parallel distribution Archives - European Industrial Pharmacists Group (EIPG)

The Pact for Research and Innovation in Europe


by Giuliana Miglierini The roadmap to support the implementation of the new vision of the European Research Area (ERA) made a concrete step forward on 16 July 2021, with the adoption by the European Commission of the proposal for a Read more

The opportunity for repurposing of oncology medicines


by Giuliana Miglierini Rare cancers, which account for approx. 22% of new cases in Europe, represent an area of low business interest for the pharmaceutical industry, due to the limited number of patients compared to the very high costs to Read more

A golden era for UK’s life sciences and a new Code of practice for its pharmaceutical industry


by Giuliana Miglierini Less than a year has gone since the Brexit, and the UK innovation landscape is experiencing a new, vivid era of expansion under the stimulus of a strong demand from global investors. According to recent data of Read more

EMA publishes Q&A Document about Parallel Distribution

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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.

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“.