Celebrating 10 years of innovative, global,
Regulatory solutions & services for Life Sciences industry

Orphan Medicines, Traditional Herbal Medicinal Products (Medicinal Products For Human Use)

As of the end of the transition period, an orphan designation holder currently located in the United Kingdom has to change the place of establishment to a Member State of the EU and submit the corresponding documentation through a change of name and/or address of the orphan designation holder procedure provided the legal entity remains the same.

Prevalence for orphan drug designation For applications for orphan designations or for its maintenance submitted as of the end of the transition period, patients in the United Kingdom should no longer be taken into account in the calculation of the prevalence of the disease in order to meet the requirements for orphan drug designation as set out in Regulations published.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en

Latest Resources

  • Blogs

    Brexit: The MHRA and The Proposed eSubmission Portal

    Read More
  • White Papers

    Impact of COIVD – 19 on FMCG Supply Chain Regulatory Compliance

    Read More
  • Case Studies

    Expedited Product Classification and NIOSH Certification for N95 Respirator

    Read More

What our Clients Say?

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Quick Inquiry
x