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Pharmeuropa 33.1 just released: don’t miss this opportunity to provide your comments

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European Pharmacopoeia
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News
06 January 2021
Strasbourg, France

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:

 

 

Drafts published in Pharmeuropa 33.1
(end of commenting period: 31 March 2021)

Group

1

2.6.39. Microbiological examination of human tissues
Reference number: PA/PH/Exp. CTP/T (20) 16 ANP
Text number: 20639
Direct link
 

CTP

2

2.9.2. Disintegration test for solid rectal and vaginal dosage forms
Reference number: PA/PH/Exp. 12/T (20) 53 ANP
Text number: 20902
Direct link
 

12

3

2.9.5. Uniformity of mass of single-dose preparations
Reference number: PA/PH/Exp. 12/T (20) 56 ANP
Text number: 20905
Direct link
 

12

4

Adrenaline
Reference number: PA/PH/Exp. 10A/T (20) 103 ANP
Text number: 2303
Direct link
 

10A

5

Amiodarone hydrochloride
Reference number: PA/PH/Exp. 11/T (20) 40 ANP
Text number: 0803
Direct link
 

11

6

Bupivacaine
Reference number: PA/PH/Exp. 10A/T (18) 89 ANP
Text number: 2761
Direct link
 

10A

7

Calcium chloride hexahydrate
Reference number: PA/PH/Exp. 9/T (20) 72 ANP
Text number: 0707
Direct link
 

9

8

Cetyl palmitate
Reference number: PA/PH/Exp. 13H/T (20) 25 ANP
Text number: 1906
Direct link
 

13H

9

Cholecalciferol concentrate (powder form)
Reference number: PA/PH/Exp. VIT/T (20) 8 ANP
Text number: 0574
Direct link
 

VIT

10

Ciprofloxacin hydrochloride hydrate
Reference number: PA/PH/Exp. 10B/T (20) 67 ANP
Text number: 0888
Direct link
 

10B

11

Clostridium botulinum vaccine for veterinary use
Reference number: PA/PH/Exp. 15V/T (20) 13 ANP
Text number: 0360
Direct link
 

15V

12

Enoxolone
Reference number: PA/PH/Exp. 11/T (20) 44 ANP
Text number: 1511
Direct link
 

11

13

Ferrum metallicum for homoeopathic preparations
Reference number: PA/PH/Exp. HOM/T (20) 3 ANP
Text number: 2026
Direct link
 

HOM

14

Fish oil, rich in omega-3 acids
Reference number: PA/PH/Exp. 13H/T (20) 58 ANP
Text number: 1912
Direct link
 

13H

15

Follitropin
Reference number: PA/PH/Exp. 6/T (20) 46 ANP
Text number: 2285
Direct link
 

6

16

Follitropin concentrated solution
Reference number: PA/PH/Exp. 6/T (20) 47 ANP
Text number: 2286
Direct link
 

6

17

Gallium (68Ga) chloride (accelerator-produced) solution for radiolabelling
Reference number: PA/PH/Exp. 14/T (20) 14 ANP
Text number: 3109
Direct link
 

14

18

Halofantrine hydrochloride
Reference number: PA/PH/Exp. 10B/T (20) 66 ANP
Text number: 1979
Direct link
 

10B

19

Levomepromazine hydrochloride
Reference number: PA/PH/Exp. 10A/T (20) 52 ANP
Text number: 0505
Direct link
 

10A

20

Magnesium chloride 4.5-hydrate
Reference number: PA/PH/Exp. 9/T (20) 73 ANP
Text number: 1341
Direct link
 

9

21

Mycoplasma gallisepticum vaccine (live) for chickens
Reference number: PA/PH/Exp. 15V/T (18) 104 ANP
Text number: 3133
Direct link
 

15V

22

Oxytocin
Reference number: PA/PH/Exp. 6/T (19) 13 ANP
Text number: 0780
Direct link
 

6

23

Quinine hydrochloride dihydrate
Reference number: PA/PH/Exp. 11/T (20) 48 ANP
Text number: 0018
Direct link
 

11

24

Shepherd’s purse
Reference number: PA/PH/Exp. 13B/T (19) 53 ANP
Text number: 2947
Direct link
 

13B

25

Simvastatin
Reference number: PA/PH/Exp. 10A/T (20) 104 ANP
Text number: 1563
Direct link
 

10A

26

Thioridazine hydrochloride
Reference number: PA/PH/Exp. 10B/T (20) 65 ANP
Text number: 0586
Direct link
 

10B

27

Toadflax herb
Reference number: PA/PH/Exp. 13B/T (20) 14 ANP
Text number: 2962
Direct link
 

13B

28

Vaginal preparations
Reference number: PA/PH/Exp. 12/T (15) 35 ANP
Text number: 1164
Direct link
 

12

 

 

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