Greece is following in the footsteps of Europe, as the traditional one is abolished on February 9, 2025 film of authenticity at medicines and will give way to modern serial QR codes.
This change with the authenticity tape is based on the regulation 2016/161 of the European Commission, aiming to strengthen safety and transparency in the pharmaceutical market, limiting the circulation of falsified medicines.
Greece, along with Italy, received two extensions to implement the regulation, delaying the full transition that had begun in the rest of the EU from 2019.
Greek pharmaceutical companies have until February to adjust their stocks, while products with the old tape can be made available for another 1-2 years.
Just recently, in fact, the National Medicines Agency (EOF) identified another mistake in the authenticity films of a widely consumed drug:
New safeguards against counterfeit medicines
The implementation of the new system is done through the Hellenic Medicines Verification System (HeMVO), financed and managed by Marketing Authorization Holders (MAHs).
The new system promises to shield the credibility of the pharmaceutical market and protect consumers from counterfeiting risks.
As specifically stated on the website of the Hellenic Medicines Verification System (HeMVO), the new system aims to combat the phenomenon of “counterfeit medicines”.
“In June 2011 the European Parliament and the Council issued Directive 2011/62/EU[1]also known as the falsified medicines directive. The purpose of the directive was twofold: i) to address the increase in the number of falsified medicines found in the EU and ii) to strengthen the supervision of the legal supply chain of medicines for human use.’
According to HeMVO, the directive introduced harmonized European rules to ensure that counterfeit medicines do not enter the legitimate single market supply chain and reach patients.
“Stipulates that prescription drugs for human use must carry safety features on their packaging. European citizens have the right to use safe, quality and effective medicines. Counterfeit medicines may contain ingredients of low quality or in an inappropriate dosage – too high or too low – and therefore pose a serious threat to the health of EU citizens.”
What does the relevant regulation say about the new system?
Article 38 Data protection and data ownership
1.Manufacturers, marketing authorization holders, wholesalers and persons licensed or authorized to make medicines available to the public are responsible for the data generated when using the repository system and stored in the audit trail. They have ownership and access only to this data, with the exception of the information referred to in Article 33(2) and the information related to the status of a unique identification code.
2.The legal entity (NMVO) managing the repository (NMVS) in which the audit trail is stored does not have access to the audit trail and the data contained therein without the written consent of the legal owners of the data, unless the purposes are served investigating possible incidents of falsification flagged in the system in accordance with Article 36.
By Gianna Soulaki \ Source: Iatropedia.gr