Medical Radiology and Radiation Safety. 2026. Vol. 71. № 1

DOI:10.33266/1024-6177-2026-71-1-42-48

A.A. Labushkina, T.A. Astrelina, Yu.D. Udalov, G.E. Kodina

Relevant Questions and the Contradictions of Current Requirements to the Instructions for Medical Use of Radiopharmaceutical Drugs

A.I. Burnazyan Federal Medical Biophysical Center, Moscow, Russia

Contact person: Anna A. Labushkina, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Contents

Introduction

Comparative analysis of regulatory requirements for instructions for medical use of radiopharmaceutical drugs

Additions to the requirements for Summary of Product Characteristics and Package leaflet of radiopharmaceutical drugs

Packaging of radiopharmaceutical drug products with information for healthcare professionals

Packaging of radiopharmaceutical drug products with package leaflets

Conclusion

Keywords: radiopharmaceutical drugs, regulatory requirements, summary of product characteristics, prescribing information, pa-
ckage leaflet, medication guides

For citation: Labushkina AA, Astrelina TA, Udalov YuD, Kodina GE. Relevant Questions and the Contradictions of Current Requirements to the Instructions for Medical Use of Radiopharmaceutical Drugs. Medical Radiology and Radiation Safety. 2026;71(1):42–48.
(In Russian). DOI:10.33266/1024-6177-2026-71-1-42-48

 PDF (RUS) Full-text article (in Russian)

Conflict of interest. The authors declare no conflict of interest.

Financing. The study had no sponsorship.

Contribution. Article was prepared with equal participation of the authors.

Article received: 20.11.2025. Accepted for publication: 25.12.2025.