Information Products on Pharmaceuticals - Renouf Publishing Co. Ltd.
Information Products on Pharmaceuticals - Renouf Publishing Co. Ltd.
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