Companies that manufacture Medicines, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, and Pharmaceutical Inputs located in Brazil, MERCOSUR or in other countries as well as companies that store, distribute and import Medicines, Health Products and Pharmaceutical Supplies located in Brazil must follow requirements set in RDC No 39/2013.

The validity of the Certification of Good Manufacturing Practices and the Certification of Good Distribution and/or Storage Practices must be renewed every two years from the date of its publication in the Official Gazette.

Incorrect petition for renewal of the Good Manufacturing Practices Certificate (CBPF) and the Good Distribution and/or Storage Practices Certificate (CBPDA) leads to the return or rejection of processes at Anvisa. Therefore, it is necessary that the company has attention when making the request and that it follows the rules of the RDC 39/2013, which provides on this subject.

How to Proceed:

Step 1:

Ensure that renewal petitions are linked to primary CBPF processes.

 In some cases, companies have made these requests by linking the petitions to Company Authorization processes (AFE) or by petitioning for a new primary process, which is incorrect, in both cases.

Step 2:

In order to be granted automatic revalidation and certification without interruption, applications must be filed between 270 and 180 days before the expiry date of the current certificate, according to RDC 39/2013. 

Step 3:

Applications shall be made using the renewal issue codes in cases where the last certificate issued is already linked to a good practice certificate process.

Regulatory Corner:

  • If the establishments are located in another country, the Certificate of Good Practices should mention the corporate name, CNPJ and Operating Authorization of the requesting importer.
  • Requests to include new pharmaceutical inputs, pharmaceutical forms or risk classes of health products in the Certificates of Good Manufacturing Practices will be subject to evaluation by the technical area and do not change the expiration date of the Certificate in force.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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