null Pharmeuropa 34.3 just released

EDQM Strasbourg, France 07/07/2022
Pharmeuropa 34.3 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 34.3 is 30 September 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 55 drafts published in Pharmeuropa 34.3 are listed here.

 

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

Group

1

2.2.42. Density of solids
Reference number: PA/PH/Exp. POW/T (16) 6 ANP
Text number: 20242
Direct link

POW

2

2.9.9. Measurement of consistency by penetrometry
Reference number: PA/PH/Exp. 12/T (22) 5 ANP
Text number: 20909
Direct link

12

3

5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products
Reference number: PA/PH/Exp. RCG/T (22) 2 ANP
Text number: 50212
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RCG

4

5.34. Additional information on gene therapy medicinal products for human use
Reference number: PA/PH/Exp. GTP/T (21) 12 ANP
Text number: 53400
Direct link

 
GTP

5

Alfadex
Reference number: PA/PH/Exp. CRB/T (22) 3 ANP
Text number: 1487
Direct link

 
CRB

6

Alpinia oxyphylla fruit
Reference number: PA/PH/Exp. TCM/T (22) 35 ANP
Text number: 3161
Direct link

 
TCM

7

Betadex
Reference number: PA/PH/Exp. CRB/T (22) 19 ANP
Text number: 1070
Direct link

 
CRB

8

Cabazitaxel acetone
Reference number: PA/PH/Exp. P4/T (17) 41 ANP
Text number: 3060
Direct link

 
P4

9

Cabazitaxel acetone concentrate for infusion
Reference number: PA/PH/Exp. P4/T (17) 43 ANP
Text number: 3061
Direct link

 
P4

10

Calcium sulfate dihydrate
Reference number: PA/PH/Exp. 9/T (22) 10 ANP
Text number: 0982
Direct link

 
9

11

Cannabidiol
Reference number: PA/PH/Exp. 11/T (21) 50 ANP
Text number: 3151
Direct link

 
11

12

Carbasalate calcium
Reference number: PA/PH/Exp. 10B/T (22) 81 ANP
Text number: 1185
Direct link

 
10B

13

Defluorotrimethylaminium-PSMA-1007 for radiopharmaceutical preparations
Reference number: PA/PH/Exp. PRP/T (20) 4 ANP
Text number: 3158
Direct link

 
PRP

14

Doxazosin mesilate
Reference number: PA/PH/Exp. 10A/T (22) 13 ANP
Text number: 2125
Direct link

 
10A

15

Fludrocortisone acetate
Reference number: PA/PH/Exp. 10B/T (22) 16 ANP
Text number: 0767
Direct link

 
10B

16

Gammadex
Reference number: PA/PH/Exp. CRB/T (22) 20 ANP
Text number: 2769
Direct link

 
CRB

17

Gene therapy medicinal products for human use
Reference number: PA/PH/Exp. GTP/T (21) 3 ANP
Text number: 3186
Direct link

 
GTP

18

Green bean pod
Reference number: PA/PH/Exp. 13B/T (21) 59 ANP
Text number: 2952
Direct link

 
13B

19

Gumweed herb
Reference number: PA/PH/Exp. 13B/T (21) 60 ANP
Text number: 2951
Direct link

 
13B

20

Haloperidol decanoate
Reference number: PA/PH/Exp. 10B/T (22) 71 ANP
Text number: 1431
Direct link

 
10B

21

Hedge mustard
Reference number: PA/PH/Exp. 13B/T (19) 19 ANP
Text number: 2942
Direct link

 
13B

22

Heparin calcium
Reference number: PA/PH/Exp. 6/T (21) 20 ANP R1
Text number: 0332
Direct link

 
6

23

Heparin sodium
Reference number: PA/PH/Exp. 6/T (21) 19 ANP R1
Text number: 0333
Direct link

 
6

24

Human normal immunoglobulin for intramuscular administration
Reference number: PA/PH/Exp. 6B/T (22) 29 ANP
Text number: 0338
Direct link

 
6B

25

Human normal immunoglobulin for intravenous administration
Reference number: PA/PH/Exp. 6B/T (22) 28 ANP
Text number: 0918
Direct link

 
6B

26

Human normal immunoglobulin for subcutaneous administration
Reference number: PA/PH/Exp. 6B/T (22) 27 ANP
Text number: 2788
Direct link

 
6B

27

Ioflupane (123I) injection
Reference number: PA/PH/Exp. 14/T (20) 27 ANP
Text number: 3144
Direct link

