Chapter 1: General Principles
Article 1: In order to protect the legitimate rights and interests of applicants for administrative protection of drugs and interested parties, and to ensure the correct implementation of the Regulation, this Procedures is hereby promulgated according to the Law of Administrative Review and other relevant regulations.
Article 2: An applicant for administrative protection and other interested parties may appeal a specific administrative act which has violated his legitimate rights and interests.
Article 3: The appeal process should observe the principles of lawfulness, fairness, transparency, timeliness and convenience.
Chapter 2: Scope and Responsibilities for Appeal
Article 4: An applicant for administrative protection may appeal in the following situations:
(a) the application for administrative protection has not been accepted;
(b) the application for administrative protection has not been granted;
(c) administrative protection has been revoked or terminated;
(d) a petition for revocation of administrative protection has not been accepted or has been dismissed;
(e) the failure to properly handle a Petition to Cease Infringement.
Article 5: An appeal shall be made to an Appeal Board established by SDA for such purposes. The Appeal Board shall consist of a director, deputy director(s) and other Board members composed of relevant leaders of SDA, and pharmacology and intellectual property rights experts.
Chapter 3 : Appeal and Acceptance
Article 6: An applicant for administrative protection or other interested party shall appeal within sixty (60) days from when he learns of the specific administrative act.
If due to force majeure, or other appropriate reasons, the appeal has been delayed, the appeal period (60 day period) shall [be tolled and] continue from the date the act of force majeure ends.
Article 7: An appeal should be submitted in writing, although an oral appeal may also be made in which case a staff member of the Appeal Board should record relevant information according to the items in Article 8 and such recording should be signed by the appellant.
Article 8: The appeal shall include the following:
(a) name, nationality, address of the appellant and the name of his legal representative;
(b) purpose and desired relief;
(c) legal basis for appeal with relevant evidence; and,
(d) date.
Article 9: The appeal should be written in Chinese.
Article 10: The Appeal Board shall complete a preliminary review of the appeal within five (5) days of receipt, accepting an appeal which meets requirements. The date of receipt of an appeal shall be the date of acceptance. An appeal which does not meet requirements shall not be accepted and a written notice sent to the appellant. If supplemental materials are needed, the appeal period shall be appropriately extended within which time the materials shall be submitted, otherwise the appeal shall be considered as not being made.
Chapter 4: Appeal Decision
Article 11: The Appeal Board may restrict its review to the record. Depending on the necessity of case, the Appeal Board may request the parties to confirm facts, hear statements of the parties, conduct other necessary investigation, and conduct a hearing.
During the review of the case, OAPP should present to the Appeal Board its investigation during the application process, and the relevant evidence, facts and reasoning on which its specific administrative act is based [the act which gave rise to the appeal].
Article 12: After review of the specific administrative act, the Appeal Board shall make a recommendation which, after being approved by responsible officials in SDA or having obtained group approval, shall be considered as the appeal decision. The appeal decision may:
(a) uphold an act based on clear facts, sound evidence, correct legal basis made within lawful authority, and in conformance with procedures, the content of which decision is appropriate;
(b) where officials have not carried out duties, order them to carry out those duties within a certain time;
(c) in the following situations, order the revocation, amendment or re-doing of an administrative acts:
(1) major fact is unclear or evidence insufficient;
(2) wrong legal basis was applied;
(3) legal procedures were violated;
(4) authority was exceeded or abused;
(5) specific administrative act is clearly inappropriate.
Article 13: The appeal decision by the Appeal Board shall include the following:
(a) name, nationality and address of the appellate and the name of his legal representative;
(b) purpose and main legal basis of appellate;
(c) facts, legal theory and relevant law;
(1) conclusions of Appeal Board;
(2) date of decision;
(3) time within which a case challenging the appeal decision shall be filed in the People's Court.
Article 14: The Appeal Board shall reach a decision within two months from the date the appeal was accepted. In special circumstances as elaborated by notice, responsible officials in SDA may approve an appropriate extension of time.
Article 15: The appeal decision shall become legally effective upon service.
Article 16: An applicant may apply to the State Council for a ruling on the decision, or file a suit with the People's Court.
Chapter 5: Miscellaneous
Article 17: This Procedures shall be interpreted by SDA.
Article 18: This Procedures shall be implemented from the date of publication. The "Procedures for Appeal of Administrative Protective Decisions" promulgated by the State Pharmaceutical Administration of China (SPAC) on July 30, 1994, shall be simultaneously annulled.
