reference medicinal product - TOPRA
reference medicinal product - TOPRA
reference medicinal product - TOPRA
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Reference Medicinal Product<br />
» A <strong>reference</strong> <strong>medicinal</strong> <strong>product</strong> is a <strong>medicinal</strong> <strong>product</strong>, which has<br />
been granted a marketing authorisation by a Member State or by<br />
the Commission on the basis of a complete dossier, i.e. with the<br />
submission of quality, pre-clinical and clinical data in accordance<br />
with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, as<br />
amended<br />
» Withdrawal of the <strong>reference</strong> <strong>product</strong> from the market or<br />
withdrawal of the authorisation based on other reasons than<br />
safety issues will not prevent the competent authority from<br />
granting an MA for a generic <strong>product</strong>.<br />
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