by In2Pharma | Jun 27, 2023 | News
Europe EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact . Medicine shortages are a global health problem and are increasingly affecting European...
by In2Pharma | Jun 6, 2023 | News
Europe Following a question from a member state, the European Court has ruled that certain forms of price indications can incite irrational use, which is not allowed in public advertising of OTC medicines. They decided that the following situations incite irrational...
by In2Pharma | Apr 3, 2023 | News
Europe Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2022 inflation rate was 10.4%. The adjusted fees for all...
by In2Pharma | Mar 29, 2023 | News
Europe Due to lack of Notified Body (NB) capacity, lack of access to NB for SMEs, supply chain disruptions (Covid-19, Ukraine war,…),…the MDR implementation is creating bottlenecks in product certification. A new regulation ((EU) 2023/607) has been published, amending...
by In2Pharma | Mar 3, 2023 | News
Europe In January 2023 EMA published a new Q&A with a clarification of Day 0 in the context of local literature review when it concerns physical copies of journals. Marketing authorisation holders (MAH) must review and assess reports of suspected adverse...
