23.06.2026
To the attention of interested persons
Information concerning the measure to block certain batches of finished products certified for the Romanian market, belonging to the manufacturer Labormed-Pharma S.A., until the evaluation of the investigations undertaken by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) is completed
Following inspections carried out by the General Directorate for Pharmaceutical Inspection of the NAMMDR at the manufacturing site located at 44B Theodor Pallady Blvd., sector 3, Bucharest, belonging to the medicinal product manufacturer Labormed-Pharma SA, some non-compliances with Good Manufacturing Practice (GMP) rules were identified.
Following the investigation report finished on 4 June 2026, the NAMMDR requested the blocking of all batches of certified finished products for the Romanian market, impacted by the identified quality defect, including those in the manufacturer’s central warehouse, and the transmission of notifications to block the impacted stocks throughout the entire supply chain up to the pharmacy level.
We would like to point out that the manufacturer currently owns batches of compliant medicinal products which they can place on the market. The NAMMDR has allowed the continuation of manufacturing activities after resolution of the non-compliances, so that the manufacturer can place on the market the necessary stocks, in order to cover the needs of Romanian patients. All batches manufactured after 20.04.2026 can be marketed, as they have not been affected by the quality defect. At the same time, 68 batches of medicinal products manufactured prior to this date, for which it has been proven that they have not been impacted by the non-compliance, can also be marketed.
For good information and coordination at international level, the NAMMDR has sent a rapid alert notification (RAN) on 5 June 2026 to all partner competent authorities and relevant European institutions.
The blocking of the marketing of the impacted batches shall remain in force until the taken measures are evaluated and the necessary evidence regarding the fulfilment of the appropriate quality requirements and the absence of risks for patient safety is provided.