Compliance Deadline Issued for ‘Good Supplying Practice of Pharmaceutical Products’

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Jul. 9 – China’s Ministry of Health recently released the newly-revised “Good Supply Practice of Pharmaceutical Products (hereinafter referred to as ‘Revised GSP Standards’)” on January 22, which imposed stricter requirements on pharmaceutical wholesalers and retailers in the country. The Revised GSP Standards came into effect on June 1, 2013, and provide that the detailed implementation plan for the new standards shall be formulated by China’s State Food and Drug Administration (SFDA).

In response, the SFDA issued the “Circular on Implementing the Revised GSP Standards (hereinafter referred to as ‘Circular’)” on June 24, which specifies the deadline for all pharmaceutical trading enterprises in the country to comply with the new requirements set out in the Revised GSP Standards. Detailed information can be found below.

According to the Circular, upon the expiration of an enterprise’s Pharmaceutical Trading License or Pharmaceutical GSP Certificate, a qualification examination should be conducted by that enterprise according to the Revised GSP Standards. Moreover, for enterprises whose relevant certificates have expired but fail to meet the new standards by December 31, 2013, relevant authorities may extend the validity period of the certificates of such enterprises to a date before June 30, 2014.

Compliance Deadline

From July 1, 2013, newly established pharmaceutical trading enterprises and those applying for the reconstruction or expansion of their business premises and warehouses shall comply with the new requirements outlined in the Revised GSP Standards. Such enterprises will be issued the new Pharmaceutical Trading License and Pharmaceutical GSP Certificate if they are qualified.

By December 31, 2014, wholesale enterprises entrusted with drug storage and distribution and enterprises engaged in the wholesale of the following pharmaceutical products shall comply with the requirements prescribed by the Revised GSP Standards:

  • Vaccines;
  • Narcotic drugs;
  • Psychotropic substances;
  • Anabolic agents; and
  • Peptide hormones.

Qualified enterprises will be issued the new Pharmaceutical Trading License and Pharmaceutical GSP Certificate, while for those failing to comply with the new standards, their corresponding business scope will be narrowed and relevant qualifications will be cancelled.

By December 31, 2015, all pharmaceutical trading enterprises must satisfy the new requirements regardless of the validity status of their Pharmaceutical Trading License and Pharmaceutical GSP Certificate.

From January 1, 2016, pharmaceutical trading enterprises that fail to meet the requirements prescribed by the Revised GSP Standards are not allowed to continue drug operation activities in the country.

One of the objectives of the Revised GSP Standards is to accelerate the consolidation of the country’s pharmaceutical distribution sector. Currently, there are approximately 13,000 drug wholesalers and 420,000 retailers in China. The Revised GSP Standards are expected to help reduce low-level repetitive development and promote market concentration. Enterprises which fail to upgrade their facilities and management systems to meet the new requirements will be forced out of the market by January 1, 2016.

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