Pharmeuropa 32.2 just released

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

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MG

3

2.9.1. Disintegration of tablets and capsules

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

Text number: 20901

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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

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POW

5

3.1.16. Cyclo-olefin polymers

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

Text number: 30116

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16

6

3.1.17. Cyclo-olefin copolymers

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

Text number: 30117

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16

7

5.30. Monographs on essential oils (information chapter)

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

Text number: 53000

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13A

8

all-rac-Phytomenadione

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

Text number: 3011

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VIT

9

Aluminium stearate

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

Text number: 1663

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9

10

Bitter apricot seed

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

Text number: 2935

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TCM

11

Chemical precursors for radiopharmaceutical preparations

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

Text number: 2902

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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

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VIT

14

Deferasirox dispersible tablets

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

Text number: 2934

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P4

15

Essential oils

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

Text number: 2098

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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

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P4

19

Foams, medicated

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

Text number: 1105

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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

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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

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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

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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

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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

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P4

41

Vibriosis vaccine (inactivated) for sea bass

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

Text number: 3090

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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