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 36.1 is 31 March 2024.
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 57 drafts published in Pharmeuropa 36.1 are listed here.
|
Drafts published in Pharmeuropa 36.1 (end of commenting period: 31 March 2024) |
Group |
|
|---|---|---|
|
1 |
2.5.42. N-Nitrosamines in active substances and medicinal products Reference number: PA/PH/SG (20) 68 ANP Text number: 20542 |
MG |
|
2 |
2.6.7. Mycoplasmas Reference number: PA/PH/Exp. MYC/T (21) 1 ANP R1 Text number: 20607 |
MYC |
|
3 |
5.1.9. Guidelines for using the test for sterility Reference number: PA/PH/Exp. 1/T (23) 17 ANP Text number: 50109 |
1 |
|
4 |
Aluminium hydroxide, hydrated, for adsorption Reference number: PA/PH/Exp. 9/T (21) 37 ANP Text number: 1664 |
9 |
|
5 |
Arachis oil, hydrogenated Reference number: PA/PH/Exp. 13H/T (23) 107 ANP Text number: 1171 |
13H |
|
6 |
Cadmium sulfuricum for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (23) 44 ANP Text number: 2143 |
HOM |
|
7 |
Cedarwood oil, Atlas or Himalaya type Reference number: PA/PH/Exp. 13A/T (18) 40 ANP Text number: 3002 |
13A |
|
8 |
Clary sage oil Reference number: PA/PH/Exp. 13A/T (20) 27 ANP Text number: 1850 |
13A |
|
9 |
Clopidogrel hydrogen sulfate Reference number: PA/PH/Exp. 10C/T (23) 33 ANP Text number: 2531 |
10C |
|
10 |
Clove Reference number: PA/PH/Exp. 13A/T (23) 28 ANP Text number: 0376 |
13A |
|
11 |
Clove oil Reference number: PA/PH/Exp. 13A/T (23) 41 ANP Text number: 1091 |
13A |
|
12 |
Cuprum metallicum for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (23) 43 ANP Text number: 1610 |
HOM |
|
13 |
Escitalopram Reference number: PA/PH/Exp. 10B/T (23) 73 ANP Text number: 2758 |
10B |
|
14 |
Escitalopram oxalate Reference number: PA/PH/Exp. 10B/T (23) 64 ANP Text number: 2733 |
10B |
|
15 |
Esomeprazole magnesium dihydrate Reference number: PA/PH/Exp. 10C/T (23) 29 ANP Text number: 2787 |
10C |
|
16 |
Esomeprazole magnesium trihydrate Reference number: PA/PH/Exp. 10C/T (23) 30 ANP Text number: 2372 |
10C |
|
17 |
Esomeprazole sodium Reference number: PA/PH/Exp. 10C/T (23) 31 ANP Text number: 2923 |
10C |
|
18 |
Ethylmorphine hydrochloride dihydrate Reference number: PA/PH/Exp. 11/T (23) 78 ANP Text number: 0491 |
11 |
|
19 |
Etodolac Reference number: PA/PH/Exp. 10D/T (23) 41 ANP Text number: 1422 |
10D |
|
20 |
Ferrum metallicum for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (23) 40 ANP Text number: 2026 |
HOM |
|
21 |
Fluconazole Reference number: PA/PH/Exp. 10B/T (23) 108 ANP Text number: 2287 |
10B |
|
22 |
Haemodialysis solutions, concentrated, water for diluting Reference number: PA/PH/Exp. DIA/T (22) 4 ANP Text number: 1167 |
DIA |
|
23 |
Haemodialysis, concentrated solutions for Reference number: PA/PH/Exp. DIA/T (22) 11 ANP Text number: 3206 |
DIA |
|
24 |
Haemodialysis, solutions for Reference number: PA/PH/Exp. DIA/T (22) 12 ANP Text number: 0128 |
DIA |
|
25 |
Haemofiltration and haemodiafiltration, concentrated solutions for Reference number: PA/PH/Exp. DIA/T (22) 3 ANP Text number: 2770 |
DIA |
|
26 |
Haemofiltration and haemodiafiltration, solutions for Reference number: PA/PH/Exp. DIA/T (22) 13 ANP Text number: 0861 |
DIA |
|
27 |
Hepatitis A vaccine (inactivated, adsorbed) Reference number: PA/PH/Exp. 15/T (23) 46 ANP Text number: 1107 |
