The Federal Government has expanded the list of substances used in the manufacture of medicines that are exempt from the PIS/Pasep and Cofins taxes. The decree published in the Official Gazette this Friday (27) includes 174 substances in the so-called “positive list,” which now contains more than one thousand items subject to the special regime. With the publication of the new decree, 75.4% of all medicines sold in the country are now exempt from PIS/Cofins.
The selection of substances covered by the presumed credit follows criteria previously established by the Ministry of Health along with the Drug Market Regulation Chamber (CMED). These criteria consider chronic and degenerative diseases, government health programs established through public policies, and the essential nature of medicines for the population. To qualify for the benefit, medicines must require a medical prescription, be classified under red- or black-label identification, and be intended for sale in the domestic market.
With the publication of the new list, the Executive Secretariat of the Drug Market Regulation Chamber (SCMED/ANVISA) will update the prices of products from companies already participating in the special presumed-credit regime. Additionally, the Chamber will be responsible for monitoring drug prices and ensuring that tax reductions are fully reflected in the price ceilings established for these products.
Pharmaceutical manufacturers that meet the criteria established in Decree No. 3.803/2001 but have not yet joined the special regime may submit a Request for Qualification for Granting of Presumed Credit on the website of the National Health Surveillance Agency.
Source: Jornal do Brasil
