Application for a certificate of satisfaction of drug-trading conditions

Drug trading is a conditional business and applying for a Certificate of satisfaction of drug-trading conditions is not easy. So, how are Certificates of satisfaction of drug-trading conditions granted?

DRUG TRADING AND APPLICATION FOR CERTIFICATES OF SATISFACTION OF DRUG-TRADING CONDITIONS

According to Article 10 of the Pharmacy Law 2005, drug trading covers drug manufacture, export, import, wholesale, retail, preservation service and assay service. Thus, wholesale of drugs is one of the activities of drug trading. Drug wholesale establishments include:

• Drug-trading enterprises;
• Cooperatives or individual business households manufacturing or trading in materia medica, traditional medicaments and/or drugs from materia medica;
• Sale agents for vaccines and medical biological products.

Because of directly relating to users’ health and life, drug trading is a conditional business line. Drug-trading agencies, organizations and individuals (hereinafter referred collectively to as drug-trading establishments) must have Certificates of satisfaction of drug-trading conditions and are entitled to the following rights:

• To purchase raw materials for drug manufacture, finished drugs, vaccines or medical biological products from drug-manufacturing or drug wholesale establishments.
• To sell raw materials for drug manufacture, finished drugs, vaccines or medical biological products to establishments with drug-trading functions and to medical examination and treatment establishments.

CONDITIONS FOR GRANTING CERTIFICATES OF SATISFACTION OF DRUG-TRADING CONDITIONS

To be granted certificates of satisfaction of drug-trading conditions, drug-trading establishments must fully satisfy the following conditions:

• Having pharmaceutically professional managers who have been granted pharmacy practice certificates suitable to their trading forms.
• Having material and technical foundations and personnel with professional qualifications necessary for each form of drug trading;
• Warehouses and ancillary systems must be designed, constructed, used and maintained in accordance with the purpose of preservation and scale of use, ensuring that the preservation must be in accordance with the conditions stated in drug labels; there must be separate areas for preservation and arrangement of different types of products; receiving and allocating areas must be able to protect drugs from unfavorable weather conditions; relevant preservation areas must have appropriate and clear signs;
• Storage and transport equipment must be equipped, arranged, designed, evaluated, used and maintained in accordance with the purpose of usage, ensuring storage conditions and activities;
• Warehouses must be equipped with emergency power systems for the operation of cold storage;
• Having transportation facilities ensuring preservation conditions, security and safety requirements for drugs;
• Having a system managing quality, document, guidelines and procedures for the activities to be carried out.

APPLICATION FOR CERTIFICATES OF SATISFACTION OF DRUG-TRADING CONDITIONS

(1) An application for a certificate of satisfaction of drug-trading conditions (made according to a form set by the Ministry of Health); (2) The original pharmaceutical practice certificate of the pharmaceutically professional manager which is consistent with the form of business organization and the copy of the Certificate of registration of individual business household or the authenticated enterprise registration certificate or the enterprise registration certificate signed and stamped by the owner (if it is an enterprise); (3) Technical documents corresponding to business conditions proposed for inspection according to regulations of the Ministry of Health, for cases where drug-trading establishments are required to be evaluated; (4) For drug sale agents of drug trading enterprises and vaccines and medical biological products sale agents, apart from the above papers, there must be the authenticated copy or the signed and stamped copy (if it is an enterprise) of the agency contract between the drug trading enterprise and the head of the drug sale agent.

COMPETENCE TO GRANT CERTIFICATES OF SATISFACTION OF DRUG-TRADING CONDITIONS

Drug-wholesale establishments shall submit dossiers for application of certificates of satisfaction of drug-trading conditions to Departments of Health of provinces and centrally-run cities where the establishments conduct their business activities.

TIME LIMIT FOR GRANTING CERTIFICATES OF SATISFACTION OF DRUG-TRADING CONDITIONS

In cases where drug-wholesale establishments are subject to evaluation, within 40 working days after receiving the dossiers of application, the provincial Departments of Health shall have to organize the appraisal and grant Certificates of satisfaction of drug-trading conditions; in cases where drug-wholesale establishments are not subject to evaluation, within 20 working days after receiving the dossiers of application, the provincial Departments of Health shall have to grant Certificates of satisfaction of drug-trading conditions. In cases where the dossiers of application are invalid, within 10 working days after receiving the dossiers, provincial Departments of Health shall notify in writing the applying organizations or individuals to supplement necessary documents. 

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