Blog
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We celebrated our 15th anniversary at the end of 2022! We started the company with the idea to tailor our services to the needs of the different types of companies we serve while taking into consideration the particularities of the local markets we operate in....

We are glad to announce that PharmDedict is now part of the family of the Digital Health and Innovations Cluster Bulgaria. The DHI Cluster is a non-profit organization that supports companies and organizations in the field of digital solutions and innovations in healthcare to build...

In order to achieve the most effective resolution of all regulatory matters, we have chosen to conduct business in a network of selected nationally based companies in almost all of the member states of the European Union plus Norway, Switzerland and Lichtenstein. We are proud to...

PharmDedict together with the law firm Kinstellar contributed to the first edition of the Bulgarian country report of the Pharma Legal Handbook, which answers essential questions about the legal and regulatory environment for pharmaceuticals in Bulgaria. Our authors provide answers in the fields of manufacturing,...

In July 2019, the National Agency for Medicines and Medical Devices (NAMMD) was reorganised and changed its name to National Agency for Medicines and Medical Devices of Romania (NAMMDR). This change needs to be considered in relation to the communication with the Agency and, more...

In the end of February 2019, the European Commission (EC) produced a letter concerning the withdrawal of the United Kingdom from the perspective of the EU rules for batch testing of medicinal products. The EC communication addressed the option that exemptions could be granted by...

After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed by Commission Delegated Regulation (EU) 2016/161) became applicable. The Bulgarian Drug Agency (BDA) and the Bulgarian Medicines Verification Organisation (BGMVO) published the first Guidelines for managing...

The Romanian Drug Agency (ANMDM) published on their website scientific decision No 4/24.10.2018 implementing the document of European Medicines Agency (EMA) on the defective product report (EMA/INS/GMP/35037/2017). Marketing authorisation holders (MAHs) have to report to ANMDM all the non-conformities related to the quality of medicinal...