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GENERAL, ECTD & HUMAN MEDICINES FORMS

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
OF-HPA-06ASAHPRA PRE-SUBMISSION MEETING REQUEST FORM

2021 Aug

2docxDownloadformgeneral-ectd-human-medicines-guidelines
OF-PEM-PRE-01JBioequivalence Trial Information Form (BTIF),

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
OF-PEM-PRE-01HAdditional Strength Biowaiver Application Form,

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
OF-PEM-PRE-01IBiopharmaceutics Classification System (BCS) Based Biowaiver Application Form,

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
1.2.1Application For Registration Of A Medicine Module 1: Administrative Information Application Form,

2020 Feb

1Downloadapplication-forms formgeneral-ectd-human-medicines-guidelines