Article 58 Applications

 

Medicinal products for human use are eligible for evaluation under Article 58 of Regulation (EC) No. 726/2004 if the are intended exclusively for markets outside the community. Eligible products include medicines that are intended for the prevention or treatment of disease of major public interest.

Following products are eligible for Article 58 of the Regulation (EC) No 726/2004:

• Vaccines that used in the WHO Expanded Program of 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 disease such as HIV/AIDS, malaria, tuberculosis, lymphatic filarisis, trachoma, leishmaniasis, schistomiasis, African trypansomiasis (sleeping sickness), onchocerciasis (river blindness), dengue fever, Chagas disease, leprosy and intestinal helminths.

Eligible products can include new pharmaceutical forms or routes of administration of medicinal products already authorized in the European Union, fixed combination products and generic products. 

Applicants need to request eligibility for evaluation under Article 58 for a medicinal products before submitting an application. The EMEA's Committee for Medicinal Products for Human Use (CHMP), evaluates data on the quality, safety and efficacy of the products contained in the application in collaboration with the WHO, before issuing a scientific opinion concluding on the benefit-risk ration of the product.

Eligibility request includes the following information:

• Evidence that the applicant is based in the European Economic Area (EEA).
• A draft summary of product characteristics (SmPC).
• A justification for product's eligibility for a evaluation under Article 58. It is recommended that any available epidemiological data on the disease, data on disease burden and a summary of any efficacy or safety data also be submitted.
• A statement that the applicant does not intend to market the medicinal product in the European Economic Area (EEA).
• The proposed classification for the supply of the medicinal product, i.e. not subject to medical prescription or subject to medical prescription. 
• A list of the countries in which the applicant intends to market the product.
• A declaration from the applicant agreeing on communication between the EMA and the WHO using the template "Agreement between EMA and the Applicant".

The eligibility of a product for evaluation under Article 58 is assessed on a case-by-case basis by the EMA in consultation with the WHO.

Once the EMA have received the eligibility request by the applicant it is sent to WHO. Within two months of the submission of the eligibility request, the WHO forwards its position to the EMA. THe EMA's CHMP then examines the eligibility for evaluation under Article 58, confirming or not confirming the WHO' position as appropriate. The applicant receives the WHO "eligibility feedback" letter and the EMA/CHMP eligibility letter. 

Types of applications:

The following types of application can be submitted under Article 58:

• Full complete (or full/mixed) applications
• Well-established use applications
• New fixed combination applications
• Informed consent applications
• Generic applications
• Hybrid applications
• Similar biological applications

Time period

The evaluation procedure follows the same steps and time-frame as the centralsied procedure. As the evaluation is a partnership between the EMA and WHO, WHO experts provide input to the procedure. Total time for evaluation is takes 300 days.

Reference:

1. Guideline on Procedural aspects regarding a CHMP scientific opinion in the context of cooperation with the World Health Organisation (WHO) for the evaluation of medicinal products intended exclusively for markets outside the community.