Messages in brief
Medical Literature Monitoring by the EMA
On May 12, 2015, the European Medicines Agency (EMA) announced that - in accordance with Article 27 of Regulation (EC) No. 726/2004 - starting on July…
Online mail order for over-the-counter medicines launched
Registration of mail order pharmacies starts
Situation in Austria
As of June 25, 2015, remote sales of over-the-counter pharmaceutical specialties approved in Austria will be made possible.…
EMA questionnaire for children on the use of medicines and clinical trials
Measures at EU level
The European Medicines Agency (EMA) would like to increase the acceptance of participation of children and adolescents in…
Warning against use of new hepatitis C drugs with amiodarone
The Federal Office informs about recommendations of the European Medicines Agency EMA regarding a restriction of the use of new hepatitis C drugs…
Results of review of generic approvals with respect to potentially falsified bioequivalence studies in India.
Measures at EU level
An inspection at the research service provider GVK Biosciences in Hyderabad (India) revealed serious deficiencies in the…
EU Commission releases "ellaOne" morning-after pill from prescription requirement
Measures at EU level The EU Commission has released the emergency contraceptive "ellaOne" (active ingredient: Ulipristal) from prescription-only…
Safety information for the use of isotretinoin
Isotretinoin is a highly effective vitamin A analogue that has been used since the early 1980s to treat severe, therapy-resistant forms of acne. When…
Review of generic approvals with regard to potentially falsified bioequivalence studies.
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious…
Falsified bioequivalence studies could lead to approval suspensions for individual generic drugs
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious…
