In Russia banned the sale of Durex condoms – RBC

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Roszdravnadzor ordered to ban the sale of British Durex condoms in Russian pharmacies. In total, the prohibition also included 11 kinds of products under this brand

The report of the Federal Service for healthcare surveillance (Roszdravnadzor) in the territorial bodies of departments and pharmacy chains (there are at the disposal of the editorial board), dated more early May, stating , the service has identified the market unregistered medical products – Durex condoms.

Registration Certificate №FSZ 2009/05004 from 08.19.2014, under which previously sold corresponding products has been issued for an indefinite period. However, in complete supporting documents did not have data on specific types of products, which means that registration does not apply to them.

In total, the prohibition also included 11 kinds of products under the brand Durex: Pleasuremax, Classic, Fruity Mix, Extra Safe, Elite, Long Play, XXL, Dual Extase , Sensation, Invisible and Real Feel. Judging by the Durex website in Russia, it is a big part of the range in the category, which contains a total of 13 positions. In addition to contraceptive Company “Reckitt Benckiser” produces under the brand Durex gels and lubricants – their sale in pharmacies continues normally

The British Reckitt Benckiser, specializes in products for the home, tools for the health care and personal hygiene.. The Russian market is well known for the brand Durex, Calgon, Clearasil and Vanish.V 2015 holding’s revenues amounted to 8.8 billion pounds, 74% of the sales of products for health and hygiene. The results of sales in the Russian market, the company does not disclose. According to Director of Development of the analytical company “PHC Pharma” Nikolai Bespalov, if during the year the company did not register products, which banned the sale Roszdravnadzor, losses will amount to 2-3 billion rubles. All market condoms in Russia experts estimate at 10 billion rubles

«Since the second popular brand -. Contex also belongs to” Reckitt Benckiser “, collectively they cover 80% of the market, do not think that the company’s share will be diluted strongly . Consumers simply switch to a second brand, but the chances to increase its market share there and in other manufacturing companies, “- explains Bespalov. According to SPARC systems turnover LLC “Reckitt Benckiser Helsker” in 2014 (more recent data are not available) amounted to 8.2 billion rubles, net profit of RUB 890.4 million.

Advisor Relations Head public Roszdravnadzor Olga Maleva reported that prohibited species are not passed state registration. “Their quality, efficacy and safety are not confirmed by the relevant technical tests, toxicology studies and clinical trials”, – says the ministry. As of June 15, the company has not filed in Roszdravnadzor for registration identified by the Office of medical devices.

According to the source of RBC in the Russian Ministry of Health, prescription of the need to properly certify these products ” Reckitt Benckiser “received in February 2016, but continued to sell” new products under the guise of an old “- says the source

The” Reckitt Benckiser “did not comment on this claim.. According to a representative of Lyudmila Sharonova company, Durex condoms have been reported Roszdravnadzor without specific variants for many years. “In accordance with the new requirements Roszdravnadzor,” Reckitt Benckiser “would have to include information about the various embodiments of Durex condoms in the registration certificate and the materials of the registration dossier,” – said Sharonov

The duty hotline “Reckitt Benckiser” reported. that is currently going on renewal of registration certificate of Durex condoms, so they can not sell now. When sales resume, she did not specify, saying that he has no such information. Nevertheless prohibited goods not withdrawn from sale in all pharmacies. For example, help desk “Gorzdrav” network responded that closest to the version of the RBC-pack of 12 Durex Elite condoms can be purchased in a pharmacy on the street Obrucheva, 28/1, for 876 rubles.

According to the classification Roszdravnadzor, barrier method belong to the class of potential risk of application of the medical product “2b” – tax cost for registration is 7 thousand rubles, in addition, for each type of product the company will need to pay 85 thousand rubles…. the quality of the examination. So, to make the necessary information in the registration dossier, “Reckitt Benckiser” will have to pay about one million rubles.

Officially if Roszdravnadzor no claims to the documents provided by the company, the decision on the state registration of medical devices taken no later than 50 working days. This does not include the time taken to clinical trials. The very introduction of registration data Roszdravnadzor must produce, not later than 24 days after the positive decision on registration. In a large manufacturer of health care products, specializing in the production of similar products, the timing of the registration of names of products account for more than 12 months. According to the association of international manufacturers of medical devices IMEDA Olga Myaleshka, surveys of association members showed that the average registration takes a year.