/PH/Exp. 9/T (19) 56 ANP Text number: 0042 |
9 |
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14 |
Paracetamol Reference number: PA/PH/Exp. 10A/T (19) 136 ANP Text number: 0049 |
10A |
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15 |
Potassium metabisulfite Reference number: PA/PH/Exp. 9/T (19) 64 ANP Text number: 2075 |
9 |
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16 |
Sodium sulfite Reference number: PA/PH/Exp. 9/T (19) 58 ANP Text number: 0775 |
9 |
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17 |
Sodium sulfite heptahydrate Reference number: PA/PH/Exp. 9/T (19) 59 ANP Text number: 0776 |
9 |
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18 |
Substances for pharmaceutical use Reference number: PA/PH/SG (19) 57 ANP Text number: 2034 |
PCM |
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19 |
Verapamil hydrochloride Reference number: PA/PH/Exp. 10B/T (19) 124 ANP Text number: 0573 |
10B |
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20 |
Zinc acetate dihydrate Reference number: PA/PH/Exp. 9/T (19) 63 ANP Text number: 1482 |
9 |
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21 |
Zinc gluconate Reference number: PA/PH/Exp. 9/T (19) 65 ANP Text number: 2164 |
9 |
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22 |
Zinc oxide Reference number: PA/PH/Exp. 9/T (19) 57 ANP Text number: 0252 |
9 |