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Price display of OTC medicines
Europe Following a question from a member state, the European Court has ruled that certain forms of price indications can incite irrational use, which is not allowed in public advertising of OTC medicines. They decided that the following situations incite irrational...
New fees for food supplement notifications
Belgium Due to the publication of the Royal decree about fees for raw materials and products (RD of 13 novembre 2011), the amount of the fees for notifications of food supplements has been modified. From May 21st 2023, the fee for a food supplement notification will...
Revision IML Code of Ethics
Luxembourg As previously announced, IML, the association of the innovative pharmaceutical industry in Luxembourg has revised and updated their Code of Ethics. The proposed amendments have been approved at the General Assembly held on 17 April 2023. The amounts of...
New guideline on the use of D-mannose in food supplements
Belgium The Mixed Committee of the FAMHP (which examines the 'grey zone' products) has issued a new guideline regarding the use of D-mannose in food supplements. Products with an amount of D-mannose higher than 750 mg/day can have a significant physiological effect....
Adjusted fees for applications to EMA
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...
MDR/IVDR Implementation – Amendment Transitional Provisions
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...
Medical devices – turnover declaration
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...
Update instructions for distribution of DHPC in Luxembourg
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...
Diploma for the Responsible Person for Information and Publicity (RIP)
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...
Update Procedure for MA applications in Luxembourg
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...
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