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Medicinal products

Draft amendments to the Rules of marketing authorization and assessment of medicinal products for human use (109 page(s), in Russian)

Detailed instructions are given for groups of unregistered medicines to which patients are granted access in case of threats of emergency situations, as well as groups of advanced therapy medicinal products, breakthrough therapy medicinal products, orphan medicinal products. Additional features are provided for:

·         parallel consideration of applications by several recognition States during the mutual recognition procedure and making changes to the registration dossier before its consideration in the recognition States are introduced;

·         remote assessment of laboratory tests of methods of quality control of a medicinal product;

·         the use of electronic document management when providing module 1 of the registration dossier of a medicinal product.

The section on the introduction of post-registration measures has been revised.

The Rules are supplemented with special procedures and appendices for:

·         registration of medicines in exceptional cases;

·         conditional registration of medicines;

·         accelerated assessment of medicines.