Biofarm announced that the medicine Colebil can no longer be temporarily marketed in Romania, after the National Agency for Medicines and Medical Devices in Romania (ANMDMR) decided to block the sale of the entire distribution chain. The company claims the decision is not related to product quality or safety.
The announcement was made on Tuesday, August 4, through a report sent to the Bucharest Stock Exchange (BVB), in which Biofarm specifies that the measure targets both Colebil dragees and Panzcebil gastro-resistant dragees.
“For Colebil products, dragees, Panzcebil, gastro-resistant dragees, a decision was issued to block the sale of the entire distribution chain, up to the level of pharmacies, as a result of the request of the National Agency of Medicines and Medical Devices in Romania, in order to clarify the documentation for the mentioned products”according to the company’s report, according to Agerpres.
The representatives of Biofarm emphasize that the decision has an administrative nature and is not determined by problems regarding the quality or safety of the two drugs.
“These products continue to meet quality and patient safety standards,” company representatives said.
For now, Biofarm has not specified how long the measure will remain in force, nor when the marketing of the two products could be resumed.
The sale will be able to resume after the completion of the process of clarifying the documentation requested by ANMDMR.
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