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Chapter Law Content

Title: Regulations for Registration of Medicinal Products CH
Category: Ministry of Health and Welfare(衛生福利部)
Attachment:
Chapter 3 Chinese Medicine
Section 4 Chinese Medicine License Transfer, Replacement, and Reissuance
Article 108
Articles 71 shall apply mutatis mutandis to the reissuance of lost licenses, and the replacement of damaged licenses.
Article 108-1
The application for transferring a domestic Chinese medicine licenses should be filed by both parties. The following documents should be provided:
1. Application form for post-approval changes signed by both parties;
2. Original copy of the drug license to be transferred;
3. A list of drug licenses to be transferred, therein recording the license number, formula, dose and dosage form. However, the foregoing documents is not required for the application for transfer of a single drug license;
4. The assurance statement made by the transferee to certify the responsibility. For the transfer of the license of locally manufactured drugs, the assurance statement should also certify the absence of drugs of the same formula;
5. Photocopy of the transfer approvals issued by the health competent authorities of the local governments where the transferor and transferee are located;
6. An assurance statement (A);
7. A photocopy each of all changed certificates and licenses;
8. Manufacturing and Control Standard. This document can be exempted, if local manufacturers have no intention to initiate production at present.
The application for transferring an imported drug distributor’s license should be filed by both parties. The following documents should be provided:
1. Documents and data set forth in Subparagraphs 1 to 4 of the preceding paragraph.
2. Photocopy of the transfer approvals issued by the health competent authorities of the local governments where the transferor and transferee are located;
3. Original copy of the transfer agreement with signets of both parties;
4. Original copy of the authorization letter issued by the original manufacturer, stating the termination of the distributing contract with the transferor and the exchange of new contract with the transferee, as well as the addresses of both parties and the drug items involved in the transfer. The authorization letter should be authenticated by the R.O.C. foreign affairs offices;
5. A statement certifies that the same manufacturer does not have any products of the same formulation as the transferred drug.
For a product not yet manufactured as set forth in Subparagraph 8 of paragraph 1, the central health competent authority shall add the words “Manufacturing is prohibited” on the Chinese medicine license; if the manufacturer intends to actually produce the medicine subsequently, it should provide required documents and data under Subparagraph 1, 2 and 8 of paragraph 1 to approved by the competent central health competent authority before manufacturing.
When applying for domestic Chinese medicine licenses transfer, if the product name on the old license includes a prefix of the trademark or transferor’s company name which is not authorized, then an application for a change in product name should be filed at the same time.