On November 17, the Ministry of Health put out for public consultation a draft regulation on drug control. The measure, which modifies the Central American Technical Regulation 472:2014, lays down provisions related to the quality control processes of batches of medicines that are commercialized in Costa Rica. Interested parties can send their comments through the following website until November 27.
The initiative states that whenever the quality control process performed on the first marketing batch of a medicine tests negative, the distribution of that batch must be suspended and it is withdrawn from the market. If the analysis of a second batch shows that the drug still fails to comply with the corresponding specifications, all batches of the medicine are withdrawn from the national market and its health registration cancelled.
A company sanctioned with the cancellation of their health registration cannot register any other drug with the same active ingredient, the same pharmaceutical form and concentration by the manufacturer involved for three years. Finally, in case there is no alternative to the medicine in the Costa Rican market, the Ministry of Health will make a risk/benefit assessment to determine whether it is appropriate to cancel the drug’s health registration or not.