First, the conditions that must be met: the conditions that must be met by an enterprise producing pharmaceutical intermediates:
It has qualified pharmaceutical technicians, engineering technicians and corresponding skilled workers.
It has workshops, facilities and sanitary environment suitable for its pharmaceutical production.
Having quality management and quality inspection institutions, personnel and necessary instruments and equipment for the drugs produced.
There are rules and regulations to ensure the quality of drugs.
2. Application for "License and GMP Certification": For enterprises producing pharmaceutical intermediates, the applicant shall apply to the provincial drug supervision and administration department for preparations. After the preparation is completed, the provincial bureau will issue the pharmaceutical production license after passing the acceptance, register with the industrial and commercial department (business license) with the pharmaceutical production license, and then submit the GNP certification to the provincial bureau. GMP certification will be issued to those who pass the certification.
Third, drug registration: after obtaining the drug production license and GMP certification. It is also necessary to have the drug production approval number of the drug produced. This is the drug registration. For the contents of drug registration, please download the newly revised Measures for the Administration of Drug Registration from the Internet.