Marketing Authorization of Medicines through WHO collaborative registration procedure

Since 2017, NMRA of Sri Lanka has been listed in the WHO/PQ website as a Drug Regulatory Authority participating in the collaborative registration procedure of the World Health Organization, which allows WHO pre-qualified medicines including vaccines to enter the Sri Lankan market through a fast-track and verification procedure.

The manufacturer should be an approved entity in Sri Lanka. If not, the manufacturer should find a suitable Sri Lankan pharmaceutical company as its authorized agent and apply through such authorized agent to be an approved manufacturer.

The manufacturer should indicate its intent of applying through the collaborative registration procedure to both NMRA and WHO and should give its consent for the WHO to share all relevant review reports, inspection reports and lab testing results etc. with the focal points of the NMRA.

NMRA once committed to accept an application for marketing authorization through the procedure, undertakes to give its decision on the relevant application within a timeline of 90 days, subjected to stop-clocks. NMRA agrees to treat any information provided by WHO/PQ team through its access-restricted website as confidential and proprietary to WHO/PQT, and to use such information only for the purpose, and to make no other use thereof.

The steps below are product specific and are triggered by the applicants / manufacturers through a submission of an application to register a prequalified in Sri Lanka.

1. Manufacturer/ Applicant: A manufacturer who is interested in marketing one of its pre-qualified products in Sri Lanka should submit an expression of interest via email to WHO by sending completed Appendix 2. The applicant also submits completed Appendix 3A to NMRA, Sri Lanka. (These appendices are formats given by WHO)
2. NMRA: Once the request from manufacturer is received, NMRA has the option to agree or decline to use the procedure for that specific product. The decision of the NMRA will be conveyed to the applicant as well as to WHO. If NMRA declines to use the procedure, reasons for such decision should be indicated.
3. Manufacturer/ Applicant: Once NMRA agrees to accept the application through the procedure, the complete dossier is submitted to NMRA through his authorized agent in Sri Lanka.
4. WHO: Proceeds to give focal points of the NMRA access to the specific folder with confidential information about that specific product (WHO prepared assessment reports and inspection reports).
5. NMRA: The focal points can download these reports and use them for review processes / decision making. The timeline for decision making is 90 days subjected to stop clocks.

NB: Once registration is granted; variations are also managed through WHO collaborative procedure.

Reference:https://extranet.who.int/prequal/content/collaborative-registration-faster-registration