q & a Archives - European Industrial Pharmacists Group (EIPG)

Trends in Drug delivery and Formulation


by Giuliana Miglierini According to the 2021 Global Drug Delivery & Formulation Report, signed by Kurt Sedo, Vice President Operations, PharmaCircle LLC and published in a three-part series on Drug Development & Delivery, the Covid-19 pandemic seems to have had Read more

The new European Innovation Agenda


by Giuliana Miglierini A new piece of legislation adds to the framework supporting the new paradigms set forth by the European Commission: the European Innovation Agenda (EIA) aims to position the EU as a global leading player in innovation, especially Read more

ICMRA, two pilot programmes to optimise regulatory assessment and inspections


by Giuliana Miglierini New flexible modalities for the management of regulatory procedures are becoming progressively accepted even for routine activities, upon the experience built during the pandemic. Efforts are ongoing at the global level in order to better harmonise the 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“.