The classifier and the reference are used to prepare marketing authorization applications in electronic form and are used in electronic interaction between the EAEU countries’ authorized authorities when conducting procedures in accordance with these rules as well as pharmaceutical manufacturers when forming electronic marketing authorization applications.
The EEC Board has approved the guidelines for pharmaceutical development of medicinal products for use in pediatric practice, which regulates unified approaches to creating special dosage forms designed for pediatric groups enabling to administer medicinal products to children accurately and without risk. The recommendation also contains instructions on the principles of putting medicines into circulation specifically for children, depending on available information about auxiliary substances in their composition from the perspective of safety and efficiency.