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 33.3 is 30 September 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 47 drafts published in Pharmeuropa 33.3 are listed here.
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Drafts published in Pharmeuropa 33.3 (end of commenting period: 30 September 2021) |
Group |
|---|---|---|
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1 |
2.6.16. Tests for extraneous agents in viral vaccines for human use Reference number: PA/PH/Exp. 15/T (18) 59 ANP Text number: 20616 |
15 |
|
2 |
2.6.40. Monocyte-activation test for vaccines containing inherently pyrogenic components Reference number: PA/PH/Exp. 15/T (18) 12 ANP Text number: 20640 |
15 |
|
3 |
2.8.2. Foreign matter Reference number: PA/PH/Exp. 13B/T (20) 34 ANP Text number: 20802 |
13B |
|
4 |
5.2.2. Chicken flocks free from specified pathogens for the production and quality control of vaccines Reference number: PA/PH/Exp. 15V/T (21) 10 ANP Text number: 50202 |
15V |
|
5 |
5.21. Chemometric methods applied to analytical data Reference number: PA/PH/Exp. SDA/T (19) 1 ANP Text number: 52100 |
SDA |
|
6 |
Amylmetacresol Reference number: PA/PH/Exp. 10A/T (21) 57 ANP Text number: 2405 |
10A |
|
7 |
Benzydamine hydrochloride Reference number: PA/PH/Exp. 10A/T (19) 133 ANP Text number: 2759 |
10A |
|
8 |
Berberis aristata stem Reference number: PA/PH/Exp. 13B/T (16) 48 ANP Text number: 2851 |
13B |
|
9 |
Calcium acetate Reference number: PA/PH/Exp. 9/T (21) 17 ANP Text number: 2128 |
9 |
|
10 |
Calcium ascorbate dihydrate Reference number: PA/PH/Exp. VIT/T (17) 26 ANP Text number: 1182 |
VIT |
|
11 |
Cholecalciferol Reference number: PA/PH/Exp. VIT/T (19) 61 ANP Text number: 0072 |
VIT |
|
12 |
Clodronate disodium tetrahydrate Reference number: PA/PH/Exp. 11/T (21) 26 ANP Text number: 1777 |
11 |
|
13 |
Crocus for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (21) 19 ANP Text number: 1624 |
HOM |
|
14 |
Dabigatran etexilate mesilate Reference number: PA/PH/Exp. P4/T (19) 17 ANP Text number: 3095 |
P4 |
|
15 |
Diclazuril for veterinary use Reference number: PA/PH/Exp. 10B/T (21) 35 ANP Text number: 1718 |
10B |
|
16 |
Disodium edetate Reference number: PA/PH/Exp. SIT/T (20) 35 ANP Text number: 0232 |
10D |
|
17 |
Erlotinib hydrochloride Reference number: PA/PH/Exp. 10C/T (20) 3 ANP Text number: 3094 |
10C |
|
18 |
Estriol Reference number: PA/PH/Exp. 10B/T (21) 59 ANP Text number: 1203 |
10B |
|
19 |
Etanercept Reference number: PA/PH/Exp. MAB/T (21) 11 ANP Text number: 2895 |
MAB |
|
20 |
Fructose Reference number: PA/PH/Exp. CRB/T (21) 18 ANP Text number: 0188 |
CRB |
|
21 |
Fulvestrant injection Reference number: PA/PH/Exp. 10B/T (20) 106 ANP Text number: 3096 |
10B |
|
22 |
Golimumab concentrated solution Reference number: PA/PH/Exp. P4Bio/T (20) 2 ANP Text number: 3103 |
P4Bio |
|
23 |
Heparin calcium Reference number: PA/PH/Exp. 6/T (21) 20 ANP Text number: 0332 |
6 |
|
24 |
Heparin sodium Reference number: PA/PH/Exp. 6/T (21) 19 ANP Text number: 0333 |
6 |
|
25 |
Heparins, low-molecular-mass Reference number: PA/PH/Exp. 6/T (21) 8 ANP Text number: 0828 |
6 |
|
26 |
Histamine dihydrochloride Reference number: PA/PH/Exp. 11/T (21) 27 ANP Text number: 0143 |
11 |
|
27 |
Influenza vaccine (live, nasal) Reference number: PA/PH/Exp. 15/T (21) 21 ANP Text number: 2772 |
15 |
|
28 |
Isoniazid Reference number: PA/PH/Exp. 10A/T (21) 8 ANP Text number: 0146 |
10A |
|
29 |
Lercanidipine hydrochloride Reference number: PA/PH/Exp. 10B/T (21) 30 ANP Text number: 3052 |
10B |
|
30 |
Levocetirizine dihydrochloride Reference number: PA/PH/Exp. 10C/T (20) 51 ANP Text number: 3115 |
10C |
|
31 |
Moxonidine Reference number: PA/PH/Exp. 10C/T (21) 16 ANP Text number: 1758 |
10C |
|
32 |
Ondansetron hydrochloride dihydrate Reference number: PA/PH/Exp. 10C/T (21) 17 ANP Text number: 2016 |
10C |
|
33 |
Palonosetron hydrochloride Reference number: PA/PH/Exp. 10C/T (19) 52 ANP Text number: 3041 |
10C |
|
34 |
Pemetrexed disodium heptahydrate Reference number: PA/PH/Exp. 10D/T (21) 13 ANP Text number: 2637 |
10D |
|
35 |
Propylthiouracil Reference number: PA/PH/Exp. 11/T (21) 28 ANP Text number: 0525 |
11 |
|
36 |
Pulsatilla root Reference number: PA/PH/Exp. TCM/T (20) 35 ANP Text number: 2972 |
TCM |
|
37 |
Rabies vaccine (inactivated) for veterinary use Reference number: PA/PH/Exp. 15V/T (21) 7 ANP Text number: 0451 |
15V |
|
38 |
Raltegravir potassium Reference number: PA/PH/Exp. P4/T (21) 18 ANP Text number: 2887 |
P4 |
|
39 |
Raltegravir potassium chewable tablets Reference number: PA/PH/Exp. P4/T (21) 20 ANP Text number: 2939 |
P4 |
|
40 |
Raltegravir potassium tablets Reference number: PA/PH/Exp. P4/T (21) 19 ANP Text number: 2938 |
P4 |
|
41 |
RRR-α-Tocopheryl acetate Reference number: PA/PH/Exp. VIT/T (20) 12 ANP Text number: 1257 |
VIT |
|
42 |
Saposhnikovia root Reference number: PA/PH/Exp. TCM/T (10) 95 ANP Text number: 2728 |
TCM |
|
43 |
Starch, hydroxypropyl Reference number: PA/PH/Exp. EXP/T (21) 9 ANP Text number: 2165 |
CRB |
|
44 |
Starch, hydroxypropyl, pregelatinised Reference number: PA/PH/Exp. EXP/T (21) 10 ANP Text number: 2645 |
CRB |
|
45 |
Thiamine nitrate Reference number: PA/PH/Exp. VIT/T (21) 23 ANP Text number: 0531 |
VIT |
|
46 |
Tibolone Reference number: PA/PH/Exp. 10B/T (21) 38 ANP Text number: 1739 |
10B |
|
47 |
Yellow fever vaccine (live) Reference number: PA/PH/Exp. 15/T (21) 22 ANP Text number: 0537 |
15 |