Guidelines
Home / Guidelines
| Title | Version (Issue) No. | Date of Implementation | Document Link |
|---|---|---|---|
| Guideline for Donation of Medicines and Related Products | 1 | 19 May 2021 |  |
| Guideline for Repackaging and Labelling of Medicines | 3 | 10 July 2020 | |
| Guideline for Marketing Authorisation (Registration) of Medicines Updated | 4 | 20 January 2025 | |
| Guideline for Renewal of Marketing Authorisation (Registration) of Medicines New | 1 | 16 January 2025 | |
| Guidance for the Application in the Common Technical Document (CTD) Updated | 3 | 20 January 2025 | |
| Guideline for Variations New | 1 | 30 January 2025 | |
| Annex 1 of the Guideline for Variation: Administrative changes and Changes to a CEP or to a confirmation of API-prequalification document New | 1 | 30 January 2025 | |
| Annex 2 of the Guideline for Variation: Quality Changes, Active Pharmaceutical Ingredient New | 1 | 30 January 2025 | |
| Annex 3 of the Guideline for Variation: Quality Changes, Finished Pharmaceutical Product (FPP) or drug product New | 1 | 30 January 2025 | |
| Annex 4 of the Guideline for Variation: Safety and Efficacy Changes New | 1 | 30 January 2025 | |
| Guideline for Investigation of Bioequivalence New | 1 | 20 January 2025 | |
| Guideline for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products New | 1 | 20 January 2025 | |
| Guideline for Excipients in the Dossier for Application for Marketing Authorisation of Medicines New | 1 | 20 January 2025 | |
| Guideline for Impurities in New Active Pharmaceutical Ingredient New | 1 | 20 January 2025 | |
| Guideline for Impurities in New Finished Pharmaceutical Products New | 1 | 20 January 2025 | |
| Guideline for Import and Export of Medicines and Related Products | 3 | 10 July 2020 | |
| Guidance for Pre-shipment Inspection and Testing of Pharmaceutical Products Exported to The Gambia from India | 1 | 15 June 2023 | |
| Guideline for Inspections by the Medicines Control Agency | 2 | 01 July 2020 | |
| Guideline for Storage and Distribution of Medicines and Related Products | 2 | 01 July 2020 | |
| Guideline for Recall of Medicines and Related Products | 2 | 01 July 2020 | |
| Guideline for Safe Disposal of Medicines and Related Products | 2 | 01 July 2020 | |
| Guideline for Advertisement of Medicines and Related Products | 2 | 25 June 2020 | |
| Guideline for Licensing as Importer of Medicines and Related Products | 3 | 10 July 2020 | |
| Guideline for Licensing of Facilities Storing Medicines and Related Products | 1 | 10 July 2020 | |
| Guideline for Reporting of Adverse Reactions to Medicines including Vaccines | 2 | 10 December 2021 | |
| Guideline for Safety Monitoring of Medicines (Pharmacovigilance) including Vaccines | 1 | 10 December 2021 | |
| Guideline for the National Pharmacovigilance System | 1 | 10 December 2021 | |
| Guideline for Clinical Trials in humans Updated | 4 | 26 February 2025 | |
| Guideline for Emergency Use Authorisation of Medi-cines including Vaccines and In-vitro Diagnostics Updated | 2 | 28 January 2025 | |
| Annex 1 of the Guideline for Emergency Use Authorisation of Medicines including Vaccines and In-vitro Diagnostics: Format of Submissions New | 1 | 28 January 2025 | |
| Annex 3 of the Guideline for Emergency Use Authorisation of Medicines including Vaccines and In-vitro Diagnostics:Details on Required Information for Submission New | 1 | 28 January 2025 | |
| Annex 3a of the Guideline for Emergency Use Authorisation of Medicines including Vaccines and In-vitro Diagnostics: Recommended Safety Data New | 1 | 28 January 2025 | |
| Annex 3b of the Guideline for Emergency Use Authorisation of Medicines including Vaccines and In-vitro Diagnostics:Recommended Effectiveness Data New | 1 | 28 January 2025 | |
| Annex 3c of the Guideline for Emergency Use Authorisation of Medicines including Vaccines and In-vitro Diagnostics: Discussion of Risks and Benefits New | 1 | 28 January 2025 | |
| Annex 4 of the Guideline for Emergency Use Authorisation of Medicines including Vaccines and In-vitro Diagnostics: Conditions of Authorisation New | 1 | 28 January 2025 | |
| Guideline for Reliance on decisions, reports, or information from other national medicines regulatory authorities (NMRAs) or regional and international bodies | 1 | 24 January 2022 | |
| Annex I of the Guideline on Reliance: List of Reference Institutions (RIs) | 1 | 24 January 2022 | |
| Annex II of Guideline on Reliance: Proposed documentation for the abridged authorisation procedure for reference institution (RI)-approved medicines | 1 | 24 January 2022 | |
| Guidance for Listing of Medicines and Related Products | 1 | 10 October 2023 | |