In the case of outsourced manufacturing, the application form for post-approval changes of Chinese medicine shall be signed by both parties.

The following documents and data are required for applications for registration of changes in the Chinese or English name of a Chinese medicine product:
1. 1. Application form for post-approval changes;
2. Original copy of the drug license;
3. Assurance Statement (A); if a trademark is used, a photocopy of the trademark registration certificate or approval letter shall be submitted;
4. Two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead;
5. 5. In the case of imported Chinese medicines, a letter of notification of post-approval changes issued by the original manufacturer and the original FSC from the country of origin are also required;

The changes in dosage forms of Chinese medicine products are limited to the changes from concentrated powders to concentrated granules, or vice versa, of standard formulas announced by the central health competent authority. Other changes in dosage forms shall be processed by filing a new application.
An applicant of registration of changes in dosage forms of Chinese medicine products shall have samples tested and the following documents and data submitted:
1. Application form for post-approval changes;
2. Original copy of the drug license;
3. Application form for drug review and registration;
4. Assurance Statement (A);
5. Two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead;
6. Form for sticking licenses and certificates;
7. Photocopy of batch records;
8. Two copies each of the following documents: testing specifications for finished products, testing methods for finished products, records of general inspection for finished products, testing report on finished products, and the identification test results (including chromatographic maps or other documents sufficient for confirmations); the testing items and specifications shall comply with Appendix 13 and the announcements made by the central health competent authority;
9. Documentation procedures and reports of stability tests;
10. In the case of imported Chinese medicine, a letter of notification of post-approval changes issued by the original manufacturer and the original FSC from the country of origin are also required.

An applicant of registration of changes in excipients of Chinese medicine products shall have samples tested and the following documents and data submitted:
1. Application form for post-approval changes;
2. Original copy of the drug license;
3. Two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead;
4. Photocopy of batch records;
5. Two copies each of the following documents: testing specifications for finished products, testing methods for finished products, records of general inspection for finished products, testing report on finished products, and the identification test results (including chromatographic maps or other documents sufficient for confirmations); the testing items and specifications shall comply with Appendix 13 and the announcements made by the central health competent authority;
6. Documentation procedures and reports of stability tests;
7. Testing specifications, methods, and reports of new excipients.
In the event that the application set forth above only involves coloring agents or capsule shell changes, without any impact on the characteristics, pharmacological effects, quality and safety of the original medicine, the following documents and data shall be submitted, and drug testing can be exempt:
1. Documents and data set forth in Subparagraphs 1 to 3 of the preceding paragraph.
2. Manufacturing and Control Standard.
3. Testing specifications and methods for finished products.
For an imported Chinese medicine under the change registration application in the preceding two paragraphs, a letter of notification of post-approval changes issued by the original manufacturer and the original FSC from the country of origin are also required.

If a change in the formula of a Chinese medicine product involves changes of active ingredients, then the applicant shall re-apply for drug registration. However, the regulation shall not apply to cases of removing cinnabar or protected medical materials, cases based on standard formulas, or cases of proportional changes of other ingredients of a formula if applications for post-approval changes in excipients may be submitted in accordance with Paragraph 1 or 3 of the preceding article.

The following documents and data are required for post-approval changes in the indications, efficacy, administration, and dosage of a Chinese medicine product:
1. Application form for post-approval changes;
2. Original copy of the drug license; however, a photocopy is acceptable for applications for changes in administration and dosage;
3. Two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead;
4. Photocopy of the references that support the change.

The following documents and data are required for post-approval changes in the product or license category for a Chinese medicine product:
1. Application form for post-approval changes;
2. Original copy of the drug license;
3. Application form for drug review and registration;
4. Two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead;
5. Photocopy of the references that support the change.

In any of the following situations, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations without any changes in the originally approved text:
1. Changing the graphic design or colors; however, the graphic design shall not be offensive, indecent, or misleading;
2. Proportionally resizing the originally approved graphic design or text, or repositioning the originally approved graphic design or text;
3. Changing the fonts; however, the font size of the English product name shall not be larger than that of the Chinese product name;
4. Adding or changing the symbol for the corporate identity system;
5. Printing labels on outer boxes instead of sticking labels on them;
6. Additionally providing outer boxes that display the same text and graphic design as those on the original labels.
In case of any of the following changes in the originally approved text without affecting drug quality or medication safety, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations:
1. Adding or changing the barcode, NHI code, ID code, “GMP” wording, names of ingredients of the formula in foreign languages, copyright registration number, trademark registration certificate number, or patent certificate number;
2. Adding or changing the suggested retail price or the customer service hotline;
3. Changing the name or address of the drug company, or adding or changing the telephone number, fax number, and contacts;
4. Adding or changing the distributor’s name and address; the font size of the distributor’s name shall not be larger than that of the drug company’s name;
5. Adding or changing seal labels for outer boxes or price labels;
6. Adding “For use by XX Hospital or hospitals only; no resale is allowed” or similar wordings on the originally approved packaging;
7. Changing the manufacturer’s name that was added to the English product name;
8. Changing the measurement unit of formulas in order to comply with the Taiwan Herbal Pharmacopoeia; or
9. Changing the terms used in describing the storage methods without altering the original storage methods; the terms shall be consistent with those used in the Taiwan Herbal Pharmacopoeia or Chinese Pharmacopoeia.
If any changes in the text involves the addition of directions for use in order to ensure drug quality and medication safety, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations.
For domestically manufactured Chinese medicine preparations to be exported, manufacturers may, at their own discretion, change the font of the product name, font of the distributor’s name, or the terms for storage method, or add an “export only” label, package insert, or packaging, without being subject to the restrictions set out in the provisos of Subparagraph 3 of Paragraph 1, and Subparagraphs 4 and 9 of Paragraph 2.
The changes or addition of an “export only” label, package insert, or packing set forth in the preceding four paragraphs shall conform to the Good Manufacturing Practices for Pharmaceuticals specified in the Pharmaceutical Good Manufacturing Practice Regulations, and records shall be made and retained by the manufacturers for recording purposes.

