Post by nilima78 on May 19, 2024 1:10:52 GMT -5
Last week, the 3rd Panel of the Federal Regional Court of the 4th Region upheld an appeal from the National Health Surveillance Agency and prevented a compounding pharmacy in Criciúma (SC) from producing controlled medication for stock without a prior prescription.
After analyzing the appeal, the Lithuania Email List case's rapporteur, federal judge Carlos Eduardo Thompson Flores Lenz, stated that Anvisa was created to protect the population's health. According to him, the agency has police powers to guarantee sanitary control over the production and sale of medicines.
First instance decision, handed down in October last year, allowed production and stock without revenue. The Agency appealed to TRF-4. For the municipality, the sentence would be contrary to Law 5,991/73, which regulates the sanitary control of drug trade.
According to Anvisa, authorizing production without a prescription would put public health at risk. The objective of the regulation that requires the existence of a prescription for the production of controlled medicines is to guarantee their quality and allow for more effective supervision.
Lenz highlighted in his vote that the restriction on the production of medicines does not affect the exercise of business activity, which can occur normally, as long as the resolutions issued by the supervisory body are followed. With information from the TRF-4 Press Office.