Messages in brief
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…
Pharmaceutical specialties containing ketoprofen
Ketoprofen-containing proprietary medicinal products are approved for the local symptomatic therapy of pain conditions, mainly in the field of…
Standards for cytostatic drugs
The "Standards for the Preparation for Use, the Application and the Disposal of Cytostatic Drugs" are quality standards according to § 2 Z 12 of the…
Drug quality: potential for improving documentation
Based on recent follow-up requests from the Drug Quality and Regulatory Affairs National Procedures Divisions, a list of the most frequently submitted…
Electronic Submission Ordinance 2011
On May 3, 2011, the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications…
