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


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