Type of Notification
regular notification
Date of Distribution
2018.10.18
WTO Country
Agency Responsible
Food and Drug Administration Ministry of Health and Welfare No.161-2, Kunyang Street Nangang District, Taipei City 115-61, Taiwan Tel: (886-2) 2787-7819 Fax: (886-2)3322-9527 E-mail: johnnylu1199@fda.gov.tw
Notified Document Details
<p style="margin:2px !important;">Regulation for the Notification of Drug Patent Linkage Agreements (Draft)</p>
Product
ICS Code
Covered Products
<p style="margin:2px !important;">Pharmaceutical products</p>
Description of Content

With a view to avoiding delays of registration of other generic drugs and negative impacts on patient's access to medicines resulted from unfair or restrictive competition agreements, the Food and Drug Administration of the Ministry of Health and Welfare drafted the "Regulation for Notification of Drug Patent Linkage Agreements” in accordance with Paragraph 2 of Article 42-19 of the Pharmaceutical Affairs Act to ensure public health and fair market transactions. The content of the draft Regulations includes:

  1. The method, content and starting date of reporting reverse payment interest agreements.
  2. Obligations of the parties that report the agreements.
  3. Notification to the Fair Trade Commission by the central health competent authority of agreements that it considers is likely to violate the Fair Trade Act.
Relevant Documents
  • Article 40-19, Pharmaceutical Affairs Act
Final Date of Comments
2018.12.17
Contact Details
WTO/TBT Enquiry Point Bureau of Standard, Metrology and Inspection Ministry of Economic Affairs No.4, Section 1, Jinan Rd. Zhongzheng Dist., Taipei City 100, Taiwan TEL: (886-2) 2343-1813 FAX: (886-2) 2343-1804 E-mail: tbtenq@bsmi.gov.tw
Document Online Link (EN)
Notified Under
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