ISO 9001: 2015 CERTIFIED

PUBLIC ANNOUNCEMENT

28^th April, 2022

APPLICATIONS FOR RENEWAL OF MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS

1. The Authority has encountered a number of deficiencies in the applications for renewal of marketing authorization since the implementation of the new Guidelines on Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products, Revision 2 of January, 2021,
2. This notice aims to remind all Marketing Authorization Holders (MAH) to familiarize themselves with the guidelines and adhere to the prescribed requirements while preparing applications for renewal of the marketing authorization of human and veterinary medicinal products. Adherence to these guidelines will ensure that all relevant information is provided in registration dossiers and hence facilitate efficient and effective evaluation.
3. In order to avoid queries that result in unnecessary delays in the approval process, the Authority has prepared Questions & Answers document and a list of common deficiencies observed in the respective applications since the implementation of the new guidelines. please click here for the Questions & Answers document and a list of common deficiencies, .
4. We thank you for your continued cooperation.