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.
PROFESSIONAL USERS
MARKETING AUTHORISATION HODLERS
SOFTWARESUPPLIERS
NMVS ALERTS
On 9th February 2024, we switched to a full EU-FMD implementation in Belgium and Luxembourg.
