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The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

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EMA publishes Q&A Document about Parallel Distribution

July 9, 2021 , ,

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“.