The sale of 75.4% of medicines in Brazil is exempt from PIS/Cofins taxes thanks to a decree published in the Diário Oficial da União last Friday, the 27th. The decree expanded the list of substances used in the manufacture of medicines that are exempt from the PIS/Pasep and Cofins taxes, adding 174 substances to the so-called “positive list,” which now includes more than a thousand items under the special tax regime.
The criteria for selecting the substances, defined by the Ministry of Health together with the Drug Market Regulation Chamber (CMED), take into account chronic and degenerative diseases, government health programs established through public policies, and the essential nature of the medicines for the population.
To qualify for the benefit, medicines must require a medical prescription, be identified with a red or black label, 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 that already participate in the special presumed credit regime. In addition, the Chamber will be responsible for monitoring medicine prices and ensuring that tax reductions are fully reflected in the price ceilings set for these products.
Pharmaceutical companies 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 the Granting of Presumed Credit on the National Health Surveillance Agency (Anvisa) website.
Source: A tarde UOL – Economia.