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GENERAL, ECTD & HUMAN MEDICINES FORMS

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-PEM-02LSameness Declaration Form for Reliance-based Models20/08/20241, , Downloadformgeneral-ectd-human-medicines-guidelines hpa pem
GLF-HPA-06BCTD Checklist23/07/20241Downloadformgeneral-ectd-human-medicines-guidelines
GLF-HPA-06AZ-Code Request Form23/07/20241Downloadformgeneral-ectd-human-medicines-guidelines
GLF-PEM-02ELetter of Access for Reliance26/05/20231, , Downloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
GLF-PEM-02ASubmission Form Template01/07/20242Downloadformgeneral-ectd-human-medicines-guidelines
GLF-BAU-HPA-07AMedicines Application Form Module 1.2.1, 18/05/20237Downloadapplication-forms formgeneral-ectd-human-medicines-guidelines
OF-PEM-PRE-01IBiopharmaceutics Classification System (BCS) Based Biowaiver Application Form12/08/20224, , Downloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-PEM-PRE-01HAdditional Strength Biowaiver Application Form18/08/20224, , Downloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-PEM-PRE-01JBioequivalence Trial Information Form (BTIF)19/08/20224, , Downloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-HPA-06ASAHPRA Pre-Submission Meeting Request Form05/08/20212, Downloadformgeneral-ectd-human-medicines-guidelines hpa