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

EDQM Strasbourg, France 06/01/2021
Pharmeuropa 33.1 just released: don’t miss this opportunity to provide your comments

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
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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
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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
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12

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

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