Brazil - Draft Technical Resolution No 273, 10 November 2016, regarding the outsourcing of manufacturing stages, analysis of quality control and storage of drugs

Brazilian Health Regulatory Agency (Anvisa)has issued draft Technical Resolution N° 273, 10 November 2016, regarding the outsourcing of manufacturing stages, analysis of quality control and storage of drugs

The outsourcing petitions which were protocoled or accepted until the date of publication of this Resolution remain valid for 12 (twelve) months

This Draft Resolution revokes the Resolution RDC n. 25/2007 and the Resolution  RDC n. 26/2013

Proposed date of adoption: To be determined after the end of the consultation period

Proposed date of entry into force: On the date of publication

Final date for comments: 19 December 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.