Medicines Regulatory Division
- Guideline on Variations for Medicines Rev no.02
- Guideline for safe disposal of expired & unwanted pharmaceuticals (Rev.No1)
- Guideline on recall of medicines, medical devices, & borderline products (Rev.No.1)
- Guideline on import control of pharmaceutical products & raw materials (Rev.No1)
- Guideline on procedure for expedited Marketing Authorization for Emergency use permission, registration/licensing of COVID 19 vaccines in Sri Lanka
- Guideline on Registration of Medicines
- Guidelines on Evaluation of Similar Bio therapeutic Products (SBPs)
- Biosimilars_EU-guide_2017
- Route of Administration
- Guidelines for Handling and Storage of Vaccines in the Private Sector
- Guideline on Advertising of Medicines & Medicinal Products to General Public
- Guideline on submitting registration sample to NMQAL
- Guideline on Labeling of Medicines
- Guideline on Post Marketing Surveillance
- Guideline on Registration of Vaccines
- Guideline on Importing Medicines for Personal Use
Medical Devices Regulatory Division
- Guideline for safe disposal of expired & unwanted pharmaceuticals (Rev.No.1)
- Guideline on import control of pharmaceutical products & raw materials (Rev.No.1)
- Guidelines for registration of Medical Devices
- Guideline on submitting registration sample to NMQAL
Borderline Products Regulatory Division
- Guideline on Amino acid requirements
- Guideline on import control of pharmaceutical products & raw materials (Rev.No.1)
- Guideline for safe disposal of expired & unwanted pharmaceuticals (Rev.No.1)
- Approved iodine guideline
- Reference details for element- Iodine
- Guidelines on product categorization reference details vitamins and elements
- Guideline on submitting registration sample to NMQAL
Cosmetics Regulatory Division
- Guidelines for registration of cosmetics in Sri Lanka
- Guideline on Non routine processing of clinical trial applications and conduct of clinical trial during Emergency situations
- Guideline on safety reporting requirements for clinical trials
- Guideline for the Management of Investigational Medicinal Products
- Guideline on Good Clinical Practice inspection
- Guideline for amendments (changes) to clinical trials
- Guidelines for the recognition of Ethics Review Committee
- Ethics Review Committee Guidelines - FERCSL
- Guidelines for the Conduct of Clinical Trials in Sri LankaGuideline for Good Clinical Practice- ICH
- Clinical trial guideline version 5- final
- Guideline on Pharmacovigilance
- Guideline on Recall of Medicines, Medical Devices & Borderline products
- Guideline on Rapid Alert System
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Guideline on complaints related to the NMRA activities & products regulated under NMRA Act
- Guideline on Transfer of Market Authorization Holder
- Guidelines for the recognition of Ethics Review Committees
- Guideline on Good Distribution Practice
- Guideline for Good Storage Practices for Pharmaceuticals