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Latest 20 Posts
- How to use the defective product report to notify a quality defect to the Romanian Drug Agency
- Bulgarian Drug Agency: reduced timelines for manufacturing authorisations and wholesale distribution licenses
- Bulgaria changes the structure of its ethics committees in clinical trials
- BDA: new requirements for the “proof of payment” document
- The Bulgarian Drug Agency initiates PIC/S membership procedure
- BDA: Guidance on the implementation of safety features in Bulgaria
- 10 Years Anniversary
- PharmDedict on Pharma Boardroom
- EudraVigilance Go-Live: expecting 22 November 2017
- The first MRP with RMS Bulgaria is now on track
- Single central submission now mandatory for all periodic safety update reports.
- The first DCP with RMS Bulgaria is now completed
- Bulgaria: the new reimbursement status maintenance procedure – have you scheduled your applications yet? *
- Type IA variations not required any more for administrative changes to EU QPPV and PSMF
- The next level upgrade of the Bulgarian reimbursement system
- Mandatory use of electronic application forms
- Regulating the OTC pricing?
- The role of the local contact for pharmacovigilance issues
- Bulgaria: first steps to e-submissions
- Romanian Drug Agency have now joined the CESP system for e-submissions