Overview:

In Brazil, drugs and pharmaceuticals must follow “the minimum discount rule”  of the Drugs Market Regulation Chamber (CMED) for public procurement of drugs and pharmaceuticals inputs. Cases of non-compliance must be reported and are taken seriously by CMED.

Guidance Key Points:

Drug Market Regulation chamber (CMED)

The Drugs Market Regulation Chamber (CMED) is an inter-ministerial body responsible for the economic regulation of drugs buying and selling activities in the country. One of CMED’s standards is that distributors, manufacturers, sales representatives, pharmacies and drugstores must comply with the mandatory minimum discount for public procurement of drugs.

CMED Enforcement of “Minimum Discount Rule”

Complaints should be made whenever companies do not apply the Coefficient of Adequacy (CAP), currently set at 20.16%, which is levied on the factory price (PF) of drugs, resulting in the maximum value of sales to the government (PMVG), which is the ceiling for government purchases.

The records of complaints must be forwarded to the Executive Secretariat of CMED, performed by Anvisa, or to the Federal or State Public Prosecution Service, which will forward the report to CMED.

CMED reinforces that it is essential to comply with this procedure, especially in the current scenario of the Covid-19 pandemic and the great demand for the purchase of drugs by health managers to confront the disease.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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