Find out the codes needed to start updating orders.
The Brazilian Health Regulatory Agency (Anvisa) is announcing the availability of new subject codes for submitting requests related to the Certification of Good Manufacturing Practices (GMP) at manufacturers that produce biological products.
Previously, requests of this type were filed using subject codes related to Medicines – Sterile Products, which generated challenges in the administration and control of processes by the responsible team.
It is important to note that applicants do not need to take any action on already filed petitions, as they will continue to be substantiated by the usual procedure.
Below you will find a list of new subject codes made available, which should be used for new orders from now on. This update aims to improve efficiency and accuracy in the processing of these important benefits.
Subject code Generating event Description of the petition subject
| 70851 | 39918 | BIOLOGICAL PRODUCTS – GMP Certification of the Mercosur Biological Products Industry |
| 70852 | 39926 | BIOLOGICAL PRODUCTS – GMP Certification of International Biological Products Industry except Mercosul |
| 70853 | 39918 | BIOLOGICAL PRODUCTS – GMP Certification from the Brazilian Biological Products Industry |
| 70854 | 39918 | BIOLOGICAL PRODUCTS – Renewal of GMP Certification for the Mercosur Biological Products Industry |
| 70855 | 39926 | BIOLOGICAL PRODUCTS – Renewal of GMP Certification for the International Biological Products Industry except Mercosul |
| 70856 | 39918 | BIOLOGICAL PRODUCTS – Renewal of GMP Certification of the Brazilian Biological Products Industry |
| 70857 | 0 | BIOLOGICAL PRODUCTS – Inclusion of Pharmaceutical Form(s) in International GMP Certificate Production Line(s) |
| 70858 | 0 | BIOLOGICAL PRODUCTS – Inclusion of Pharmaceutical Form(s) in Brazilian GMP Certificate Production Line(s) |
| 70859 | 0 | BIOLOGICAL PRODUCTS – Addition (Certification and Inspection) |
| 70860 | 0 | BIOLOGICAL PRODUCTS – Administrative Appeal (Certification and Inspection) |
| 70861 | 0 | BIOLOGICAL PRODUCTS – Publication Rectification – Anvisa (Certification and Inspection) |
| 70862 | 39985 | BIOLOGICAL PRODUCTS – Publication Rectification – Company (Certification and Inspection) |
| 70863 | 0 | BIOLOGICAL PRODUCTS – Addition – change of applicant for International GMP Certificate (not yet published) due to corporate operations |
| 70864 | 0 | BIOLOGICAL PRODUCTS – Addition – change of applicant for Brazilian GMP or BPDA Certificate (not yet published) due to corporate operations |
| 70865 | 0 | BIOLOGICAL PRODUCTS – Change of Company Name in Current Certificate of Site Product Certified in Other Countries or Mercosur |
| 70866 | 0 | BIOLOGICAL PRODUCTS – Update of International GMP Certificate as a result of corporate operations or commercial operations |
| 70867 | 0 | BIOLOGICAL PRODUCTS – Update of Brazilian GMP or BPDA Certificate as a result of corporate transactions or commercial operations |
| 70868 | 0 | BIOLOGICAL PRODUCTS – Conclusive Report on the Recall of Medicines (Biological Products) |
| 70869 | 0 | BIOLOGICAL PRODUCTS – Monitoring Reports on Recall of Medicines (Biological Products) |