Volume 9 of "The rules governing medicinal products in the European Union" contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
For citizens
For companies
For medical specialists
Information for companies
In relation to the release of new EudraVigilance functionalities we would like to inform you that as of 22.11.2017 are valid the following electronic reporting rules:
- MAHs need to submit electronically to EVPM information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the MAH concerned gained knowledge of the event.
- MAHs need to submit electronically to EVPM information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the MAH concerned gained knowledge of the event.
- MAHs need to use the EVWEB functionalities to gain access and download ICSR reports reported by NCA to the EVPM.
After 22.11.2017 there will be no changes to the reporting of SUSARs during clinical trials until the application of the Clinical Trial Regulation. Sponsors of clinical trials should follow the current SUSAR reporting principles set out in the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (2011/C 172/01).
More information on the following link:
Contact details:
Responsible person for EudraVigilance at the BDA:
Violeta Getova, MScPharm
Pharmacovigilance and Clinical Trials Department
+359 2 89034 91
This email address is being protected from spambots. You need JavaScript enabled to view it.
For the documentation provided through the Common European Submission Portal (CESP) – applications for all types of Marketing authorisation; applications for all types of Renewal; applications for all types of Variations and Notifications under Article 61(3) with the only exception - application for Transfer of Marketing authorisation:
- when the documentation is submitted through CESP, it is not necessary to submit it on CD/DVD;
- when the documents for which an original signature is required (cover letter, application form, QP declaration) are signed with a qualified electronic signature - their submission in paper is not necessary.
The submission of Product Information (Summary of Product Characteristics, Patient Leaflet, Labelling and mock-ups), in two copies printed on one side for all procedures that require it, remains mandatory.
Announcements for companies Article Count: 2
Marketing authorisation of medicinal products Article Count: 2
Medical devices Article Count: 5
Pharmacovigilance / «Companies» Article Count: 1
Clinical trials Article Count: 4
Control of the medicinal products Article Count: 1
Announcements - Medical devices Article Count: 4
Information for companies, Medical devices
