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Regulatory Focus™ > News Articles > Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure

Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure

Posted 24 July 2015 | By Michael Mezher 

Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure

Today, the European Medicines Agency (EMA) recommended the world's first malaria vaccine. However, unlike most of the medicines EMA reviews, the agency's recommendation won't be forwarded to the European Commission for authorization.

In fact, EMA's recommendation only applies to regions outside the EU. Instead, the World Health Organization (WHO) and other non-EU regulators will review EMA's recommendation and make a determination on the vaccine's use.


The vaccine, known as Mosquirix or RTS, S/AS01, is the first vaccine for malaria to be reviewed by a regulatory agency. Mosquirix was developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, with partial funding from the Bill and Melinda Gates Foundation (BMGF).

Mosquirix was reviewed by EMA using a procedure that allows the agency to review medicines that will be used exclusively outside the EU. EMA's scientific review found the vaccine to be safe and effective in preventing malaria in infants.

Why is EMA Reviewing a Product That Won't be Used in Europe?

First, many regulators have provisions to allow the exportation of unlicensed medicines, including the US Food and Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Therapeutic Goods Administration (TGA).

These provisions allow for medicines that are unlikely to be used in their country of origin to be exported to countries where the products are needed without being authorized in the country of origin. This is particularly useful for treatments for so-called neglected tropical diseases (NTDs) that have high incidence in areas such as Africa and South America.

To further facilitate the review of such medicines, Article 58 of Regulation (EC) No 726/2004 gives EMA, in collaboration with WHO, the ability to evaluate high priority medicines for global public health needs:

  • "The Agency may give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply.
  • The said Committee shall establish specific procedural rules for the implementation of paragraph 1, as well as for the provision of scientific advice."

The types of products eligible for Article 58 applications include:

  • vaccines that are or could be used in the WHO Expanded Program on Immunization(EPI)
  • vaccines for protection against a WHO “public health priority disease”
  • vaccines that are part of a WHO-managed stockpile for emergency response
  • medicinal products for WHO target diseases such as human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), malaria, tuberculosis, lymphatic filariasis (elephantiasis), trachoma, leishmaniasis, schistosomiasis, African trypanosomiasis (sleeping sickness), onchocerciasis (river blindness), dengue fever, Chagas disease, leprosy and intestinal helminths

EMA recommends that companies interested in submitting Article 58 applications contact the agency for a pre-submission meeting to ensure they "conform to legal and regulatory requirements" involved with the procedure.

For more information, see EMA's Article 58 applications: Regulatory and Procedural Guidance.

Once an application is accepted for review under Article 58, the Committee for Medicinal Products for Human Use (CHMP) will "assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance."

Once the CHMP issues its opinion, WHO will review it and make a policy recommendation for how the product will be used. In making its recommendation, WHO will consider the "feasibility of implementation, affordability and cost-effectiveness, and the public health value," of the product.

After WHO makes its policy recommendation, it will be up to national regulators in countries where the product will be used to register the product.


EMA Press Release, Article 58 Infographic, Article 58 applications: Regulatory and Procedural Guidance


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