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Information Products on Pharmaceuticals - Renouf Publishing Co. Ltd.

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oms-catalogue 15/07/03 11:34 Page 26<br />

LEGISLATION AND REGULATION<br />

Marketing Authorizati<strong>on</strong><br />

of Pharmaceutical <str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

with Special Reference<br />

to Multisource (Generic)<br />

<str<strong>on</strong>g>Products</str<strong>on</strong>g><br />

A Manual for a Drug<br />

Regulatory Authority<br />

26<br />

A detailed guide to the establishement<br />

of a system for the marketing<br />

authorizati<strong>on</strong> of multisource (generic)<br />

pharmaceutical products. Addressed<br />

to drug regulatory authorities, the<br />

guidelines are intended for use in<br />

countries that do not presently have<br />

a fully functi<strong>on</strong>al system of premarket<br />

evaluati<strong>on</strong> and market authorizati<strong>on</strong>,<br />

and want to establish such a system,<br />

giving priority to the assessment and<br />

authorizati<strong>on</strong> of generic drugs.<br />

Regulatory Support Series, No. 5<br />

1999, v + 213 pages [E]<br />

WHO/DMP/RGS/98.5<br />

Swiss francs 40.–/US $36.00<br />

In developing countries: Sw.fr. 28.–<br />

Order no. 1930169

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