null Pharmeuropa 34.4 just released

EDQM Strasbourg, France 11/10/2022
Pharmeuropa 34.4 just released

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.4 is 31 December 2022.

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 Ph. Eur. 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 34 drafts published in Pharmeuropa 34.4 are listed here.

 

Drafts published in Pharmeuropa 34.4 (end of commenting period: 31 December 2022)

Group

1

2.6.27. Microbiological examination of cell-based preparations

Reference number: PA/PH/Exp. CTP/T (22) 10 ANP

Text number: 20627

Direct link

CTP

2

5.33. Design of experiments

Reference number: PA/PH/Exp. SDA/T (22) 4 ANP

Text number: 53300

Direct link

SDA

3

Acamprosate calcium

Reference number: PA/PH/Exp. 10A/T (22) 34 ANP

Text number: 1585

Direct link

10A

4

Aluminium magnesium silicate

Reference number: PA/PH/Exp. 9/T (22) 27 ANP

Text number: 1388

Direct link

9

5

Aluminium oxide, hydrated

Reference number: PA/PH/Exp. 9/T (22) 25 ANP

Text number: 0311

Direct link

9

6

Aluminium sodium silicate

Reference number: PA/PH/Exp. 9/T (22) 29 ANP

Text number: 1676

Direct link

9

7

Amomum fruit

Reference number: PA/PH/Exp. TCM/T (16) 147 ANP

Text number: 2554

Direct link

TCM

8

Calcitriol

Reference number: PA/PH/Exp. VIT/T (22) 16 ANP

Text number: 0883

Direct link

VIT

9

Cannabis flower

Reference number: PA/PH/Exp. 13B/T (20) 4 ANP

Text number: 3028

Direct link

13B

10

Ethylcellulose

Reference number: PA/PH/Exp. EXP/T (22) 20 ANP

Text number: 0822

Direct link

EXP

11

Eye preparations

Reference number: PA/PH/Exp. 12/T (22) 34 ANP

Text number: 1163

Direct link

12

12

Grapevine leaf

Reference number: PA/PH/Exp. 13A/T (15) 42 ANP

Text number: 2667

Direct link

13A

13

Homoeopathic pillules, coated

Reference number: PA/PH/Exp. HMM/T (22) 3 ANP

Text number: 2786

Direct link

HMM

14

Homoeopathic preparations

Reference number: PA/PH/Exp. HMM/T (22) 6 ANP

Text number: 1038

Direct link

HOM

15

Hydroxypropylcellulose

Reference number: PA/PH/Exp. EXP/T (22) 21 ANP

Text number: 0337

Direct link

EXP

16

L-Malic acid

Reference number: PA/PH/Exp. 10D/T (22) 23 ANP

Text number: 3143

Direct link

10D

17

Lauromacrogol 400

Reference number: PA/PH/Exp. 13H/T (22) 9 ANP

Text number: 2046

Direct link

13H

18

Magnesium peroxide

Reference number: PA/PH/Exp. 9/T (22) 28 ANP

Text number: 1540

Direct link

9

19

Magnesium trisilicate hydrate

Reference number: PA/PH/Exp. 9/T (22) 26 ANP

Text number: 0403

Direct link

9

20

Meadowsweet

Reference number: PA/PH/Exp. 13A/T (20) 24 ANP

Text number: 1868

Direct link

13A

21

Mefloquine hydrochloride

Reference number: PA/PH/Exp. 10D/T (22) 24 ANP

Text number: 1241

Direct link

10D

22

Memantine hydrochloride

Reference number: PA/PH/Exp. 10B/T (22) 102 ANP

Text number: 2773

Direct link

10B

23

Methods of preparation of homoeopathic stocks and potentisation

Reference number: PA/PH/Exp. HMM/T (22) 5 ANP

Text number: 2371

Direct link

HMM

24

Oxygen (98 per cent)

Reference number: PA/PH/Exp. 9G/T (18) 2 ANP R8

Text number: 3098

Direct link

9G

25

Oxytetracycline dihydrate

Reference number: PA/PH/Exp. 7/T (22) 52 ANP

Text number: 0199

Direct link

7

26

Polygonum multiflorum stem

Reference number: PA/PH/Exp. TCM/T (11) 33 ANP

Text number: 2725

Direct link

TCM

27

Preparations for irrigation

Reference number: PA/PH/Exp. 12/T (22) 33 ANP

Text number: 1116

Direct link

12

28

Quillaia bark

Reference number: PA/PH/Exp. 13A/T (20) 31 ANP

Text number: 1843

Direct link

13A

29

Round amomum fruit

Reference number: PA/PH/Exp. TCM/T (16) 148 ANP

Text number: 2555

Direct link

TCM

30

Solutions for organ preservation

Reference number: PA/PH/Exp. 12/T (22) 35 ANP

Text number: 1264

Direct link

12

31

Suxamethonium chloride dihydrate

Reference number: PA/PH/Exp. 10A/T (17) 118 ANP

Text number: 0248

Direct link

10A

32

Szechwan lovage rhizome

Reference number: PA/PH/Exp. TCM/T (22) 39 ANP

Text number: 2634

Direct link

TCM

33

Ursodoxicoltaurine dihydrate

Reference number: PA/PH/Exp. 11/T (22) 34 ANP

Text number: 3150

Direct link

11

34

Walnut Leaf

Reference number: PA/PH/Exp. 13B/T (20) 6 ANP

Text number: 2946

Direct link

13B