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Compatibility studies - Medicinal Product and Medical Device

#1
A Company wants to authorise their medicinal product in Europe. The Medicinal Product is contained in cartridges and will be administered with an already CE Marked specific re-usable pen (medical device, MD), not a pre-filled pen injector.

According to EMA draft quality guideline from 2019, the compatibility between the drug product and the MD should be assessed on bases of chemical and physical stability (i.e. stability, precipitation and sorption).

I would like to ask you how compatibility will be demonstrated in this case where the medicinal product is not in direct contact with the MD. Compatibility between the medicinal product and the cartridges (primary packaging) has been already conducted

Thus, should an in-use stability study performed with the drug product and the MD be enough to demonstrate compatibility? Or shall the applicant perform other studies to show compatibility between the drug product and the MD?

Thank you in advanced.
 
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