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Pharmeuropa 32.1 just released

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European Pharmacopoeia
Public enquiry
News
07 January 2020
Strasbourg, France

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:

 

Drafts published in Pharmeuropa 32.1 (end of commenting period: 31 March 2020)

Group

1

2.1.7. Balances

Reference number: PA/PH/Exp. MG/T (19) 14 ANP

Text number: 20107

Direct link

MG

2

2.8.26. Contaminant pyrrolizidine alkaloids

Reference number: PA/PH/Exp. PA/T (18) 1 ANP

Text number: 20826

Direct link

PA

3

Allergen products

Reference number: PA/PH/Exp. ALG/T (19) 12 ANP

Text number: 1063

Direct link

ALG

4

Bumetanide

Reference number: PA/PH/Exp. 10B/T (19) 81 ANP

Text number: 1076

Direct link

10B

5

Calcium hydroxide

Reference number: PA/PH/Exp. 9/T (19) 62 ANP

Text number: 1078

Direct link

9

6

Calcium phosphate

Reference number: PA/PH/Exp. 9/T (19) 61 ANP

Text number: 1052

Direct link

9

7

Copper sulfate pentahydrate

Reference number: PA/PH/Exp. 9/T (19) 60 ANP

Text number: 0894

Direct link

9

8

Dimetindene maleate

Reference number: PA/PH/Exp. 10B/T (19) 80 ANP

Text number: 1417

Direct link

10B

9

Dipotassium clorazepate monohydrate

Reference number: PA/PH/Exp. 10A/T (19) 123 ANP

Text number: 0898

Direct link

10A

10

Etomidate

Reference number: PA/PH/Exp. 10B/T (19) 83 ANP

Text number: 1514

Direct link

10B

11

Ferrous sulfate, dried

Reference number: PA/PH/Exp. 9/T (19) 66 ANP

Text number: 2340

Direct link

9

12

Flubendazole

Reference number: PA/PH/Exp. 10B/T (18) 101 ANP

Text number: 1721

Direct link

10B

13

Magnesium carbonate, light

Reference number: PA/PH/Exp. 9/T (19) 56 ANP

Text number: 0042

Direct link

9

14

Paracetamol

Reference number: PA/PH/Exp. 10A/T (19) 136 ANP

Text number: 0049

Direct link

10A

15

Potassium metabisulfite

Reference number: PA/PH/Exp. 9/T (19) 64 ANP

Text number: 2075

Direct link

9

16

Sodium sulfite

Reference number: PA/PH/Exp. 9/T (19) 58 ANP

Text number: 0775

Direct link

9

17

Sodium sulfite heptahydrate

Reference number: PA/PH/Exp. 9/T (19) 59 ANP

Text number: 0776

Direct link

9

18

Substances for pharmaceutical use

Reference number: PA/PH/SG (19) 57 ANP

Text number: 2034

Direct link

PCM

19

Verapamil hydrochloride

Reference number: PA/PH/Exp. 10B/T (19) 124 ANP

Text number: 0573

Direct link

10B

20

Zinc acetate dihydrate

Reference number: PA/PH/Exp. 9/T (19) 63 ANP

Text number: 1482

Direct link

9

21

Zinc gluconate

Reference number: PA/PH/Exp. 9/T (19) 65 ANP

Text number: 2164

Direct link

9

22

Zinc oxide

Reference number: PA/PH/Exp. 9/T (19) 57 ANP

Text number: 0252

Direct link

9

 

 

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