Laws 13,410/2016 and 13,411/2016: National System of Drugs Control and New Terms for Conclusion of Analysis of Market Authorization Applica

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January 05, 2017


On December 29, 2016, Laws 13,410/2016 and 13,411/2016 were published on the Official Gazette, altering, respectively, the already existing Laws 11,903/2009 and 6,360/76 and 9,782/99. 

The main modifications brought by new laws concern to the implementation of a National System of Drugs Control, the implementation of new terms for conclusion of analysis of market authorization applications and new transparency mechanisms involving the publicity of administrative processes involving market authorization applications.

I – Law 13.410/2016

Law 13.410/15 provides for the creation of the National System of Drugs Control, which aims at controlling the production, distribution, commercialization and medical and odonatological prescription of drugs for human use. 

The control shall be performed by an automatized identification system which will read and analyze specific data that is contained in drugs packages.   

Moreover, Law 13.410/16 determines that the National Health Surveillance Agency – ANVISA shall issue specific regulation regarding the National System of Drugs Control, determining the specificities for implementation of the System within 4 months. 

All parties of the production and distribution chain of drugs will be obliged to feed information to the automatized system in order to inform relevant movements involving the drugs of their responsibility. 

As of the issuance of the specific regulation, after some randomized test phases, the National System of Drugs Control shall be completely implemented within 3 years. 

II – Law 13.411/2016

Modifications to Law 6.360/76 brought by Law 13.411/16 foresee to expedite and assure a more transparent administrative process for granting of market authorizations involving drugs in Brazil. 

The new regulation establishes new terms for analysis and decision of application for market authorization and post-registration modifications. As of Law 13.411/16 comes into force, ANVISA shall have to observe the following terms involving market authorization applications:

  1. 120 days to complete analysis and grant a decision involving drugs classified as “priority”[1], and
  2. 365 days to complete analysis and grant a decision involving drugs classified as “ordinary”. 


Furthermore, Law 13.411/16 determines that ANVISA must have to publicize information involving market authorization applications, post-registration modifications and requests for market authorization renewal. ANVISA shall have to inform at least the (i) current analysis status; (ii) estimated term for issuance of a final decision on the matter; and (iii) the technical grounds of the decision. 

Please note that the provisions involving publicity obligations shall be a relevant argument in access to information requests under Law 12,527/2011 (“Freedom of Information Act”).

The above-mentioned provisions shall entry into force in 90 days counted from their publication date.  

If you need any further clarification on this matter, please do not hesitate to contact us.


[1] The priority classification refers to the fast-track requests provided by ANVISA Resolution RDC 37/2014.


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