22.12.2021 (Обновлено: 17.02.2022 16:27)

Number of amendments made to documents in the field of circulation of medicines and medical products in EAEU

The Eurasian Economic Commission’s Board has updated items of the classifier of types of documents for marketing authorization applications of medicinal products as well as the reference of structural elements of marketing authorization applications of medicinal products with due regard to the current version of the Rules for registration and examination of medicinal products for human use approved by Decision No. 78 of the Commission’s Council dated November 3, 2016.

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.