CPHI may not be a specialised regulatory event, but almost every commercial decision made there has a regulatory consequence. Early regulatory involvement helps prevent compliance hurdles, additional costs and delayed market entry. We look forward to meeting you in Milan!...
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...
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...
Bulgaria is set to adopt the euro on 1 January 2026, marking a major shift in its monetary regime and one that carries important implications for pharmaceutical pricing and market dynamics. Although the domestic legislative transition appears relatively straightforward — with automatic conversion rules for local...
💶 Here’s what Marketing Authorisation Holders (MAHs) need to know about medicine prices Bulgaria is officially switching to the euro on 1 January 2026. As part of this change, the prices of all medicinal products will be aligned with the new currency, in accordance with the...
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,...
After the amendments to the Bulgarian regulation on pricing and reimbursement in December 2014, it became increasingly difficult to determine whether the government is regulating or merely registering OTC prices in Bulgaria. Under the Bulgarian Law on Medicinal Products in Human Medicine (the Drug Law), the...
Due to Brexit the European Medicines Agency (EMA) had to relocate from London to Amsterdam, which at the time created huge internal turbulences for the Agency starting with loss of staff and the additional workload to handle the Brexit. Many activities remained on hold as...