Covid-19 | Subscribe | FAQs

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
GLF-PEM-02ASubmission Form

2022 Oct

1docxDownloadformgeneral-ectd-human-medicines-guidelines