WE ARE INTO SHARING
Regulatory Intelligence
Stay Up To Date
Latest regulatory changes
Mdeon, the Belgian ethical health platform, announces several novelties effective from January 1st, 2023.
Belgium Most important is the increase of hospitality that can be provided to healthcare professionals. The maximum amount for a lunch will be increased to 45€, for a dinner to 90€. A total maximum of 135€/day may be offered as hospitality to HCPs in the context of at...
Update on the pharmacovigilance system for Luxembourg
Luxembourg There has been an update on: New instructions for the preparation and submission of additional risk minimisation material (aRMM) for evaluation and approval in Luxembourg: update contact detail adverse event reportingupdate address to send the printed...
EMA recommends withdrawal of pholcodine medicines from EU market
Europe EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of...
Drug shortages
The Netherlands Drug shortages are an important issue since the COVID-19 pandemic. According to the Medicines Act, each Marketing Authorisation Holder (MAH) and Wholesaler must ensure that sufficient supply of each medicine is available. The interpretation of...
The FAMHP added a Q&A to their FAQ of Unmet Medical Need
Belgium Please note that the FAMHP added a Q&A to their FAQ of Unmet Medical Need. It concerns the provision of medicinal products for free (or at a reduced cost) to patients when a Medical Need Program is not in place or has ended. Is it possible to give a...
Update Commission Regulation regarding green tea extracts
Europe The Commission Regulation (EU) 2022/2340 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards green tea extracts containing (-)-epigallocatechin-3-gallate has been published on 30 November 2022. This...
New questions and answers from the EMA regarding Titanium Dioxide in Medicines
Europe A new questions and answers concerning titanium dioxide was published by the EMA. The Q&A, including five questions, gives guidance about the replacement or removal of titanium dioxide in medicines. Titanium dioxide (E 171) is commonly used in the...
Register your Industry Single Point of Contact (i-SPOC) on supply and availability
Europe All Marketing authorisation holders (MAHs) should register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’...
Update Commission Regulation regarding monacolins from red yeast rice
Europe The Commission Regulation (EU) 2022/860 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice has been published on 2nd June 2022. This Regulation entered into force on 22nd...
The FAMHP launches the Medicinal Product Management database
Belgium On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch of the new database, existing databases will temporarily not be updated. As from 22nd June data will be...
Want To Join
Our Current Open Vacancies
There are currently no open positions at IN2Pharma. But this may well change quickly at times, so we are always open to a spontaneous application.
Interested? Send your CV and job description to jobs@in2pharma.com
Stay Up To Date
In2Pharma News
Phone
+32 16 891 600
Location
Hof Ter Loonst
Terloonststraat 22
1910 Kampenhout
Belgium
info@in2pharma.com