What is GITE?

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What is GITE?

GITE stands for GRUPOS E INDICAÇÕES TERAPÊUTICAS ESPECIFICADAS. GITE is a list of therapeutics as per ANVISA, a Health Authority (HA) that oversees drug registrations in Brazil. It constantly amends the guidelines to make drug registrations an easy procedure and to provide quality drugs for everyone in the country.

GITE is a list of specified therapeutic groups and indications. The drugs described in GITE can be sold as over-the-counter (OTC) products. However, parenteral drugs can only be sold with a prescription.

On the contrary, the drugs not listed in GITE cannot be sold without a due prescription. Apart from this, any new drug cannot be sold under GITE. Only if the drug has a history of a minimum of five (05) years of selling in the USA or Europe markets along with FDA or EMEA approval, then the applicant may request ANVISA to classify it as an OTC product, applied that the given drug comes under GITE list.

Want to know whether your product comes under the GITE listing or not? Let us take you through the entire process and make the drug approval process smoother. We at Freyr have an on-ground team of Regulatory experts in Brazil who can help you with end-to-end Regulatory services. Consult Freyr now!

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