Regulations for Registration of Medicinal Products Article 16

The applicant should honestly and completely fill out the application form, including the company name, code, address, telephone number, drug company license number, the person in charge of the business, the pharmacist in charge of the management or manufacturing, and the pharmacist’s address, and license number. The information should be confirmed by using private signets. The signets can be exempted, if the application is submitted via the electronic submission platform.The same signets or stamps used in the application form should be used for any follow-up applications. The applicant should report to the authority if the signet or stamp is lost.In the situation of toll-manufacturing, the names, codes and addresses of all manufacturers involved in the manufacturing processes should be listed in the data field of manufacturers on the application form.