ANVISA PUBLISHES PUBLIC CONSULTATION TO REGULATE THE IMPORT OF NON-REGISTERED PRODUCTS

On 10 April 2017, the Brazilian Health Surveillance Agency (ANVISA) published Public Consultation No. 327/2017, concerning the criteria and procedure for the import of non-registered products subject to health surveillance when exclusively intended for exceptional cases within programs of the Ministry of Health (MoH) in the Brazilian public health system.

The consultation proposes a resolution that aims to regulate the procedure for ANVISA to authorise the import of products without valid registrations in Brazil, including immuno-biological products, insecticides and strategic inputs that are purchased through multilateral international organisations. The consultation provides some requirements, such as:

• Registered therapeutically equivalent products in the Brazilian market must be unavailable.
• Imported products shall be prequalified by the World Health Organization or, if that is not possible, the products shall be registered in the country of origin or commercialisation and must be manufactured according to the good manufacturing practices of that country.

In addition, the consultation also identifies that the MoH shall establish mechanisms for public services to monitor the use of the imported products and for reporting technical complaints and adverse events to ANVISA.

Responses to the consultation may be submitted by interested parties from 17 April to 16 June 2017 through ANVISA’s website.

Source: ANVISA: Public Consultation No. 327/2017, 7 April 2017 (Portuguese Language).

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