On September 18, the Brazilian Health Surveillance Agency (“ANVISA”) published Resolution-RDC 304, dated as 17/09/2019 (“Resolution 304”), to provide for Best Practices for the Distribution, Storage and Transportation of pharmaceutical products (“BPDST”).
Resolution 304 revises and modernizes Ordinance 802, dated 10/08/1998, which established the control and inspection system for the entire pharmaceutical chain (“Ordinance 802”), one of ANVISA’s oldest regulations at 21 years.
The legal instruments of Resolution 304 aim to promote better control and traceability over the drug distribution, storage and transportation chain to ensure higher quality of these products during such logistic phases, and represents an important tool against counterfeit, unapproved, illegally imported, stolen, damaged or adulterated pharmaceutical products.
Resolution 304 will enter into force on 03/18/2020, with the exception of article 7, whose validity and effectiveness began on the official date of publication of Resolution 304. This article allows the acquisition of drugs from distributors that are not holders of the product’s marketing authorization, provided that the traceability of the chain is ensured through the National Drug Control System (“NDCS”). If the NDCS is not applicable, the traceability must be certified through documents proving that the origin of the products is lawful and authentic.
The transportation companies will also have 12 months from the date Resolution 304 enters into force to apply the corrective actions necessary to implement passive or active temperature and humidity control systems necessary to maintain the conditions required by the product’s marketing authorization and other specifications applicable to the product, as provided for in Article 64, item III of Resolution 304.
With the entry into force of Resolution 304, Ordinance 802 and Resolution-RDC 320 of 11/22/2002, which deal with commercial transactions and circulation of pharmaceutical products, will be fully repealed.
The Public and Regulatory Law team has been following the subject and remains available for any further clarification.