by In2Pharma | Oct 6, 2020 | News
Europe The CMDh has agreed on an update of the Best Practice Guide (BPG) on multilingual packaging (MLP), in order to improve availability of medicines in smaller markets. The update includes a pilot exercise to explore whether it is feasible to implement a...
by In2Pharma | Oct 6, 2020 | News
Europe Following the announcement of the CMDh decision to stop the pilot on splitting of MRP/DCPs in the CMDh press release of June 2019, the CMDh has agreed on a further update of the related guidance document to clarify in which exceptional cases the CMDh will...
by In2Pharma | Jul 6, 2020 | News
Europe The CMDh recently published a revised version of the Q&A paper regarding variations. With the revision of the document a new question 1.9 has been introduced: “How do I notify an update of the contact details of the qualified person for...
by In2Pharma | May 23, 2018 | News
FAMHP Following the amendment to Article 65quater of the Royal Decree of 14 December 2006, the procedure for approval of risk minimisation activities (RMA) has been adapted. This article was amended to adapt the deadlines for the evaluation and approval of RMAs....
by In2Pharma | May 22, 2018 | News
EU Due to Brexit, there is a higher number of files for changes in Reference Member State (RMS). That is why CMDh (Coordination Group for Mutual Recognition and Decentralized Procedures, Human) developed a new template allowing this to run more efficiently. This...
