Overview
The transfer of Good Manufacturing Practice Certificates (GMP) at Anvisa is a specific process, usually related to changes in certificate ownership due to corporate reorganization, such as mergers or acquisitions.
In order to change the ownership of a company with a Good Manufacturing Practices Certificate (GMPC) at Anvisa, it is necessary to submit a request via the Solicita system. This process includes updating registration data, but does not alter the technical and health characteristics previously approved. The CBPF, in itself, is not considered a transferable asset between companies; however, the change of ownership can occur if it also involves the transfer of registration of products manufactured at the plant.
It is not possible to just transfer the Good Manufacturing Practices Certificate (GMPP) without transferring ownership of the products manufactured in the certified plant. According to Anvisa, the CBPF is linked to the plant and the specific products registered under its ownership. The only circumstance in which a CBPF transfer occurs is when there is a change in ownership of the registrations for the products manufactured at that plant.
Introduction
Anvisa considers the Certificates GMP to be a technical document attesting to the plant’s compliance with Good Manufacturing Practices standards, but it is not transferable in isolation between companies. Therefore, any operation involving the Certificates GMP must include the transfer of product registrations, maintaining the relationship between the plant and the products for which the certificate was issued.
It is not possible to just transfer the Good Manufacturing Practices Certificate (Certificates GMP) without transferring ownership of the products manufactured in the certified plant. According to Anvisa, the CBPF is linked to the plant and the specific products registered under its ownership. The only circumstance in which a CBPF transfer occurs is when there is a change in ownership of the registrations for the products manufactured at that plant.
In order to change the ownership of a company with a Good Manufacturing Practices Certificate (GMP) at Anvisa, it is necessary to submit a request via the Solicita system. This process includes updating registration data, but does not alter the technical and health characteristics previously approved. The Certificates GMP in itself, is not considered a transferable asset between companies; however, the change of ownership can occur if it also involves the transfer of registration of products manufactured at the plant.
What is the GMP Certificate and Why is it Important?
The Certificates GMP certifies that a plant operates according to Good Manufacturing Practices (GMP), guaranteeing the quality and safety of the products. This certificate is a requirement for registering products with Anvisa and must be renewed periodically, usually every two years.
Transfer of Ownership of Products
When ownership is transferred, for example, due to the sale of a product or the merger of companies, the new owner must ask Anvisa to update the registration. This includes submitting supporting documentation and paying the corresponding fees, depending on the company’s economic size.
Important: The change of ownership does not directly affect the Certificates GMP, as long as the plant remains unchanged and under regulatory compliance.
Transfer of Certificates GMP
The Certificates GMP is not transferable from one company to another. However, when a plant changes control, the acquiring company must ensure that the previously certified processes and standards remain compliant. If there are significant changes in operation or location, a new inspection and certification may be required.
Fee involved
Both processes are subject to the Health Surveillance Inspection Fee (TFVS). The amounts vary according to the size of the company:
- Large companies pay the full amount.
- Micro, small and medium-sized enterprises receive proportional discounts.
Tips for companies
- Planning is essential: Anticipating renewal and transfer deadlines avoids interruptions in production or marketing.
- Maintain compliance: Any change in the production process must be reported to Anvisa.
- Use the Solicita System: All petitions related to Certificates GMP, and product registrations must be made through the agency’s official portal.
Maintaining regulatory compliance is key to ensuring competitiveness in the market and protecting public health. For more details, consult the guides and legislation available on Anvisa’s official website.
About Global Regulatory Partners
Global Regulatory Partners is a company that specializes in regulatory matters such as registering companies and products with ANVISA, INMETRO, as well as hosting product registrations for foreign companies interested in bringing their products to Brazil.
What are the advantages of hiring a consultancy?
There are many advantages to choosing a regulatory consultancy. We can highlight the agility, specialized knowledge, practicality and security of handling the entire process.
In addition, there is less bureaucracy when you hire specialists who are able to help at all stages, making it easier for the interested party.
Finally, we can conclude that hiring a company specializing in regulatory affairs in Brazil brings many benefits to those who hire it.
You can find out more about the subject or clarify your doubts by talking to one of our experts.
Conclusion
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
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, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.