Module 18 - Drug Device Combinations and Other Technologies

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CONTROL OF THE FINISHED PRODUCT

Government approval has to be sought before you can administer drugs/medicines to patients

• Prior to commencing clinical trials • Prior to commercial sales

A separate authorisation is needed for each product/variant

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INVESTIGATIONAL PRODUCT AUTHORISATIONS

 Known in the EU and UK as:

CTA Clinical Trial Authorisation

 Known in the USA as

IND Investigational New Drug

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