Medicines Regulatory Division
Guidelines for Handling and Storage of Vaccines in the Private Sector
Guidelines on Evaluation of Similar Bio therapeutic Products (SBPs)
Application for license to import medicine as sample {Schedule XI-Regulation 59(1)}
Application for license to Import medicines
Information required for registration of a drug (Schedule IV form A)
Guideline on Registration of Medicines
Guidelines on Evaluation of Similar Bio therapeutic Products (SBPs)
Guidelines for Handling and Storage of Vaccines in the Private Sector
Guideline for safe Disposal of Expired & Unwanted pharmaceuticals
Guideline on Advertising of Medicines & Medicinal Products to General Public
Guideline on submitting registration sample to NMQAL
Guideline on Labaling of Medicines
Guideline on Variations for Medicines
Guideline on Post Marketing Surveillance
Guideline on Registration of Vaccines
Guideline on Importing Medicines for Personal Use
Schedule-I---Application-for-certificate-of-registration
Schedule-V--Application-for-licence-to-manufacture-a-registered-medicine
Schedule-VII--Application-for-renewal-of-a-licence-to-manufacture-a-registered-medicine
Schedule-VIII----Application-to-import-a-registered-medicine
Schedule-X---Application-for-renewal-of-licence-of-a-licensed-importer-of-medicines
Schedule-XI---Application-for-licence-to-import-samples
Schedule-XXI---Application-for-a-licence-to-transport-therapeutic-goods-for-distribution
Medical Device
Application for import a device as a sample (Form C Schedule IV)
Information required for registration of a device (Schedule I, Form A)
Application form for Waiver of Registration of a Medical device
Guidelines for registration of Medical Devices
Guidelines for registration of Medical Devices
Guideline for safe Disposal of Expired & Unwanted pharmaceuticals
Guideline on submitting registration sample to NMQAL
Borderline Products
Application for a License to Import a Limited Quantity of any Borderline Product
Guidelines on product categorization reference details vitamins and elements
Guideline for safe Disposal of Expired & Unwanted pharmaceuticals
Cosmetics
Information for registration of a cosmetic (Schedule I form A)
Guidelines for registration of cosmetics in Sri lanka
Clinical Trials Regulatory Division
Ethics Review Committee Guidelines - FERCSL
Guidelines for the Conduct of Clinical Trials in Sri Lanka
Guideline for Good Clinical Practice- ICH
Clinical Trial Regulations of National Medicines Regulatory Authority Act No 5 of 2015- EN
Pharmacies Regulatory Division
Guideline on Good Pharmacy Practice
Guideline on Good Distribution Practice
Guideline for Good Storage Practices for Pharmaceuticals
Guidelines for Community Pharmacy Practice
Annex 01 - Retail New Application form XV
Annex 02 - Retail Renewal Application form XVII
Annex 03 - Wholesale New Application form XVIII
Annex 04 - Wholesale Renewal Application form XX
Annex 06 - Retail_Renewal_WithoutChanges
Annex_07 - Retail_Renewal_WithChanges
Annex_09 _Wholesale_Renewal_WithoutChanges
Annex_10_Wholesale_WithChanges
Declaration form Responsible Pharmacist
Manufacturing Regulatory Division
Guideline on Approval of an Overseas Manufacturing Plant of Medicines
Guideline on Preparation of Site Master Files
Guideline on Good Manufacturing Practice
Guideline for preparation and conduct of the GMP inspection
Pharmacovigilance Regulatory Division
Guideline on Pharmacovigilance
Guideline on Recall of Medicines, Medical Devices & Borderline products
Guideline on Rapid Alert System
Education and publication Regulatory Division
Guideline on Education & Training for staff of NMRA
Fees Table Effective from 01/05/2024 to 31/05/2024
NMRA Monthly fee for Medicines - Effective from 01/05/2024 to 31/05/2024
NMRA Monthly fee for Medical Device - Effective from 01/05/2024 to 31/05/2024
NMRA Monthly fee for Bordrline - Effective from 01/05/2024 to 31/05/2024
NMRA Monthly fee for Pharmacy - Effective from 01/05/2024 to 31/05/2024
NMRA Monthly fee for Cosmetic - Effective from 01/01/2024
Others
Application for Advertising of Medicines, Medical devices and Borderline products [ 111 KB ]
General Guideline on Complaints
General Guideline for the Waivers of Registration (WOR)
General Guideline on Transfer of Market Authorization Holder
Requirment for site master file
Letter of decleration for all types of application
Post-Marketing-Surveillance- Plan
Schedule XXI _APPLICATION_FOR_LICENCE_TO_TRANSPORT_THERAPEUTIC_GOODS_FOR_DISTRIBUTION
Directive_of_official_languages_commission