May 14, 2025 3:09 pm
Published by katja.pecjak@billeveast.webtim.dev
Billev Pharma East at the Slovenian Pharmaceutical Society Symposium showcased its commitment to regulatory excellence and innovation during the 50th anniversary congress in Portorož. From May 8–10, our team actively participated in discussions shaping the future of the pharmaceutical industry, highlighting key developments in compliance and digital transformation. Expert Presentation on Electronic Product Information (ePI)... View Article
May 6, 2025 2:06 pm
Published by katja.pecjak@billeveast.webtim.dev
Poorly structured files or missing information can delay certification, cause regulatory setbacks, or even prevent your device from entering the market. Many manufacturers underestimate how vital the medical device technical file requirements are – right from the early design phase to post-market surveillance. A well-organized technical file, starting with a detailed device description and specification,... View Article
April 28, 2025 9:06 am
Published by marjan@webtim.si
In April 2025, the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) released fourth version of the electronic bulletin. The PRAC Committee, at its monthly meetings and as part of its regular tasks covering all aspects of risk management in the use of medicines, reviewed the assessment of safety signals, risk management plans, regular... View Article
September 23, 2024 8:43 am
Published by marjan@webtim.si
As of September 1, 2024, the European Medicines Agency (EMA) has implemented a new guideline (EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.*) requiring all applicants for medicinal products, including generic medicines, to submit Environmental Risk Assessment (ERA) reports. The updated directive marks a significant shift in the regulatory landscape, reflecting the EMA’s commitment to minimizing the environmental impact... View Article
February 23, 2024 5:27 pm
Published by blaz@webtim.si
In order to combat critical medicines shortages The European Medicines Agency (EMA) together with the European Commission and the Heads of Medicines Agencies (HMA) recently published the first version of the “Union list of critical medicines“. The list identifies medicines for human use for which continuity of supply in the EU is a priority and... View Article