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Fees for regulatory activities related to human drugs (pharmaceutical and biological) are charged as per the Fees in Respect of …
The guidance is intended to advise both internal and external stakeholders regarding the filing requirements for post market changes and …
This guidance document provides information on the regulatory requirements for when: a drug is not sold for 12 or more …
Drug Identification Numbers for Schedule C Drugs.
General COVID-19 flexibilities for all disinfectant application/submission pathways.
Steps to select the applicable fee category, the proper application stream and the pathways used to seek an authorization for …
This document provides information on the application process and application contents for a disinfectant drug product regulated under the Food …
Types of products eligible in receiving a Drug Identification Number (DIN).
Existing processes and guidance for manufacturers and sponsors applying for a Drug Identification Number (DIN) for hand sanitizers.
This policy describes the requirements relating to the assignment of Drug Identification Numbers (DINs) for drug products sold in kits …