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The risk of falsified medicines entering the distribution chain is increasing worldwide. The European Union therefore set out a number of measures to prevent falsified medicinal products from entering the legal supply chain (DIRECTIVE 2011/62/EU). The DELEGATED REGULATION (EU) 2016/161 describes the additional technical details for the further design of safety features.
From 9 February 2019, only prescription medicines with the new safety features may be marketed. For this purpose, a European verification system (EMVS) was developed to check whether a medicine packaging has the correct safety features.
As the health and safety of patients is of greatest importance to the pharmaceutical industry, a comprehensive strategy at European level is needed.
This is why the European Medicines Verification Organisation (EMVO) was created as a joint initiative of EU stakeholders representing manufacturers (Medicines for Europe, EFPIA, EAEPC), wholesalers (GIRP) and community pharmacists (PGEU). In addition, almost every European country also has a national organisation. For Belgium, this is the Belgian Medicines Verification Organisation (BeMVO vzw)
BeMVO ensures a secure and reliable pharmaceutical supply chain in Belgium, supported by a robust National Medicines Verification System (NMVS).
In line with 28 other European countries, Belgium started implementing the Falsified Medicines Directive (FMD) on 9 February 2019.
This European Directive provides additional security for all (prescription and reimbursable) medicine packagings to ensure their authenticity, safety and quality.
On 9th February 2024, we switched to a full EU-FMD implementation in Belgium and Luxembourg.