Immunization standards

EMEA's Scientific Opinion

A new European pharmaceutical legislation (Regulation 726/2004) excluded licensure of vaccines and other medicinal products for exclusive use outside the European Community. The new legislation generated considerable concern since licensure of priority vaccines for developing countries would become the responsibility of the national regulatory authorities (NRAs) of user countries, which, in the past, relied on the regulatory evaluation of the NRA of the country of origin to assure quality.

To ensure that there was no disruption in the supply of vaccines and medicinal products that are important for developing countries and that there is no disincentive for the timely discovery and development of these products, a consultation and collaboration between EMEA and WHO led to the Article 58 in the new Regulation.

Article 58 establishes a mechanism whereby the EMEA may give a Scientific Opinion, in the context of cooperation with WHO, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. The procedure for implementation of Article 58 Scientific Opinion procedure, effective since May of 2005 begins with the request from the company to EMEA to assess the eligibility of the product for Scientific Opinion. WHO's input takes place in two instances:

  • evaluation of eligibility of the vaccine for Scientific Opinion by EMEA;
  • prticipation of experts proposed by WHO in the product evaluation process.

So far, one vaccine has gone through the review by WHO and deemed eligible for Scientific Opinion. There is indication that a few more vaccines will follow shortly.

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Last update:

10 November 2011 21:02 CET