EMA publishes new Q&A Document on Remote RP Activities

The European Medicines Agency (EMA) provides answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website, which have been compiled and agreed by the GMP/GDP Inspectors Working Group.

Now, a new PDF file on Remote RP activities in English language was published. The document was made available on 18 April 2024 in the subsection on GDP requirements.

The document was prepared against the background that a recurring observation made in GDP inspections was that certain RP activities are delegated to employees located outside of the EU/EEA.

According to the document, remote activities by the Responsible Person "could be allowed if accepted by the national competent authority where the authorised site is located", however "RP activities should take place within the EU/EEA (or Northern Ireland) in all cases". In other words, "any RP activities being carried out by a person localised and employed in a country outside of the union should not be accepted."

As there may be country specific rules, it is recommended that wholesalers should consult with their national competent authority in order to determine what requirements apply.

For further information, please see the complete PDF file.