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Chapter 4 Procedure for the Outsourcing of Accreditation Work
Article 19
The central competent health authority intending to outsource the accreditation work to a related body (institution), (hereafter referred as independent provider) pursuant to the provisions of Paragraph 2 of Article 104-4 of the Pharmaceutical Affairs Act shall process assignment through an open selection process.
Article 20
The independent provider shall meet the following requirements:
1. Possession of the experiences required for the accreditation of testing institutions and the necessary documents supporting said eligibility.
2. Employment of personnel meeting the following qualifications:
(1) Graduates from the undergraduate or graduate program of a local college or university, or a foreign college or university and the academic records of which are recognized in accordance with the Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education, with a major in food science, nutrition, biomedical engineering, medicine, chemistry, biology, life science, or other related disciplines, and with verified capabilities and experience performing inspection functions of inspection bodies;
(2) Having completed studies of at least 15 academic credits of legal subjects involving civil law, criminal law, and administrative laws and regulations in a domestic university, with a transcript of records reflecting said credits.
3. Fulfillment of all other requirements announced by the central competent health authority.