This Decree amends regulations relating to application, procedures for issuance, re-issuance, and renewal of the GMP Certificate with regard to manufacturers of veterinary drugs
Accordingly, manufacturers of veterinary drugs may apply for issuance, re-issuance, and renewal of the GMP Certificate via online media in addition to the form of direct submission and submission by post.
The application for issuance of the GMP Certificate is removed these papers: A Certificate of Enterprise registration; manufacturing practice certificates of the employees in charge of technical matters and veterinary testing laboratory.
With regard to the application for renewal of the GMP Certificate, the requirement for submission of a report on environmental impact assessment approved by an environment authority is removed. However, manufacturers of veterinary drugs have to describe information on environmental protection measures in the report on operations and changes of the facility in 05-year application of GMP;
This Decree takes effect from the date of its signing.