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 33.2 is 30 June 2021.
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 48 drafts published in Pharmeuropa 33.2 are listed here.
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Drafts published in Pharmeuropa 33.2 (end of commenting period: 30 June 2021) |
Group |
|---|---|---|
|
1 |
2.1.3. Ultraviolet ray lamps for analytical purposes Reference number: PA/PH/Exp. CST/T (20) 8 ANP Text number: 20103 |
MG |
|
2 |
2.7.26. Cell-based assays for potency determination of TNF-alpha antagonists Reference number: PA/PH/Exp. MAB/T (21) 3 ANP Text number: 20726 |
MAB |
|
3 |
2.9.19. Particulate contamination: sub-visible particles Reference number: PA/PH/Exp. 12/T (21) 1 ANP Text number: 20919 |
12 |
|
4 |
3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders Reference number: PA/PH/Exp. 16/T (20) 8 ANP Text number: 30209 |
16 |
|
5 |
Bryonia for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (13) 55 ANP Text number: 2490 |
HOM |
|
6 |
Calcium pantothenate Reference number: PA/PH/Exp. VIT/T (20) 45 ANP Text number: 0470 |
VIT |
|
7 |
Carprofen for veterinary use Reference number: PA/PH/Exp. 10A/T (20) 131 ANP Text number: 2201 |
10A |
|
8 |
Ciprofibrate Reference number: PA/PH/Exp. 10B/T (20) 92 ANP Text number: 2013 |
10B |
|
9 |
Dequalinium chloride hydrate Reference number: PA/PH/Exp. 10B/T (18) 159 ANP Text number: 1413 |
10B |
|
10 |
Difloxacin hydrochloride trihydrate for veterinary use Reference number: PA/PH/Exp. 10A/T (20) 134 ANP Text number: 2239 |
10A |
|
11 |
Dihydrostreptomycin sulfate for veterinary use Reference number: PA/PH/Exp. 7/T (20) 83 ANP Text number: 0485 |
7 |
|
12 |
Enrofloxacin for veterinary use Reference number: PA/PH/Exp. 10A/T (20) 132 ANP Text number: 2229 |
10A |
|
13 |
Ephedra vulgaris for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (13) 1 ANP Text number: 2710 |
HOM |
|
14 |
Etanercept Reference number: PA/PH/Exp. MAB/T (21) 6 ANP Text number: 2895 |
MAB |
|
15 |
Everolimus Reference number: PA/PH/Exp. 7/T (21) 1 ANP Text number: 2918 |
7 |
|
16 |
Febantel for veterinary use Reference number: PA/PH/Exp. 10D/T (20) 60 ANP Text number: 2176 |
10D |
|
17 |
Fenbendazole for veterinary use Reference number: PA/PH/Exp. 10A/T (20) 129 ANP Text number: 1208 |
10A |
|
18 |
Flunarizine dihydrochloride Reference number: PA/PH/Exp. 10B/T (20) 90 ANP Text number: 1722 |
10B |
|
19 |
Glucose Reference number: PA/PH/Exp. SIT/T (20) 41 ANP Text number: 0177 |
CRB |
|
20 |
Glucose monohydrate Reference number: PA/PH/Exp. SIT/T (20) 40 ANP Text number: 0178 |
CRB |
|
21 |
Hyoscyamus for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (16) 16 ANP Text number: 2091 |
HOM |
|
22 |
Infliximab concentrated solution Reference number: PA/PH/Exp. MAB/T (21) 7 ANP Text number: 2928 |
MAB |
|
23 |
Isradipine Reference number: PA/PH/Exp. 10B/T (20) 94 ANP Text number: 2110 |
10B |
|
24 |
Lactose Reference number: PA/PH/Exp. SIT/T (20) 42 ANP Text number: 1061 |
CRB |
|
25 |
Lactose monohydrate Reference number: PA/PH/Exp. SIT/T (20) 39 ANP Text number: 0187 |
CRB |
|
26 |
Lufenuron for veterinary use Reference number: PA/PH/Exp. 10D/T (20) 61 ANP Text number: 2177 |
10D |
|
27 |
Mandragora for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (16) 14 ANP Text number: 2840 |
HOM |
|
28 |
Marbofloxacin for veterinary use Reference number: PA/PH/Exp. 10A/T (21) 7 ANP Text number: 2233 |
10A |
|
29 |
Mefloquine hydrochloride Reference number: PA/PH/Exp. 10D/T (20) 65 ANP Text number: 1241 |
10D |
|
30 |
Melatonin Reference number: PA/PH/Exp. 10C/T (20) 2 ANP Text number: 3059 |
10C |
|
31 |
Morantel hydrogen tartrate for veterinary use Reference number: PA/PH/Exp. 10D/T (20) 59 ANP Text number: 1546 |
10D |
|
32 |
Moxidectin for veterinary use Reference number: PA/PH/Exp. 7/T (20) 85 ANP Text number: 1656 |
7 |
|
33 |
Pharmaceutical preparations Reference number: PA/PH/SG (21) 5 ANP Text number: 2619 |
PHP |
|
34 |
Pimobendan for veterinary use Reference number: PA/PH/Exp. 10D/T (20) 62 ANP Text number: 2179 |
10D |
|
35 |
Rhubarb Reference number: PA/PH/Exp. 13A/T (04) 40 ANP R3 Text number: 0291 |
13A |
|
36 |
Rhubarb dry extract, standardised Reference number: PA/PH/Exp. 13A/T (05) 9 ANP R1 Text number: 1845 |
13A |
|
37 |
Selamectin for veterinary use Reference number: PA/PH/Exp. 7/T (20) 86 ANP Text number: 2268 |
7 |
|
38 |
Sodium feredetate trihydrate Reference number: PA/PH/Exp. 10D/T (20) 66 ANP Text number: 2985 |
10D |
|
39 |
Stramonium for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (16) 15 ANP Text number: 2734 |
HOM |
|
40 |
Substances for pharmaceutical use Reference number: PA/PH/SG (21) 4 ANP Text number: 2034 |
PCM |
|
41 |
Sulfadimethoxine sodium for veterinary use Reference number: PA/PH/Exp. 7/T (20) 87 ANP Text number: 2745 |
7 |
|
42 |
Sulfamethoxypyridazine for veterinary use Reference number: PA/PH/Exp. 7/T (20) 84 ANP Text number: 0638 |
7 |
|
43 |
Theophylline-ethylenediamine Reference number: PA/PH/Exp. SIT/T (19) 27 ANP Text number: 0300 |
10A |
|
44 |
Theophylline-ethylenediamine hydrate Reference number: PA/PH/Exp. SIT/T (20) 37 ANP Text number: 0301 |
10A |
|
45 |
Vaccines for veterinary use Reference number: PA/PH/Exp. 15V/T (20) 59 ANP Text number: 0062 |
15V |
|
46 |
Vedaprofen for veterinary use Reference number: PA/PH/Exp. 10A/T (20) 135 ANP Text number: 2248 |
10A |
|
47 |
Water for injections Reference number: PA/PH/Exp. WAT/T (21) 2 ANP Text number: 0169 |
WAT |
|
48 |
Xylazine hydrochloride for veterinary use Reference number: PA/PH/Exp. 10A/T (20) 130 ANP Text number: 1481 |
10A |