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