Regulation for the Issuance and Management of Western Pharmaceuticals Distribution Licenses and Certificates Article 4

When the western pharmaceuticals distribution license is expiring and needs to extend the expiration date, the pharmaceutical firms shall submit the application to the central competent health authority after filling out an application form, submitting the photocopy of pharmaceutical firm business permit license and the basic information of the pharmaceutical firm, and pay the application fee 6 months before the expiration date; after passing the inspection conducted by the central competent health authority, the expiration date may be extended. The extension period may be approved for 3 to 5 years according to the type of the western pharmaceuticals, operation items, the preceding Paragraph and inspection record indicated in the Paragraph 1 of Article 71 of the Act.