Overview:
The Resolution RDC No. 590/2021 published on December 29th, 2021, the List of Brazilian Common Denominations (DCBs). The regulation included 28 new designations and changed two.
Introduction
Brazil’s National Health Surveillance Agency (Anvisa) has approved for the updating of the list of Brazilian Common Denomination (DCB) is the name of the drug or pharmacologically active ingredient approved by the federal agency responsible for sanitary surveillance (Law No. 9.787/1999).
With the advent of electronic registration, it has acquired a broader conception and also includes the denomination of inactive ingredients, hyperimmune serums and vaccines, radiopharmaceuticals, medicinal plants, homeopathic and biological substances.
Important Explanatory Notes to the Brazilian Common Denomination
The historical field of the Consolidated List of Brazilian Common Appellations (DCB) contains information on the history of inclusions, rectifications, alterations and exclusions of DCB, as of the publication of Resolution – RDC nº 469, of February 23, 2021.
The nomenclatures in brackets are not in effect, according to their respective publications in the Official Gazette of the Union.
Classification Legend:
- BIO – biological products;
- EXA – excipients and adjuvants;
- HOM – homeopathic;
- API – active pharmaceutical ingredients;
- PM – vegetal species;
- RAD – radiopharmaceuticals;
- INF – pharmaceutical ingredients not classified in the DCB establishment process.
The input classification adopted in the Consolidated List of the BCDs is not related to any Anvisa approval of a purpose of use for the input. The purpose of use applied to the inputs is approved by Anvisa through specific acts, granted after evaluation and approval of products by Anvisa’s registration.
Technical Information on the Brazilian Common Denomination
Learn more about Radicals: translation, abbreviations and chemical groups: Available only in Portuguese
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides Pharma & life-consumer companies services to register their products in different countries in compliance with local regulations. GRP services include regulatory affairs, clinical, quality and safety services.
GRP headquarters is located in Massachusetts USA and its branch offices are located in China, Japan, Brazil, Mexico and South Korea.