resolution - rdc n. 179 27 september2017. portuguese. this resolution amends the resolution - rdc n 39 of 14 august 2013. art. 4 of the resolution - rdc no. 39 of 2013 which provides for administrative procedures to grant certification of good manufacturing practices and certification of good distribution and or storage practices shall be in force with the following wording art. 4 - ................................. anvisa may use confidential information on inspections received under agreements or agreements with health authorities of other countries to subsidize the granting of the certification referred to in the caput of this article. nr it includes art. 4-a in the resolution - rdc no. 39 of 2013 with the following wording article 4-a - for health products the concession of the certification of good manufacturing practices referred to in the caput of article 4 regarding establishments located outside the national territory and mercosur may occur at the discretion of the anvisa i - from results of inspections carried out by anvisa in loco ii - upon presentation of a valid audit report attesting to the effective compliance with the technical regulation of good manufacturing practices for medical products and products for diagnosis of in vitro use as set forth in resolution rdc no. 16 of 28 03 2013 and its updates issued by a third auditor according to specific programs both recognized by anvisa iii - upon evaluation of technical documents requested by anvisa related to the quality assurance system of the company and to the verification of compliance with good manufacturing practices issued by the sanitary authority of the country of origin or by a third auditing body accredited by it as will be established in normative instruction to be published by anvisa. art. 5 of the resolution - rdc no. 39 of 2013 shall become effective with the following wording article 5 - ................................. anvisa may establish exceptions to the provisions of the caput of this article in favour of the efficiency and optimization of resources related to international inspections according to previously defined criteria. nr this resolution revokes the resolution - rdc no. 15 dated 28 march2014 published in the official gazette of the union of 31 march 2014.