Key points:

• Regulation (EU) 2019/6, which became applicable on 28 January 2022, brought in some major changes to our regulatory processes. For example, the introduction of the Union product database (UPD) substantially altered how processes are handled for both applicants and regulators. Major challenges had to be addressed, such as the resolution of data quality issues in the UPD
• Another major challenge is the obligation to update the packaging and labelling of all existing products to comply with Regulation 2019/6 within a five-year period ending in January 2027

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