Tag Archives: medicines

A new decree (and new obligations) to tackle counterfeiting in the pharmaceutical sector

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On January 28, 2025 the Italian government approved a legislative decree (“Decree”) implementing EU regulation 2016/161 through which the European Union has introduced specific measures aimed at fighting counterfeit medicines.

Packaging. Packaging of pharmaceutical products will have to include: (i) a two-dimensional bar code (i.e. “unique identifier”) able to guarantee the authenticity and the identification of the single individual pack of medicinal products; and (ii) an anti-tampering device.

Marketing authorization. Any new or existing marketing authorization (“MA”) requests must include information on the unique identifier and anti-tampering device when it has an impact on the primary packaging, the locking system or the label’s legibility. MA holders must update their MA to ensure full compliance with the new regulation.

Timeline.  The Decree should come into force on February 9, 2025, but its publication in the official Gazette is still awaited. However, the Decree has provided for a transition period between February 9, 2025, to February 8, 2027, where it will be possible to continue using the old “Bollino” system without incurring penalties.

Sanctions.  The manufacturer who does not apply and activate the unique identifier may be sanctioned with an administrative fine ranging from Euro 10,000 up to 60,000 for each batch. An MA holder may be sanctioned with a fine, ranging from Euro 10,000 up to 60,000 for each batch, for trading a medical product lacking an anti-tampering device. Manufacturers, wholesalers, and suppliers of medicines to the public who do not notify immediately to the competent authorities of any case of tampering or counterfeiting may be sanctioned with a fine starting from Euro 20,000 up to Euro 80,000 for each batch.

AIFA Guidelines Regarding Observational Studies on Medicines: What’s New?

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The Italian Medicines Authority (“AIFA”) has recently issued new guidelines for the classification and conduct of observational studies on medicines (“Guidelines”) repealing the previous version of 2008. Through such new Guidelines AIFA has given full implementation to what was provided for in Article 6, par. 3 of the Ministry of Health November 30, 2021 decree, which had mandated that AIFA issues new guidelines for the classification and conduct of observational studies on medicine.

The new Guidelines have extended the perimeter of observational studies and now include:

  • Retrospective studies related to unauthorized uses;
  • Pharmacogenetics and pharmacogenomics studies;
  • Databases and other data on drug therapies collected through online platforms, wearables, or other devices when the following conditions are met:
    1. They pursue the aim of keeping track of the medicines used by patients;
    2. They follow a specific protocol;
    3. They are carried out in accordance with Guidelines’ indications.

Other new elements introduced by the Guidelines are:

  • The duty for ethics committees, in case of non-profit observational studies, to verify the independence from commercial promoters;
  • The duty to insert a specific section on informed consent in the protocol;
  • The duty to publish the results of the research (even if they are negative) within 12 months from the end of the study;
  • The duty to retain documents on observational studies for 7 years;
  • The possibility for the territorial ethics committee to apply a fee on profit observational studies;
  • The inclusion of universities among facilities where observational studies can be carried out;
  • The inclusion of new documents that the promoters must submit to ethics committee, such as a cover letter with the precise identification of the competent ethics committee, a summary of the protocol, and investigators/coordinators’ curricula; 
  • The duty of the legal representative of the research centre to execute an administrative agreement prior to the start of the study.

The Guidelines confirm that there is no mandatory AIFA assessment on observational studies, even though the ethics committee may decide to consult AIFA if necessary. The Guidelines also confirm the duty to transmit the information on the studies to the “Registry of observational studies” run by AIFA.

The definition of observational studies has not changed, i.e., studies that meet the following conditions:

  • Medicines are prescribed and delivered according to the conditions of use authorized for marketing in Italy;
  • Medicines are prescribed in the normal clinical practice;
  • The decision to prescribe the medicine to the patient must precede and be independent with the decision to include the patient in the study;
  • Diagnostic and evaluative procedures correspond to the current clinical practice without leading to negative consequences for the patient or the National Healthcare System.

EMA Issues New Guidelines to Prevent Medication Errors

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On April 14, 2015 the European Medicines Agency (“EMA”) released two drafts of good practice guides aimed at improving the reporting, evaluation and prevention of medication errors. The new guides are addressed to regulatory authorities, as well as the pharmaceutical industry.

Medication errors generally refer to unintended mistakes in the processes of prescribing, dispensing or administering of medicinal products in clinical practice and according to EMA they account for an estimated 18.7 – 56% of all adverse drug events among hospitalized patients.

The first guide released by EMA provides an overview of the main sources and types of medication errors, as well as measures to minimize the risks that such errors are made. The second guide, on the other hand, focuses on suspected adverse reactions caused by medication errors, providing guidance and recommendations on how to record, code, report and assess such errors.

The guidelines from EMA recommend a number of actions to marketing authorization holders, including the periodical reporting of information concerning medication errors. Recommendations to the industry include periodical safety update reports and risk management plans to be adopted for each marketed pharmaceutical product. The overall scope of these reporting obligations is to implement a real-life continuous evaluation of the risks and benefits of all medicines placed on the European market.

The two draft guidelines are now open to comments from all relevant stakeholders: the public consultation procedure will expire on June 14, 2015. The final version of the guidelines is expected to be finally adopted later in 2015.

More information and the new draft guides can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002307.jsp&mid=WC0b01ac058004d5c1.