Amendment to FDA Memorandum Circular (FMC) No. 2013-004 by Providing for the Accreditation of Lawyers as Legal Representatives and Qualified Person in Industry (Food, Drug, Cosmetic and Device) Regulatory Affairs (QPIRA) and Imposing Sanctions to QPIRAs f

Amendment to FDA Memorandum Circular (FMC) No. 2013-004 by Providing for the Accreditation of Lawyers as Legal Representatives and Qualified Person in Industry (Food, Drug, Cosmetic and Device) Regulatory Affairs (QPIRA) and Imposing Sanctions to QPIRAs for Violation of Part IV of FMC No. 2013-004 and other Similar Violations

I. BACKGROUND/RATIONALE

on 4 February 2013, FDA Memorandum Circular No. 2013-004 was issued to provide the guidelines for the registration / Training-Accreditation of liaison officers and regulatory affairs to be considered as Qualified Person in Industry (Food, Drug, Cosmetics and Device) Regulatory Affairs (QPIRA). Said circular was issued pursuant to Book I Article II section 2(n) of the Implementing Rules and Regulations of Republic Act No. 9711, granting the FDA the power to develop and issue policies, standards, regulations and guidelines that would cover establishment, facilities and health products.

 

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