State Food and Drug Administration, Administration of Pharmaceutical Business Permits Procedures

Issued: February 4 2004
Effective: April 1 2004
Applicability: The Procedures apply to the issuance, replacement, amendment and regulation of pharmaceutical business permits (Article 2).

Main contents: The Procedures specify the criteria for pharmaceutical wholesale and retail enterprises to apply for a pharmaceutical business permit (Articles 4 and 5). The criteria concern the quality guarantee of the pharmaceuticals; compliance of the enterprise, enterprise legal person or person in charge and the person responsible for quality control; qualifications of the pharmacists; and the standard of the place of business, equipment and storage facilities. In the case of a pharmaceutical retail enterprise, it must be equipped with the pharmaceuticals that can satisfy the demand of the consumers at the locality and guarantee a 24-hour supply. Parts Three and Four of the Procedures detail the procedures for the application for, the amendment to, and the renewal of a pharmaceutical business permit. A pharmaceutical business permit is valid for five years. An enterprise will be subject to an examination of the business application qualifications as set forth in the Procedures before renewal of its pharmaceutical business permit (Article 19).
Related legislation: PRC Administration of Pharmaceuticals Law (Revised), Feb 8 2001, CLP 2001 No.3 p26 and State Council, PRC Administration of Pharmaceuticals Law Implementing Regulations, Aug 4 2002, CLP 2002 No.7 p14