SAMR Issued Measures for Supervision and Administration of Online Sale of Medicinal Products
ISSUING AUTHORITY:
State Administration for Market Regulation
DATE OF ISSUANCE:
August 3, 2022
EFFECTIVE DATE:
December 1, 2022
On August 3, 2022, the State Administration for Market Regulation issued the Measures for the Supervision and Administration of Online Sale of Medicinal Products (the “Measures”), which shall come into force on December 1, 2022. The Measures set out the responsibilities and obligations to be borne by third-party platforms for online drug sales, drug marketing authorization holders and drug wholesalers.
The Measures point out that only the drug marketing authorization holders or medicinal products business enterprises with business operation licenses can engage in the online sale of medicinal products. In addition, the Measures further refine the obligations imposed on third-party platforms. For example, the Measures require third-party platforms to establish a medicinal products quality and safety management institution, be equipped with pharmacy technicians to manage the quality and safety of medicinal products, and make public its business license, relevant administrative license and contact information. Within the scope of the online selling of drugs, the Measures emphasizes that narcotic drugs, psychotropic drugs, medical toxic drugs and other medicinal products subject to particular administration shall not be sold online.
When inspecting third-party platforms and enterprises selling medicinal products online, the medical products administrative department may take measures prescribed by laws and regulations, such as on-site inspections, sampling inspections, inquiring about relevant personnel and sealing up and detaining drugs. Whoever violates the Measures shall be ordered to take corrective action within a prescribed time limit and be subject to a fine ranging from RMB10,000 to RMB200,000 depending on the seriousness of the circumstances. Additionally, if the illegal online sale of medicinal products is suspected of comprising a criminal offence, the case shall be transferred to the public security organ.
Although the Measures set a series of strict obligations and corresponding legal responsibilities on drug online sales companies and third-party platforms, this should not be regarded as a restriction on the development of the pharmaceutical e-commerce industry. As a matter of fact, no industry can develop at a high speed for a long time in a disorderly manner. Therefore, we encourage relevant entities engaged in online drug sales to actively comply with the latest regulatory requirements and make their sales behaviors legal and compliant to seek sustainable and long-term development in the industry.
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