1 Arzinger. Life Sciences & Healthcare Newsletter October 2014 Newsletter GENERAL REGULATORY ISSUES • Cancellation of decision on liquidation of the State Service for Regulatory Policy and Entrepreneurship • Mandatory seal requirement cancelled TURNOVER OF MEDICINAL PRODUCTS — STATE REGISTRATION • Law cancelling re-registration (renewal of marketing authorization) of medicinal products every 5 years cancelled • Simplified procedure for expert examination of registration (marketing authorization) materials has been extended to immunobiological drugs • Draft Amendments to Registration Procedure for Medicinal Products Life Sciences&Healthcare For detailed information, please, contact authors: Timur Bondaryev, Managing Partner, Attorney-at-law, Head of the Life Sciences & Healthcare Practice Timur.Bondaryev@arzinger.ua Lana Sinichkina, Partner, Head of the Life Sciences & Healthcare Practice Lana.Sinichkina@arzinger.ua Disclaimer: This publication is not a legal advice and provides only general information about development trends in the regulation and practice of its application in Ukraine. In order to avoid any risks prior to making any decisions related to information contained in this publication, please, seek legal counsel. CONTENTS: Eurasia Business Centre, 75 Zhylyanska St., 5th Floor, 01032 Kyiv, Ukraine Tel.: +38 (044) 390 55 33; Fax. +38 (044) 390 55 40 mail@arzinger.ua; www.arzinger.ua Kyiv, October 2014 2 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — LICENSE TERMS • New form of compliance check protocols under license terms for medicines — TAXES, DUTIES AND OTHER OBLIGATORY PAYMENTS • Classification of some products as alcoholic beverages — PRICING • Draft Law on maximum markups for medicinal products • Draft amendments to the conclusion form of the State Price Inspectorate on the reasonableness of wholesale and retail prices — PUBLIC PROCUREMENT • AMCU’s notice on considering complaints in the public procurement of medicinal products TURNOVER OF MEDICAL DEVICES • State Fiscal Service clarified some VAT issues regarding medical devices CUSTOMS ISSUES • Customs declaration in the movement of goods across borders of the Free Economic Zone "Crimea" CURRENCY REGULATION • The National Bank of Ukraine amended the previously passed resolutions to steady Ukrainian currency market Newsletter Life Sciences&Healthcare CONTENTS: Kyiv, October 2014 3 Arzinger. Life Sciences & Healthcare Newsletter October 2014 GENERAL REGULATORY ISSUES Cancellation of decision on liquidation of the State Service for Regulatory Policy and Entrepreneurship — On September 18, 2014 the District Administrative Court of Kyiv passed its Resolution No.826/10927/14 (hereinafter, the Resolution) upon consideration of the claim for the cancellation of the allegedly unlawful Resolution of the Cabinet of Ministers of Ukraine1 (hereinafter, the CMU) that envisaged the liquidation of the State Service of Ukraine for Regulatory Policy and Entrepreneurship and the establishment of the State Regulatory Service (hereinafter, the CMU Resolution). In particular, the Court established that the CMU committed numerous violations when considering the Draft Resolution, in particular: — The Draft Resolution was not approved by all interested parties, in particular with the State Service for Regulatory Policy and Entrepreneurship (hereinafter, the State Entrepreneurship Service); — an authorized representative of all-Ukrainian associations of employers’ organisations2 as well as the State Entrepreneurship Service were not involved in drafting the Resolution; — the Resolution was adopted without the necessary annexes, in particular without an explanatory note, certificate of act approval, memorandum of agreement, conclusion of the Ministry of Justice and other necessary documents; — etc. Moreover, in the court’s opinion, the transcript of the CMU meeting on which the Resolution was adopted confirmed the fact that the main reason of its adoption was the desire to replace the head of the State Entrepreneurship Service. Given the above violations, the District Administrative Court of Kyiv ruled that the Resolution was unlawful and cancelled it. 1 Resolution of the Cabinet of Ministers of Ukraine "On the State Regulatory Service of Ukraine" No.252 dated 30.04.2014 2 According to Par. 7 of the Regulations of the Cabinet of Ministers of Ukraine approved by Resolution of the Cabinet of Ministers of Ukraine dated 18.07.2007 № 950, this body should be mandatorily involved in drafting the acts of the Cabinet of Ministers of Ukraine on issues relating to the formation and implementation of the state social and economic policy, regulation of labour, social and economic relations. 