Article 8
A contract manufacturer shall be a medicinal product factory in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.
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Article 12
An entity that conforms with any of the following descriptions may accept a contract for analysis of drug (medicinal) products:
1. A medicinal product factory that is in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.
2. A domestic or foreign academic research institute that meets the requirements of good laboratory practices for non-clinical laboratory studies.
3. An analysis institution or laboratory that meets the certification requirements under Article 104-4 of the Act.
4. Other entity approved on an ad-hoc basis by the competent central health authority.
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