EMA reminds companies about Article 58 applications

The European Medicines Agency (EMA) has published a document on the regulatory support available to companies seeking to submit applications via the Article 58 procedure to try to encourage its use.

Article 58 of Regulation (EC) No 726/2004 is available for medicinal products for human use if they are intended exclusively for markets outside the EU. Eligible medicines are those used to prevent or treat diseases of major public health interest such as HIV/AIDS, malaria, or tuberculosis.

The EMA’s committee for Medicinal Products for Human Use (CHMP) carries out a scientific assessment of an Article 58 application and consults with the World Health Organisation (WHO) before adopting a scientific opinion.

The document reminds companies of 3 main areas of support:

  • The EMA recommends obtaining scientific advice on quality, non-clinical and clinical aspects in the context of the intended markets outside the EU. Experts from WHO and national regulators may be involved in this procedure.
  • The EMA encourages companies to present their development pipeline at specific ‘business pipeline meetings’. These meetings are an opportunity to discuss their pipelines with a small group of senior agency staff to identify areas where the company may need future guidance.
  • Having small and medium-sized enterprise (SME) status in order to be able to request financial, regulatory and administrative assistance from the ‘SME office’.


Additionally, EMA says that accelerated assessment, conditional approval and approval under exceptional circumstances are potentially available for Article 58 applications.

To read the EMA document, click here.