Except for the situations mentioned in the preceding article, a domestically manufactured Chinese medicine demanded for exporting which of any its “export only” label, package insert, or packing may be allowed to be changed without prior application and approval in any of the following circumstances where the originally approved text is changed without affecting the drug quality or medication safety:
1.Changing or deleting the manufacturer’s name or designation of the dosage form included in the product name;
2.The name of the Chinese medicine is changed to the approved name for “export-only” by the central health competent authority;
3.Changing the labeling method of the formula or deleting the excipient without changing the original formula proportion;
4.Deleting the domestic drug license number or adding license number approved by the destination country for export;
5.Changing or deleting the administration and dosage, but the changed administration and dosage shall not exceed the originally approved ones;
6.Deleting or simplifying the efficacy and indications;
7.Translating into a foreign language for the destination country for export;
8.Adding the trademark;
9.Adding precautions, warnings, or other text for ensuring drug quality and medication safety;
10.Other items as announced by the central health competent authority.
The changes or addition of an “export only” label, package insert, or packing set forth in the preceding paragraph shall conform to the Good Manufacturing Practices for Pharmaceuticals specified in the Pharmaceutical Good Manufacturing Practice Regulations, and records shall be made and retained by the manufacturers for future reference.

Except for the situations mentioned in the preceding two articles, applications for registration of changes in the packaging of Chinese medicine preparations shall comply with the following regulations:
1. The following documents and information are required for applications for changes in the maximum packaging size, provided that there are no changes in the packaging materials:
(1) Application form for post-approval changes;
(2) Original copy of the drug license.
2. The following documents and information are required for changes in the packaging materials:
(1) Application form for post-approval changes;
(2) Original copy of the drug license;
(3) Documentation procedures and reports of stability tests;
(4) Photocopy of batch records.
If the changes in the packaging materials mentioned in the preceding paragraph involve changes in labels, package inserts, or packaging, two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead shall also be submitted.
In case of imported Chinese medicine preparations, on top of the provisions in the two preceding paragraphs, a letter of notification of post-approval changes issued by the original manufacturer and the original FSC from the country of origin are also required.

Except for the situations described in the preceding article, the following information shall be submitted for application for change registration where domestically manufactured Chinese medicine preparations are making “export only” changes or adding “export only” drug name, maximum package quantity, packaging materials, efficacy, indications, administration and dosage, label, package insert, or packaging:
1.Application form for post-approval changes;
2.Assurance Statement for Export Only (C);
3.For changes in the drug name, maximum package quantity, packaging materials, efficacy or indications, the original copy of the drug license is required;
4.For changes in the administration and dosage, label, package insert, or packaging, the photocopy of the drug license (front and back) are required;
5.For changes in the drug name, the Assurance Statement (A) is required;
6.For changes in the packaging materials, photocopies of the documentation procedures and reports of stability tests, as well as the batch records are required;
7.For changes in the efficacy or indications of the drug, photocopy of the references that support changes is required;
8.For changes of the label, package insert, or packaging, two copies each of the forms for sticking outer box, package insert, and label are required.

The Assurance Statement (A) is required for applications for registration of outsourced manufacturing of Chinese medicine products and for applications for registration of self-manufacturing of products retrieved after outsourced manufacturing. Article 64 and Article 65 shall also apply mutatis mutandis respectively.
Article 66 applies mutatis mutandis to the outsourced inspection of Chinese medicine products.

Articles 47, 57, and 60 to 63 shall apply mutatis mutandis to post-approval changes in Chinese medicine licenses, including letters of notification of post-approval changes issued by the original manufacturer, changes in testing specifications and methods, changes in the name or address of the drug company (including the manufacturer), changes in labels, package inserts, outer boxes, and aluminum blister foils (packets), and the reissuance of the approved copies due to loss.