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Pharmeuropa 32.2 just released

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European Pharmacopoeia
Public enquiry
News
15 April 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 32.2 is 30 June 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.

In view of the current situation faced by users in areas affected by COVID-19, such as the temporary lockdown of manufacturing sites and disruption of supply chains, the European Pharmacopoeia strongly recommends users who wish to provide comments on the Ph. Eur. text but are not able to do so before 30 June 2020, to contact:

  • the National Pharmacopoeia Authorities of the Ph. Eur. member state (NPA):
    • for manufacturers and other interested parties from member states of the Ph. Eur. convention;
    • for manufacturers and other interested parties from non-member states of the Ph. Eur. convention, and for multinational interested parties;
  • the EDQM (via its HelpDesk) for industry associations or other associations.

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 42 drafts published in Pharmeuropa 32.2 are:

 

Drafts published in Pharmeuropa 32.2 (end of commenting period: 30 June 2020)

Group

1

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

2

2.4.36. N-Nitrosamines in active substances

Reference number: PA/PH/Exp. MG/T (19) 23 ANP

Text number: 20436

Direct link

MG

3

2.9.1. Disintegration of tablets and capsules

Reference number: PA/PH/Exp. 12/T (19) 44 ANP

Text number: 20901

Direct link

12

4

2.9.50. Particle size analysis by dynamic light scattering

Reference number: PA/PH/Exp. POW/T (17) 21 ANP

Text number: 20950

Direct link

POW

5

3.1.16. Cyclo-olefin polymers

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

Text number: 30116

Direct link

16

6

3.1.17. Cyclo-olefin copolymers

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

Text number: 30117

Direct link

16

7

5.30. Monographs on essential oils (information chapter)

Reference number: PA/PH/Exp. 13A/T (19) 78 ANP

Text number: 53000

Direct link

13A

8

all-rac-Phytomenadione

Reference number: PA/PH/Exp. VIT/T (19) 53 ANP

Text number: 3011

Direct link

VIT

9

Aluminium stearate

Reference number: PA/PH/Exp. 9/T (19) 72 ANP

Text number: 1663

Direct link

9

10

Bitter apricot seed

Reference number: PA/PH/Exp. TCM/T (19) 39 ANP

Text number: 2935

Direct link

TCM

11

Chemical precursors for radiopharmaceutical preparations

Reference number: PA/PH/Exp. PRP/T (19) 12 ANP

Text number: 2902

Direct link

PRP

12

Cholecalciferol concentrate (oily form)

Reference number: PA/PH/Exp. VIT/T (19) 51 ANP

Text number: 0575

Direct link

VIT

13

Cholesterol for parenteral use

Reference number: PA/PH/Exp. VIT/T (17) 33 ANP

Text number: 2397

Direct link

VIT

14

Deferasirox dispersible tablets

Reference number: PA/PH/Exp. P4/T (17) 28 ANP

Text number: 2934

Direct link

P4

15

Essential oils

Reference number: PA/PH/Exp. 13A/T (17) 46 ANP

Text number: 2098

Direct link

13A

16

Fluoroethyl-l-tyrosine (18F) injection

Reference number: PA/PH/Exp. 14/T (19) 45 ANP

Text number: 2466

Direct link

14

17

Flurbiprofen

Reference number: PA/PH/Exp. 10B/T (18) 102 ANP

Text number: 1519

Direct link

10B

18

Fluticasone furoate

Reference number: PA/PH/Exp. P4/T (12) 25 ANP

Text number: 2768

Direct link

P4

19

Foams, medicated

Reference number: PA/PH/Exp. 12/T (20) 1 ANP

Text number: 1105

Direct link

12

20

Fosinopril sodium

Reference number: PA/PH/Exp. 10C/T (19) 14 ANP

Text number: 1751

Direct link

10C

21

Miconazole

Reference number: PA/PH/Exp. 10B/T (19) 84 ANP

Text number: 0935

Direct link

10B

22

Miconazole nitrate

Reference number: PA/PH/Exp. 10B/T (19) 156 ANP

Text number: 0513

Direct link

10B

23

Nettle root

Reference number: PA/PH/Exp. 13B/T (19) 67 ANP

Text number: 2538

Direct link

13B

24

Oxytetracycline hydrochloride

Reference number: PA/PH/Exp. 7/T (19) 73 ANP

Text number: 0198

Direct link

7

25

Peach seed

Reference number: PA/PH/Exp. TCM/T (16) 86 ANP

Text number: 2975

Direct link

TCM

26

Riboflavin sodium phosphate hydrate

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

Text number: 0786

Direct link

VIT

27

RRR-α-Tocopheryl hydrogen succinate

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

Text number: 1259

Direct link

VIT

28

Scrophularia root

Reference number: PA/PH/Exp. TCM/T (18) 77 ANP

Text number: 2973

Direct link

TCM

29

Senna fruit dry aqueous extract, standardised

Reference number: PA/PH/Exp. 13A/T (17) 43 ANP

Text number: 3084

Direct link

13A

30

Senna fruit dry hydroalcoholic extract, standardised

Reference number: PA/PH/Exp. 13A/T (19) 66 ANP

Text number: 3127

Direct link

13A

31

Senna leaflet dry extract, standardised

Reference number: PA/PH/Exp. 13A/T (18) 1 ANP

Text number: 1261

Direct link

13A

32

Sodium molybdate (99Mo) solution (fission)

Reference number: PA/PH/Exp. 14/T (19) 47 ANP

Text number: 1923

Direct link

14

33

Sodium stearate

Reference number: PA/PH/Exp. 9/T (20) 1 ANP

Text number: 2058

Direct link

9

34

Sucrose

Reference number: PA/PH/Exp. CRB/T (19) 32 ANP

Text number: 0204

Direct link

CRB

35

Technetium (99mTc) macrosalb injection

Reference number: PA/PH/Exp. 14/T (18) 48 ANP

Text number: 0296

Direct link

14

36

Terazosin hydrochloride dihydrate

Reference number: PA/PH/Exp. 10C/T (19) 48 ANP

Text number: 2021

Direct link

10C

37

Teriflunomide tablets

Reference number: PA/PH/Exp. P4/T (18) 13 ANP

Text number: 3037

Direct link

P4

38

Tetra-O-acetyl-mannose triflate for radiopharmaceutical preparations

Reference number: PA/PH/Exp. PRP/T (19) 14 ANP

Text number: 2294

Direct link

PRP

39

Thunberg fritillary bulb

Reference number: PA/PH/Exp. TCM/T (09) 36 ANP

Text number: 2588

Direct link

TCM

40

Tigecycline

Reference number: PA/PH/Exp. P4/T (19) 98 ANP

Text number: 2825

Direct link

P4

41

Vibriosis vaccine (inactivated) for sea bass

Reference number: PA/PH/Exp. 15V/T (18) 52 ANP

Text number: 3090

Direct link

15V

42

Winter ulcer vaccine (inactivated, oil-adjuvanted, injectable) for salmonids

Reference number: PA/PH/Exp. 15V/T (18) 45 ANP

Text number: 2151

Direct link

15V

 

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