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 28, 2023 | News
Belgium As from the start of 2023, a new system for funding market surveillance of medical devices by FAMHP applies. Unlike before, this will no longer be limited to the sale of medical devices to retailers and end users. All actors that carry out an activity...
by In2Pharma | Mar 24, 2023 | News
Luxembourg Division de la Pharmacie et des Médicaments de la Direction de la Santé has published updated instructions for the distribution of DHPC in Luxembourg (version 2.0 – 02/2023). A significant change in the updated version is the addition of the paragraph...
by In2Pharma | Mar 22, 2023 | News
Belgium The Royal Decree of April 7, 1995 on information and publicity of medicinal products for human use, describing which diplomas are eligible for recognition as RIP is being amended. The adaptation is made to follow the evolution in terminology of the relevant...
by In2Pharma | Mar 20, 2023 | News
Luxembourg On 20 January 2023, the Luxembourg authorities updated their document ‘Procedure for marketing authorisation applications in Luxembourg’, version 3.A new tab was created in the excel file with information regarding the Product information. The DPM of...
by In2Pharma | Mar 20, 2023 | News
Belgium The FAMHP would like to remind the pharmaceutical industry regarding the following topics: Pictograms related to the environment and recycling (e.g. green dot pictogram) do not comply with art.56§1 of the Royal Decree on medicines. The current guideline...
