In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for making some changes to the registration dossier for a medicinal product (MP). Thus, the changes have impact on grounds for making changes to the registration dossiers that do not require an examination of quality, efficacy and safety. Now examination of

In November 2022, Roszdravnadzor received a notification from the Novo Nordisk manufacturing company about the planned termination of supplies of the Ozempic drug to the Russian Federation. It should be noted that according to the current legislation of the Russian Federation, the holder of the registration certificate must notify Roszdravnadzor in advance (1 year in advance) of the termination of

Regulatory affairs specialists often come across the concept of grace period. For an ordinary consumer who buys a particular drug, this phrase usually does not have any meaning. However, not only but grace period determines the “speed” of updating instructions and packaging materials on the market. Let’s imagine the situation when the manufacturer has discovered a new contraindication to the

In 2022, the Government of the Russian Federation developed a number of regulations regarding the circulation of medicines for medical use in the event of inventory shortage or risk of inventory shortage of medicinal products (Orders No. 593, PP No. 440, Order No. 339n). On February 13, 2023, Order No. 724n “On Amendments to the Regulations on the Interdepartmental Commission

In 2022, the so-called “accelerated” registration procedure for medicines for which there is a risk of inventory shortage was organized in Russia (read more about this phenomenon in previous articles). In December 2022, the first marketing authorization (MA) was obtained in the frame of this procedure. The Ministry of Health of Russia approved the antitumor drug Pembroria (international non-proprietary name