EMA: Remote Activities of the Responsible Person (GDP)
The GMP/GDP Inspectors Working Group has amended their FAQs on GDP. Two new questions deal with the possibility and conditions for remote activities of the resposible person (RP) for GDP.
It is a recurring observation in GDP inspections that certain RP activities are delegated to employees outside the EU/EEA, particularly post-Brexit.
Remote activities could be allowed if accepted by the national competent authority where the authorised site is located. Wholesalers and RPs should ensure compliance with local requirements by consulting their national competent authority.
The Q&A clearly states that remote RP activities must occur within the EU/EEA (or Northern Ireland).
Source:
EMA: Guidance on good manufacturing practice and good distribution practice: Questions and answers: Remote RP Activities
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