Product Evaluation and Registration

To register your product, you will be required to submit a full product dossier for evaluation to determine whether the medicine is safe, of good quality and efficacious. The dossier is first submitted for screening together with the applicable fee. Our assessors will screen the dossier to determine whether all the appropriate sections of the dossier have been submitted. This is not a full assessment but checking for completeness of the submission. If there is outstanding information, communication will be sent and an updated dossier will be requested. After passing screening, applicants will be advised to pay application fees, submit samples of the product and an application form signed by the applicant. Please refer to our Service Standards for the timelines. After evaluation, you will receive a letter communicating any outstanding issues with a deadline to respond. Once all queries are addressed, the application is presented before the Registration Committee who will make a regulatory decision based on the provided quality, safety and efficacy data.