Bulgaria and the CESP system
Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. Durin...
PharmDedict offer regulatory affairs support services in Bulgaria and Romania for pharmaceutical products, herbal medicines, medical devices, food supplements and cosmetics. For pan-European projects we rely on our partnership with and support by competent regulatory consultancy companies within the EuDRAcon network which we joined in 2010.
Marketing authorisations. Our services include strategic regulatory planning according to client’s needs efficiently in pace with planned market launch. We provide full range of services related to pre- and post-submission issues, follow up and communication with healthcare authorities as follows:
– Regulatory submissions under national authorisation procedures;
– National phase completion for MRP/DCP;
– Post-marketing applications and marketing authorisation (MA) maintenance support – variations, renewals, MA transfers;
– Regulatory documentation assessment and upgrade;
– Compilation of quality, non-clinical and clinical overviews;
– Readability testing of package leaflets.
Advice and assistance with local authorisation/notification procedures: advertising and promotional materials, educational materials, direct healthcare professional communication (DHPC).
We can also provide local representation and assistance in relation to:
– Medical devices notifications;
– Food supplements notifications;
– Cosmetic products;
– Translation and adaptation of the local labelling and leaflet in compliance with the relevant requirements.
Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. Durin...
In July 2019, the National Agency for Medicines and Medical Devices (NAMMD) was reorganised and changed its name to National Agency for Medicines and ...
After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed ...
The Romanian Drug Agency (ANMDM) published on their website scientific decision No 4/24.10.2018 implementing the document of European Medicines Agency...