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 33.4 is 31 December 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 41 drafts published in Pharmeuropa 33.4 are listed here.
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Drafts published in Pharmeuropa 33.4 (end of commenting period: 31 December 2021) |
Group |
|---|---|---|
|
1 |
2.2.35. Osmolality Reference number: PA/PH/Exp. MG/T (21) 4 ANP Text number: 20235 |
MG |
|
2 |
2.9.48. Particle size and shape determination by image analysis Reference number: PA/PH/Exp. POW/T (15) 9 ANP Text number: 20948 |
POW |
|
3 |
Adhatoda vasica leaf Reference number: PA/PH/Exp. 13A/T (18) 25 ANP Text number: 2738 |
13A |
|
4 |
Ampicillin sodium Reference number: PA/PH/Exp. 7/T (21) 59 ANP Text number: 0578 |
7 |
|
5 |
Betamethasone valerate Reference number: PA/PH/Exp. SIT/T (21) 38 ANP Text number: 0811 |
10B |
|
6 |
Buserelin Reference number: PA/PH/Exp. 6/T (21) 50 ANP Text number: 1077 |
6 |
|
7 |
Cholesterol Reference number: PA/PH/Exp. VIT/T (19) 40 ANP Text number: 0993 |
VIT |
|
8 |
Coccidiosis vaccine (live) for chickens Reference number: PA/PH/Exp. 15V/T (21) 28 ANP Text number: 2326 |
15V |
|
9 |
Ether Reference number: PA/PH/Exp. 10D/T (18) 53 ANP R1 Text number: 0650 |
10D |
|
10 |
Flumetasone pivalate Reference number: PA/PH/Exp. 10B/T (19) 158 ANP Text number: 1327 |
10B |
|
11 |
Fluorocholine (18F) injection Reference number: PA/PH/Exp. 14/T (21) 31 ANP Text number: 2793 |
14 |
|
12 |
Goldenrod Reference number: PA/PH/Exp. 13B/T (21) 15 ANP Text number: 1892 |
13B |
|
13 |
Goldenrod, European Reference number: PA/PH/Exp. 13B/T (21) 16 ANP Text number: 1893 |
13B |
|
14 |
Indometacin Reference number: PA/PH/Exp. SIT/T (21) 35 ANP Text number: 0092 |
10A |
|
15 |
Ketoconazole Reference number: PA/PH/Exp. SIT/T (21) 37 ANP Text number: 0921 |
10B |
|
16 |
Lysine acetate Reference number: PA/PH/Exp. 10D/T (21) 33 ANP Text number: 2114 |
10D |
|
17 |
Methylprednisolone acetate Reference number: PA/PH/Exp. SIT/T (21) 19 ANP Text number: 0933 |
10B |
|
18 |
Mirabegron Reference number: PA/PH/Exp. P4/T (19) 58 ANP Text number: 3132 |
P4 |
|
19 |
Monoclonal antibodies for human use Reference number: PA/PH/Exp. MAB/T (21) 14 ANP Text number: 2031 |
MAB |
|
20 |
Nicardipine hydrochloride Reference number: PA/PH/Exp. SIT/T (21) 34 ANP Text number: 2776 |
10D |
|
21 |
Oxygen (98 per cent) Reference number: PA/PH/Exp. 9G/T (18) 2 ANP R3 Text number: 3098 |
9G |
|
22 |
Polysorbate 40 Reference number: PA/PH/Exp. EXP/T (21) 15 ANP Text number: 1914 |
13H |
|
23 |
Polysorbate 20 Reference number: PA/PH/Exp. EXP/T (21) 14 ANP Text number: 0426 |
13H |
|
24 |
Polysorbate 60 Reference number: PA/PH/Exp. EXP/T (21) 16 ANP Text number: 0427 |
13H |
|
25 |
Polysorbate 80 Reference number: PA/PH/Exp. EXP/T (21) 17 ANP Text number: 0428 |
13H |
|
26 |
Prednisolone Reference number: PA/PH/Exp. SIT/T (21) 20 ANP Text number: 0353 |
10B |
|
27 |
Prednisone Reference number: PA/PH/Exp. 10B/T (21) 63 ANP Text number: 0354 |
10B |
|
28 |
Promazine hydrochloride Reference number: PA/PH/Exp. 10A/T (21) 9 ANP Text number: 1365 |
10A |
|
29 |
Propylene glycol monocaprylate Reference number: PA/PH/Exp. 13H/T (20) 29 ANP R1 Text number: 2799 |
13H |
|
30 |
Pumpkin seed Reference number: PA/PH/Exp. 13B/T (20) 1 ANP Text number: 2941 |
13B |
|
31 |
Rutoside trihydrate Reference number: PA/PH/Exp. 11/T (21) 36 ANP Text number: 1795 |
10A |
|
32 |
Saxagliptin monohydrate Reference number: PA/PH/Exp. P4/T (19) 48 ANP Text number: 3136 |
P4 |
|
33 |
Sildenafil citrate Reference number: PA/PH/Exp. SIT/T (21) 36 ANP Text number: 2270 |
10B |
|
34 |
Somatropin Reference number: PA/PH/Exp. 6/T (21) 13 ANP Text number: 0951 |
6 |
|
35 |
Somatropin concentrated solution Reference number: PA/PH/Exp. 6/T (21) 12 ANP Text number: 0950 |
6 |
|
36 |
Somatropin injection Reference number: PA/PH/Exp. 6/T (21) 15 ANP Text number: 2370 |
6 |
|
37 |
Somatropin powder for injection Reference number: PA/PH/Exp. 6/T (21) 14 ANP Text number: 0952 |
6 |
|
38 |
Tazobactam Reference number: PA/PH/Exp. 7/T (19) 34 ANP Text number: 2210 |
7 |
|
39 |
Technetium (99mTc) sestamibi injection Reference number: PA/PH/Exp. 14/T (21) 21 ANP Text number: 1926 |
14 |
|
40 |
Thiopental sodium and sodium carbonate Reference number: PA/PH/Exp. 10A/T (13) 22 ANP Text number: 0212 |
10A |
|
41 |
Winter ulcer vaccine (inactivated, oil-adjuvanted, injectable) for salmonids Reference number: PA/PH/Exp. 15V/T (18) 45 ANP R1 Text number: 2151 |
15V |