Administrative Measures for Pharmaceutical Trading Licenses (Revised in 2017)
Administrative Measures for Pharmaceutical Trading Licenses (Revised in 2017)
Administrative Measures for Pharmaceutical Trading Licenses (Revised in 2017)
Order of the China Food and Drug Administration No.37
November 17, 2017
(Promulgated by the Order of the China Food and Drug Administration No.6 on February 4, 2004; and amended by the Decision of the China Food and Drug Administration on Revising Some Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017)
Chapter I General Provisions
Article 1 With a view to strengthening the supervision and administration of pharmaceutical trade licensing, these Measures have been formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementing Regulations of the Drug Administration Law of the People's Republic of China (hereinafter respectively referred to as the Pharmaceutical Administration Law and the Regulations on the Implementation of the Pharmaceutical Administration Law).
Article 2 These Measures shall apply to the issuance, renewal and modification of pharmaceutical trading licenses and to the supervision and administration of pharmaceutical trade licensing.
Article 3 The China Food and Drug Administration shall be responsible for the supervision and administration of pharmaceutical trade licensing throughout China.
The food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the issuance, renewal and modification of licenses and for the routine supervision and administration of pharmaceutical trading licenses held by pharmaceutical wholesale enterprises within their respective jurisdictions, and shall direct and supervise the food and drug administration departments at the lower on the supervision and administration of pharmaceutical trading licenses.
The food and drug administration departments at the level of cities divided into districts or those at the county level which are set up directly by the food and drug administration departments at the levels of provinces, autonomous regions, and municipalities directly under the Central Government, shall be responsible for the issuance, renewal and modification of licenses and for the routine supervision and administration of pharmaceutical trading licenses held by pharmaceutical retail enterprises within their respective jurisdictions.
Chapter II Application Criteria for Pharmaceutical Trading Licenses
Article 4 In accordance with the provisions of Article 14 of the Pharmaceutical Administration Law, where a pharmaceutical wholesale enterprise is launched, it shall conform to the requirements for the reasonable overall arrangement of pharmaceutical wholesale enterprises applicable in the relevant province, autonomous region or municipality directly under the Central Government, and shall meet the following standards for its establishment:
1. It shall have rules and regulations designed to ensure the quality of pharmaceuticals in which it deals;
2. Neither the enterprise, the legal representative, the responsible individual, nor the person responsible for quality control within the enterprise shall fall within any of the circumstances described in Articles 76 and 83 of the Pharmaceutical Administration Law;
3. It shall have a number of practicing pharmacists appropriate to its business scale. The person responsible for quality control shall have a bachelor's degree or above, and shall also be a practicing pharmacist;
4. It shall have normal temperature warehouses, cool warehouses or refrigerators capable of ensuring that quality standards for the storage of pharmaceuticals are met and that are appropriate to the variety and scale of its business, in which there shall be special goods shelves for the storage of pharmaceuticals, and modern logistical systems and equipment in its warehouses for the arrival and dispatch of pharmaceuticals to and from its warehouses and for the conveyance, sorting and shelving of pharmaceuticals;
5. It shall have an independent computer management information system capable of covering the whole process of the purchase, storage, sale and management of pharmaceuticals and for quality control within the enterprise, and that is capable of recording all information on the management and implementation of the Good Distribution Practices (GDP)for Pharmaceutical Products within the enterprise; it shall in addition meet the requirements of the Good Distribution Practices (GDP)for Pharmaceutical Products for each of its pharmaceutical management processes, and be in a position to accept the supervision of the local food and drug administration departments; and
6. It shall have operations that conform to the requirements of those parts of the Good Distribution Practices (GDP)for Pharmaceutical Products that are applicable to its pharmaceutical trading premises, auxiliary and office buildings and warehouse management, quality and safety safeguards applicable to pharmaceuticals in its warehouses, and to standards applicable to its arrangements for the arrival and dispatch of pharmaceuticals to and from its warehouses and for warehouse storage and maintenance.
Where other state provisions on the management of anesthetics, psychotropic pharmaceuticals, toxic pharmaceuticals for medical treatment, or preventive biological products apply, those provisions shall prevail.
Article 5 The establishment of a pharmaceutical retail enterprise shall conform to the applicable requirements on the number of local permanent residents, regions, traffic conditions and actual need, shall follow the principle of convenience for the general public in purchasing pharmaceuticals, and shall accord with the following provisions on establishment:
1. It shall have rules and regulations designed to ensure the quality of pharmaceuticals in which it deals; and
2. It shall have pharmacologists whose qualifications have been certified by law.
Any pharmaceutical retail enterprise that trades in prescriptive pharmaceuticals or Class A non-prescriptive pharmaceuticals (OTC), shall have practicing pharmacists or other pharmacologists whose qualifications have been certified by law. The person responsible for quality control shall have no less than one year's work experience in quality control for pharmaceutical trading.
Any pharmaceutical retail enterprise that trades in Class B non-prescriptive pharmaceuticals (OTC) and any pharmaceutical retail enterprise established in an area below the level of a rural village or town shall recruit business personnel in accordance with Article 15 of the Regulations on the Implementation of the Pharmaceutical Administration Law, and where conditions permit, shall also recruit practicing pharmacists.
