Hebei, Sichuan, Zhejiang... 7 places have cancelled GMP certification work!

[industry trends of pharmaceutical network] from December 1, 2019, the new version of drug administration law has been officially implemented The law clearly stipulates that GMP and GSP certification will be cancelled The author understands that in order to link up the implementation of the newly revised Drug Administration Law, GMP and GSP certification have been officially cancelled in many places, and relevant certification related applications are no longer accepted On November 28th in Gansu Province, Gansu Drug Administration issued a document confirming that it will no longer accept the application for GMP and GSP certification from December 1, 2019 After December 1, 2019, the application related to GMP and GSP shall be handled in accordance with the relevant supporting policies and regulations issued by the state On November 27, Sichuan food and Drug Administration issued a notice on GMP / GSP certification It is required that the application for GMP and GSP certification will not be accepted from December 1, 2019, and the original certification certificate will continue to be valid within the validity period For those who meet the conditions for renewal of the certificate, the application for certification can be submitted before December 1, 2019 If the state issues new regulations, they shall be implemented in accordance with relevant regulations On November 25, Guangxi food and Drug Administration issued a notice to cancel GMP certification and GSP certification After December 1, 2019, when handling the application matters related to GMP and GSP, the relevant new policies and regulations issued by the State shall be followed On October 30, Jiangxi Provincial Food and Drug Administration issued a notice that it will not accept GMP certification related matters since December 1, 2019 For pharmaceutical manufacturers of dosage forms or varieties without valid GMP certificate, they must comply with relevant laws and regulations, and inform our bureau three months before the decision of production, which will conduct GMP supervision and inspection as the case may be On October 25, Hebei Provincial Food and Drug Administration issued a notice that, since December 1, 2019, it will no longer accept the applications related to the certification of drug production quality management specifications and drug distribution quality management specifications If the validity of the certificate expires before June 1, 2020, and the applicant intends to continue to apply for the certification of drug production quality management specifications and drug distribution quality management specifications, the application for certification shall be submitted before December 1, 2019 After December 1, 2019, when handling the application matters related to the pharmaceutical production quality management specifications and pharmaceutical trading quality management specifications, the certificate within the validity period shall be deemed as the valid certificate As early as October 8, Zhejiang Provincial Food and Drug Administration announced that it will not accept GMP and GSP certification related matters since December 1, 2019
Before December 1, 2019, pharmaceutical manufacturers that have obtained the GMP certificate can apply for the GMP certification six months before the expiry of the corresponding certificate (the validity period of the certificate is before June 1, 2020), and can accept the on-site inspection of the certification at any time after the application; if the validity period of the certificate is after June 1, 2020, Zhejiang drug administration will no longer accept the GMP certification from October 20, 2019 Manage GMP certification related matters If there is a new or rebuilt workshop or there is a major change, it can apply for certification before December 1 In addition, for drug distributors who have obtained the drug GSP certificate, if the certificate is valid after June 1, 2020, they will not accept the relevant matters of drug GSP certification from October 20, 2019 In addition to the above, the author also found that Hainan will optimize the guidelines and procedures for 14 administrative licensing matters, which will be implemented from December 1, 2019 It is clear that when the administrative licensing matters are indicated on the drug trading license, the applicant is no longer required to provide the business license, GMP certificate and drug production license This means that Hainan will also cancel GMP certification.