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
Open this folder and view contentsII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
Close this folderIII. OPERATING ACTIVITIES
View the documentA. Transparency
View the documentB. Policies
View the documentC. Administrative procedures
View the documentD. Guidelines for applicants
View the documentE. Model application form
View the documentF. Communication among departments within the DRA
View the documentG. Relationship of evaluators with GMP inspectors
View the documentH. Relationship of evaluators with the quality control laboratories
View the documentI. Functional relationship of the evaluators with the expert advisory body
View the documentJ. Relationship of evaluators with the pharmaceutical industry and confidentiality of data
View the documentK. Meetings with applicants
View the documentL. Procedures for appeals
View the documentM. Collaboration with other DRAs
View the documentN. Collaboration with WHO
View the documentO. Use of external experts as evaluators
View the documentP. Timeframes for processing of applications
View the documentQ. Publication of marketing authorization decisions
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
 

L. Procedures for appeals

Appeal procedures should be laid down in the legislation (see Annex 1) and administrative details should be described in the DRA’s guidelines for applicants (see above).

Informal appeal mechanisms can also be made available and described in policy guidelines. These are often effective and they avoid the need for legal processes, which are costly and time-consuming for all parties. In their simplest form, the DRA may wish to encourage applicants to telephone and discuss decisions with the decision-maker. If necessary and useful, a meeting can be set up as described above. In appropriate cases, and where available, professional mediation may avoid the need for legal action.

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Last updated: January 19, 2012