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TitleVersion No.Implementation DateCategoryDocument Link (PDF)Document Link (Other Format)
Application Form for Marketing Authorisation (Registration) of Medicines Updated520 January 2025Product Registration
Related Product Registration Application Form 119 April 2021Product Registration
Model Cover Letter New120 January 2025Product Registration
Application Form for Renewal of Authorisation of Medicine New116 January 2025Product Registration
Model application Cover Letter for the Renewal of Marketing Authorisation of Medicine New116 January 2025Product Registration
Content of the Annual Product Quality Review Report New116 January 2025Product Registration
Application Form for Variation New130 January 2025Variation
Application Form For Licensing as Importer of Medicines and Related Products 310 July 2020Licensing
Application Form for Licensing of Storage Facilities for Medicines and Related Products110 July 2020Licensing
Application Form for Application for License for Repackaging of Medicines 210 July 2020Licensing
Application Form for Advertisement120 June 2020 Advertising
Clearance Permit Form for Donations 119 May 2021Donations
Checklist for Medicines and Related Products Donations119 May 2021Donations
Import Clearance Permit Form519 April 2021Importation
Medicines and Related Products Listing Form New314 November 2024ImportationN/A
Medical Devices Listing Form New314 November 2024ImportationN/A
Application Form for Import/ Export of
Controlled Medicines 		111 May 2022Importation/Exportation
Export Permit Form For Medicines and Related Products 210 July 2020Exportation
Recall Information Form201 July 2020Recall
Recall Report Form201 July 2020Recall
Reporting Form for Suspected Adverse Drug Reactions210 December 2021Pharmacovigilance
Adverse Event Following Immunization Reporting Form110 December 2021Pharmacovigilance
Clinical Trial Application Form 130 October 2020Clinical Trials
Declaration and Workload of Principal Investigator Form 130 October 2020Clinical Trials
Curriculum Vitae For Key Personnel Conducting Clinical Trials Form130 October 2020Clinical Trials
Declaration of Sufficient Funds Form130 October 2020Clinical Trials
Import Application Form 130 October 2020Clinical Trials
Clinical Trial Progress Report Form Updated226 February 2025Clinical Trials
Clinical Trial Amendment Form 228 April 2021Clinical Trials
Serious Adverse Event (SAE) Report Form 130 October 2020Clinical Trials
Final Clinical Trial Report Form 130 October 2020Clinical Trials
Declaration of Investigator Form130 October 2020Clinical Trials
Non-Interventional Study Application Form 130 October 2020Clinical Trials
Non-Interventional Study Report Form 130 October 2020Clinical Trials
Sponsor Indemnification For Sites and Investigators130 October 2020Clinical Trials
Notification of the End of a Clinical Trial New126 February 2025Clinical Trials
Request for Consideration for an EUA (Annex I)130 March 2022EUA
Annex 1 of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics: Pre-Submission Meeting Request Form New		131 January 2025EUA
Annex 5a of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics: Healthcare Provider or Authorised Dispenser Information Template New		131 January 2025EUA
Annex 5b of the Guideline for Emergency Use Authorisation of Medicines
including Vaccines and In-vitro Diagnostics: Recipients Information Template New		131 January 2025EUA
Manufacturer’s request for reference institution’s (RI) permission for sharing
RI-owned non- public information with MCA (Annex III)		124 January 2022Reliance
Quality Information Summary Of The Finished Pharmaceutical Product Approved By The Reference Institution (RI) (QIS-RI-FPP(crp)) (Annex IV a) 124 January 2022Reliance
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by a Reference Institution (RI) (QIS-RI-BTP) (Annex IV b) 124 January 2022Reliance