Notice to All Applicants of Medicine Registration
Analytical method of all drug products claimed inhouse specifications needs to be approved by the National Medicines Quality Assurance Laboratory (NMQAL).
- Following documents should be submitted to the NMQAL for the approval of analytical method
- Copy of the acknowledgement issued by the MRD after accepting the CTD of the drug product
- Declaration from the manufacturer to the effect that the same details which are included in the CTD submitted to the MRD are included
- Test methods of the finished product
- Validation reports of the test methods
- Label of the finished product
- Certificate of analysis of the finished product
- Details of all reference materials used in the test methods
- Complete formulation of the finished product
- Container closure details
- Local agent/local manufacturer contact details (must include the name of the responsible contact person/s, designation, address, phone number, email address)
- Send soft copies of all of above 1-10 documents in the pdf format to the email: nmqal@nmra.gov.lk
(Date: 18 January 2022)