Brazil : Updated Regulations on Pharmaceutical Registration

tradecircular

27-11-2014

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 413/2

27 November 2014

Dear Sirs,

Commercial Information Circular No. 1013/2014

Brazil : Updated Regulations on Pharmaceutical Registration

The National Health Agency of Brazil ("Agência Nacional de Vigilância Sanitária"/ANVISA in Portuguese) issued Resolution No. 60/2014 on 10 October 2014 to establish the criteria and basic documentation required for the registration and renewal of pharmaceutical products with synthetic and semi-synthetic active ingredients, classified as new, generic and similar ones. The Resolution will take effect from 13 January 2015.

2. For registration of pharmaceutical products, it requests the submission of, among others, a document confirming good manufacturing practices issued by the agency responsible for health surveillance in the manufacturing country, a technical report for the formulation development, and a summary report on the validation of the manufacturing process. The Resolution also simplifies the registration procedures for renewal.

3. For details, traders are advised to consult their importers in Brazil and/or the above Brazilian Resolution (in Portuguese) at: http://www.poderesaude.com.br/novosite/images/publicacoes_13.10.2014-III.pdf.

ENQUIRIES

4. For enquiries about the content of this circular, please contact Mr Lewis LAU at telephone number 2398 5405.

Yours faithfully,

(Ms Cindy CHENG)
for Director-General of Trade and Industry

Note:

While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.

2024-10-04

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