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Order of the China Food and Drug Administration No.37
November 17, 2017
(Promulgated by the Order of the China Food and Drug Administration No.6 on February 4, 2004; and amended by the Decision of the China Food and Drug Administration on Revising Some Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017)
Chapter I General Provisions
Article 1 With a view to strengthening the supervision and administration of pharmaceutical trade licensing, these Measures have been formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementing Regulations of the Drug Administration Law of the People's Republic of China (hereinafter respectively referred to as the Pharmaceutical Administration Law and the Regulations on the Implementation of the Pharmaceutical Administration Law).
Article 2 These Measures shall apply to the issuance, renewal and modification of pharmaceutical trading licenses and to the supervision and administration of pharmaceutical trade licensing.
Article 3 The China Food and Drug Administration shall be responsible for the supervision and administration of pharmaceutical trade licensing throughout China.
The food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the issuance, renewal and modification of licenses and for the routine supervision and administration of pharmaceutical trading licenses held by pharmaceutical wholesale enterprises within their respective jurisdictions, and shall direct and supervise the food and drug administration departments at the lower on the supervision and administration of pharmaceutical trading licenses.
The food and drug administration departments at the level of cities divided into districts or those at the county level which are set up directly by the food and drug administration departments at the levels of provinces, autonomous regions, and municipalities directly under the Central Government, shall be responsible for the issuance, renewal and modification of licenses and for the routine supervision and administration of pharmaceutical trading licenses held by pharmaceutical retail enterprises within their respective jurisdictions.
Chapter II Application Criteria for Pharmaceutical Trading Licenses
Article 4 In accordance with the provisions of Article 14 of the Pharmaceutical Administration Law, where a pharmaceutical wholesale enterprise is launched, it shall conform to the requirements for the reasonable overall arrangement of pharmaceutical wholesale enterprises applicable in the relevant province, autonomous region or municipality directly under the Central Government, and shall meet the following standards for its establishment:
1. It shall have rules and regulations designed to ensure the quality of pharmaceuticals in which it deals;
2. Neither the enterprise, the legal representative, the responsible individual, nor the person responsible for quality control within the enterprise shall fall within any of the circumstances described in Articles 76 and 83 of the Pharmaceutical Administration Law;
3. It shall have a number of practicing pharmacists appropriate to its business scale. The person responsible for quality control shall have a bachelor's degree or above, and shall also be a practicing pharmacist;
4. It shall have normal temperature warehouses, cool warehouses or refrigerators capable of ensuring that quality standards for the storage of pharmaceuticals are met and that are appropriate to the variety and scale of its business, in which there shall be special goods shelves for the storage of pharmaceuticals, and modern logistical systems and equipment in its warehouses for the arrival and dispatch of pharmaceuticals to and from its warehouses and for the conveyance, sorting and shelving of pharmaceuticals;
5. It shall have an independent computer management information system capable of covering the whole process of the purchase, storage, sale and management of pharmaceuticals and for quality control within the enterprise, and that is capable of recording all information on the management and implementation of the Good Distribution Practices (GDP)for Pharmaceutical Products within the enterprise; it shall in addition meet the requirements of the Good Distribution Practices (GDP)for Pharmaceutical Products for each of its pharmaceutical management processes, and be in a position to accept the supervision of the local food and drug administration departments; and
6. It shall have operations that conform to the requirements of those parts of the Good Distribution Practices (GDP)for Pharmaceutical Products that are applicable to its pharmaceutical trading premises, auxiliary and office buildings and warehouse management, quality and safety safeguards applicable to pharmaceuticals in its warehouses, and to standards applicable to its arrangements for the arrival and dispatch of pharmaceuticals to and from its warehouses and for warehouse storage and maintenance.
Where other state provisions on the management of anesthetics, psychotropic pharmaceuticals, toxic pharmaceuticals for medical treatment, or preventive biological products apply, those provisions shall prevail.
Article 5 The establishment of a pharmaceutical retail enterprise shall conform to the applicable requirements on the number of local permanent residents, regions, traffic conditions and actual need, shall follow the principle of convenience for the general public in purchasing pharmaceuticals, and shall accord with the following provisions on establishment:
1. It shall have rules and regulations designed to ensure the quality of pharmaceuticals in which it deals; and
2. It shall have pharmacologists whose qualifications have been certified by law.
Any pharmaceutical retail enterprise that trades in prescriptive pharmaceuticals or Class A non-prescriptive pharmaceuticals (OTC), shall have practicing pharmacists or other pharmacologists whose qualifications have been certified by law. The person responsible for quality control shall have no less than one year's work experience in quality control for pharmaceutical trading.
Any pharmaceutical retail enterprise that trades in Class B non-prescriptive pharmaceuticals (OTC) and any pharmaceutical retail enterprise established in an area below the level of a rural village or town shall recruit business personnel in accordance with Article 15 of the Regulations on the Implementation of the Pharmaceutical Administration Law, and where conditions permit, shall also recruit practicing pharmacists.
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