Brazil establishes requirements to grant and renew the registration of medicinal products

The purpose of this Resolution is to establish the criteria and minimum documentation required to grant and renew the registration of medicinal products with synthetic and semi-synthetic active principles, classified as new, generic and similar, in order to guarantee the quality, safety and efficacy of these drugs.

This Regulation applies to all medicines with synthetic and semi-synthetic active ingredient, classified as new, generic and similar, with the exception of those governed by specific legislation. Official documents in foreign languages used for registration purposes, issued by foreing health authorities, must be accompanied by a certified translation in accordance with the law. For the purposes of the provisions of these Resolutions, if there are specific legislation or guides, these should be fulfilled and the respective evidence must be presented. For the purpose of renewing the registration of the medicine in Anvisa, all companies must present the documents cited in this Resolution in the first half of the last year of the five- year period of validity of the registration already granted.

The company that holds the registration or manufactures the drug may be inspected for on-site verification of data and information regarding the grant application and renewal of registration, at Anvisa's discretion. Anvisa may issue technical guidance on the applicability of this Resolution to specific cases of drug registration, such as the submission of data to prove safety and efficacy for incremental innovations, whenever necessary This Resolution revokes: - Resolution - RDC nº. 136, of 29 May 2003; - Resolution - RDC no. 16, dated 2 March 2007, with the exception of items 1 and 2, VI, of Annex I; - Resolution - RDC no. 17, dated 2 March 2007, with the exception of items 1 and 2, VI, of the Annex, arts. 1 and 4 of the Resolution - RDC nº. 210, dated 2 September 2004, and Section I and II of Chapter XVIII of Resolution-RDC No. 48 of 6 October 2009.