Tag: Roszdravnadzor

New Edition of Administrative Provision of Russia’s Roszdravnadzor Published

On 26 July 2019, the Russian Ministry of Health published order no. 3371 – with a new version of the administrative provision of Russian medical device regulator Roszdravnadzor – on the procedure for ...

New Law, Control Russian Med Products

The President of the Russian Federation has signed Federal Law no. 511-FZ "On amendments to certain legislative acts of the Russian Federation" According to the new law, the regulator (Roszdravnadz...

Over 10,000 Russian pharma market participants joined the labeling system

According to the head of Roszdravnadzor, about 10,000 of pharma market participants across the country have joined the program for monitoring of preparedness for the project on the labeling of drugs.

Roszdravnadzor: percentage of counterfeit or substandard drugs is 0.4%

Less than one percent of drugs officially sold in pharmacies are fake, counterfeit or substandard. More precisely, their share is 0.4 percent, Mikhail Murashko, Head of Roszdravnadzor, said.

Roszdravnadzor identified 6 falsified drugs and 2 substances in 2017

The measures taken by Roszdravnadzor in 2017 allowed to withdraw 915 batches of medicinal products with substandard quality, which is 0.34% of the total number of batches released into circulation in that year.

Russian State Duma opposes draft law on sales of medicines in supermarkets

This was announced by Alexander Petrov, a deputy of State Duma, at the meeting of the Board of Roszdravnadzor. The State Duma supported the draft law on online sales, but the discussion on prescription drugs was not over.

Few cases of counterfeit drugs to get into circulation via internet in Russia

counterfeit drug
The amount of substandard medicines available on the market has been halved in 2017, while some falsified drugs get into circulation via the Internet, said Mikhail Murashko, the Head of Roszdravnadzor.

Roszdravnadzor is authorized to make control purchases of drugs

The Russian State Duma adopted in the first reading a draft law that authorizes Roszdravnadzor to make control purchases, which will allow to combat the sales of substandard medicines

Mandatory labeling for 7 nosologies may be introduced in 2018

drug marking
In 2020, the labeling of medicinal products will become mandatory for all manufacturers. But, for some drugs, including the expensive medicines, it may happen as early as in 2018

Counterfeit products will even not get into the licensed pharmacy chains

Russian State Duma adopted a bill on labeling of medicinal products with Data Matrix labels. This procedure will become mandatory from January 1, 2020

Drug labeling allowed to detect illegal resale of expensive medicines

A joint operation uncovered the illegal resale of expensive drugs MabThera and Acerbia

Russian drug labeling system is ready to operate at its full capacity

The drug labeling system was finalized in accordance with the functional requirements of the Russian Ministry of Health and Roszdravnadzor

Roszdravnadzor expects savings from the labeling of medicinal products

Roszdravnadzor expects that the total savings from the introduction of labeling of medicinal products will amount to several billion rubles a year

Russia defines objectives for control over circulation of biomed cell products

biomedical cells products
Russian Prime Minister Dmitry Medvedev signed a Decree defining the objectives for state control over the circulation of biomedical cell products

Availability of vital and essential drugs in Russia is 65% on average

The number of regions in Russia with the availability of vital and essential drugs below the national average level has increased

Labeling will become a compulsory process in Russia from 2018

The labeling system for medicinal products will become compulsory from 2018, said Mikhail Murashko, the Head of Federal Service for Surveillance in Healthcare