Measures for the Administration of Imported Medicinal Materials

Measures for the Administration of Imported Medicinal Materials Order of the State Administration for Market Regulation (No. 9) The Measures for the Administration of Imported Medicinal Materials, as deliberated and adopted at the eighth executive meeting of the State Administration for Market Regulation (“SAMR”) on April 28, 2019, are hereby issued, and shall come into force on January 1, 2020. Director General: Zhang Mao May 16, 2019 Measures for the Administration of Imported Medicinal Materials (Issued by Order No. 9 of the SAMR on May 16, 2019) Chapter I General Provisions Article 1 For purposes of strengthening the supervision and administration of imported medicinal materials and guaranteeing the quality of imported medicinal materials, these Measures have been developed in accordance with the Drug Administration Law of the People's Republic of China , and the Regulation for the Implementation of the Drug Administration Law of the People's Republic of China , as well as other relevant laws and administrative regulations. Article 2 These Measures shall apply to the application for, the examination, approval, record filing, port inspection, supervision and administration of imported medicinal materials. Article 3 Medicinal materials shall be imported via the ports permitting the import of drugs or the border ports permitting the import of medicinal materials as approved by the State Council. Article 4 The National Medical Products Administration (“NMPA”) shall be responsible for the supervision and administration of imported medicinal materials throughout the country. The NMPA shall authorize the medical products administrations in the provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as the “provincial medical products administrations”) to conduct examination on and grant approval to the initial import of medicinal materials, and supervise and guide the authorized examination and approval activities. The provincial medical products administrations shall supervise and administer the imported medicinal materials according to law, and conduct examination on and grant approval to the initial import of medicinal materials in the name of the NMPA within the scope of authorization. The medical products administration at the place of a port permitting the import of drugs or a border port permitting the import of medicinal materials (hereinafter referred to as the “port medical products administration departments”) shall be responsible for the record filing of imported medicinal materials, organize port inspections, and conduct supervision and administration. Article 5 For the purpose of these Measures, “importers of medicinal materials” mean the applicants who apply for the examination and approval of the initial import of medicinal materials or the entities that conduct record filing for imported medicinal materials. Importers of medicinal materials shall include marketing license holders of Chinese patent medicines, traditional Chinese medicine (“TCM”) producers, and business operators of TCM decoction pieces. Article 6 For the initial import of medicinal materials, an importer shall obtain an Approval Document for Import of Medicinal Materials according to of the present Measures, and file them for recordation at the competent port medical products administration. Initially imported medicinal materials refer to the medicinal materials imported for the first time with a different original plant, from a different country (region), and by a different applicant than before. For non-initially imported medicinal materials, an importer shall directly file them for recordation at the competent port medical products administration according to these Measures. Non-initially imported medicinal materials shall be administered with a specific catalogue prepared and adjusted by the NMPA. Those not listed in the catalogue but the applicant, original plant, and country (region) remaining unchanged shall be administered as non-initially imported medicinal materials. Article 7 Imported medicinal materials shall comply with the state pharmaceutical standards. The varieties not included in the current Pharmacopoeia of China shall follow the standards of imported medicinal materials; and those included neither in the current Pharmacopoeia of China nor in the standards of imported medicinal materials shall follow the pharmaceutical standards of other countries. If there is no state pharmaceutical standard for the imported medicinal materials traditionally used by an ethnic minority group in an ethnic minority area, they shall comply with the standards of medicinal materials in the relevant province or autonomous region. Chapter II Application for, Examination and Approval of the Initial Import of Medicinal Materials Article 8 To apply for the initial import of medicinal materials, an applicant shall fill out an application form for the import of medicinal materials through the information system of the NMPA (hereinafter referred to as the “information system”), and submit the following documents to the provincial medical products administration of the place where the applicant is located: 1. an application form for the import of medicinal materials; 2. where the applicant is a marketing license holder of Chinese patent medicine, a photocopy of the applicant's Permit for Pharmaceutical Manufacture or Permit for Drug Operation, as well as a photocopy of relevant approval certificate of pharmaceuticals; 3. a photocopy of the registration certification document for the exporter; 4. photocopies of the purchasing contract and notarial documents; 5. ecological environment, resource reserves, wild-growing or planting and breeding conditions, harvesting, primary processing, and other information of the place of origin of medicinal materials; 6. standards of medicinal materials and sources of standards; and 7. original copy of the authentication certificate of the origin of medicinal materials issued by a Chinese institution with the qualification of authenticating the animal and plant origin (including such information as authentication basis, authentication result, sample pictures, authenticator, authenticat......