Countdown to Serialization

Pharmaceutical companies have until February 9, 2025 to update their production systems and adapt to the new regulations.

Starting from February 9, 2025, each drug package will be equipped with a unique identification code (data matrix) and an anti-tampering seal. These elements will guarantee the traceability of the product along the entire distribution chain, from production to the final patient, effectively combating the phenomenon of counterfeiting.

The Italian Government, within twelve months of the entry into force of the law (10 March 2024), must:

    Adapt national legislation to Delegated Regulation (EU) 2016/161: this will involve the introduction of a sanctioning system for violations of the new provisions on serialization.
    Link national provisions to the European regulation: the current national rules will be adapted to the European ones.
    Defining the management of the national archive: the Istituto Poligrafico Zecca dello Stato will collaborate with the NMVO (National Medicines Verification Organisation) for the establishment and management of the national archive containing information on the safety characteristics of medicines.
    Guarantee control of the archive: the Ministry of Health and AIFA will have access to the archive to monitor its functioning regarding:
        Investigations into potential cases of forgery
        Reimbursement of medicines
        Pharmacovigilance
        Pharmacoepidemiology

Normative requirements:

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by establishing detailed rules on the safety features appearing on the packaging of medicinal products for human use

Law 21 February 2024, n. 15 Delegation to the Government for the transposition of European directives and the implementation of other acts of the European Union - European Delegation Law 2022-2023.

NEWS - BIO CHEM S.R.L.