null Pharmeuropa 34.2 just released

EDQM Strasbourg, France 04/04/22
Pharmeuropa 34.2 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 34.2 is 30 June 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 56 drafts published in Pharmeuropa 34.2 are listed here.

 

Drafts published in Pharmeuropa 34.2 (end of commenting period: 30 June 2022)

Group

1

2.6.30. Monocyte-activation test

Reference number: PA/PH/Exp. BET/T (19) 13 ANP

Text number: 20630

Direct link

BET

2

2.6.7. Mycoplasmas

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

Text number: 20607

Direct link

MYC

3

2.7.37. Assay of Phl p 5 allergen

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

Text number: 20737

Direct link

ALG

4

3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations

Reference number: PA/PH/Exp. 16/T (19) 16 ANP

Text number: 30118

Direct link

16

5

5.2.2. Chicken flocks free from specified pathogens for the production and quality control of vaccines

Reference number: PA/PH/Exp. 15V/T (22) 4 ANP

Text number: 50202

Direct link

15V

6

5.27. Comparability of alternative analytical procedures

Reference number: PA/PH/Exp. MG/T (18) 23 ANP

Text number: 52700

Direct link

MG

7

Aujeszky’s disease vaccine (inactivated) for pigs

Reference number: PA/PH/Exp. 15V/T (21) 39 ANP

Text number: 0744

Direct link

15V

8

Avian infectious bronchitis vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 42 ANP

Text number: 0959

Direct link

15V

9

Avian infectious bursal disease vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 43 ANP

Text number: 0960

Direct link

15V

10

Avian infectious encephalomyelitis vaccine (live)

Reference number: PA/PH/Exp. 15V/T (21) 50 ANP

Text number: 0588

Direct link

15V

11

Avian paramyxovirus 3 vaccine (inactivated) for turkeys

Reference number: PA/PH/Exp. 15V/T (21) 46 ANP

Text number: 1392

Direct link

15V

12

Brivaracetam

Reference number: PA/PH/Exp. P4/T (20) 15 ANP

Text number: 3139

Direct link

P4

13

Brivaracetam injection or infusion

Reference number: PA/PH/Exp. P4/T (20) 18 ANP

Text number: 3142

Direct link

P4

14

Brivaracetam oral solution

Reference number: PA/PH/Exp. P4/T (20) 17 ANP

Text number: 3141

Direct link

P4

15

Brivaracetam tablets

Reference number: PA/PH/Exp. P4/T (20) 16 ANP

Text number: 3140

Direct link

P4

16

Bromperidol

Reference number: PA/PH/Exp. 10B/T (21) 84 ANP

Text number: 1178

Direct link

10B

17

Bromperidol decanoate

Reference number: PA/PH/Exp. 10B/T (21) 88 ANP

Text number: 1397

Direct link

10B

18

Calcium folinate hydrate

Reference number: PA/PH/Exp. 11/T (22) 4 ANP

Text number: 0978

Direct link

11

19

Calcium iodatum for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (21) 56 ANP

Text number: 2144

Direct link

HOM

20

Calcium levofolinate hydrate

Reference number: PA/PH/Exp. 11/T (22) 5 ANP

Text number: 1606

Direct link

11

21

Carmellose calcium

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

Text number: 0886

Direct link

CEL

22

Chloroxylenol

Reference number: PA/PH/Exp. 10A/T (18) 172 ANP

Text number: 2980

Direct link

10A

23

Chrysanthemum flower

Reference number: PA/PH/Exp. TCM/T (21) 53 ANP

Text number: 3162

Direct link

TCM

24

Cola

Reference number: PA/PH/Exp. 13B/T (21) 49 ANP

Text number: 1504

Direct link

13B

25

Croscarmellose sodium

Reference number: PA/PH/Exp. CEL/T (21) 28 ANP

Text number: 0985

Direct link

CEL

26

Dapsone

Reference number: PA/PH/Exp. 11/T (21) 58 ANP

Text number: 0077

Direct link

11

27

Egg drop syndrome ‘76 vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 45 ANP

