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 34.2 is 30 June 2022.
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 56 drafts published in Pharmeuropa 34.2 are listed here.
|
Drafts published in Pharmeuropa 34.2 (end of commenting period: 30 June 2022) |
Group |
|
|---|---|---|
|
1 |
2.6.30. Monocyte-activation test Reference number: PA/PH/Exp. BET/T (19) 13 ANP Text number: 20630 |
BET |
|
2 |
2.6.7. Mycoplasmas Reference number: PA/PH/Exp. MYC/T (21) 1 ANP Text number: 20607 |
MYC |
|
3 |
2.7.37. Assay of Phl p 5 allergen Reference number: PA/PH/Exp. ALG/T (21) 6 ANP Text number: 20737 |
ALG |
|
4 |
3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations Reference number: PA/PH/Exp. 16/T (19) 16 ANP Text number: 30118 |
16 |
|
5 |
5.2.2. Chicken flocks free from specified pathogens for the production and quality control of vaccines Reference number: PA/PH/Exp. 15V/T (22) 4 ANP Text number: 50202 |
15V |
|
6 |
5.27. Comparability of alternative analytical procedures Reference number: PA/PH/Exp. MG/T (18) 23 ANP Text number: 52700 |
MG |
|
7 |
Aujeszky’s disease vaccine (inactivated) for pigs Reference number: PA/PH/Exp. 15V/T (21) 39 ANP Text number: 0744 |
15V |
|
8 |
Avian infectious bronchitis vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 42 ANP Text number: 0959 |
15V |
|
9 |
Avian infectious bursal disease vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 43 ANP Text number: 0960 |
15V |
|
10 |
Avian infectious encephalomyelitis vaccine (live) Reference number: PA/PH/Exp. 15V/T (21) 50 ANP Text number: 0588 |
15V |
|
11 |
Avian paramyxovirus 3 vaccine (inactivated) for turkeys Reference number: PA/PH/Exp. 15V/T (21) 46 ANP Text number: 1392 |
15V |
|
12 |
Brivaracetam Reference number: PA/PH/Exp. P4/T (20) 15 ANP Text number: 3139 |
P4 |
|
13 |
Brivaracetam injection or infusion Reference number: PA/PH/Exp. P4/T (20) 18 ANP Text number: 3142 |
P4 |
|
14 |
Brivaracetam oral solution Reference number: PA/PH/Exp. P4/T (20) 17 ANP Text number: 3141 |
P4 |
|
15 |
Brivaracetam tablets Reference number: PA/PH/Exp. P4/T (20) 16 ANP Text number: 3140 |
P4 |
|
16 |
Bromperidol Reference number: PA/PH/Exp. 10B/T (21) 84 ANP Text number: 1178 |
10B |
|
17 |
Bromperidol decanoate Reference number: PA/PH/Exp. 10B/T (21) 88 ANP Text number: 1397 |
10B |
|
18 |
Calcium folinate hydrate Reference number: PA/PH/Exp. 11/T (22) 4 ANP Text number: 0978 |
11 |
|
19 |
Calcium iodatum for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (21) 56 ANP Text number: 2144 |
HOM |
|
20 |
Calcium levofolinate hydrate Reference number: PA/PH/Exp. 11/T (22) 5 ANP Text number: 1606 |
11 |
|
21 |
Carmellose calcium Reference number: PA/PH/Exp. CEL/T (21) 6 ANP Text number: 0886 |
CEL |
|
22 |
Chloroxylenol Reference number: PA/PH/Exp. 10A/T (18) 172 ANP Text number: 2980 |
10A |
|
23 |
Chrysanthemum flower Reference number: PA/PH/Exp. TCM/T (21) 53 ANP Text number: 3162 |
TCM |
|
24 |
Cola Reference number: PA/PH/Exp. 13B/T (21) 49 ANP Text number: 1504 |
13B |
|
25 |
Croscarmellose sodium Reference number: PA/PH/Exp. CEL/T (21) 28 ANP Text number: 0985 |
CEL |
|
26 |
Dapsone Reference number: PA/PH/Exp. 11/T (21) 58 ANP Text number: 0077 |
11 |
|
27 |
