Module 5 Presentations

18/07/2024

Manufacture and Importation

The Organisation for Professionals in Regulatory Affairs

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Manufacture and Importation:

• Article 13 of 2001/20/EC states that:

• Manufacturer/importer must hold manufacturing authorisation MIA(IMP) - Exception for assembly only by hospital/ health centre • QP at disposal “permanently and continuously” • QP certifies each batch of product manufactured or imported including comparator • Manufacture to meet the requirements of 2003/94/EC • Comparators from a third country whereby a statement cannot be obtained concerning the GMP of manufacture must undergo all relevant analysis, tests or checks necessary to confirm its quality.

The Organisation for Professionals in Regulatory Affairs

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