The European Commission Delegated Regulation (EU) 2016/161 specifies in Article 33 section 2, the information that must be uploaded in the repositories system by the marketing authorization holder (MAH) 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.

Following a Federal Agency for Medicines and Health Products (FAHMP) inspection of EMVO in the summer of 2023, it was spotted that the Product Master Data (PMD) uploaded by the On-Boarding Partners (OBPs) in the EU Hub has discrepancies for some medicinal products and data which must, as per the DR (EU) 2016/161, be uploaded to the EU Hub is not being uploaded consistently. EMVO performed a thorough investigation and gap-analysis of the requirements aiming to spot the irregularities in the data upload.

Consequently, some 2 additional fields shall be made mandatory which will further strengthen the EU Hub and ensure the consistency and completeness of the data uploaded.