Egg drop syndrome ‘76 vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 45 ANP Text number: 1202 |
15V |
|
28 |
Equine influenza vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 40 ANP Text number: 0249 |
15V |
|
29 |
Etonogestrel Reference number: PA/PH/Exp. 10B/T (21) 55 ANP Text number: 3049 |
10B |
|
30 |
Fenticonazole nitrate Reference number: PA/PH/Exp. 11/T (21) 62 ANP Text number: 1211 |
11 |
|
31 |
Fingolimod hydrochloride Reference number: PA/PH/Exp. P4/T (21) 54 ANP Text number: 2988 |
P4 |
|
32 |
Flunitrazepam Reference number: PA/PH/Exp. 10B/T (22) 17 ANP Text number: 0717 |
10B |
|
33 |
Fowl cholera vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 51 ANP Text number: 1945 |
15V |
|
34 |
Green tea Reference number: PA/PH/Exp. 13B/T (17) 75 ANP Text number: 2668 |
13B |
|
35 |
Guarana Reference number: PA/PH/Exp. 13B/T (17) 76 ANP Text number: 2669 |
13B |
|
36 |
Hypromellose acetate succinate Reference number: PA/PH/Exp. CEL/T (18) 10 ANP Text number: 3101 |
CEL |
|
37 |
Isopropyl myristate Reference number: PA/PH/Exp. 13H/T (22) 12 ANP Text number: 0725 |
13H |
|
38 |
Lonicera japonica flower Reference number: PA/PH/Exp. TCM/T (21) 36 ANP Text number: 3159 |
TCM |
|
39 |
Mate leaf Reference number: PA/PH/Exp. 13B/T (20) 15 ANP Text number: 2678 |
13B |
|
40 |
Mycoplasma gallisepticum vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 47 ANP Text number: 1942 |
15V |
|
41 |
Nettle root Reference number: PA/PH/Exp. 13B/T (21) 43 ANP Text number: 2538 |
13B |
|
42 |
Newcastle disease vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 41 ANP Text number: 0870 |
15V |
|
43 |
Nux-vomica for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (21) 57 ANP Text number: 2514 |
HOM |
|
44 |
Omega-3-acid triglycerides Reference number: PA/PH/Exp. 13H/T (22) 7 ANP Text number: 1352 |
13H |
|
45 |
Phenoxymethylpenicillin Reference number: PA/PH/Exp. 7/T (22) 6 ANP Text number: 0148 |
7 |
|
46 |
Porcine influenza vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (21) 44 ANP Text number: 0963 |
15V |
|
47 |
Rabbit haemorrhagic disease vaccine (inactivated) Reference number: PA/PH/Exp. 15V/T (22) 3 ANP Text number: 2325 |
15V |
|
48 |
Raltegravir potassium chewable tablets Reference number: PA/PH/Exp. P4/T (21) 20 ANP R1 Text number: 2939 |
P4 |
|
49 |
Raltegravir potassium tablets Reference number: PA/PH/Exp. P4/T (21) 19 ANP R1 Text number: 2938 |
P4 |
|
50 |
Ropinirole hydrochloride Reference number: PA/PH/Exp. 10D/T (21) 59 ANP Text number: 2604 |
10D |
|
51 |
Salmonella Enteritidis vaccine (inactivated) for chickens Reference number: PA/PH/Exp. 15V/T (21) 48 ANP Text number: 1947 |
15V |
|
52 |
Salmonella Typhimurium vaccine (inactivated) for chickens Reference number: PA/PH/Exp. 15V/T (21) 49 ANP Text number: 2361 |
15V |
|
53 |
Soya-bean oil, refined Reference number: PA/PH/Exp. 13H/T (22) 1 ANP Text number: 1473 |
13H |
|
54 |
Technetium (99mTc) tin pyrophosphate injection Reference number: PA/PH/Exp. 14/T (21) 45 ANP Text number: 0129 |
14 |
|
55 |
Trimethoprim Reference number: PA/PH/Exp. 10A/T (18) 207 ANP Text number: 0060 |
10A |
|
56 |
Zopiclone Reference number: PA/PH/Exp. 10D/T (21) 39 ANP Text number: 1060 |
10D |