 
14

28

Isopropyl palmitate
Reference number: PA/PH/Exp. 13H/T (22) 25 ANP
Text number: 0839
Direct link

 
13H

29

Isosorbide dinitrate, diluted
Reference number: PA/PH/Exp. SIT/T (22) 19 ANP
Text number: 1117
Direct link

 
10D

30

Isosorbide mononitrate, diluted
Reference number: PA/PH/Exp. SIT/T (22) 20 ANP
Text number: 1118
Direct link

 
10D

31

Morphine hemisulfate 2.5-hydrate
Reference number: PA/PH/Exp. 11/T (22) 24 ANP
Text number: 1244
Direct link

 
11

32

Morphine hydrochloride trihydrate
Reference number: PA/PH/Exp. 11/T (22) 25 ANP
Text number: 0097
Direct link

 
11

33

Nadroparin calcium
Reference number: PA/PH/Exp. 6/T (22) 32 ANP
Text number: 1134
Direct link

 
6

34

Oxytetracycline dihydrate
Reference number: PA/PH/Exp. 7/T (22) 31 ANP
Text number: 0199
Direct link

 
7

35

Oxytetracycline hydrochloride
Reference number: PA/PH/Exp. 7/T (22) 30 ANP
Text number: 0198
Direct link

 
7

36

Pentaerythrityl tetranitrate, diluted
Reference number: PA/PH/Exp. SIT/T (22) 21 ANP
Text number: 1355
Direct link

 
10D

37

Pirfenidone capsules
Reference number: PA/PH/Exp. P4/T (20) 8 ANP
Text number: 3154
Direct link

 
P4

38

Pirfenidone tablets
Reference number: PA/PH/Exp. P4/T (20) 9 ANP
Text number: 3155
Direct link

 
P4

39

Polysorbate 40
Reference number: PA/PH/Exp. 13H/T (22) 28 ANP
Text number: 1914
Direct link

 
13H

40

Polysorbate 20
Reference number: PA/PH/Exp. 13H/T (22) 27 ANP
Text number: 0426
Direct link

 
13H

41

Polysorbate 60
Reference number: PA/PH/Exp. 13H/T (22) 29 ANP
Text number: 0427
Direct link

 
13H

42

Polysorbate 80
Reference number: PA/PH/Exp. EXP/T 13H/T (22) 30 ANP
Text number: 0428
Direct link

 
13H

43

Rhodiola root and rhizome
Reference number: PA/PH/Exp. 13B/T (21) 61 ANP
Text number: 2893
Direct link

 
13B

44

Ribwort plantain
Reference number: PA/PH/Exp. 13B/T (22) 13 ANP
Text number: 1884
Direct link

 
13B

45

Rose flower
Reference number: PA/PH/Exp. 13B/T (21) 13 ANP
Text number: 2949
Direct link

 
13B

46

Simvastatin
Reference number: PA/PH/Exp. 10A/T (20) 104 ANP R1
Text number: 1563
Direct link

 
10A

47

Sodium lauroylsarcosinate
Reference number: PA/PH/Exp. 13H/T (22) 24 ANP
Text number: 2542
Direct link

 
13H

48

Sorbitol, liquid, partially dehydrated
Reference number: PA/PH/Exp. CRB/T (21) 10 ANP
Text number: 2048
Direct link

 
CRB

49

Suxibuzone for veterinary use
Reference number: PA/PH/Exp. 10A/T (22) 21 ANP
Text number: 1574
Direct link

 
10A

50

Tamoxifen citrate
Reference number: PA/PH/Exp. SIT/T (22) 22 ANP
Text number: 1046
Direct link

 
10B

51

Temazepam
Reference number: PA/PH/Exp. 10B/T (22) 64 ANP
Text number: 0954
Direct link

 
10B

52

Tetracosactide
Reference number: PA/PH/Exp. 6/T (21) 53 ANP
Text number: 0644
Direct link

 
6

53

Veterinary semi-solid preparations for oral use
Reference number: PA/PH/Exp. 12/T (21) 4 ANP
Text number: 2638
Direct link

 
12

54

Water for injections
Reference number: PA/PH/Exp. WAT/T (21) 13 ANP
Text number: 0169
Direct link

 
WAT

55

Water, purified
Reference number: PA/PH/Exp. WAT/T (21) 12 ANP
Text number: 0008
Direct link

 
WAT