Applications for a license extension shall be filed within six months prior to the expiration date.
If an application is not filed before the deadline set forth in the preceding paragraph, the applicant shall reapply for registration. However, if the applicant reapplies for registration within six months after the expiration of the original license, he/she may submit an original copy of the application form for registration and proceed in accordance with Article 109-1.
If an application for a license extension also involves post-approval changes, then a separate application shall be submitted.

The following documents and data are required for the applications set forth in Paragraph 1 of the preceding article:
1. Application form for a drug license extension, otherwise which shall be applied by the drug license holder on the circumstances of contract manufacturing;
2. Original copy of the drug license;
3. If the “expiration date” field on the drug license is filled with extension stamps, the original copy of the application form for drug registration is also required;
4. If the drug concerned is among those announced by the central health competent authority after it has conducted an evaluation in accordance with Article 48 of the Act, the documents required in the announcement shall be submitted for applications for extension;
5. If the manufacturing of the drug concerned is outsourced to a domestic manufacturer, a manufacturing outsourcing agreement shall also be submitted;
6. In the case of imported Chinese medicine, the original FSC from the country of origin, the authorization letter issued by the original manufacturer, and a photocopy of documents proving that the foreign manufacturer of imported medicines complies with the Good Manufacturing Practice for Medicinal Products are also required; if the applicant is not the holder of the documents proving the compliance with the Good Manufacturing Practice for Medicinal Products, the applicant may submit the authorization letter issued by the original manufacturer or the authorization letter issued by the domestic manufacturer that holds such documents and indicate the approval number instead.
For Chinese medicine listed in the Taiwan Herbal Pharmacopeia, the testing specifications and methods for finished products as well as a photocopy of the approval letter for the latest change of the Taiwan Herbal Pharmacopeia, shall be otherwise submitted. However, if the testing specifications meet or are better than the latest edition of the Taiwan Herbal Pharmacopeia, the testing specifications and methods for finished products may be adopted instead.
If any application for a license extension submitted involves concerns about the safety, efficacy, or indications of a product, the central health competent authority may request the applicant to submit relevant documents and data.