Error of the Chief Pharmaceutical Inspector

On December 7, 2022, the following announcement was issued: "The Wielkopolska Voivodship Pharmaceutical Inspector reminds you of the obligation to serialize medicinal products when accepting them at the pharmacy and when dispensing them to the patient. A medicinal product that does not undergo proper verification cannot be issued to a patient. The Wielkopolska Provincial Pharmaceutical Inspector pays special attention to Clexane 0.04/0.4ml of the FCD61A series, which, according to the request of the Chief Pharmaceutical Inspector, in the absence of a positive serialization message, is to be returned to the pharmaceutical wholesaler as part of the complaint.”

The Provincial Inspector used an incorrect term, because drug manufacturers are required to serialize drugs, while pharmacies are required to verify the authenticity of drugs in the PLMVS system.

On December 9, 2022, the MAH issued a letter in which it states, inter alia, that "in relation to the batch in question, the manufacturer carried out explanatory activities which confirmed the discrepancy consisting in the presence of the same SN code printed on different unit packages of the product, in within the same FCD61A production series. The reason for this deviation was a communication failure of the serialization system at the manufacturer's batch packing level. Due to the fact that the product is qualitatively appropriate and safe to use for the patient, we recommended our position to the Pharmaceutical Inspection to leave this series of the product on the market."

It is very worrying that the mistake made at the very beginning by the manufacturer has gone all the way to distribution, despite the fact that the drug verification system has been in force since February 9, 2019.

The Chief Pharmaceutical Inspector (GIF) as the central authority of the government administration, exercises supervision to the extent resulting from the provisions of the pharmaceutical law and other acts. GIF's consent to the company's recommendations is more than a mistake - it is a violation of generally applicable law.

M.Sc. farm. Walenty Zajdel