The Brazilian health surveillance agency Anvisa launched a Public Consultation for a proposed change to a regulation that deals with the criteria and procedures to be followed when importing products which are subject to health surveillance but without registration with Anvisa, on an exceptional basis. The regulation is RDC 203, of December 26, 2017.
Public Consultation 775 (published in the official gazette DOU on January 28) was originally scheduled to be open from February 4 to February 18, but it was extended until March 4.
The purpose of this Public Consultation is to discuss a less bureaucratic review procedure by Anvisa in case of urgent import of drugs, thus allowing the universal healthcare program (SUS) users access to drugs without registration.
Under the new proposed text, the Ministry of Health and related agencies would have to follow a simpler import procedure, provided that there is proof of (i) grave risk to health and the absence of a registered therapeutic substitute, and (ii) a temporary or permanent shortage of a product registered in Brazil to be offered to SUS users.
Under the rule as currently in force, the Ministry of Health must request Anvisa’s authorization to import any drug that has not yet been analyzed for use in Brazil and Anvisa must reply in 10 business days from its receipt of such request for importation on an exceptional basis. Today, Anvisa is also in charge of monitoring any technical complaint and adverse events arising in connection with the use of such imported products.
Under the new proposed text, the Ministry of Health and its related agencies will be in charge of applying for such importation with Anvisa, on an exceptional basis, and such import will be automatically authorized in Brazil’s foreign trade system SISCOMEX. Nonetheless, it will be up to the Ministry of Health – and no longer to Anvisa – to monitor the quality, efficacy and safety of such imported drugs
Also worth noting is that, under the proposed text, the products to be imported on an exceptional basis must be prequalified by the World Health Organization. For non-prequalified products, the Ministry of Health may use the following criteria: (i) the product is validly registered in the country of origin; (ii) the product is registered with a regulatory agency that is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and (iii) the product has good manufacturing practices certification or similar certification issued by a country that is member of the Pharmaceutical Inspection Co-operation Scheme – PIC/S.
The use of the above criteria by the Ministry of Health is optional. Nonetheless, it will be up to the Ministry of Health to set any criteria for the purchase and importing of products that are subject to health surveillance but not registered with Anvisa, in case of public health emergency of national concern (as defined in Decree No. 7,616 of 2011) and public health emergency of international concern – PHEIC (as defined in the International Health Regulation).
Even though importation processes are to be automatically authorized under the proposed new rule, Anvisa may audit such procedure at any time and, if any irregularity is found, Anvisa may take all reasonable measures. In this case, responsibility for any damages arising from the purchase, provision and use in Brazil of any product not registered with Anvisa and acquired under the new rule will lie with the Ministry of Health and its related agencies.
Suggestions will be accepted until March 4. After that, Anvisa’s Plenary Board will vote.