4 Arzinger. Life Sciences & Healthcare Newsletter October 2014 Mandatory seal requirement cancelled — On October 30, 2014 the Law of Ukraine "On Amendments to Some Legislative Acts of Ukraine to Simplify Business Opening Procedure"3 (hereinafter, the Law) came into effect. The Law provides inter alia for the following changes: — the mandatory seal requirement for business entities is cancelled. A company may have a seal, if it deems it reasonable; however, no permits will be required for making a seal; — cancellation of the requirement of sealing some documents, in particular for deals concluded by legal entities (a seal is required only if the parties agree thereon in writing), for powers of attorney or documents issued by legal entities, etc. It should be noted that some bylaws should also be changed to be in line with the Law; — the State Registration Service of Ukraine should publish information from the Unified State Register of Legal Entities and Individual Entrepreneurs according to the list approved by it, which should, in particular, include information required for the issuance of permits and licenses, for concluding civil agreements, including information regarding entries on state registration of a legal entity’s termination or its being in the state of termination, information about persons that may act on behalf of a legal entity, about an existing restriction of representative powers, etc.; — cancellation of state registration duty for legal entities and individual entrepreneurs. Payments will only be charged for state registration of amendments to constitutive documents of a legal entity as well as to names and places of residence of individual entrepreneurs; — Exclusion of electronic digital signatures from the list of details of electronic documents submitted for state registration as well as electronic settlement documents confirming the payment of registration duty/payment for publication of notices, — etc. 3 Law of Ukraine "On Amendments to Some Legislative Acts of Ukraine to Simplify Business Opening Procedure" dated 15.04.2014 No.1206-VII 5 Arzinger. Life Sciences & Healthcare Newsletter October 2014 TURNOVER OF MEDICINAL PRODUCTS STATE REGISTRATION Law cancelling re-registration (renewal of marketing authorization) of medicinal products every 5 years — On October 20, 2014 the Parliament of Ukraine passed the Bill "On Amendments to the Law of Ukraine "On Medicinal Products" regarding the turnover and state control of the quality of medicinal products imported to the customs territory of Ukraine" into law (hereinafter, the Law). The Law stipulates that medicinal products may be used subject to their re-registration (renewal of marketing authorization) upon expiry of the 5-year registration (marketing authorization) period. After re-registration (renewal of marketing authorization), the period of use of medicinal products in Ukraine shall be unlimited. At the same time, medicinal products released into circulation during the period of their authorized use in Ukraine may be allowed for use in Ukraine till expiry of their shelf life determined by the manufacturer and stated on their packaging. Apart from that, the Law on Medicinal Products has been supplemented by a rule, under which the state quality control procedure for medicinal products imported to the customs territory of Ukraine shall be established by the Cabinet of Ministers of Ukraine; while the rule of state quality control for medicinal products before or after their release into circulation at the customs territory of Ukraine has been cancelled. In general, the amendments are welcome, as they will considerably simplify the turnover of medicinal products in Ukraine and will facilitate patients’ access to treatment. Moreover, they are in line with Directive 2001/83/EC (hereinafter, the Directive). The amendments will allow applicants to reduce the costs of re-registration (renewal of marketing authorization) of medicinal products as well as to avoid losses that sometimes arise due to risks of time gaps between the date after the expiry of the previous marketing authorization and the issue of the next one. Due to the permission to use medicinal products till expiry of their shelf life even after expiry of the relevant marketing authorization, they will be further used in medical institutions. However, the issue of their possible circulation (sale by distributors or pharmacies, public procurement during their shelf life) requires clarification. Moreover, after re-registration (renewal of marketing authorization) the declared changes in wholesale and retail prices will not be rendered invalid upon expiry of the relevant marketing authorization. Therefore, the mentioned amendments are expected to reduce the costs of market participants and thus the prices for medicines. At the same time, the amendments are not fully in line with the Directive. Thus: 1. they do not entitle the State to establish another 5-year term of a marketing authorization based on the relevant pharmacovigilance data in case of re-registration (renewal of marketing authorization) ; 2. they do not allow the applicant to terminate the effect of a marketing authorization at its own discretion and do not envisage any additional possibilities to cancel registration (marketing authorization) after 6 Arzinger. Life Sciences & Healthcare Newsletter October 2014 re-registration (renewal of marketing authorization) (except for identified previously unknown hazardous properties of a medicinal product). The amendments came into effect on 05.11.2014. It should be taken into account that a number of by-laws should be improved to implement the described amendments. Simplified procedure for expert examination of registration (marketing authorization) materials has been extended to immunobiological drugs — On August 11, 2014 the Ministry of Health of Ukraine (hereinafter, the MOH) approved its order4 amending the Procedure for Expert Examination of Registration Materials of Medicinal Products that are Submitted for State Registration (Re-Registration) as well as for Expert Examination of Materials regarding Amendments to Registration Materials during the Validity Period of the Relevant Marketing Authorization.5 The amendments extend the list of medicinal products that fall under the simplified expert examination procedure for registration (marketing authorization) materials. Thus, the amended list also includes medical immunobiological drugs used for specific immunoprophylaxis of infectious diseases that are: 1. included into the immunization calendar in Ukraine and are registered (hold marketing authorization) in a country with regulatory authorities applying high quality standards in line with the standards recommended by the WHO (in particular, U.S. Food and Drug Administration (FDA); European Medicines Agency (EMA) (under a centralized procedure); Swiss Agency for Therapeutic Products (Swissmedic); Pharmaceuticals and Medical Devices Agency of Japan (PMDA); Medicines and Healthcare Products Regulatory Agency of UK (MHRA); Therapeutic Goods Administration (TGA)), or 2. included into the immunization calendar per age / epidemic indications, have passed the WHO prequalification procedure and are included in the WHO List of Prequalified Medicines (hereinafter, the WHO List). In this case, a medicinal product filed for registration (marketing authorization) should be manufactured at a production site that has passed the WHO’s inspection as part of prequalification program and mentioned in the WHO List; the type and size of packaging of a medicinal product filed for registration shall be mentioned in the WHO List. It should be recalled that the simplified expert examination procedure for registration (marketing authorization) materials implies gratuity, priority, and reduced timing (90 instead of 210 days). The Order has come into effect on 26.09.2014. 4 Order of the Ministry of Health of Ukraine "On amendment’s to Procedure for expert examination of registration materials of medicinal products that are submitted for state registration (re-registration) as well as for expert examination of materials regarding amendments to registration materials during the validity period of the relevant marketing authorization" dated 11.08.2014 No.566 5 Procedure for expert examination of registration materials of medicinal products that are submitted for state registration (re-registration) as well as for expert examination of materials regarding amendments to registration materials during the validity period of the relevant marketing authorization, approved by Order of the Ministry of Health of Ukraine dated 26.08.2005 No.426 7 Arzinger. Life Sciences & Healthcare Newsletter October 2014 Draft Amendments to Registration (Marketing Authorization) Procedure for Medicinal Products — On October 13, 2014 the MOH published the Draft CMU Resolution "On Amendments to State Registration (Re-registration) Procedure for Medicinal Products" (hereinafter, the Draft). The Draft is intended to amend the State Registration (Re-registration) Procedure for Medicinal Products6 (hereinafter, the Procedure), in particular: 1. to incorporate the provisions of the Law providing for simplified registration (marketing authorization) of medicinal products for the treatment of orphan and socially dangerous diseases7 into the Procedure. You may read about the provisions of the Law in more detail in our August issue; 2. to abolish the registration (marketing authorization) requirement for products obtained through the finished-product manufacturing process, which contain an active pharmaceutical ingredient (hereinafter, the API) in the physical state needed for further production of a finished dosage form in accordance with the relevant master file; 3. to provide for a simplified registration (marketing authorization) procedure for original medicinal products registered (holding marketing authorization) with the European Medicines Agency. In such cases registration (marketing authorization) will be carried out based on an application, master file and master file verification report of the ЕМА. The State Expert Center of the Ministry of Health of Ukraine (hereinafter, the Center) will only have to check whether texts of instructions for medical use and quality control methods containing a package labeling text, provided by the applicant and certified in the prescribed manner, comply with the registration (marketing authorization) materials, without any expert examination of such materials or additional studies, in particular, relating to quality control, and to provide the relevant conclusion to the Ministry of Health in the manner prescribed by the latter; 4. to establish that the MOH may decide on invalidation of a marketing authorization for a medicinal product that has not been put into circulation within three years upon its state registration, unless it is conditioned by the production/application specifics of such a medicinal product. It should be recalled that the current relevant period is two years; 5. to abolish the need to re-register (renew marketing authorization for) medicinal products every other 5 years after their registration (marketing authorization) (unless the MOH decides that repeated reregistration (renewal of marketing authorization) is necessary in 5 years after the first re-registration (renewal)). It should be noted that this exception is not provided for