Messages in brief
EU Clinical Trials Registry
The World Health Organization (WHO) has recognized the EU Clinical Trials Register (CTR) as the primary registry for the International Clinical Trials…
Public Statement: Variation-Regulation
Commission Regulation (EC) No. 1234/2008 of Nov. 24, 2008, concerning the examination of variations to the terms of marketing authorizations for…
Electronic submission
Since 01.09.2011 the new harmonized validation criteria are in force.
From now on, the validation of dossiers includes the following criteria:
- P…
Xenical, Alli (Orlistat)
The preparations Xenical and Alli Vimpat (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for…
Improved QRD template for human medicines
The QRD (Quality Review of Documents) working group of the European Medicines Agency (EMA) published the new version of the QRD template for central…
Public comment: pharmacovigilance activities.
The proposals are intended to harmonize the pharmacovigilance system provided for in Regulation (EU) No. 1235/2010 and Directive 2010/84/EU.
To…
Information on the use of isotretinoin
Orally administered isotretinoin is highly teratogenic and strictly contraindicated in pregnancy. Reliable pregnancy prevention is therefore essential…
AGES PharmMed
Public comment: Fee regulation
On 05.08.2011, the Federal Office for Safety in Health Care sent a draft of the "Regulation of the Federal Office for Safety in Health Care amending…
Public comment: Medical Device Tax Ordinance 2011
On August 5, 2011, the Federal Office for Safety in Health Care sent a draft of the "Ordinance of the Federal Office for Safety in Health Care on the…
