A brief overview of the wholesalers` obligations regarding verification and traceability according to EU FMD requirements.

What is a designated wholesaler?

A designated wholesaler is a company (sales affiliate/licensee/co-marketer and holder of a wholesale distribution authorization), designated through a license/agreement with the Marketing Authorization Holder (MAH) to place the product on the market.

According to DR 2016/161, Art. 33 (2) (h),

• the marketing authorization holder or,
• in case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier to comply with Article 47a of Directive 2001/83/EC, the person responsible for placing those medicinal products on the market

 is obliged to upload to the EMVS a list of ‘Designated Wholesalers’

What is the difference between NMVS and EMVS?

The European Medicines Verification System (EMVS) consists of a European Hub operated by the European Medicines Verification Organisation (EMVO) and 28 National Medicines Verification Systems operated by the National Medicines Verification Organizations (NMVOs)…