Messages in brief
Project start VAC2VAC
VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing) is a research and development project in which new, innovative tests for…
PSUR submissions exclusively via central platform
Changed account data (BIC change)
Please note the changed BIC for transfers to the accounts of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht. (The…
PSUR repository mandatory in force as of June 13
Due to legal requirements (Reg. (EC) 726/2004, Article 25a), EMA is obliged to set up a database for periodic safety update reports (PSUR) and the…
Pyrrolizidine alkaloids in medicinal products
Recently, pyrrolizidine alkaloids have also been detected in herbal preparations made from plants that do not biosynthesize pyrrolizidine alkaloids.…
Christa Wirthumer-Hoche elected Chairwoman of the EMA Management Board
At the European Medicines Agency (EMA) Management Board meeting in London on March 17, 2016, Christa Wirthumer-Hoche was elected Chair of the EMA…
Electronic application form (eAF)
HPV vaccination - no causal relationship with CRPS and POTS.
A re-examination of the safety and efficacy of human papillomavirus vaccines (HPV vaccines) has been completed. After evaluation of the current data…
Use of codeine no longer indicated in children with cough under 12 years of age
The Federal Agency informs about recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC, BASG initial notification…
Technical malfunction in the electronic transmission of adverse event reports
Dear registration holder,due to a technical malfunction in the period
from 20.09.2015 (15h) until 28.09.2015 (12h)
an electronic transmission of…
