Labelling Exemptions and Foreign Language Packs in EU/EEA

Navigating pharmaceutical labelling requirement in the EU/EEA can be complex, but certain exemptions can provide flexibility for manufacturers while maintaining regulatory compliance. Join an insightful 30-minute webinar, “Labelling Exemptions and Foreign Language Packs in EU/EEA,” hosted by regulatory affairs expert Karina Jelkinaite.

Navigating the intricate landscape of labelling exemptions across different countries can be a daunting task. Understanding the nuances of each country’s regulations requires a level of expertise and experience. Learn about the key exemptions to EU/EEA labeling regulations, including orphan medicinal products, hospital-only medicines, emergency situations and supply shortages. Discover practical applications, case studies, and best practices to ensure compliance without compromising efficiency or patient safety. This webinar will provide valuable insights into how companies can ensure compliance without compromising patient safety or efficiency.

Join us on the 26th of February at 12:00 EET

Presenter: Karina Jelkinaitė is Regulatory Affairs Professional with 5 years of experience regulatory field. Her professional career includes working at regulatory affairs service providers, where she represented various Marketing Authorization Holders, offering strategic guidance and ensuring compliance from a regulatory affairs perspective. Karina specializes in navigating complex regulatory landscapes and ensuring compliance with EU/EAA regulations.

Agenda:

• Importance of Labelling in the EU
• Overview of Labeling Exemptions
• Country-Specific Case Studies
• Future Outlook
• Q&A Session

Date: 26 February at 12:00 EET

Language: English

Duration: up to 25 mins.

The webinar is free of charge, please register above to attend.