i-SPOC registration has been mandatory since September 2, 2022 and applies to all pharmaceutical companies with a centrally- or nationally-authorised human medicinal product in the EU.

Drug authorities around the world are reminding people of the importance of reporting suspected adverse drug reactions in a joint campaign called MedSafetyWeek.

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

For the new QRD templates Vers. 9 veterinary, which take into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6, updated accessible Word templates are available for download.

With the entry into force of the Regulation (EU) 2019/6 a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation.

The new EU Veterinary Medicinal Products Regulation, which entered into force on 27/01/2019, is applicable from 28/01/2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products shall be submitted to the competent authority of the Member State in which the clinical trial is to be conducted.

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2022/2023 (published 29 March 2022).

Clinical studies and the war in Ukraine - Information for Consumers.

Clinical studies and the war in Ukraine - Information for Healthcare Professionals.