Form V: Declaration re: Patent List Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 471 KB).Form IV: Patent List - Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 466 KB).Drug Identification Number (DIN) Submission Certification for Human and Disinfectant Drugs (PDF fillable/saveable - 412 KB).Drug Establishment Licence Application Form (FRM-0033).Details for Payment of Invoice (formerly Details of Payment of a Drug Submission Invoice).Instructions for completing the Clinical Trial Site Information Form.Clinical Trial Site Information Form (Effective January 2, 2020) (PDF fillable/saveable - 233 KB).Certificate of Supplementary Protection (CSP) Application Form (Effective May 15, 2019 to March 31, 2020).Certificate of Supplementary Protection (CSP) Application Form (from September 22, 2018 to May 14, 2019).Certificate of Supplementary Protection (CSP) Application Form (from September 21, 2017 to September 21, 2018).Certificate of Supplementary Protection (CSP) Application Form (Effective April 1, 2020 to January 5, 2021).Certificate of Supplementary Protection (CSP) Application Form (Effective January 6, 2021).Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications.Adverse Drug Reaction Reporting Form for Drugs Used in Clinical Trials (this document is available in English only).Administrative Changes - Certification Form for Human and/or Disinfectant Drug Submissions and Applications (PDF fillable/saveable - 433 KB).Template authorizing unrestricted sharing of information.Serious adverse drug reaction reporting form for hospitals.
Medical Device Foreign Risk Notification.Sponsor Attestation: SNDS for Biosimilar Products - Addition of Indication to Product Monograph to be in line with the Innovator Product.
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