News

Newsletter

New subject codes for filing applications for GMP certification for biological products industries

Last Friday, September 9th, the Brazilian FDA (ANVISA) published and made available new subject codes for submitting requests related to the Good Manufacturing Practices certifications – GMP (“BPF” in Portuguese) for biological products industries.

Formerly, the protocol was carried out under subject codes related to Medicines – Sterile Products. In such scenario, the Brazilian FDA faced difficulties in monitoring the processes, and the procedures were more complex.

According to the Agency, the applicant is not required to make any changes to the petitions that have already been filed, as they will be regularly analyzed by the responsible department.

Find below the list of new subjects that must be used for new requests:

For more news and content related to ANVISA, please do not hesitate to contact us at: regulatorio@kasznarleonardos.com.

Back

Last related news

September 13, 2023

New subject codes for filing applications for GMP certification for biological products industries

Last Friday, September 9th, the Brazilian FDA (ANVISA) published and made available new subject codes for submitting requests related to the Good New subject codes for filing applications for GMP certification for biological products industries

Ler notícia

September 13, 2023

BPTO publishes the 2nd ed. of the Industrial Designs Manual

By means of Ordinance INPI/PR Nr. 36 of September 6, 2023, published on September 12, 2023, the Brazilian PTO has published the BPTO publishes the 2nd ed. of the Industrial Designs Manual

Ler notícia

August 30, 2023

Approval of the Budapest Treaty moves forward in Brazil for International Recognition of the Deposit of Microorganism.

The approval of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure moves Approval of the Budapest Treaty moves forward in Brazil for International Recognition of the Deposit of Microorganism.

Ler notícia