Regulations for Registration of Medicinal Products｜第 60 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 三 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
The following documents are required for changes in the pharmaceutical company’s name without transfer of rights: 1.Application form for post-approval changes; 2.Original copy of drug license; 3.A list of all drug licenses; 4.A photocopy of the changed drug company licenses. No supporting documents of factory registration are required when the complete manufacturing process is commissioned to toll-manufacturers. For imported drugs, the applicant may submit a photocopy of the changed drug company licenses. When applying for changes mentioned in the preceding paragraph, the applicant can include all drug licenses in one application. If the applicant divides the licenses in different applications, the follow-up applications should quote the document reference number of the first approval or attach a photocopy of the approval letter to the follow-up applications. A photocopy of the drug company’s license is not required. If the merger of multinational companies causes the changes of a drug company’s name and the reorganization of different subsidiaries and agents in Taiwan, the application of changes should comply with the following regulations. If the merger involves the transfer of rights, the applications should be jointly filed by both sides. 1.Application form for post-approval changes: The application should be signed jointly by the companies involved in the merger, specifying that the change is due to the merger of multinational companies. However, if the original drug company name is no longer available after the reorganization, then the application can be filed only by the new drug company under the new name; 2.The notification letter of the company merger issued by the foreign manufacturer, its headquarters or the foreign license holder, or officially certified by responsible competent authorities; 3.An original copy of the authorization letter issued by the foreign manufacturer or its headquarters after the merger, or by the foreign license holder. The authorization letter should be authenticated by the R.O.C. foreign affairs offices; 4.Photocopy of the drug company license after the merger; 5.Assurance statement signed by the person in charge of the drug company after the merger. By signing the statement, the drug company assures that all drugs are imported and sold in compliance with related regulations and the company will take full responsibilities. The company should also make a statement to certify that the manufacturer does not have other products of the same formulation. 6.If prior to the merger, the drug company already held some drug licenses, then the original copies of all drug licenses and a list of all licenses of imported drugs should be attached to the application of changes. In principle, the transfer for all licenses is done in a single application. After the application is approved, the applicant should, of their own accord, change the company’s name on all labels, package inserts, outer boxes, aluminium blister foil, etc. Those materials should be submitted upon request for inspection; 7.If prior to the merger the drug company has some drug application cases still in progress, the applicant should fill in another application form (both original and duplicate copies), therein stating the new drug company name.