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ADDITIONAL STRENGTH BIOWAIVER APPLICATION FORM1 – For Comments

Comments to be send to PEMPre-reg@sahpra.org.za

Copy: Mabatane.Mahlatji@sahpra.org.za

Closing date : 12 October 2020

BIOEQUIVALENCE TRIAL INFORMATION FORM1 – For Comments

Comments to be send to PEMPre-reg@sahpra.org.za

Copy: Mabatane.Mahlatji@sahpra.org.za

Closing date : 12 October 2020

BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER APPLICATION FORM1 – For Comments

Comments to be send to PEMPre-reg@sahpra.org.za

Copy: Mabatane.Mahlatji@sahpra.org.za

Closing date : 12 October 2020

SUMMARY OF CRITICAL REGULATORY ELEMENTS (SCoRE) DOCUMENT – For Comments

Comments to be send to PEMPre-reg@sahpra.org.za

Copy: Mabatane.Mahlatji@sahpra.org.za

Closing date : 12 October 2020