Electronic Product Information (ePI) refers to the authorised, statutory product information for a medicine (i.e., the Summary of Product Characteristics, Package Leaflet and Labelling) in a semi-structured format. Unlike a simple PDF, ePI uses the HL7 FHIR (Fast Healthcare Interoperability Resources) international standard. This technical...
The digital transformation of the European pharmaceutical regulatory landscape is accelerating. For healthcare professionals, the slow transition from paper-based leaflets to a structured digital format is one of the significant shifts in how we manage and communicate medicine information. In March 2026, the European Medicines...
Reflections from BADI’s 15th Anniversary The 15th anniversary of the Bulgarian Association for Drug Information (BADI) was more than a celebration of history. It was a forward-looking discussion about the future of regulatory affairs, the pharmaceutical industry and market access in Europe. Bringing together regulators, experts...
PharmDedict proudly represents Bulgaria & Romania in the EuDRAcon family - the European Drug Regulatory Affairs Consultants Network. EuDRAcon covers 30+ countries, including all EU member states, Norway, Switzerland, and Liechtenstein. Every member is selected based on proven regulatory expertise, reliability, and responsiveness. Founded in 2007,...
In the dynamic world of pharmaceuticals, regulatory affairs (RA) play a critical role in ensuring that products meet all necessary legal and safety requirements before reaching the market. However, with the complexity of regulations and the ever-changing global landscape, RA departments are facing increasing challenges....
On May 20, 2024 the Romanian Drug Agency posted an announcement about the necessity to amend the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) regarding the waste management of unused and/or expired medicines from the population, as follows: Annex 1 (PIL) to...
Have you ever struggled with the local adaptation and approval/notification of promo materials for medicinal products? If yes, then you know it could be challenging and you might be interested to see our successful experience with promotional materials in Bulgaria. The legal provisions that contain guidelines...
Regulatory Intelligence, as a systematic approach, includes the processes of regularly and proactively collecting regulatory information and analysing the latest updates that impact the operations of an organization. Regulatory Intelligence helps companies cope with the dynamics in regulations, accommodate changes, and ensure compliance. On February 23,...
A Transfer of Marketing Authorisation (MA) is the formal process for medicinal products through which the MA shifts from the current approved Marketing Authorisation Holder (MAH) to a new MAH, which is a distinct legal entity. This transfer may be prompted by a strategic decision...
In the fast-paced world and dynamic environment of a Pharma Company where critical business processes demand constant attention, the Regulatory Affairs (RA) Managers often find themselves facing a dilemma, especially in the holidays season, but not only...