Guangdong Province: enterprises holding drug number directly become the holders of listing license

On December 12, Guangdong food and Drug Administration issued a circular on the implementation of the drug administration law of the people's Republic of China It is clear in the notice that, from December 1, 2019, if the holder of the drug listing license is approved to be the holder of the drug listing license during the pilot work of Guangdong Province, its ownership will remain unchanged; other manufacturers holding the drug approval number will directly become the holder of the drug listing license GMP and GSP certification applications accepted before December 1, 2019 shall continue to be handled in accordance with the relevant standards and procedures of the original GMP and GSP certification GMP and GSP certificates shall not be issued, and the on-site inspection results shall be notified to the enterprise The original text is as follows: Guangdong Drug Administration Announcement No 107, 2019 In order to implement the work requirements of the newly revised Drug Administration Law of the people's Republic of China and the announcement of the State Drug Administration on relevant matters concerning the implementation of the drug administration law of the people's Republic of China (No 103, 2019), the specific requirements for the implementation of the newly revised drug administration law are hereby notified as follows: 1、 From December 1, 2019, if the holder of drug listing license is approved to be the holder of drug listing license during the pilot work of drug listing license holder in our province, its ownership will remain unchanged, and other manufacturers holding drug approval number will directly become the holder of drug listing license 2、 From December 1, 2019, our bureau will no longer accept the supplementary application of pilot drug listing license holders; if it is necessary to change the entrusted drug manufacturing enterprise, the drug listing license holder shall submit a supplementary application for drug registration to the State Drug Administration 3、 From December 1, 2019, the GMP and GSP certification will be cancelled, the GMP certification application of drug manufacturing enterprises and the GSP certification application of drug trading enterprises (including wholesale, retail chain headquarters and retail enterprises) will not be accepted, and the GMP and GSP certificates will not be issued GMP and GSP certification applications accepted before December 1, 2019 shall continue to be handled in accordance with the relevant standards and procedures of the original GMP and GSP certification, and the GMP and GSP certificates shall not be issued, and the on-site inspection results shall be notified to the enterprise (see the attachment for the notice template of inspection results); if the inspection results do not meet the requirements, they shall be handled in accordance with the provisions.