The European Medicines Agency (EMA) has published a new document entitled “Frequently asked questions about parallel distribution” (EMA/297155/2021). The 30-page PDF file contains answers to the most common questions. It is divided into the following sections:
- General information
- Initial notification
- Parallel distribution notification check
- Post – Parallel distribution notice guidance
- Safety Updates / bulk changes / annual update
The document is clearly laid out and contains a number of internal references as well as links to Directives, Guidances and other references. The PDF is available on the EMA homepage under “Frequently asked questions about parallel disctribution“. The questions are also listed on the EMA Website.
Furthermore, the EMA has updated the following three documents on parallel distribution:
- “List of centrally authorised products requiring a notification of a change for update of annexes” (EMA/278602/2021)
- “Checklist for initial notifications for parallel distribution: guidance for industry” (EMA/267299/2020 Rev. 1)
- “Checklist for annual updates for parallel distribution: guidance for industry (EMA/405782/2020 Rev.1)
All documents are available on the EMA website in the section “Parallel distribution: Regulatory and procedural guidance“.