Clinical trial processes exempt from a manufacturer’s authorisation
Article 61(5) of the Clinical Trial Regulation (EU Regulation 536/2014) allows certain processes for investigational medicines to be done without a manufacturer’s authorisation. The HPRA must keep a 'Register of Exemptions' for these processes.
The HPRA guide contains information about the processes that are exempt, and answers frequently asked questions about Article 61(5).
Guide to Registration of Processes under Article 61(5) of the Clinical Trial Regulation
PDF : 191 KB | 19/05/2025
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Sponsors must apply to be included in the Register by using the application form below.
Application for register for exemption DOCX : 69 KB | 19/05/2025