Forms
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| Title | Version No. | Implementation Date | Category | Document Link (PDF) | Document Link (Other Format) |
|---|---|---|---|---|---|
| Medicines Registration Application Form | 4 | 19 April 2021 | Product Registration |  | |
| Herbal Medicines Registration Application Form | 3 | 19 April 2021 | Product Registration | | |
| Medicines Variation Registration Application Form | 3 | 19 April 2021 | Product Registration | | |
| Related Product Registration Application Form | 1 | 19 April 2021 | Product Registration | | |
| Application Form For Licensing as Importer of Medicines and Related Products | 3 | 10 July 2020 | Licensing | | |
| Application Form for Licensing of Storage Facilities for Medicines and Related Products | 1 | 10 July 2020 | Licensing | | |
| Application Form for Application for License for Repackaging of Medicines | 2 | 10 July 2020 | Licensing | | |
| Application Form for Advertisement | 1 | 20 June 2020 | Advertising | | |
| Clearance Permit Form for Donations | 1 | 19 May 2021 | Donations | | |
| Checklist for Medicines and Related Products Donations | 1 | 19 May 2021 | Donations | | |
| Import Clearance Permit Form | 5 | 19 April 2021 | Importation | | |
Medicines and Related Products Listing Form New | 3 | 14 November 2024 | Importation | N/A | |
Medical Devices Listing Form New | 3 | 14 November 2024 | Importation | N/A | |
| Application Form for Import/ Export of Controlled Medicines | 1 | 11 May 2022 | Importation/Exportation | | |
| Export Permit Form For Medicines and Related Products | 2 | 10 July 2020 | Exportation | | |
| Recall Information Form | 2 | 01 July 2020 | Recall | | |
| Recall Report Form | 2 | 01 July 2020 | Recall | | |
| Reporting Form for Suspected Adverse Drug Reactions | 2 | 10 December 2021 | Pharmacovigilance | | |
| Adverse Event Following Immunization Reporting Form | 1 | 10 December 2021 | Pharmacovigilance | | |
| Clinical Trial Application Form | 1 | 30 October 2020 | Clinical Trials | | |
| Declaration and Workload of Principal Investigator Form | 1 | 30 October 2020 | Clinical Trials | | |
| Curriculum Vitae For Key Personnel Conducting Clinical Trials Form | 1 | 30 October 2020 | Clinical Trials | | |
| Declaration of Sufficient Funds Form | 1 | 30 October 2020 | Clinical Trials | | |
| Import Application Form | 1 | 30 October 2020 | Clinical Trials | | |
| Clinical Trial Progress Report Form | 1 | 30 October 2020 | Clinical Trials | | |
| Clinical Trial Amendment Form | 2 | 28 April 2021 | Clinical Trials | | |
| Serious Adverse Event (SAE) Report Form | 1 | 30 October 2020 | Clinical Trials | | |
| Final Clinical Trial Report Form | 1 | 30 October 2020 | Clinical Trials | | |
| Declaration of Investigator Form | 1 | 30 October 2020 | Clinical Trials | | |
| Non-Interventional Study Application Form | 1 | 30 October 2020 | Clinical Trials | | |
| Non-Interventional Study Report Form | 1 | 30 October 2020 | Clinical Trials | | |
| Sponsor Indemnification For Sites and Investigators | 1 | 30 October 2020 | Clinical Trials | | |
| Request for Consideration for an EUA (Annex I) | 1 | 30 March 2022 | EUA | | |
| Manufacturer’s request for reference institution’s (RI) permission for sharing RI-owned non- public information with MCA (Annex III) | 1 | 24 January 2022 | Reliance | | |
| Quality Information Summary Of The Finished Pharmaceutical Product Approved By The Reference Institution (RI) (QIS-RI-FPP(crp)) (Annex IV a) | 1 | 24 January 2022 | Reliance | | |
| Quality Information Summary (QIS) of the Biotherapeutic Product Approved by a Reference Institution (RI) (QIS-RI-BTP) (Annex IV b) | 1 | 24 January 2022 | Reliance | | |