Pharmeuropa 33.1 released: don’t miss this opportunity to provide your comments
All new texts of the European Pharmacopoeia and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.1 is 31 March 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 European Pharmacopoeia 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 28 drafts published in Pharmeuropa 33.1 are:
Drafts published in Pharmeuropa 33.1
(end of commenting period: 31 March 2021)
2.6.39. Microbiological examination of human tissues
Reference number: PA/PH/Exp. CTP/T (20) 16 ANP
Text number: 20639
2.9.2. Disintegration test for solid rectal and vaginal dosage forms
Reference number: PA/PH/Exp. 12/T (20) 53 ANP
Text number: 20902
2.9.5. Uniformity of mass of single-dose preparations
Reference number: PA/PH/Exp. 12/T (20) 56 ANP
Text number: 20905
Adrenaline
Reference number: PA/PH/Exp. 10A/T (20) 103 ANP
Text number: 2303
Amiodarone hydrochloride
Reference number: PA/PH/Exp. 11/T (20) 40 ANP
Text number: 0803
Bupivacaine
Reference number: PA/PH/Exp. 10A/T (18) 89 ANP
Text number: 2761
Calcium chloride hexahydrate
Reference number: PA/PH/Exp. 9/T (20) 72 ANP
Text number: 0707
Cetyl palmitate
Reference number: PA/PH/Exp. 13H/T (20) 25 ANP
Text number: 1906
Cholecalciferol concentrate (powder form)
Reference number: PA/PH/Exp. VIT/T (20) 8 ANP
Text number: 0574
Ciprofloxacin hydrochloride hydrate
Reference number: PA/PH/Exp. 10B/T (20) 67 ANP
Text number: 0888
Clostridium botulinum vaccine for veterinary use
Reference number: PA/PH/Exp. 15V/T (20) 13 ANP
Text number: 0360
Enoxolone
Reference number: PA/PH/Exp. 11/T (20) 44 ANP
Text number: 1511
Ferrum metallicum for homoeopathic preparations
Reference number: PA/PH/Exp. HOM/T (20) 3 ANP
Text number: 2026
Fish oil, rich in omega-3 acids
Reference number: PA/PH/Exp. 13H/T (20) 58 ANP
Text number: 1912
Follitropin
Reference number: PA/PH/Exp. 6/T (20) 46 ANP
Text number: 2285
Follitropin concentrated solution
Reference number: PA/PH/Exp. 6/T (20) 47 ANP
Text number: 2286
Gallium (68Ga) chloride (accelerator-produced) solution for radiolabelling
Reference number: PA/PH/Exp. 14/T (20) 14 ANP
Text number: 3109
Halofantrine hydrochloride
Reference number: PA/PH/Exp. 10B/T (20) 66 ANP
Text number: 1979
Levomepromazine hydrochloride
Reference number: PA/PH/Exp. 10A/T (20) 52 ANP
Text number: 0505
Magnesium chloride 4.5-hydrate
Reference number: PA/PH/Exp. 9/T (20) 73 ANP
Text number: 1341
Mycoplasma gallisepticum vaccine (live) for chickens
Reference number: PA/PH/Exp. 15V/T (18) 104 ANP
Text number: 3133
Oxytocin
Reference number: PA/PH/Exp. 6/T (19) 13 ANP
Text number: 0780
Quinine hydrochloride dihydrate
Reference number: PA/PH/Exp. 11/T (20) 48 ANP
Text number: 0018
Shepherd’s purse
Reference number: PA/PH/Exp. 13B/T (19) 53 ANP
Text number: 2947
Simvastatin
Reference number: PA/PH/Exp. 10A/T (20) 104 ANP
Text number: 1563
Thioridazine hydrochloride
Reference number: PA/PH/Exp. 10B/T (20) 65 ANP
Text number: 0586
Toadflax herb
Reference number: PA/PH/Exp. 13B/T (20) 14 ANP
Text number: 2962
Vaginal preparations
Reference number: PA/PH/Exp. 12/T (15) 35 ANP
Text number: 1164
