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Fiscal importation of medicines from 3rd countries
Belgium The FAMHP again confirms and clarifies their interpretation of the rules set out in Annex 21 in the light of fiscal importation of medicines: “Fiscal importation” means the purchase/procurement 'on paper' of medicines that have not left the territory of the...
NARCOTIC/PSYCHOTROPIC LEGISLATION: important clarifications concerning the narcotic order forms
Belgium As previously announced, the FAMHP is actively working on an electronic system to replace the current system of paper narcotic order forms. From 1 July 2023 to 31 August 2023, there will be a transition period during which the new system will be available to...
Negative formulations no longer allowed on packaging of medicinal products for human use
Belgium Since 2019, negative formulations are no longer allowed on the packaging of medicinal products for human use in Belgium. This decision came after consultation at European level and in agreement with the other European Member States. The FAMHP will therefore...
Guidance for industry to prevent and mitigate medicine shortages
Europe EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact . Medicine shortages are a global health problem and are increasingly affecting European...
Publication guideline on BE/LU packages
Belgium/Luxembourg On Thursday 1st of June, the Luxembourg authority DPM published the "Guideline on BE/LU packages". This guideline assists applicants/MAH in creating or updating a common BE/LU pack and Product information (PI) for medicinal products for human use....
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...
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