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Pharmeuropa 32.3 just released

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European Pharmacopoeia
Public enquiry
News
15 July 2020
Strasbourg, France

All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.3 is 30 September 2020.

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 (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 32.3 are:

 

Drafts published in Pharmeuropa 32.3 (end of commenting period: 30 September 2020)

Group

1

2.2.48. Raman spectroscopy

Reference number: PA/PH/Exp. SDA/T (20) 1 ANP

Text number: 20248

Direct link

SDA

2

2.4.35. Extractable elements in plastic materials for pharmaceutical use

Reference number: PA/PH/Exp. 16/T (19) 22 ANP

Text number: 20435

Direct link

16

3

3.1.16. Cyclo-olefin polymers

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

Text number: 30116

Direct link

16

4

3.1.17. Cyclo-olefin copolymers

Reference number: PA/PH/Exp. 16/T (19) 17 ANP

Text number: 30117

Direct link

16

5

Arnica flower

Reference number: PA/PH/Exp. 13A/T (19) 80 ANP

Text number: 1391

Direct link

13A

6

Arnica tincture

Reference number: PA/PH/Exp. 13A/T (19) 81 ANP

Text number: 1809

Direct link

13A

7

Atorvastatin calcium

Reference number: PA/PH/Exp. 10A/T (13) 59 ANP R3

Text number: 2191

Direct link

10A

8

Atorvastatin magnesium trihydrate

Reference number: PA/PH/Exp. 10A/T (17) 86 ANP

Text number: 2755

Direct link

10A

9

Botulinum toxin type A for injection

Reference number: PA/PH/Exp. 15/T (19) 70 ANP

Text number: 2113

Direct link

BOT

10

Carmellose sodium

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

Text number: 0472

Direct link

CEL

11

Chlortalidone

Reference number: PA/PH/Exp. 10B/T (20) 13 ANP

Text number: 0546

Direct link

10B

12

Clostridium novyi (type B) vaccine for veterinary use

Reference number: PA/PH/Exp. 15V/T (19) 25 ANP

Text number: 0362

Direct link

15V

13

Clostridium perfringens vaccine for veterinary use

Reference number: PA/PH/Exp. 15V/T (19) 26 ANP

Text number: 0363

Direct link

15V

14

Clostridium septicum vaccine for veterinary use

Reference number: PA/PH/Exp. 15V/T (15) 28 ANP

Text number: 0364

Direct link

15V

15

Cod-liver oil

Reference number: PA/PH/Exp. 13H/T (20) 30 ANP

Text number: 1192

Direct link

13H

16

Diphtheria and tetanus vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 12 ANP

Text number: 0444

Direct link

15

17

Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content)

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

Text number: 0647

Direct link

15

18

Diphtheria vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 11 ANP

Text number: 0443

Direct link

15

19

Diphtheria vaccine (adsorbed, reduced antigen content)

Reference number: PA/PH/Exp. 15/T (20) 14 ANP

Text number: 0646

Direct link

15

20

Diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 21 ANP

Text number: 2062

Direct link

15

21

Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 16 ANP

Text number: 1931

Direct link

15

22

Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content)

Reference number: PA/PH/Exp. 15/T (20) 27 ANP

Text number: 2764

Direct link

15

23

Diphtheria, tetanus and pertussis (whole cell) vaccine (adsorbed)

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

Text number: 0445

Direct link

15

24

Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)

Reference number: PA/PH/Exp. 15/T (20) 25 ANP

Text number: 2328

Direct link

15

25

Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 17 ANP

Text number: 1932

Direct link

15

26

Diphtheria, tetanus, pertussis (acellular, component) and hepatitis B (rDNA) vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 18 ANP

Text number: 1933

Direct link

15

27

Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 19 ANP

Text number: 1934

Direct link

15

28

Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)

Reference number: PA/PH/Exp. 15/T (20) 26 ANP

Text number: 2329

Direct link

15

29

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 24 ANP

Text number: 2067

Direct link

15

30

Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 22 ANP

Text number: 2065

Direct link

15

31

Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis (inactivated) vaccine (adsorbed)

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

Text number: 2061

Direct link

15

32

Diphtheria, tetanus, pertussis (whole cell), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)

Reference number: PA/PH/Exp. 15/T (20) 23

Text number: 2066

Direct link

15

33

Domperidone

Reference number: PA/PH/Exp. 10B/T (19) 153 ANP

Text number: 1009

Direct link

10B

34

Domperidone maleate

Reference number: PA/PH/Exp. 10B/T (19) 152 ANP

Text number: 1008

Direct link

10B

35

Ezetimibe

Reference number: PA/PH/Exp. 10D/T (13) 54 ANP

Text number: 2767

Direct link

10D

36

Formoterol fumarate dihydrate

Reference number: PA/PH/Exp. 10B/T (20) 27 ANP

Text number: 1724

Direct link

10B

37

Human anti-D immunoglobulin

Reference number: PA/PH/Exp. 6B/T (20) 3 ANP

Text number: 0557

Direct link

6B

38

Human anti-D immunoglobulin for intravenous administration

Reference number: PA/PH/Exp. 6B/T (20) 4 ANP

Text number: 1527

Direct link

6B

39

Hydrochloric acid, concentrated

Reference number: PA/PH/Exp. 9/T (20) 22 ANP

Text number: 0002

Direct link

9

40

Hydrochloric acid, dilute

Reference number: PA/PH/Exp. 9/T (20) 23 ANP

Text number: 0003

Direct link

9

41

Methods of preparation of homoeopathic stocks and potentisation

Reference number: PA/PH/Exp. HMM/T (20) 3 ANP

Text number: 2371

Direct link

HMM

42

Nebivolol hydrochloride

Reference number: PA/PH/Exp. 10A/T (18) 11 ANP

Text number: 2775

Direct link

10A

43

Notopterygium root

Reference number: PA/PH/Exp. TCM/T (10) 37 ANP R3

Text number: 2662

Direct link

TCM

44

Paraffin, white soft

Reference number: PA/PH/Exp. 13H/T (09) 11 ANP R3

Text number: 1799

Direct link

13H

45

Paraffin, yellow soft

Reference number: PA/PH/Exp. 13H/T (09) 8 ANP R3

Text number: 1554

Direct link

13H

46

Propylene glycol monocaprylate

Reference number: PA/PH/Exp. 13H/T (20) 29 ANP

Text number: 2799

Direct link

13H

47

Stearic acid

Reference number: PA/PH/Exp. 13H/T (20) 32 ANP

Text number: 1474

Direct link

13H

48

Tetracaine hydrochloride

Reference number: PA/PH/Exp. 10A/T (18) 206 ANP

Text number: 0057

Direct link

10A

 

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