Compassionate Use: EMA supports Submission of Medicinal Product Information

Recommendation

27-29 February 2024

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To support voluntary submissions of medicinal product information for medicinal products supplied in the European Union (EU) or the European Economic Area (EEA) that fall out of scope of the Article 57 requirements (e.g. parallel importation, emergency use, compassionate use), new 'Legal basis' values will be made available in the Article 57 database.

What is Compassionate Use?

The term compassionate use refers to the use of not yet authorized medicinal products for patients in particularly serious cases of illness that cannot be treated satisfactorily with currently authorized medicinal products.

The European Medicines Agency, EMA, defines compassionate use as follows: "Compassionate use is a treatment option that allows the use of an unauthorized medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorized therapies and who cannot enter clinical trials."

Extended EudraVigilance medicinal product dictionary (xEVMPD) "Article 57 database" - New legal basis

According to the agency, the addition of the new legal basis will allow companies supplying products without a marketing authorization in the EU / EEA, which are provided under emergency use, compassionate use or other national schemes, to correctly record and identify such products in the Article 57 database, on a voluntary basis. However, companies are not required to perform a dedicated, immediate update of their product entities in the Article 57 database to reference the new legal basis values, as this can be done as part of a regular maintenance.

The EMA has published a notice on its website in which it also announces the adaptation of the corresponding documents. These include the "Legal Basis" and the "Detailed Guidance Chapter 3.II".