Tthe National Authority for Medicines and Health Activities (Infarmed) has suspended the license to two distributors for illegal export of a drug and for “serious irregularities” in drug distribution activity and has filed nine infringement proceedings.
In a note sent to the Lusa agency, Infarmed also says it has 10 other cases with additional investigations underway.
One of the distributors who had his license suspended was identified to market a medicine to the intra-Community market when it had been banned for public health reasons. The other had several serious irregularities during the distribution activity.
Infarmed recalls that since August, when the new legislation came into force that only allows exports of medicines to Europe if the Portuguese market is stocked, to avoid ruptures in pharmacies, 173 inspections have been made to several entities.
Among the entities inspected were 56 laboratories, 25 wholesale distributors and 92 pharmacies, covering mainly 157 medicines.
The National Medicines Authority explains that, among the various irregularities, it identified non-supply or unfair supply by pharmaceutical industry laboratories in situations of stock and non-fulfillment of pharmacy orders even when stock was available. medicines concerned in the stores of wholesale distributors.
It was also detected “the communication of faults to the National Association of Pharmacies (ANF), electronically, despite the existence, in some cases, a significant number of packages in stock in pharmacies,” explains the note.
Infarmed underlines that it has been developing various inspection and market surveillance actions, already in accordance with the new legal framework, “in order to verify the availability of medicines and to verify the fulfillment of the supply and dispensation obligations by the circuit entities. of the medicine ”.
Cited in the statement, Infarmed president Rui Santos Ivo points out that the problem is complex and “affects all European countries”, and the Medicines Authority “is doing everything to combat this phenomenon”.
“Infarmed will continue to act incisively to preserve the Portuguese’s confidence in the drug circuit and its stakeholders,” says the official.