On April 8, the National Institute for the Surveillance of Drugs and Foods (INVIMA) adjusted its tariff regime. This introduced new duties, and adapted existing ones to recently introduced regulations from the Ministry of Health. The measure covers numerous products, including biosimilar drugs as well as medicines that form part of international donations. The updated tariff regime is available here.
The new regime will simplify modifications to the registration of medical devices or biomedical equipment. It will also lead to alterations in the authorization fees for importing donations for humanitarian purposes, including drugs. According to Decree 218 -published in February this year-, drug donations will be accepted under the condition that the active ingredients of the drugs are covered by the pharmacological norms of the Review Commission of INVIMA, or they are on the List of Essential Medicines of the World Health Organization (WHO).
Addressing the measures, director of INVIMA Julio César Aldana said one of his priorities this year will be facilitating the entry to Colombia of biosimilars. While César Aldana underlined his respect for intellectual property, he stressed that “today there are products that are monopolies and that, under the new rules, will have new competitors”. In this regard, he alluded to Decree 1782 -signed by former President of the Republic Juan Manuel Santos-, which regulates the importation of biotechnological products to the country; according to César Aldana, “the only thing left to do is to comply with the decree”. INVIMA is expected to make further announcements on this in the coming months.