Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs Testing Institutions Article 9

The accreditation certificate has a validity period of three years. An application for extension, when necessary, shall be filed between six and eight months preceding the date of expiration. The maximum period of an extension is three years.The provisions of Articles 4 to 6 shall apply mutatis mutandis to the document, information and procedures required for accreditation period extension application. The documents and information specified in all sections thereof, except for those listed in Paragraph 2 of Article 4, need not be included in the application provided that there is no change in the content since the previous application for accreditation or extension.If the application for extension filed during the period as specified in Paragraph 1 does not receive a decision of approval or dismissal from the central competent health authority within the original accreditation validity period, the validity of the original accreditation is extended to the date of the decision.