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 15, 2019 | News
Europe EMA launched a five-month pilot study to increase the correct submissions of initial marketing authorisations applications (MAAs). The pilot is a result of the 2016 EMA survey that showed validation issues occur in 90% of all initial applications. The pilot...
by In2Pharma | May 9, 2017 | News
MEB The Medicines Evaluation Board (MEB) introduced MEB 48, a new policy concerning the application of marketing authorizations for medicines that are identical to medicines already authorized. For this, a national informed consent marketing authorization application...
by In2Pharma | Apr 19, 2017 | News
FAMHP As described in a new Circular Letter (circular 634), FAMHP now accepts electronic submissions of advertising notifications and visum applications (for TV or radio spots) as well as information campaigns. Although it is not a requirement, FAMHP strongly...
