reference medicinal product - TOPRA
reference medicinal product - TOPRA
reference medicinal product - TOPRA
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DCP – National Phase<br />
» Can be initiated at Days 105, 120, 150, 210 or 275 depending<br />
on when consensus is reached<br />
» Individual MSs should grant national licences upon receipt of<br />
high quality national translations of SmPC, labelling and PIL<br />
» Highly variable between MSs: 30 days to 1 year +<br />
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