COLOMBIA
INVIMA ESTABLISHES THE PROCESS FOR OBTAINING OF THE MARKETING AUTHORIZATIONS OF PRODUCTS BASED ON MEDICINAL PLANTS SUCH AS CANNABIS
Decree 1156 of 2018 establishes the process and documents required to obtain marketing authorizations for products based on medicinal plants such as cannabis
Those interested in obtaining the marketing authorizations for manufacturing and selling, importing and selling or importing, conditioning and selling must submit their application before INVIMA for its study.
Once the application is filed, INVIMA will take thirty (30) business days for the technical and legal evaluation, after this evaluation a request will be issued to the applicant in order to clarify or provide the missing information, this, if the entity considers it and for only one time. Then, the applicant will have a term of sixty (60) business days to reply the request and finally the INVIMA will decide within a term of thirty (30) business days and after the response of the applicant. This final decision may be debated by filing an appeal by the applicant.
The marketing authorizations for these products will be granted for a period of 10 years, which may be renewed for equal periods.
