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reference medicinal product - TOPRA

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How to Get the Best Out of Your Procedures<br />

» Planning well in advance,<br />

» Understand data required and the legal basis of your application<br />

» Remember specific national requirements<br />

» CMDh guidance on issues such PSRPH and barriers to<br />

withdrawal have resolved many issues – read and observe<br />

them!<br />

» Keep updated on individual HA performance and issues.<br />

» Timings quoted are rarely adhered to - prepare contingency options<br />

» Quality dossiers will minimise delays<br />

55

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