Module 5 Presentations

18/07/2024

Manufacture and Importation:

• The act of bringing an IMP from outside the EU/EEA is considered to be importation. • Third Country any country outside the EU/EEA that does not hold an operational MRA • “QP responsible for ensuring IMP from outside the EU is manufactured and checked in accordance with EU GMP or equivalent and PSF and Clinical Trial Application” (2001/20/EC) • “Importer shall ensure IMPs imported from a third country have been manufactured to standards at least equivalent to EU GMP” (2003/94/EC) • “When IMPs are imported from third countries, analytical control shall not be mandatory” (2003/94/EC)

The Organisation for Professionals in Regulatory Affairs

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Manufacture and Importation:

• “IMPs from a country that have an MRA (Mutual Recognition Agreement) have equivalent standards of GMP concluded between the community and that country” (Annex 13) • MRA countries = Japan, Australia, New Zealand, Switzerland, Canada, Israel • MRA with US with regards to mutual recognition of Inspections is operation with 8 Member States • Relevant to the product in question! E.g. MRA with Japan does not include IMPs!

The Organisation for Professionals in Regulatory Affairs

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