Council for europe portal
Language : en Search
Choose language

Pharmeuropa 33.2 just released

Back
News
09 April 2021
Strasbourg, France

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 33.2 is 30 June 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 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 48 drafts published in Pharmeuropa 33.2 are listed here.

 

 

Drafts published in Pharmeuropa 33.2 (end of commenting period: 30 June 2021)

Group

1

2.1.3. Ultraviolet ray lamps for analytical purposes

Reference number: PA/PH/Exp. CST/T (20) 8 ANP

Text number: 20103

Direct link

MG

2

2.7.26. Cell-based assays for potency determination of TNF-alpha antagonists

Reference number: PA/PH/Exp. MAB/T (21) 3 ANP

Text number: 20726

Direct link

MAB

3

2.9.19. Particulate contamination: sub-visible particles

Reference number: PA/PH/Exp. 12/T (21) 1 ANP

Text number: 20919

Direct link

12

4

3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders

Reference number: PA/PH/Exp. 16/T (20) 8 ANP

Text number: 30209

Direct link

16

5

Bryonia for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (13) 55 ANP

Text number: 2490

Direct link

HOM

6

Calcium pantothenate

Reference number: PA/PH/Exp. VIT/T (20) 45 ANP

Text number: 0470

Direct link

VIT

7

Carprofen for veterinary use

Reference number: PA/PH/Exp. 10A/T (20) 131 ANP

Text number: 2201

Direct link

10A

8

Ciprofibrate

Reference number: PA/PH/Exp. 10B/T (20) 92 ANP

Text number: 2013

Direct link

10B

9

Dequalinium chloride hydrate

Reference number: PA/PH/Exp. 10B/T (18) 159 ANP

Text number: 1413

Direct link

10B

10

Difloxacin hydrochloride trihydrate for veterinary use

Reference number: PA/PH/Exp. 10A/T (20) 134 ANP

Text number: 2239

Direct link

10A

11

Dihydrostreptomycin sulfate for veterinary use

Reference number: PA/PH/Exp. 7/T (20) 83 ANP

Text number: 0485

Direct link

7

12

Enrofloxacin for veterinary use

Reference number: PA/PH/Exp. 10A/T (20) 132 ANP

Text number: 2229

Direct link

10A

13

Ephedra vulgaris for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (13) 1 ANP

Text number: 2710

Direct link

HOM

14

Etanercept

Reference number: PA/PH/Exp. MAB/T (21) 6 ANP

Text number: 2895

Direct link

MAB

15

Everolimus

Reference number: PA/PH/Exp. 7/T (21) 1 ANP

Text number: 2918

Direct link

7

16

Febantel for veterinary use

Reference number: PA/PH/Exp. 10D/T (20) 60 ANP

Text number: 2176

Direct link

10D

17

Fenbendazole for veterinary use

Reference number: PA/PH/Exp. 10A/T (20) 129 ANP

Text number: 1208

Direct link

10A

18

Flunarizine dihydrochloride

Reference number: PA/PH/Exp. 10B/T (20) 90 ANP

Text number: 1722

Direct link

10B

19

Glucose

Reference number: PA/PH/Exp. SIT/T (20) 41 ANP

Text number: 0177

Direct link

CRB

20

Glucose monohydrate

Reference number: PA/PH/Exp. SIT/T (20) 40 ANP

Text number: 0178

Direct link

CRB

21

Hyoscyamus for homoeopathic preparations

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

Text number: 2091

Direct link

HOM

22

Infliximab concentrated solution

Reference number: PA/PH/Exp. MAB/T (21) 7 ANP

Text number: 2928

Direct link

MAB

23

Isradipine

Reference number: PA/PH/Exp. 10B/T (20) 94 ANP

Text number: 2110

Direct link

10B

24

Lactose

Reference number: PA/PH/Exp. SIT/T (20) 42 ANP

Text number: 1061

Direct link

CRB

25

Lactose monohydrate

Reference number: PA/PH/Exp. SIT/T (20) 39 ANP

Text number: 0187

Direct link

CRB

26

Lufenuron for veterinary use

Reference number: PA/PH/Exp. 10D/T (20) 61 ANP

Text number: 2177

Direct link

10D

27

Mandragora for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (16) 14 ANP

Text number: 2840

Direct link

HOM

28

Marbofloxacin for veterinary use

Reference number: PA/PH/Exp. 10A/T (21) 7 ANP

Text number: 2233

Direct link

10A

29

Mefloquine hydrochloride

Reference number: PA/PH/Exp. 10D/T (20) 65 ANP

Text number: 1241

Direct link

10D

30

Melatonin

Reference number: PA/PH/Exp. 10C/T (20) 2 ANP

Text number: 3059

Direct link

10C

31

Morantel hydrogen tartrate for veterinary use

Reference number: PA/PH/Exp. 10D/T (20) 59 ANP

Text number: 1546

Direct link

10D

32

Moxidectin for veterinary use

Reference number: PA/PH/Exp. 7/T (20) 85 ANP

Text number: 1656

Direct link

7

33

Pharmaceutical preparations

Reference number: PA/PH/SG (21) 5 ANP

Text number: 2619

Direct link

PHP

34

Pimobendan for veterinary use

Reference number: PA/PH/Exp. 10D/T (20) 62 ANP

Text number: 2179

Direct link

10D

35

Rhubarb

Reference number: PA/PH/Exp. 13A/T (04) 40 ANP R3

Text number: 0291

Direct link

13A

36

Rhubarb dry extract, standardised

Reference number: PA/PH/Exp. 13A/T (05) 9 ANP R1

Text number: 1845

Direct link

13A

37

Selamectin for veterinary use

Reference number: PA/PH/Exp. 7/T (20) 86 ANP

Text number: 2268

Direct link

7

38

Sodium feredetate trihydrate

Reference number: PA/PH/Exp. 10D/T (20) 66 ANP

Text number: 2985

Direct link

10D

39

Stramonium for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (16) 15 ANP

Text number: 2734

Direct link

HOM

40

Substances for pharmaceutical use

Reference number: PA/PH/SG (21) 4 ANP

Text number: 2034

Direct link

PCM

41

Sulfadimethoxine sodium for veterinary use

Reference number: PA/PH/Exp. 7/T (20) 87 ANP

Text number: 2745

Direct link

7

42

Sulfamethoxypyridazine for veterinary use

Reference number: PA/PH/Exp. 7/T (20) 84 ANP

Text number: 0638

Direct link

7

43

Theophylline-ethylenediamine

Reference number: PA/PH/Exp. SIT/T (19) 27 ANP

Text number: 0300

Direct link

10A

44

Theophylline-ethylenediamine hydrate

Reference number: PA/PH/Exp. SIT/T (20) 37 ANP

Text number: 0301

Direct link

10A

45

Vaccines for veterinary use

Reference number: PA/PH/Exp. 15V/T (20) 59 ANP

Text number: 0062

Direct link

15V

46

Vedaprofen for veterinary use

Reference number: PA/PH/Exp. 10A/T (20) 135 ANP

Text number: 2248

Direct link

10A

47

Water for injections

Reference number: PA/PH/Exp. WAT/T (21) 2 ANP

Text number: 0169

Direct link

WAT

48

Xylazine hydrochloride for veterinary use

Reference number: PA/PH/Exp. 10A/T (20) 130 ANP

Text number: 1481

Direct link

10A

 

 

twitter facebook googleplus pinterest linkedin email