What is the importance of the Russian market for companies where production is carried out under cleanroom conditions, such as the pharmaceutical industry?
Alex Stolarsky: “As a result of Russian localisation policies, the importance of the Russian market to international pharmaceuticals firms has been increasing since 2015, particularly for those companies looking to participate in governmental tender processes. Here, it is necessary to demonstrate sufficient local content and production within Russia, or to contract production out to Russian firms. Furthermore, since May 2017 there has – at least officially – been a uniform pharmaceuticals market within the Eurasian Economic Union (EAEU), including the requisite processes for uniform drug approvals etc.
Healthcare and medical supplies are areas of key strategic importance to the Russian government. According to Russia’s ‘Pharma 2020’ strategy, up to 90 percent of all essential pharmaceuticals and 50 percent of all other medicines are to be produced within Russia by 2020. We believe that this offers tremendous growth potential for foreign pharmaceuticals manufacturers.”
In your opinion, what are conditions currently like?
Alex Stolarsky: “In view of the current geopolitical upheaval and sanctions, the Russian market is viewed with a certain degree of ambivalence, and it is treated with tremendous caution. With spiralling sanctions and other characteristics of the Russian market, this is certainly not misplaced. Even so, we are also witnessing a certain degree of over-compliance. There is no doubt that lasting success in Russia demands structured preparations for legal affairs, tax matters and operations, and these efforts must be accompanied by a healthy dose of pragmatism and a willingness to take decisions. In the pharmaceutical industry in particular, we are witnessing a great deal of activity focused on Russia and the EAEU, as well as increased interest in local production.”
What topics will you be exploring in your presentation at Cleanzone Plaza?
Alex Stolarsky: “I will be starting off with a brief overview of the overall economic situation in Russia before proceeding to address the uniform pharmaceuticals market within the EAEU. I will then go into the details of the legal and tax aspects of setting up production; in other words, I will be presenting the rules for localisation in Russia. Furthermore, I will be discussing GMP in the EAEU for the pharmaceuticals field, and exploring how it will be necessary to serialise all pharmaceuticals (both those available solely on prescription (Rx) and over-the-counter medications (OTC)) in Russia starting in 2020.
In addition to Alex Stolarsky’s presentation, the country profile will also include an example from actual practice from a Czech company concerning the planning and construction of a pharmaceutical production facility in Russia. Exhibitors will also be taking advantage of the event stage to showcase their latest developments, while Cleanroom Award nominees present their innovations. Once the winners have been chosen by public vote, this is also were the awards ceremony will be held. Another highlight is ‘Cleanroom technology 5.0’, a panel discussion on the exciting topic of people in a digitised world. Furthermore, Professor Dr. Gernod Dittel will be talking about the use of mobile laboratories for the development of substitutes for antibiotics in oceanographic fish farming. The programme also includes a presentation on international product liability law.
On 12 and 13 November 2018, Cleanzone Middle East (www.cleanzoneme.com) will be making its debut in Dubai. The conference and trade fair brings international providers of cleanroom technology together with their customers in the region.
More information on Cleanzone and the very latest programme of events can be found at:
Background information on Messe Frankfurt
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