Any person who notifies the Central Competent Health Authority in accordance with Paragraph 1 of Article 48-7 stipulated in the Act shall submit written explanations and evidence information in duplicate.The new drug permit license holder, in compliance with Paragraph 3 in Article 48-7 of the Act, shall respond to the Central Competent Health Authority with written explanations. The holder shall also, on the basis of the format provided in Annex I, upload to the Registration System its receipt of saidnotification, explanations of the response and how the actions have been taken.Annex I：Submit of patent information of new drug & third person.DOCAnnex II：Declaration form of the status of pharmaceutical patents.PDFAnnex II：Declaration form of the status of pharmaceutical patents.doc