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

1. Copy of the acknowledgement issued by the MRD after accepting the CTD of the drug product
2. Declaration from the manufacturer to the effect that the same details which are included in the CTD submitted to the MRD are included
3. Test methods of the finished product
4. Validation reports of the test methods
5. Label of the finished product
6. Certificate of analysis of the finished product
7. Details of all reference materials used in the test methods
8. Complete formulation of the finished product
9. Container closure details
10. 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)