The Director General of the National Agency for Pharmaceutical Products, Sherif Delih, confirmed that the suspension of activity and the temporary closure of the pharmaceutical laboratories “Hope Pharm SARL HUP.P PHARMA” are due to the production of “falsified” medicines, after the results of the inspection carried out by it. National Agency for Pharmaceutical Products.
Dalih explained in a statement to Waj that this procedure concerns medicines “produced at unlicensed sites on the one hand, as well as changing the supply of active ingredients and raw materials from an unlicensed and uncontrolled supplier.”
As the Director General of the National Agency for Pharmaceutical Products indicated, these practices are sufficient reason that led to “the withdrawal of all shares from the market and their placement in quarantine, in addition to the closure and cessation of the production activity of the “Hope Pharma LLC” laboratories.”
The same official added that the laboratories concerned had directly violated the provisions of Article 211 of Law No. 18-11 relating to health, as well as the provisions of Executive Decree No. 21-82 relating to pharmaceutical institutions and the conditions for their accreditation, as well as Executive Decree No. 22-247 relating to the rules of good practices. To manufacture pharmaceutical materials for use in human medicine.
Dalih continued, “These measures were taken in a conservative manner in view of the confirmed effects of the results on the quality, safety and effectiveness of the medicines produced, as well as because of the potential risks to public health and health safety.”
For her part, the Director of Production, Industrial Development and Export Promotion, Nadia Bouabdellah, confirmed that the interests of the Ministry and the interests of the National Agency for Pharmaceutical Products are in the process of studying the measures taken by the laboratories of “LLC Hope Pharma” in order to comply with the requirements imposed by the Ministry. After its temporary closure.
Bouabdallah said, “Investigations are ongoing and the customer has been notified of the recorded deviations and is currently working to comply with the standards,” stressing that “reopening cannot be achieved except after the pharmaceutical institution lifts the reservations, and in some cases the penalty can reach Until the final withdrawal of accreditation.
She also clarified that this is not the first action of this kind taken against a pharmaceutical institution following an inspection of the production site to verify respect for good manufacturing practices with the aim of protecting public health.
She concluded by emphasizing that “all decisions taken during and after investigations related to a possible deficiency in quality must reflect the level of registered risk, given the requirements of the product registration file,” stressing that these decisions must be made “quickly in order to ensure patient safety.”
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