EMA publishes Q&A Document about Parallel Distribution

Recommendation

11/12 October 2022

The GDP Compliance Manager - Live Online Training

Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing authorisation holder. Centrally authorised products are marketed in all Member States under the same name and must comply with the Community Marketing Authorisation.

The task of the European Medicines Agency (EMA) is to check compliance of products distributed in parallel with the conditions laid down in Community legislation on medicinal products and in the marketing authorisation of the product.

Frequently Asked Questions about Parallel Distribution

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
• Fees

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.

Update of Further Guidance Documents

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".