15 |
|
28 |
Homatropine hydrobromide Reference number: PA/PH/Exp. 11/T (23) 77 ANP Text number: 0500 |
11 |
|
29 |
Indometacin Reference number: PA/PH/Exp. 10A/T (23) 65 ANP Text number: 0092 |
10A |
|
30 |
Influenza vaccine (split virion, inactivated) Reference number: PA/PH/Exp. 15/T (23) 41 ANP Text number: 0158 |
15 |
|
31 |
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Reference number: PA/PH/Exp. 15/T (23) 45 ANP Text number: 2149 |
15 |
|
32 |
Influenza vaccine (surface antigen, inactivated, virosome) Reference number: PA/PH/Exp. 15/T (23) 44 ANP Text number: 2053 |
15 |
|
33 |
Influenza vaccine (surface antigen, inactivated) Reference number: PA/PH/Exp. 15/T (23) 43 ANP Text number: 0869 |
15 |
|
34 |
Influenza vaccine (whole virion, inactivated) Reference number: PA/PH/Exp. 15/T (23) 42 ANP Text number: 0159 |
15 |
|
35 |
JK-PSMA-7 (18F) injection Reference number: PA/PH/Exp. 14/T (22) 15 ANP Text number: 3205 |
14 |
|
36 |
Lacosamide Reference number: PA/PH/Exp. P4/T (23) 24 ANP Text number: 2992 |
P4 |
|
37 |
Lamivudine Reference number: PA/PH/Exp. P4/T (23) 25 ANP Text number: 2217 |
P4 |
|
38 |
Levetiracetam Reference number: PA/PH/Exp. 10B/T (23) 74 ANP Text number: 2535 |
10B |
|
39 |
Liquorice dry extract for flavouring purposes Reference number: PA/PH/Exp. 13A/T (20) 32 ANP Text number: 2378 |
13A |
|
40 |
Liquorice root Reference number: PA/PH/Exp. 13A/T (20) 33 ANP Text number: 0277 |
13A |
|
41 |
Magnesium phosphoricum for homoeopathic preparations Reference number: PA/PH/Exp. HOM/T (23) 45 ANP Text number: 2505 |
HOM |
|
42 |
Nicotine ditartrate dihydrate Reference number: PA/PH/Exp. 11/T (23) 86 ANP Text number: 2599 |
11 |
|
43 |
Nitrendipine Reference number: PA/PH/Exp. 10B/T (23) 109 ANP Text number: 1246 |
10B |
|
44 |
Peritoneal dialysis, solutions for Reference number: PA/PH/Exp. DIA/T (22) 14 ANP Text number: 0862 |
DIA |
|
45 |
Poliomyelitis vaccine (inactivated) Reference number: PA/PH/Exp. 15/T (23) 47 ANP Text number: 0214 |
15 |
|
46 |
Pregabalin Reference number: PA/PH/Exp. 10C/T (23) 32 ANP Text number: 2777 |
10C |
|
47 |
Remifentanil hydrochloride Reference number: PA/PH/Exp. 10B/T (23) 63 ANP Text number: 2644 |
10B |
|
48 |
Rivaroxaban Reference number: PA/PH/Exp. 10B/T (23) 76 ANP Text number: 2932 |
10B |
|
49 |
Ropivacaine hydrochloride monohydrate Reference number: PA/PH/Exp. P4/T (23) 26 ANP Text number: 2335 |
P4 |
|
50 |
Rotigotine Reference number: PA/PH/Exp. P4/T (23) 27 ANP Text number: 3014 |
P4 |
|
51 |
Salicylic acid Reference number: PA/PH/Exp. 10A/T (23) 6 ANP Text number: 0366 |
10A |
|
52 |
Sitagliptin phosphate monohydrate Reference number: PA/PH/Exp. P4/T (23) 28 ANP Text number: 2778 |
P4 |
|
53 |
Smallpox vaccine (live) Reference number: PA/PH/Exp. 15/T (23) 50 ANP Text number: 0164 |
15 |
|
54 |
Tapentadol hydrochloride Reference number: PA/PH/Exp. P4/T (23) 29 ANP Text number: 3035 |
P4 |
|
55 |
Tick-borne encephalitis vaccine (inactivated) Reference number: PA/PH/Exp. 15/T (23) 48 ANP Text number: 1375 |
15 |
|
56 |
Vaccines for veterinary use Reference number: PA/PH/Exp. 15V/T (23) 30 ANP Text number: 0062 |
15V |
|
57 |
Yellow fever vaccine (live) Reference number: PA/PH/Exp. 15/T (23) 49 ANP Text number: 0537 |
15 |