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Structured Dialogue with the EU commission to prevent shortages
Europe An important piece of the new Pharmaceutical Strategy adopted in November 2020 by the von der Leyen Commission is represented by the structured dialogue with the actors of the pharmaceuticals manufacturing chain in order to better identify causes and drivers of...
Sartan Medicinal Products: EMA’s Assesment Report defines Nitrosamine Limits and Reporting Deadlines
Europe In a final assessment report, the EMA has published important information for marketing authorisation holders of angiotensin II receptor antagonists (sartans) regarding nitrosamine contamination limits and deadlines for risk mitigation measures. On 2 April...
Release of FarmaStatus 2.0 by FAMHP
Belgium FarmaStatus is the online application that collects information about the availability of medicines in Belgium. The application shows when medicines are temporarily unavailable, when the commercialization was temporarily or permanently stopped and when...
Updated policy on DHPCs
The Netherlands The Dutch Medicines Evaluation Board (MEB) published an update of the policy document (MEB 44) regarding Direct Healthcare Professional Communications (DHPCs). This policy presents a framework for the way in which the MEB deals with DHPCs and the...
Falsified medicines Directive – Clarification on decommissioning of medical samples, IMP products and MNP products
Belgium The question was raised by some of the members whether it is needed to decommission commercial packages during (re)-labelling to medical samples, Medical Need Program (MNP) products and Investigational Medicinal Products (IMP). After verification in the...
New reporting point for medication incidents in the Netherlands
The Netherlands As from 1 January 2021, there is a new national reporting point for healthcare professionals (i.e. doctors, pharmacists…) to report any kind of incidents with medication: from errors in the prescription up to the administration of medicines, including...
Publication of Guidance document for the Regulation on the mutual recognition of goods
Europe Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another Member State started to apply on 19 April 2020 and replaced Regulation (EC) No 764/2008. The aim of the Regulation is to strengthen the functioning of the single market by...
Modification Regulation as regards botanical species containing hydroxyanthracene derivatives
Europe Commission Regulation (EU) 2021/468 of 18 March 2021 amends Annex III to Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to food as regards botanical species containing hydroxyanthracene...
New Regulation amending Directive regarding vitamins and minerals and their use in food supplements
Europe Commission Regulation (EU) 2021/418 of 9 March 2021 amends Directive 2002/46/EC of the European Parliament and of the Council regarding nicotinamide riboside chloride and magnesium citrate malate used in the manufacture of food supplements and the units of...
MedTech Europe and EFPIA have joined forces
Europe On 1 January 2021, MedTech Europe and EFPIA have joined forces to ensure consistency and harmonization in the assessment of medical conferences’ compliance across the healthcare industry. Both compliance platforms, the Conference Vetting System and e4ethics,...
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