Newsletter – March 2018

 

Newsletter7This newsletter covers the recent legislation related to following matters in Brazil:
1. Institutional information of Anvisa and MAPA;
2. Pharmaceutical products;
3. Food and Agribusiness.

Please do not hesitate to contact us should you need the legislation in English version for your convenience or any further clarification on the matter.
You may contact us by email at regulatoriolifescience@gmail.com


1. INSTITUTIONAL

Ordinance MAPA no. 249 of February 22, 2018
Approves the Code of Ethical Conduct for MAPA Officials.

Resolution RDC Anvisa no. 220 of March 9, of 2018
Amends Resolution RDC no. 61 of February 03, 2016, which approves and enacts Anvisa Internal Rules.


2. PHARMACEUTICAL PRODUCTS

Communiqué CMED no. 2 of March 6,2018
Discloses the Inter-Sector Relative Price Adjustment Factor (Factor Y) for 2018, relating to the adjustment of pharmaceutical prices.

Communiqué CMED no. 3 of March 9, 2018
Discloses, in Anvisa´s website, the list of new presentations of pharmaceuticals, recognized by the Technical Excecutive Committee as similar to those included in the list of Resolution no. 5, of October 9, 2003, which are also exempted from the criteria of adjustment or establishment of Factory Price dealt with in article 6, IV, of Law No. 10,742 of October 6, 2003.

Ordinance Anvisa no. 369 of March 19, 2018
Approves the Internal Rules of the Committee for Monitoring the Implementation of the Experimental Phase of the National Pharmaceutical Control System.

Executive Branch Decree no. 9,307 of March 15, 2018
Amends Decree no. 9,245 of December 20,2017, that institutes the National Policy on Technological Innovation in Healthcare.

Ordinance MS no. 559 of March 09, 2018
Amends the Consolidation Ordinance GM/MS no. 5 of September 28, 2017, to create the Action Plan for Clinical Research in Brazil.

Resolution RDC Anvisa no. 222 of March 28, 2018
Good Practices on Healthcare Waste Management.


3. FOOD and AGROCHEMICAL

Ordinance MAPA no. 266 of March 7, 2018

Defines the coverage area of Services in connection with the Monitoring and Inspection of Products of Animal Origin.

Resolution RDC Anvisa no. 221 of March 28,2018
Deals with the criteria and procedures for toxicological reevaluation of active ingredients of agrochemicals in the ambit of Anvisa.


Glossary
Anvisa – National Health Surveillance Agency
CMED – Medications Regulation Chamber
MAPA – Ministry of Agriculture, Cattle Breeding and Supply

This newsletter is meant for general information purposes only and should not be relied upon as legal advice on any specific deal or matter. The material shoul be shared through social networks.

 

 

 

 

 

 

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