COLOMBIA

On March 11, the Ministry of Health published Decree 335 which establishes the procedure for manufacturers of biological, biotechnological and chemical synthesis drugs to obtain certificates of compliance with good manufacturing, laboratory and manufacturing practices. In this way, the ministry seeks to establish the general requirements for the application for the certificate of compliance with good practices and establishes the rules for its validity, renewal, extension and cancellation. The decree will enter into force on June 30. 

The decree indicates that drug manufacturers and those who develop any of the stages of the production process of chemical synthesis, biological, biotechnological and radiopharmaceuticals that are marketed in Colombia and wish to be certified in Good Manufacturing Practices (BPIVI in Spanish) must submit the application and the Self-Assessment Document of the Inspection Guide to INVIMA, according to the provisions of Resolution 2619 of 2013. 

During the next 15 days after receipt of the application for certification of good practices, INVIMA will respond to the entity detailing whether it complies with the requirements, and if it does, it will include the institution in a schedule of visits for Good Practices Certification. INVIMA may enter into recognition agreements with laboratories and establishments located abroad to issue good practice certificates.