gov lk

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)

Biosimilars_EU-guide_2017

Route of Administration

Guidelines for Handling and Storage of Vaccines in the Private Sector

Guideline for safe Disposal of Expired & Unwanted pharmaceuticals

Guideline on Import control

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

Application-for-WOR-medicine

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

 

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