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14 Oct Template of Standardised Content of Letter of Access

Posted at 16:55h in

Letter of access for SAHPRA, in reference to APIMF record [APIMF number, if allocated]...

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20 Sep Residue Overall Summary (ROS)

Posted at 17:57h in

Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species.

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01 Sep Veterinary Clinical Trial Application Template

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Download Version 2

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01 Apr Conformity of assessment body DoC template

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2022 Mar...

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01 Feb Validation template CM

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Download Version 2 (6.18)

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01 Feb Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form

Posted at 10:23h in

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Version 3 - 6.39

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01 Feb Additional Strength Biowaiver Application Form

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Version 3 - 6.38

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01 Feb Verified review template

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Download Version 2 (6.34)

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01 Feb Abridged review template

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Download Version 2 (6.33)

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01 Feb Bioequivalence Trial Information Form (BTIF)

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Version 3 - 6.32

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