Guidelines

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TitleVersion (Issue) No. Date of ImplementationDocument Link
Guideline for Donation of Medicines and Related Products
119 May 2021
Guideline for Repackaging and Labelling of Medicines
310 July 2020
Guideline for Registration of Medicines
315 April 2020
Guidance for the Application in the Common Technical Document (CTD)215 April 2020
Guideline for Import and Export of Medicines and Related Products
310 July 2020
Guidance for Pre-shipment Inspection and Testing of Pharmaceutical Products Exported to The Gambia from India New 115 June 2023
Guideline for Registration of Herbal Medicinal Products
315 April 2020
Guideline for Inspections by the Medicines Control Agency
201 July 2020
Guideline for Storage and Distribution of Medicines and Related Products
201 July 2020
Guideline for Recall of Medicines and Related Products
201 July 2020
Guideline for Safe Disposal of Medicines and Related Products
201 July 2020
Guideline for Advertisement of Medicines and Related Products
225 June 2020
Guideline for Licensing as Importer of Medicines and Related Products
310 July 2020
Guideline for Licensing of Facilities Storing Medicines and Related Products
110 July 2020
Guideline for Reporting of Adverse Reactions to Medicines including Vaccines Updated210 December 2021
Guideline for Safety Monitoring of Medicines (Pharmacovigilance)
including Vaccines New
110 December 2021
Guideline for the National Pharmacovigilance System New110 December 2021
Guideline for Clinical Trials in humans
215 February 2021
Guideline for Emergency Use Authorisation New130 March 2022
Guideline for Reliance on decisions, reports, or
information from other national medicines
regulatory authorities (NMRAs) or regional and
international bodies New
124 January 2022
Annex I of the Guideline on Reliance: List of Reference
Institutions (RIs) New
124 January 2022
Annex II of Guideline on Reliance: Proposed
documentation for the abridged authorisation procedure
for reference institution (RI)-approved medicines New
124 January 2022
Guidance for Listing of Medicines and Related Products New 110 October 2023