Joint Resolution No. 1/2020: Health Emergency - Maximum Prices for Certain Drugs
The Joint Resolution No. 1/2020 of the Ministry of Health of the Nation and the Ministry of Domestic Trade of the Ministry of Productive Development (the "Resolution") published in the Official Gazette on November 6, provides for the setting of maximum prices of institutional sale to the public, private and social security subsystems of the entire country (the "Organisms"), for certain drugs, within the framework of the health emergency declared by the National Congress and expanded by the National Executive Power.
In this executive summary you will find the most relevant points of the Resolution:
- The drugs for which maximum prices are set according to the annex to the Resolution are Atracurium (50mg x 5ml ampoule), Pancuronium bromide (4mg x 2ml ampoule), Fentanyl (0.25mg x 5ml ampoule), Midazolam ( 15mg x 3ml ampoule) and Propofol (200mg x 20ml ampoule).
- The term for which the Resolution sets the maximum prices for institutional sales to the Entities is 150 days.
- Producers, distributors and marketers may not establish sales prices to the Organizations higher than those provided in the Resolution, without considering VAT.
- For non-detailed presentations of the active principles included in the annex to the Resolution, the maximum institutional sale price to the Bodies may not exceed 40% of the public sale price published for that same presentation, on the last business day of the October 2020, excluding VAT.
- The companies that are an integral part of the chain of production, distribution and commercialization of the medicines included in the annex to the Resolution must increase their production to the maximum of their installed capacity and must determine the necessary measures to ensure their transport, distribution and marketing throughout the country during the period of the health emergency.
- The laboratories that produce, processors and / or authorized to commercialize the indicated products, must inform the ANMAT and the Ministry of Health of their maximum production capacity. Said report must be made through the Remote Procedures Platform (TAD) within ten calendar days from the entry into force of the Resolution and must be updated periodically from the 1st to the 5th of each calendar month.
- Failure to comply with the provisions of the Resolution will be sanctioned in accordance with the provisions of Law No. 20,680.
- The Resolution will enter into force as of its publication in the Official Gazette (06.11.2020).
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