The Ministry of Health is working on the draft of a decree on sanitary provisions, which introduces amendments to the Sanitary Registry of medicines, biological, natural and homeopathic products.

One of the amendments the text will introduce is the incorporation of a procedure of manufacturing and export of medicines, biological, natural and homeopathic products that are not in pharmacological norm, into the Sanitary Registry. At the same time, the text clarifies that interested parties may register in this new modality as long as an application to the National Institute for Surveillance of Drugs and Foods (Instituto Nacional de Vigilancia de Medicamentos y Alimentos – Invima) is submitted. Likewise, it bans products that have been granted the sanitary register under this new modality to be commercialized in Colombia.

The preliminary draft states that the Ministry of Health and Social Protection (Ministerio de Salud y Protección Social) will set the criteria and requirements for bioavailability and bioequivalence studies and will outline the medicines that will have to be presented. It also explains that the requirements to be complied with by the institutions that wish to carry out these studies will be defined. These institutions must previously obtain a certification of compliance from INVIMA.

It also grants the power to Invima to set and permanently update the list of vital medicines unavailable and their exemption from the Sanitary Registry. Up to now, this task has been a faculty of the Invima Review Commission.