Pharmacovigilance
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28 Sep

Posted at 08:56h in Pharmacovigilance

Supplier qualification, ongoing oversight and quality management of subcontractors have always been integral parts of an effective pharmacovigilance (PV) system. In the context of the recent legislative development (Implementing Regulation (EU) 2025/1466) the importance of the contractual clarity with service providers was reinforced and marketing...

19 Mar

Posted at 10:50h in Pharmacovigilance

The interpretation of day 0 in local literature screening historically encountered challenges, particularly regarding hard copy journals. In January 2023 European Medicines Agency (EMA) posted an interesting view of the Pharmacovigilance Inspectors Working Group regarding Day 0 in the context of Individual Case Safety Reports...

18 Oct

Posted at 14:49h in Pharmacovigilance

The Announcement of the EMA Management Board earlier in May 2017 confirmed the full functionality of the EudraVigilance database. Hence, the transitional period in pharmacovigilance reporting in the EEA is about to expire. The simplified electronic reporting of suspected adverse reactions related to medicines by...

01 Dec

Posted at 17:11h in Pharmacovigilance

Following the developments of the pharmacovigilance legislations at EU level Bulgaria imposed the requirement for the appointment by the marketing authorisation holders (MAHs) of a local contact person for pharmacovigilance issues (LPPV) for medicinal products for human use. The national legislation does not contain detailed requirements...

22 Feb

Posted at 18:59h in Pharmacovigilance

With the Bulgarian Drug Law amendments published on 21-Dec-2012 a new obligation was imposed concerning all marketing authorisation holders (MAHs) in Bulgaria. Based on article 104, paragraph 4 of Directive 2001/83/EC as amended by Directive 2010/84/EU, Bulgaria has opted to implement obligation for the MAHs...