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Main  >  News  >  Directory of structural elements of drug registration dossier approved in the EAEU

Directory of structural elements of drug registration dossier approved in the EAEU

09/20/2019 | EAEU, drug registration

On September 19, 2019, the Decision of the EEC Board No. 159 “On the classifier of types of documents for the registration dossier of a medicinal product and the reference book of structural elements of the registration dossier of a medicinal product” was published. The document was adopted on September 17, 2019 and posted on the docs.eaeunion.org portal.

According to the information provided, the classifier and reference should be included in the resources of the unified system of normative and reference information of the Eurasian Economic Union (EAEU).

The use of classifier codes and reference codes is mandatory for the implementation of common processes within the framework of the Eurasian Economic Union in the field of pharmaceuticals circulation.

The classifier of types of documents and the directory of structural elements of the registration dossier of a medicinal product are the basis for the formation of an electronic registration dossier. The approval of the directory will allow business entities to create a registration dossier in electronic format, and the authorized bodies to uniformly validate the submitted dossiers.

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