Text number: 1202

Direct link

15V

28

Equine influenza vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 40 ANP

Text number: 0249

Direct link

15V

29

Etonogestrel

Reference number: PA/PH/Exp. 10B/T (21) 55 ANP

Text number: 3049

Direct link

10B

30

Fenticonazole nitrate

Reference number: PA/PH/Exp. 11/T (21) 62 ANP

Text number: 1211

Direct link

11

31

Fingolimod hydrochloride

Reference number: PA/PH/Exp. P4/T (21) 54 ANP

Text number: 2988

Direct link

P4

32

Flunitrazepam

Reference number: PA/PH/Exp. 10B/T (22) 17 ANP

Text number: 0717

Direct link

10B

33

Fowl cholera vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 51 ANP

Text number: 1945

Direct link

15V

34

Green tea

Reference number: PA/PH/Exp. 13B/T (17) 75 ANP

Text number: 2668

Direct link

13B

35

Guarana

Reference number: PA/PH/Exp. 13B/T (17) 76 ANP

Text number: 2669

Direct link

13B

36

Hypromellose acetate succinate

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

Text number: 3101

Direct link

CEL

37

Isopropyl myristate

Reference number: PA/PH/Exp. 13H/T (22) 12 ANP

Text number: 0725

Direct link

13H

38

Lonicera japonica flower

Reference number: PA/PH/Exp. TCM/T (21) 36 ANP

Text number: 3159

Direct link

TCM

39

Mate leaf

Reference number: PA/PH/Exp. 13B/T (20) 15 ANP

Text number: 2678

Direct link

13B

40

Mycoplasma gallisepticum vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 47 ANP

Text number: 1942

Direct link

15V

41

Nettle root

Reference number: PA/PH/Exp. 13B/T (21) 43 ANP

Text number: 2538

Direct link

13B

42

Newcastle disease vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 41 ANP

Text number: 0870

Direct link

15V

43

Nux-vomica for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (21) 57 ANP

Text number: 2514

Direct link

HOM

44

Omega-3-acid triglycerides

Reference number: PA/PH/Exp. 13H/T (22) 7 ANP

Text number: 1352

Direct link

13H

45

Phenoxymethylpenicillin

Reference number: PA/PH/Exp. 7/T (22) 6 ANP

Text number: 0148

Direct link

7

46

Porcine influenza vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (21) 44 ANP

Text number: 0963

Direct link

15V

47

Rabbit haemorrhagic disease vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (22) 3 ANP

Text number: 2325

Direct link

15V

48

Raltegravir potassium chewable tablets

Reference number: PA/PH/Exp. P4/T (21) 20 ANP R1

Text number: 2939

Direct link

P4

49

Raltegravir potassium tablets

Reference number: PA/PH/Exp. P4/T (21) 19 ANP R1

Text number: 2938

Direct link

P4

50

Ropinirole hydrochloride

Reference number: PA/PH/Exp. 10D/T (21) 59 ANP

Text number: 2604

Direct link

10D

51

Salmonella Enteritidis vaccine (inactivated) for chickens

Reference number: PA/PH/Exp. 15V/T (21) 48 ANP

Text number: 1947

Direct link

15V

52

Salmonella Typhimurium vaccine (inactivated) for chickens

Reference number: PA/PH/Exp. 15V/T (21) 49 ANP

Text number: 2361

Direct link

15V

53

Soya-bean oil, refined

Reference number: PA/PH/Exp. 13H/T (22) 1 ANP

Text number: 1473

Direct link

13H

54

Technetium (99mTc) tin pyrophosphate injection

Reference number: PA/PH/Exp. 14/T (21) 45 ANP

Text number: 0129

Direct link

14

55

Trimethoprim

Reference number: PA/PH/Exp. 10A/T (18) 207 ANP

Text number: 0060

Direct link

10A

56

Zopiclone

Reference number: PA/PH/Exp. 10D/T (21) 39 ANP

Text number: 1060

Direct link

10D