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...
The interpretation of day 0 in local literature screening historically encountered challenges, particularly regarding hard copy journals. In January 2023 European Medicines Agency (EMA) posted an interesting view of the Pharmacovigilance Inspectors Working Group regarding Day 0 in the context of Individual Case Safety Reports...
Vagabond Magazine*: The General Manager of PharmDedict knows the ins and outs of drug regulations Drugs in the pharmacies have gone a long way before reaching us and improving our health. To a significant extent, this is thanks to the work of companies such as PharmDedict....
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...
At PharmDedict, we firmly believe in nurturing our team's talents to achieve excellence. We understand that our people are critical to our success, and that's why we're committed to finding, engaging, and growing the best talent. With a strong focus on local expertise, we recognize...
The Bulgarian Drug Agency (BDA) officially joined the PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme as its 55th Participating Authority, effective from July 1, 2023. PIC/S is a non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of...
We are pleased to announce that, in order to facilitate the growth of our team, we have relocated our business to a new location. With easy access from the airport and a nearby Metro station, as well as a much larger parking lot available to...