Resolution published on Wednesday (10/23) establishes the 10-year period for the validity of drug registration and deals with the necessary documents for its regularization.
The Resolution of the Collegiate Board (RDC) 317/2019, published this Wednesday (10/23) in the Federal Official Gazette (DOU), establishes the period of 10 years for the validity of drug registration and lists the necessary documents for the maintenance of the regularization of these products. The standard takes effect on January 21, 2020.
According to the Resolution, the registration of a drug granted upon consent of the Term of Commitment will have an initial validity of three years. After the first renewal, the registration will be valid for five years and after the second renewal, 10 years.
The maintenance of regularization of medicines exempt from registration and subject to notification is linked to compliance with RDC 317/2019, the norms on notification and the declaration of interest in the continuation of marketing. This statement must be made every ten years from the date of notification of the drug to Anvisa. Interest in continuing commercialization should therefore be declared within the last six months of the decade of regularization.
It is important to note that the registration validity periods granted prior to the effective date of RDC 317/2019 will be automatically extended to 10 years, counted from the granting of the registration or the last renewal, excluding the medicines registered by the Term of Commitment. Registration renewal requests already received will be reviewed under the new terms.
Registration Renewal
For renewal of drug registration, the new Resolution states that the application must be filed with the petition form (completed and signed); proof of payment of the Sanitary Surveillance Inspection Fee (TFVS) and respective Union Collection Guide (GRU), or exemption, if applicable; and proof of commercialization of the drug, by pharmaceutical form and concentration, for at least the final two thirds of the validity period of the expired registration.
Regarding the proof of commercialization of the drug, if the product was discontinued - and duly notified to Anvisa - within the final two thirds of the expiration period of the expired registration, the company must present a document expressing interest in maintaining the registration and justification. technique.
In the case of medicines that have been granted registration upon consent of the Commitment Term, it is also necessary to provide proof of the protocol sending the supporting documentation of the fulfillment of the completed commitments or justifying their absence.
Official laboratories and companies that commercialize medicines exclusively under public demand may present justification for non-commercialization in the period.
Access the resolution in: http://portal.anvisa.gov.br/documents/10181/2957412/RDC_317_2019_.pdf/2bbe93d6-05bd-4b19-9d25-75d28d1eadae
Source of information: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&p_p_col_id=column-2&p_p_col_pos=1&p_p_col_count=2&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=medicamentos-rdc-dispoe-sobre-validade-e-regularizacao&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=5672763&_101_INSTANCE_FXrpx9qY7FbU_type=content