Messages in brief
Information about prescription drugs
On Oct. 11, 2011, the European Commission published revised proposals to amend Regulation (EC) No. 726/2004 and to amend Directive 2001/83/EC. The…
Background: Pangea IV
The BMF, BMI, BMG and BASG participated in this year's action week. The operation took place this year from 20.09. to 29.09.2011. A total of 84…
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
