Those interested in filing proceedings before the Health Research Institute (INIS) and the National Health Regulatory Authority must comply to the new established fees

On July 7, 2023, after its signature, Ministerial Resolution No. 347-2023 became effective. On August 14 of this year, the Ministry of Health was notified and approved the updated list service fees provided by the Health Research Institute (INIS) and the National Authority of Sanitary Regulation, as well as regulatory entities to obtain sanitary operating licenses, sanitary registrations, and other related procedures.

The Ministerial Resolution resulted in fee increases between 30% and 130%. Previously, sanitary licenses had an official fee of approximately US$137.00, and starting this week, this procedure will have an approximate value of US$199.00 - a 30% increase versus its original cost.

Other examples are the inspections to grant licenses which had a 70% increase, the sanitary registration fee for medical devices previously was US$220.00 and increased to US$398.00, the sanitary registration fee or recognition of food products on the other hand had an almost 400% increase from US$14.00 to be approximately US$75.00.

Additionally, services that did not have an established fee, such as post-registration modifications for pharmaceutical products, or advertising approval, now have an official fee between US$50.00 per product, per service.

Laboratory analysis fees for pharmaceutical or food products, food supplements, among others, were also subject to this increase.

Dentons Central America has a team specialized in regulatory issues at your disposal to provide further related information. Do not hesitate to contact us.