Article 58 applications: Regulatory and procedural guidance

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Article 58 of Regulation (EC) No 726/2004 allows the Agency's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with the World Health Organization (WHO), on medicinal products for human use that are intended exclusively for markets outside of the European Union (EU).

Medicines eligible for this procedure are used to prevent or treat diseases of major public health interest. This includes vaccines used in the WHO Expanded Programme on Immunization or for protection against a public health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria, or tuberculosis.

The CHMP carries out a scientific assessment of applications submitted under Article 58, and, after consultation with the WHO, adopts a scientific opinion. A summary of opinion is published at the time of adoption of the opinion.

For all positive opinions adopted under Article 58 the Agency prepares and publishes a European public assessment report (EPAR), which reflects the scientific conclusions reached at the end of the evaluation process.

Promoting awareness and use of Article 58

The Article 58 procedure was introduced in 2004 to help increase access to medicines by low- and middle-income countries and improve public health.

EMA has in place a range of regulatory tools to support applicants in the development and submission of applications for medicinal products relevant to Article 58.

Taking into account ten years of experience, EMA, the European Commission and the Bill & Melinda Gates Foundation carried out a study in 2015 to look at stakeholder awareness, experience and views on the procedure. A slide presentation and a summary document present the study's findings and recommendations:

EMA has included a number of activities relating to Article 58 in its work programme and future activities will take into account the global regulatory aspects of the EU Medicines Agencies Network Strategy to 2020

Guidance and forms

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