Newsletter № 8

Pharmaceutical law is of the high priority for our Company. We provide legal services to more than dozen multinational pharmaceutical companies. We would like to introduce to you Legal Alliance www.l-a.com.ua, the Ukrainian law firm, that has the strongest legal practice in the area of the pharmaceutical law in Ukraine according to the Ukrainian Law Firms Review 2010. It would be great to establish cooperation with you in this practice. Please find below the latest pharmaceutical digest of Legal Alliance. If you have any additional question, please feel free to contact us. Best regards, Legal Alliance Team GMP The MOH of Ukraine by itshas presented in new version Annexes 3, 6, 13 to regulation "Pharmaceutical products. Good Manufacturing Practice. СТ-Н MOH 42-4.0:2008". These annexes relate to manufacture of radiopharmaceutical products (Annex № 3), manufacture of medical gases (Annex № 6), manufacture of investigated pharmaceutical products (Annex № 13) Obligatory medical tests The MOH of Ukraine by itshas approved an Order of medical surveillance of citizens. The order foresees a complex of measures directed for securing of annual medical tests performance, defines methods of performance of such medical tests and their volume. However, the order does not foresee a mechanism of financing of measures related to medical surveillance. In accordance with the explanatory note to thof this order, authors have not considered additional costs for realization of the Draft, neither from the State, nor from the legal entities, and nor from the individuals. Drafts of legislative acts Advertising without doctors Thewas published on the web-site of Derzhspozhyvstandart. The draft foresees imposing of prohibition for any use of doctors or medical workers, or persons whose appearance imitates doctors in any advertisement. To this date such prohibition relates exclusively to advertising of pharmaceutical products. Control over issuance of disability leaves On September 02, 2010 thwas published on the web-site of the MOH for public hearings. According to the Draft the aim of control is checking of accuracy of issuance of disability leaves, execution by the workers of healthcare establishments the regulatory orders and instructions on their issuance, prolongation and preparing of disability leaves. Control over accuracy of issuance of The Ministry of Health of the Autonomous Republic of Crimea, The health departments of regional, Kyiv and Sevastopol city state administrations, The executive direction of the Fund of social insurance against temporary disability, The Fund of social insurance against accidents on production and professional diseases of Ukraine (hereinafter – the Trade unions and their associations with engagement of other specialists in case if necessary. Depending on types the control is divided for scheduled (not less than one time for three years) and unscheduled, which is held on the basis of application of citizens, managers (commissions on social insurance) of enterprises, institutions, organizations, authorized workers of prosecutor’s office, court, central bodies of executive power, in particular concerning cases of issuance of disability leaves by the healthcare establishments. During a check the members of commission estimate a “procedural part” of issuance of disability leaves, such as following the terms, compliance of records in the disability leaf and other reporting documents of the healthcare establishment, following the order of prolongation of disability leaf and so on. Licensing of production and selling of pharmaceutical products On September 03, 2010 thwas published on the web-site of the State inspection for quality control of pharmaceutical products of the MOH of Ukraine for public hearings. Among key novels of the Draft it is worth noting the following: The Draft foresees that it is possible to mention in the license a type of commercial activity fully or partially. The Draft defines a term of distribution of pharmaceutical products as any activity related to purchasing, preservation, transportation and import/export, except for direct realization to citizens. The Draft foresees that a copy of license is issued in order stipulated for issuance of a license under the current legislation and the Licensing conditions. In accordance with the Draft the fact of revealing absence of initial accounting documents concerning purchasing and trading of pharmaceutical products prevents implementation of the licensing condition. In accordance with the Draft wholesale trading of pharmaceutical products shall be performed exclusively in cashless form. The fact of issuance pharmaceutical products from the drugstores for cash prevents execution of Licensing conditions by the licensee. In accordance with the Draft issuance from the drugstore, drug point one or more Rx pharmaceutical products without a recipe prevents execution of Licensing conditions by the licensee. In accordance with the Draft the fact of existence or issuance from the drug point of one or more Rx pharmaceutical products or documentary evidence of shipment (delivery) of Rx pharmaceutical products to the drug point prevents execution of Licensing conditions by the licensee. Registration of disinfection products On September 09, 2010 the was published on the web-site of the MOH for public hearings. The Draft foresees amending of the Order of state registration (re-registration) of disinfection products, approved by the resolution of the Cabinet of Ministers of Ukraine dated on July 3, 2006 № 908, according to which, the state registration (re-registration) of disinfection products is conducted by the MOH upon the results of state sanitary-epidemiological expertise (hereinafter- the Expertise), researching of special activity, safety, quality of the product and testing in practice. In accordance with the current provisions the sanitary-epidemiological expertise is enough. Creation of the Unified state medical register On September 15, 2010 thewas published on the web-site of the MOH for public hearings. According to the Draft the Unified state medical register is an automated database, which includes collection, processing and storing data for securing of unified state accounting: Legal entities – subjects of entrepreneurship regardless of its subordination and ownership form (hereinafter – the Healthcare establishments), which solely or through structural (separate) units perform commercial activity on medical practice, processing of donor blood and its components, production products from it, execution of disinfection, disinsection, deratization works (hereinafter – the Medical practice) and/or production of pharmaceutical products, wholesale and retail trading of pharmaceutical products (hereinafter – the Pharmaceutical practice); Higher educational establishments of І-ІV levels of accreditation regardless of their subordination and ownership form, providing training, upgrading of qualification and retraining of personnel in the fields „Medicine" and „Pharmacy" (hereinafter – Educational establishments); Medical, pharmaceutical, scientific and scientific-pedagogical workers (doctors, chemists, pharmacists, junior specialists with medical education), working in Healthcare establishments, Educational establishments and being employed with physical persons-entrepreneurs and according to the current legislation having right to perform medical and pharmaceutical activity і (hereinafter – Medical workers); physical persons-entrepreneurs, which according to the current legislation perform on the territory of Ukraine their commercial activity on Medical and/or Pharmaceutical practice. The state register is created with a purpose of forming on the unified methodological basis the state accounting of the Healthcare establishments, Educational establishments and Medical workers. Registration of dietary supplements On September 22, 2010 thwas published on the web-site of the MOH for public hearings. The Draft foresees amendment to the Order of the placement of food products to the category of food products with special dietary consuming, functional food products and dietary supplements, and the Order of state registration of food products of special dietary consuming, functional food products and dietary supplements. Amendments are related to the order of expertise connected with placing of the food products to the category of special, and also list of documents, being submitted by the interested persons for conduction of such expertise. Donor activity On September 22, 2010 thwas published on the web-site of the MOH for public hearings. The Draft foresees amending of the paragraph 2 of the part 3 of the article 290 of the Civil code of Ukraine by stipulating that a donor shall not be known by a recipient, and a recipient – to the donor’s family, except cases of transplantation from a parent donor. Antimonopoly committee of Ukraine Fine for anticompetitive agreed actions Sumy regional department of the AMCU has fined the “Fito-Lek” LLC, “Medtehnika-Sumy” LLC and JV “Optima-Pharm LTD” together overall for UAH 21 000 for anticompetitive agreed actions that resulted in distortion of tender results. The Department determined that the subjects of entrepreneurship agreed upon tender proposals during execution by Krolevetsky central regional medical hospital of the tender on procurement of the pharmaceutical products. Sumy regional department of the AMCU has fined the “Sumy health center” LLC, “BIK-A” LLC and “Medtehnika-Sumy” LLC together overall for UAH 6000 for anticompetitive agreed actions that resulted in distortion of tender results. The Department determined that the subjects of entrepreneurship agreed upon tender proposals during execution by Sumy city children clinical hospital of the tender on procurement of the disinfection products. The subjects of entrepreneurship admitted the violation and paid the fine to the state budget. Foreign news TheThe advertising held a statement that the pharmaceutical product «Diflucan», produced by Pfizer International LLC is more effective than its generics in 2-4 times. The Advertising brochures held a comparative schedules of effectiveness of the pharmaceutical product « Diflucan » with the pharmaceutical product “Flucostat”. The advertising had been distributing within 2009 in drugstores and medical establishments of Yaroslav, Ivanov, and Penza regions. While adoption of the decision the Federal antimonopoly service of Russia was guided by the studies of bioequivalence, which took place during registration of generic (“Flucostat”). As a result, the Federal antimonopoly service of Russia obliged the Representative office of Pfizer International LLC in Russia to remove the violation of the legislation of Russia in advertising.

Source: http://legalalliance.com.ua/Files/Digests/31.pdf