HS CODE: 30 – pharmaceutical products

Draft resolution (Consulta Pública) number 453, December 28th 2017. 28 pages, Portuguese. Republished on D.O.U, 2 January 2018, page 74.

Establishes the criteria for conducting Stability Studies of active pharmaceutical ingredients and medicines, other than biological, and makes other arrangements.

It establishes the criteria for carrying out Stability Studies of active pharmaceutical inputs (IFAs), and of new, generic, similar, dynamised, specific, simplified notification, herbal and radiopharmaceutical medicines.

This Resolution does not apply to biological medicines.

The Stability Studies of the medicines and IFAs to be marketed and used in Brazil should be performed whenever required in regulation regarding registry or post-registration changes, and according to the parameters defined in this Resolution.

Long-Term Stability Studies still in progress may be accepted at the petition application with results of at least 6 (six) months, provided they are accompanied by completed Accelerated Stability Studies.

The completed Accelerated Stability Study should be submitted even though the Long-Term Stability Study is complete. Protocols, stability reports and raw data regarding stability should be made available whenever required by a competent health authority.

ANVISA shall be immediately notified in the case of results outside the specification in Stability Studies, of approved condition.

For simplified medicine notifications, studies that comply with the standards written in Art. 130 of this Resolution will be accepted if all of the following conditions are met:

I - the study must have been finalized before the publication of this Resolution, while the respective notification to the Anvisa must have been made within 180 (one hundred and eighty) days as of the publication of this Resolution;

or II - the study must have been started before the publication of this Resolution, while the respective notification to Anvisa must have been made up to 540 (five hundred and forty) days counted from the beginning of the study.

This Resolution revokes: Resolution RE No 1 of 29 July 2005; Resolution RDC No. 45 of 9 August 2012; item 5.6.3 of Resolution - RDC No. 08 of 2 January 2001 and the Normative Instruction IN No. 4 of 11 April 2007.