Brazil proposed quality control analysis, transportation and storage of medicaments and biological products

National Institute of Metrology, Quality and Technology (INMETRO) proposed Resolution changes RDC 234 of 20 June 2018, regarding the outsourcing of production steps, quality control analysis, transportation and storage of medicaments and biological products, among other measures.

Art.30 and art.31 of the RDC 234 (notified under the document G/TBT/N/BRA/700), 20 June 2018 are suspended for two years from the date of publication of this Resolution.

The art.33 of RDC 234, 20 June 2018, is now in force with the following text:

"Art.33. Article 52 of the RDC 17. April 16^th, 2010, and the RDC 25, March 29^th, 2007, are hereby revoked."

This Resolution also changes art. 8, art. 9 and the subsection VIII of art. 10 of the RDC 10, 21 March 2011.

This Resolution enter into force on the date of its publication.

Products covered: Medicaments and biological products

HS code: 30

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: NA

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.