EU Focus Archives - Page 2 of 2 - European Industrial Pharmacists Group (EIPG)

Approval of the Data Governance Act, and EMA’s consultation on the protection of personal data in the CTIS


by Giuliana Miglierini The Data Governance Act (DGA) was approved and adopted in May 2022 by the European Council, following the positive position of the EU Parliament; the new legislation will entry into force after being signed by the presidents Read more

The transition towards EMA's new Digital Application Dataset Integration (DADI) user interface


by Giuliana Miglierini The Digital Application Dataset Integration (DADI) network project is aimed to replace the current PDF-based electronic applications forms (eAFs) used for regulatory submissions with new web-forms accessible through the DADI user interface. The European Medicines Agency (EMA) has Read more

IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics


by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into force on 26 May 2022. The new rules define a completely renewed framework for the development, validation and use of these important 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“.