Circular on the Re-Implementation of Permits for the Targeted Production and Operation of Pharmaceutical Precursor Chemicals

National Food and Drug Administration Supervisor [2010] 228

Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:

In order to strengthen the management of pharmaceutical precursor chemicals and prevent their inflow into illicit channels, the Ministry of Health has promulgated the “Measures for the Administration of Pharmaceutical Precursor Chemicals” (Order No. 72 of the Ministry of Health, hereinafter referred to as the “Measures”) in 2010. May 1 will be implemented. Before the implementation of the Measures, an enterprise that has been approved by the food and drug regulatory authorities to engage in the production and operation of precursor chemicals of pharmaceuticals shall re-apply for production and business licenses within three months from the date of issuance of this notice. The relevant matters are hereby notified as follows:

1. The food and drug regulatory authorities of all provinces (autonomous regions and municipalities) should attach great importance to the re-implementation of licenses for the production and management of precursor chemicals for pharmaceuticals, strengthen leadership, and organize carefully, and formulate a work plan in light of the actual situation of supervision in the region. Within 3 months after the issuance of the notice, the re-licensing work shall be completed in accordance with the conditions stipulated in the Measures.

2. The food and drug regulatory authorities of all provinces (autonomous regions and municipalities) shall promptly notify the relevant drug production enterprises and drug trading enterprises in their administrative areas to apply in accordance with the provisions of the Measures and submit their application materials.

3. The food and drug regulatory authorities of all provinces (autonomous regions and municipalities) shall, in accordance with the conditions and requirements stipulated in the Measures, carefully review the enterprise application materials, organize on-site inspections, and inspect the safety management of production, storage, and sales links of the company. Put the approval off. No license shall be granted to any drug trading company that fails to provide relevant safety management facilities and formulate a safety management system.

IV. Enterprises that have been approved to obtain fixed-point production qualifications but are currently not producing properly are not included in this re-implementation license. In the future, if an enterprise intends to resume production, it may submit an application to the local food and drug regulatory authority in the locality according to the conditions and procedures stipulated in the Measures.

5. The application for re-licensing will not be accepted for any of the following circumstances:

(1) The pharmaceutical production enterprise has not obtained the GMP certification for the corresponding species or dosage form or has not re-certified by the expiration date;

(2) The drug trading enterprise does not have the designated business qualifications for quinoa products and the first class of psychotropic drugs or the designated business qualifications for the second class of psychotropic drugs;

(3) Pharmaceutical companies fail to obtain the GSP certification or have not re-certified within the time limit;

(4) The company's legal representatives and related staff have ** criminal records;

(5) Having received administrative penalties under Article 38 of the "Regulations on the Administration of Precursor-produced Chemicals" for a violation of the relevant regulations on the management of precursor chemicals for less than three years;

(6) In cases involving the loss of special drugs, public security agencies are setting up investigations to investigate cases that have not yet been closed;

(7) There is false content in the company's application materials or concealment of the relevant circumstances;

(8) The "Business License" failed to pass the 2010 annual inspection by the administrative department of industry and commerce;

(9) The enterprise enters bankruptcy proceedings.

6. Enterprises that have been approved to engage in the production and operation of precursor chemicals of pharmaceuticals prior to the implementation of the Measures, failing to re-apply for the relevant licenses in accordance with regulations, or re-licensing those that have not been approved, may not resume production from September 1, 2010 onwards. Purchase pharmaceutical precursor chemicals. The pharmaceutical precursor chemicals of the company's original stockpiles shall be registered and put on record, and reported to the city-level food and drug regulatory agency of the locality where it is located and sold out as required. The food and drug regulatory authorities at the place where the enterprise is located shall strengthen supervision and management to ensure safety.

7. The food and drug regulatory authorities of all provinces (autonomous regions and municipalities) shall, before October 15, 2010, report to the Department of Drug Safety Supervision of the State Administration the re-implementation of licensing work for pharmaceutical precursor chemicals production and operating companies. If you have any problems or suggestions during your work, please contact the Department of Drug Safety Supervision of the State Administration.

State Food and Drug Administration

June 4, 2010