Non-licensed medicines of advanced treatments (cell therapies-ATMP) are a serious risk to public health.

The European Medicines Agency (EMA) and the Organization of the Heads of Medicines Agencies, HMAs, warn the public about the risks of non -licensed medicines (Advanced Therapy Medicine MEDICINALLA Products, ATMP).

ATMPs are drugs based on cells, tissues or genes.

When advanced treatments (ATMP) are licensed (that is, their use has been approved either by EMA or by the competent National Authority – AEO for Greece), they can provide significant benefits as they follow the guidelines established by the EU to ensure that they are required to ensure that they are required to meet the requirements.

However, the disposal of non -licensed ATMP countries has been found by individuals or companies or clinics, including dendritic cell therapies against cancer. Unsaturated advanced treatments are not tested in their safety, efficacy and quality. Consequently, their use poses serious risks, as they can cause serious side effects without at the same time providing benefits, leaving patients not only unsecured against the disease for which they seek treatment and burden on additional health problems.

In addition, these treatments are accompanied by significant financial costs.

National authorities across the EU are taking measures to stop the disposal of such products in patients. The contribution of the public is crucial to the success of this effort, by reporting the suspicious cases in the AEO ([email protected]). The following information is provided for this purpose:

How are ATMPs legally provided in Greece?

In Greece, all advanced-atmp remedies, including products made from cells or tissues of the patient themselves, are legally only available if:

• provided in the context of a clinical trial approved by the AEO

• have received a registration license from EMA

ATMPs available in patients and do not meet at least one of the two criteria above violate the law and put patients at risk.

What are the suspicious indications of an unlawful disposition of an ATMP in Greece?

• The provider has the product on the market as an experimental but grant it out of approved clinical trial

• The provider does not confirm that the product has received a marketing authorization by EMA or that it is granted under an approved clinical trial

• The product is promoted to websites or social media as the last hope, aiming for the concerns of patients and their families (however, it may also be suggested directly to the sufferer or their relatives by an individual person or clinic or clinic).

If you suspect that the product they are recommending is unlawful

  • Contact reliable sources of information, such as EOF (email: [email protected] https://www.eof.gr/) or the European Medicines-EMA to confirm that its use has been approved for this therapeutic indication
  • Contact specialized doctors to discuss the approved possible treatment options for your condition – do not hesitate to seek a second opinion.