Member Article

On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatory
body) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. 

The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved. However, the matter
returned to the scene when the Brazilian Government created an Interministerial Group comprised of representatives from the Ministry of Health, Ministry of
Development, Industry and Foreign Trade, ANVISA, Brazilian PTO and the Attorney General of the Republic to examine the question. 

On May 25, 2012 the Group published a report which was approved via Ordinance No. 1065, proposing that pharmaceutical applications should first be
sent over to ANVISA to be examined. In case the application is approved by ANVISA it will return to the BPTO for further examination. However, if ANVISA rejects approval, the application will be shelved and the decision will be published in the Official Bulletin. 

Until the present date there are no further details on the procedures to be taken by both Agencies, but a Normative Act is expected to be issued on the matter. 

We shall monitor all information from the Normative Act to be issued on the instant subject and will keep all of you posted on developments.