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Pharmeuropa 31.3 just released

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European Pharmacopoeia
Public enquiry
News
12 July 2019
Strasbourg, France

All new texts and texts having undergone technical revisions are published in Pharmeuropa for public consultation.

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. Thus changes to general texts might 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. would be too late to be considered. Users may then be in a position where their product is not compliant to the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product could no longer be released for and thus placed on the European market.

So don’t miss this opportunity to provide your comments. The drafts published in Pharmeuropa 31.3 are:

 

Drafts published in Pharmeuropa 31.3 (end of commenting period: 30.09.2019) 

  1. 2.9.4. Dissolution test for patches
    Reference number: PA/PH/Exp. 12/T (19) 12 ANP
    Text number: 20904
  1. 5.28. Multivariate statistical process control
    Reference number: PA/PH/Exp. VSADM/T (18) 6 ANP
    Text number: 52800
  1. Aripiprazole
    Reference number: PA/PH/Exp. 10C/T (18) 40 ANP
    Text number: 2617
  1. Baical skullcap root
    Reference number: PA/PH/Exp. TCM/T (19) 19 ANP
    Text number: 2438
  1. Benserazide hydrochloride
    Reference number: PA/PH/Exp. 10A/T (19) 53 ANP
    Text number: 1173
  1. Caspofungin acetate
    Reference number: PA/PH/Exp. 7/T (17) 7 ANP
    Text number: 3029
  1. Chenodeoxycholic acid
    Reference number: PA/PH/Exp. 11/T (19) 1 ANP
    Text number: 1189
  1. Chlorpromazine hydrochloride
    Reference number: PA/PH/Exp. 10A/T (19) 30 ANP
    Text number: 0475
  1. Codeine phosphate sesquihydrate
    Reference number: PA/PH/Exp. 11/T (19) 22 ANP
    Text number: 0075
  1. Cyproheptadine hydrochloride sesquihydrate
    Reference number: PA/PH/Exp. 10A/T (19) 85 ANP
    Text number: 0817
  1. Dapsone
    Reference number: PA/PH/Exp. 11/T (19) 20 ANP
    Text number: 0077
  1. Dihydrostreptomycin sulfate for veterinary use
    Reference number: PA/PH/Exp. 7/T (19) 24 ANP
    Text number: 0485
  1. Disopyramide
    Reference number: PA/PH/Exp. 10A/T (19) 10 ANP
    Text number: 1006
  1. Dosulepin hydrochloride
    Reference number: PA/PH/Exp. 10A/T (19) 23 ANP
    Text number: 1314
  1. Feverfew
    Reference number: PA/PH/Exp. 13B/T (19) 21 ANP
    Text number: 1516
  1. Florfenicol for veterinary use
    Reference number: PA/PH/Exp. 7/T (17) 3 ANP
    Text number: 2920
  1. Flucloxacillin sodium monohydrate
    Reference number: PA/PH/Exp. 7/T (13) 65 ANP
    Text number: 0668
  1. Forsythia fruit
    Reference number: PA/PH/Exp. TCM/T (14) 24 ANP
    Text number: 2720
  1. Gemcitabine hydrochloride
    Reference number: PA/PH/Exp. 11/T (19) 24 ANP
    Text number: 2306
  1. Intravesical preparations
    Reference number: PA/PH/Exp. 12/T (19) 14 ANP
    Text number: 2811
  1. Levomepromazine hydrochloride
    Reference number: PA/PH/Exp. 10A/T (19) 86 ANP
    Text number: 0505
  1. Levomepromazine maleate
    Reference number: PA/PH/Exp. 10A/T (18) 77 ANP
    Text number: 0925
  1. Lovastatin
    Reference number: PA/PH/Exp. 10A/T (19) 38 ANP
    Text number: 1538
  1. Norfloxacin
    Reference number: PA/PH/Exp. 10A/T (19) 29 ANP
    Text number: 1248
  1. Paroxetine hydrochloride hemihydrate
    Reference number: PA/PH/Exp. 10A/T (19) 88 ANP
    Text number: 2018
  1. Paroxetine hydrochloride
    Reference number: PA/PH/Exp. 10A/T (19) 87 ANP
    Text number: 2283
  1. Patches
    Reference number: PA/PH/Exp. 12/T (17) 8 ANP
    Text number: 1011
  1. Piracetam
    Reference number: PA/PH/Exp. 10B/T (18) 103 ANP
    Text number: 1733
  1. Plasters, medicated
    Reference number: PA/PH/Exp. 12/T (19) 13 ANP
    Text number: 3032
  1. Prednicarbate
    Reference number: PA/PH/Exp. 10B/T (19) 35 ANP
    Text number: 1467
  1. Preparations for inhalation
    Reference number: PA/PH/Exp. INH/T (18) 10 ANP
    Text number: 0671
  1. Promazine hydrochloride
    Reference number: PA/PH/Exp. 10A/T (19) 24 ANP
    Text number: 1365
  1. Promethazine hydrochloride
    Reference number: PA/PH/Exp. 10A/T (19) 25 ANP
    Text number: 0524
  1. Propyphenazone
    Reference number: PA/PH/Exp. 10A/T (19) 14 ANP
    Text number: 0636
  1. Sanguisorba root
    Reference number: PA/PH/Exp. TCM/T (19) 18 ANP
    Text number: 2385
  1. Semi-solid preparations for cutaneous application
    Reference number: PA/PH/Exp. 12/T (19) 15 ANP
    Text number: 0132
  1. Sodium aminosalicylate dihydrate
    Reference number: PA/PH/Exp. 10A/T (18) 75 ANP
    Text number: 1993
  1. Sodium cromoglicate
    Reference number: PA/PH/Exp. 10A/T (19) 8 ANP
    Text number: 0562
  1. Tigecycline
    Reference number: PA/PH/Exp. P4/T (19) 38 ANP
    Text number: 2825
  1. Xylazine hydrochloride for veterinary use
    Reference number: PA/PH/Exp. 10A/T (19) 26 ANP
    Text number: 1481
  1. myo-Inositol
    Reference number: PA/PH/Exp. CRB/T (19) 6 ANP
    Text number: 1805
 

 

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