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:
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Drafts published in Pharmeuropa 32.2 (end of commenting period: 30 June 2020) |
Group |
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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 |
16 |
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2 |
2.4.36. N-Nitrosamines in active substances Reference number: PA/PH/Exp. MG/T (19) 23 ANP Text number: 20436 |
MG |
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3 |
2.9.1. Disintegration of tablets and capsules Reference number: PA/PH/Exp. 12/T (19) 44 ANP Text number: 20901 |
12 |
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4 |
2.9.50. Particle size analysis by dynamic light scattering Reference number: PA/PH/Exp. POW/T (17) 21 ANP Text number: 20950 |
POW |
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5 |
3.1.16. Cyclo-olefin polymers Reference number: PA/PH/Exp. 16/T (16) 15 ANP Text number: 30116 |
16 |
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6 |
3.1.17. Cyclo-olefin copolymers Reference number: PA/PH/Exp. 16/T (19) 17 ANP Text number: 30117 |
16 |
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7 |
5.30. Monographs on essential oils (information chapter) Reference number: PA/PH/Exp. 13A/T (19) 78 ANP Text number: 53000 |
13A |
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8 |
all-rac-Phytomenadione Reference number: PA/PH/Exp. VIT/T (19) 53 ANP Text number: 3011 |
VIT |
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9 |
Aluminium stearate Reference number: PA/PH/Exp. 9/T (19) 72 ANP Text number: 1663 |
9 |
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10 |
Bitter apricot seed Reference number: PA/PH/Exp. TCM/T (19) 39 ANP Text number: 2935 |
TCM |
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11 |
Chemical precursors for radiopharmaceutical preparations Reference number: PA/PH/Exp. PRP/T (19) 12 ANP Text number: 2902 |
PRP |
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12 |
Cholecalciferol concentrate (oily form) Reference number: PA/PH/Exp. VIT/T (19) 51 ANP Text number: 0575 |
VIT |
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13 |
Cholesterol for parenteral use Reference number: PA/PH/Exp. VIT/T (17) 33 ANP Text number: 2397 |
VIT |
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14 |
Deferasirox dispersible tablets Reference number: PA/PH/Exp. P4/T (17) 28 ANP Text number: 2934 |
P4 |
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15 |
Essential oils Reference number: PA/PH/Exp. 13A/T (17) 46 ANP Text number: 2098 |
13A |
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16 |
Fluoroethyl-l-tyrosine (18F) injection Reference number: PA/PH/Exp. 14/T (19) 45 ANP Text number: 2466 |
14 |
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17 |
Flurbiprofen Reference number: PA/PH/Exp. 10B/T (18) 102 ANP Text number: 1519 |
10B |
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18 |
Fluticasone furoate Reference number: PA/PH/Exp. P4/T (12) 25 ANP Text number: 2768 |
P4 |
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19 |
Foams, medicated Reference number: PA/PH/Exp. 12/T (20) 1 ANP Text number: 1105 |
12 |
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20 |
Fosinopril sodium Reference number: PA/PH/Exp. 10C/T (19) 14 ANP Text number: 1751 |
10C |
|
21 |
Miconazole Reference number: PA/PH/Exp. 10B/T (19) 84 ANP Text number: 0935 |
10B |
|
22 |
Miconazole nitrate Reference number: PA/PH/Exp. 10B/T (19) 156 ANP Text number: 0513 |
10B |
|
23 |
Nettle root Reference number: PA/PH/Exp. 13B/T (19) 67 ANP Text number: 2538 |
13B |
|
24 |
Oxytetracycline hydrochloride Reference number: PA/PH/Exp. 7/T (19) 73 ANP Text number: 0198 |
7 |
|
25 |
Peach seed Reference number: PA/PH/Exp. TCM/T (16) 86 ANP Text number: 2975 |
TCM |
|
26 |
Riboflavin sodium phosphate hydrate Reference number: PA/PH/Exp. VIT/T (19) 10 ANP Text number: 0786 |
VIT |
|
27 |
RRR-α-Tocopheryl hydrogen succinate Reference number: PA/PH/Exp. VIT/T (20) 1 ANP Text number: 1259 |
VIT |
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28 |
Scrophularia root Reference number: PA/PH/Exp. TCM/T (18) 77 ANP Text number: 2973 |
TCM |
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29 |
Senna fruit dry aqueous extract, standardised Reference number: PA/PH/Exp. 13A/T (17) 43 ANP Text number: 3084 |
13A |
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30 |
Senna fruit dry hydroalcoholic extract, standardised Reference number: PA/PH/Exp. 13A/T (19) 66 ANP Text number: 3127 |
13A |
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31 |
Senna leaflet dry extract, standardised Reference number: PA/PH/Exp. 13A/T (18) 1 ANP Text number: 1261 |
13A |
|
32 |
Sodium molybdate (99Mo) solution (fission) Reference number: PA/PH/Exp. 14/T (19) 47 ANP Text number: 1923 |
14 |
|
33 |
Sodium stearate Reference number: PA/PH/Exp. 9/T (20) 1 ANP Text number: 2058 |
9 |
|
34 |
Sucrose Reference number: PA/PH/Exp. CRB/T (19) 32 ANP Text number: 0204 |
CRB |
|
35 |
Technetium (99mTc) macrosalb injection Reference number: PA/PH/Exp. 14/T (18) 48 ANP Text number: 0296 |
14 |
|
36 |
Terazosin hydrochloride dihydrate Reference number: PA/PH/Exp. 10C/T (19) 48 ANP Text number: 2021 |
10C |
|
37 |
Teriflunomide tablets Reference number: PA/PH/Exp. P4/T (18) 13 ANP Text number: 3037 |
P4 |
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38 |
Tetra-O-acetyl-mannose triflate for radiopharmaceutical preparations Reference number: PA/PH/Exp. PRP/T (19) 14 ANP Text number: 2294 |
PRP |
|
39 |
Thunberg fritillary bulb Reference number: PA/PH/Exp. TCM/T (09) 36 ANP Text number: 2588 |
TCM |
|
40 |
Tigecycline Reference number: PA/PH/Exp. P4/T (19) 98 ANP Text number: 2825 |
P4 |
|
41 |
Vibriosis vaccine (inactivated) for sea bass Reference number: PA/PH/Exp. 15V/T (18) 52 ANP Text number: 3090 |
15V |
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42 |
Winter ulcer vaccine (inactivated, oil-adjuvanted, injectable) for salmonids Reference number: PA/PH/Exp. 15V/T (18) 45 ANP Text number: 2151 |
15V |