Regulations for Registration of Medicinal Products Article 60
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.
中文原文 藥品查驗登記審查準則第60條
藥商名稱變更如不涉及權利移轉者，申請變更登記，應檢附下列資料：
一、藥品變更登記申請書。
二、藥品許可證正本。
三、藥品許可證清冊。
四、已完成變更之證照影本各一份。
但全廠委託製造者免附工廠登記證明文件；如係輸入藥品之藥商，得僅附變更後之藥商許可執照影本。
依前項規定申請變更登記時，得將所有藥品許可證一次報備。
但如未能一次報備者，其於分次報備時，應註明第一次報備核准函之文號或檢附其核准函影本，免附藥商許可執照影本。
如國外藥廠合併，致其原設立於國內之不同分公司或代理商重新改組合併且變更藥商名稱者，應依下列規定辦理變更登記，如涉及權利移轉者，並應由讓與人及受讓人共同提出申請：
一、變更登記申請書：其應由合併之藥商共同具名提出，載明申請藥商名稱變更登記，係因國外藥廠合併。
但如藥商經改組後，原藥商名稱消滅者，得僅由更名後之新藥商提出申請。
二、國外藥廠合併之變更通知函，並應由國外製造廠或其總公司、或國外許可證持有者出具或有關主管機關出具之官方證明文件。
三、合併後之國外製造廠或其總公司、或國外許可證持有者出具之委託書正本，並經我國駐外館處文書驗證。
四、合併前後藥商之藥商許可執照影本。
五、合併後之藥商及其負責人出具之切結書，載明對所有藥品切結依法輸入販賣，並願負全責；另加具對同一製造廠無相同處方之切結書。
六、如變更前之藥商已持有藥品許可證者，應另附藥證正本及原持有之輸入藥品許可證清冊，並以一件申請案辦妥全部許可證變更為原則。
其變更登記申請案如經核准，申請人應自行變更所有藥品標籤、仿單、外盒、鋁箔片等之藥商名稱，必要時應提出備查。
七、如變更前之藥商有查驗登記申請案仍在審查中者，應另重新填具藥品查驗登記申請書正、副本，載明合併之藥商名稱。
一、藥品變更登記申請書。
二、藥品許可證正本。
三、藥品許可證清冊。
四、已完成變更之證照影本各一份。
但全廠委託製造者免附工廠登記證明文件；如係輸入藥品之藥商，得僅附變更後之藥商許可執照影本。
依前項規定申請變更登記時，得將所有藥品許可證一次報備。
但如未能一次報備者，其於分次報備時，應註明第一次報備核准函之文號或檢附其核准函影本，免附藥商許可執照影本。
如國外藥廠合併，致其原設立於國內之不同分公司或代理商重新改組合併且變更藥商名稱者，應依下列規定辦理變更登記，如涉及權利移轉者，並應由讓與人及受讓人共同提出申請：
一、變更登記申請書：其應由合併之藥商共同具名提出，載明申請藥商名稱變更登記，係因國外藥廠合併。
但如藥商經改組後，原藥商名稱消滅者，得僅由更名後之新藥商提出申請。
二、國外藥廠合併之變更通知函，並應由國外製造廠或其總公司、或國外許可證持有者出具或有關主管機關出具之官方證明文件。
三、合併後之國外製造廠或其總公司、或國外許可證持有者出具之委託書正本，並經我國駐外館處文書驗證。
四、合併前後藥商之藥商許可執照影本。
五、合併後之藥商及其負責人出具之切結書，載明對所有藥品切結依法輸入販賣，並願負全責；另加具對同一製造廠無相同處方之切結書。
六、如變更前之藥商已持有藥品許可證者，應另附藥證正本及原持有之輸入藥品許可證清冊，並以一件申請案辦妥全部許可證變更為原則。
其變更登記申請案如經核准，申請人應自行變更所有藥品標籤、仿單、外盒、鋁箔片等之藥商名稱，必要時應提出備查。
七、如變更前之藥商有查驗登記申請案仍在審查中者，應另重新填具藥品查驗登記申請書正、副本，載明合併之藥商名稱。