Medicines for use outside the European Union

The European Medicines Agency (EMA), in cooperation with the World Health Organization (WHO), can provide scientific opinions on high priority human medicines, including vaccines, that are intended for markets outside of the European Union (EU).

The aim is to facilitate patient access to essential medicines in low- and middle-income countries, including new or improved therapies for unmet medical needs, which are intended to prevent or treat diseases of major public health interest.

The procedure combines EMA's scientific review capabilities with the local epidemiology and disease expertise of WHO and national regulators in the target countries, to provide a unique development and assessment pathway. It is targeted both at innovative medicines and new developments of already authorised medicines.

EMA's Committee for Medicinal Products for Human Use (CHMP) assesses medicines and vaccines under this procedure to the same rigorous standards as medicines intended for use in Europe.

Following the evaluation, EMA publishes its scientific opinion of the benefit-risk balance of the product, which aims to facilitate prequalification of the medicine by WHO and registration in the target countries.

The procedure is called EU-Medicines for all or 'EU-M4all'. It was previously known as the Article 58 procedure, as the legal basis is Article 58 of Regulation (EC) No 726/2004. It has been in place since 2004.

For guidance on procedural and regulatory steps involved, see Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union.

Benefits of the procedure

Medicine developers who obtain a scientific opinion from EMA for markets exclusively outside of the EU benefit from:

  • rigorous scientific assessment by European experts to the same high standards as for medicines intended for use in Europe;
  • involvement of experts from WHO and national regulatory authorities in target countries;
  • benefit-risk assessment tailored to intended non-EU population;
  • a streamlined assessment under the WHO prequalification programme;
  • facilitated registration in target countries.

Eligible medicines

Medicines and vaccines eligible for this procedure are used to prevent or treat public health priority diseases. These include:

  • vaccines:
  • other medicines:
    • for WHO target diseases such as human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), malaria and tuberculosis.
    • for maternal and newborn healthcare.

Eligible products may include new formulations, new pharmaceutical forms or routes of administration of medicines already authorised in the EU, fixed-dose combinations and generic medicines.

Applicants need to request eligibility for evaluation under Article 58 for a medicinal product before submitting an application. This request will be evaluated by the EMA's CHMP in collaboration with the WHO.

Early support for medicine developers

EMA has in place a range of regulatory tools to support medicine developers which are valid for developers of medicines for use exclusively outside the EU, including:

For further details, see:

Applying in parallel with an EU marketing authorisation application

Applicants may apply in parallel for an EU marketing authorisation under the centralised procedure and an opinion under EU-M4all for their medicine to be used outside the EU.

The same CHMP and PRAC rapporteurs evaluate the applications in parallel, although the timetables may differ. 

For a medicine to be eligible for a parallel evaluation, the active substance(s) must be identical in both applications, with comparable indications.

However, the formulation, pharmaceutical form and route of administration may be different in the two applications.

Update: Guidance on applying for the two procedures in parallel is available below, together with the outcome of a public consultation:

Related information materials

Visual guide: Parallel application for EU-M4all opinion and centralised marketing authorisation procedure
Promoting parallel application for EU-M4all opinion and centralised marketing authorisation procedure

Fees

EMA applies the same fees as for the centralised marketing authorisation procedure.

In exceptional cases, applicants can request a total or partial fee waiver from EMA's Executive Director. They should submit a request as early as possible, and not later than 3 months before applying for scientic advice or submitting an application.

Promoting use and awareness

Based on 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.

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