This is to inform all Marketing Authorization Holders and Importers of Medicines that the National Medicines Regulatory Authority (NMRA) will restart the procedure of including the Maximum Retail Price (MRP) on import licenses and the submission of pricing information for import license renewals. This procedure is in line with the provisions of the NMRA Act and relevant regulations.
Accordingly, the approved MRP will be included in import licenses at the time of renewal for all import licenses expiring on or after 1st of November 2025. Therefore, all import license renewal applications for licenses expiring on or after 1st of November 2025 must be submitted ten (10)weeks prior to the license expiry date.
Applicants are required to commence document submission immediately, from today on wards, to ensure timely processing of renewal applications for licenses expiring on or after 1st of November 2025.
In addition, the NMRA Pricing Division will send an email request for price details as part of this process. Marketing Authorization Holders and importers are requested to respond and submit the price details in the standard pricing format within two weeks to ensure timely processing.
Failure to comply with the specified timeline may result in delays in license renewal and potential disruption to product availability.
We urge all import license holders to strictly adhere to the above requirements and ensure the timely submission of all necessary documentation.
CEO
National Medicines Regulatory Authority(NMRA)