Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for Drug Regulatory Authorities - Regulatory Support Series No. 005
(1998; 213 pages)
Table of Contents
View the documentPREFACE
View the documentI. INTRODUCTION
Close this folderII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
View the documentA. Political will and commitment
View the documentB. Legislation
View the documentC. Accountability
View the documentD. Resources for the marketing authorization function
View the documentE. Fees and cost recovery
View the documentF. Inventory of existing products on the market
View the documentG. Rational selection of products
View the documentH. Special access schemes
View the documentI. Postmarketing activities
Open this folder and view contentsIII. OPERATING ACTIVITIES
Open this folder and view contentsIV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
View the documentV. ISSUE OF WRITTEN MARKETING AUTHORIZATION
View the documentVI. VARIATIONS
View the documentVII. PERIODIC REVIEWS
View the documentVIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
View the documentGLOSSARY
View the documentABBREVIATIONS
View the documentREFERENCES
Open this folder and view contentsANNEXES
 

H. Special access schemes

Legislation should allow access to unregistered drug products in special or emergency situations. In general, either the patient has a severe or life-threatening illness and existing therapy has failed, or the disease is a rare one for which specialist medicines do not have a local marketing authorization. In many cases the drugs are still experimental, or at any rate unproven, and the government is not obliged to fund their supply. Care is necessary in the administration of these schemes to avoid de facto marketing.

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Last updated: May 3, 2013