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Title: Regulations for Registration of Medicinal Products CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter 2 Western Medicine
Section 4 License Transfer, Renewal and Reissuance
Article 70
The application for transferring a domestic drug license or an imported drug distributor’s license 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;
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.The following documents are required for the application for license transfer of locally manufactured drugs:
(1) Photocopy of the transfer approvals issued by the health competent authorities of the local governments where the transferor and transferee are located;
(2) A list of valid drug licenses held by the transferee, a record of the license number, formula, dose and dosage form;
(3) An assurance statement (A);
(4) A photocopy each of all changed certificates and licenses;
(5)Manufacturing and Control Standard. This document can be exempted, if local manufacturers have no intention to initiate production at present. The certificates should be noted with the phrase: “Manufacturing is prohibited”. Manufacturers have to submit the Manufacturing and Control Standards and obtain an approval from the central health competent authority before production can be started.
6.The following documents are required for the application of imported drug distributor’s license transfer:
(1) A photocopy of the company license of both transferor and transferee;
(2) Original copy of the transfer agreement with signets of both parties;
(3) 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;
(4) A statement certifies that the same manufacturer does not have any products of the same formulation as the transferred drug.
When applying for domestic drug license transfer, if the product name on the old license includes a prefix of the transferor’s company name which is not authorized to be used by the transferee, then an application for a change in product name should be filed at the same time. If domestic drug license transfer includes toll-manufactured, then the application should comply with Article 46.
Article 71
The following documents are required for the renewal or reissuance of damaged or lost drug licenses:
1.Application form for post-approval changes;
2.A photocopy of drug license (front and back sides). Original drug license is required, if the application is filed due to damages to licenses;
3.Original copy of the application form for drug registration;
4.Assurance statement certifying the loss of drug licenses. This document would not be required for cases of damaged licenses.
5. For locally manufactured drugs appling for changes in license number, one copy each of the originally approved copy of labels and package inserts and two copies of the form for sticking label and package insert. The affixing form can be exempted, if the documents said in the preceding paragraph are submitted via the electronic submission platform.
6.For imported drugs, the original copy of an authorization letter issued by the original manufacturer. The letter has to be authenticated by the R.O.C. foreign affairs offices.