by the Law of Ukraine "On Amendments to the Law of Ukraine "On Medicinal Products" (hereinafter, the Law) regarding the circulation and state quality control of medicinal products imported to the territory of Ukraine" described above; 6. to permit the circulation of medicinal products put into circulation within the period of their being permitted for use in Ukraine till the end of their shelf life as determined by their manufacturer and stated on the packaging; 7. to establish that decisions on re-registration (renewal of marketing authorization) of medicinal products (except for APIs and in-bulk products) or refusal of such re-registration (renewal) must be adopted by the MOH based on the Center’s conclusions approving the positive ratio of expected benefits and possible risks in the application of medicinal products; 6 Procedure for State Registration (Re-registration) of Medicinal Products approved by Resolution of the Cabinet of Ministers of Ukraine dated 26.05.2005 No.376 7 Law of Ukraine “On Amendments to the Law of Ukraine “On Medicinal Products” to improve the procedure for providing the population with medicines intended for the treatment of socially dangerous and serious diseases” dated 12.08.2014 No.1637-VII 8 Arzinger. Life Sciences & Healthcare Newsletter October 2014 8. to envisage that the period of allowed use of APIs or in-bulk products contained in a finished medicinal product, with information about them stated in the marketing authorization for the finished medicinal product, shall be extended upon its re-registration (renewal of marketing authorization). Obviously, the legislator means extending the validity period of a permit to use APIs or in-bulk products for the period of re-registration (renewal of marketing authorization) . 9. etc. It is worth noting that such regulatory approach to the circulation of medicinal products is rather inconsistent, as the above rules are supposed to be codified on the level of bylaws. However, as we stated above, the rules of a similar regulation subject (on circulation terms and re-registration (renewal of marketing authorization) procedure for medicinal products) are codified at the level of the Law, taking precedence. At the same time, the proposed rules are not quite in line with the adopted amendments to the Law and thus create rules that are not provided for by the Law. LICENSE TERMS New form of compliance check protocols under license terms for medicines — On September 2, 2014 the MOH approved its order8 on amendments to the Compliance Control Procedure under the License Terms for Business Activities for the Manufacture of Medicinal Products, and Wholesale and Retail Trade in Medicinal Products.9 The amendments approve a new form of compliance check authorizations as well as a new form of compliance check protocols under the License Terms for business activities in the industrial manufacture of medicinal products (hereinafter, the protocol form). Among other things, the new protocol form contains a more detailed compliance check list. Thus, the compliance check list regarding the pharmaceutical quality system, personnel, premises and facilities, documentation, manufacturing process etc. is outlined in more detail. TAXES , DUTIES AND OTHER OBLIGATORY PAY MENTS Classification of some products as alcoholic beverages — On November 1, 2014 amendments10 to the Tax Code of Ukraine and the Law of Ukraine "On State Regulation of Production and Turnover of Ethyl, Cognac and Fruit Alcohol, Alcoholic Beverages and Tobacco Products" came into effect. Under the amendments, alcoholic beverages also include products containing 8.5 % and more volume units of ethyl alcohol, which is specified in the following headings: 8 Order of the Ministry of Health of Ukraine "On Amendments to the Compliance Control Procedure under the License Terms for business activities for the manufacture of medicinal products, and wholesale and retail trade in medicinal products" dated 02.09.2014 No.609 9 Compliance Control Procedure under the License Terms for business activities for the manufacture of medicinal products, and wholesale and retail trade in medicinal products approved by Order of the Ministry of Health of Ukraine dated 31.10.2011 No. 724 10 Law of Ukraine "On Amendments to the Tax Code of Ukraine and some other Legislative Acts of Ukraine" dated 31.07.2014 No.1621-VII 9 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — 2103 90 30 00 (bitter aromatic liqueur containing 44.2 - 49.2 vol. % of alcohol and 1.5-6 wt.% of gentian, spices and various ingredients, with sugar content of 4-10%, in containers holding less than 0,5 l), and — 2106 90 (compound semi-finished alcohol products other than those based on odoriferous substances used in the manufacture of beverages; sugar syrups flavoured or supplemented with colouring agents, etc.) according to the UKTZED Codes. The excise tax for these products is set at the rate of UAH 70.53 per liter of 100% alcohol. Also, the relevant products should be labeled with excise duty stamps. After the entry into force of the amendments, the above products shall be considered as alcoholic beverages. Therefore, their distribution shall be subject to the legal requirements for the sale and advertising of alcoholic beverages, in particular: — Law of Ukraine "On Licensing of Certain Types of Business Activities," 11 — Law of Ukraine "On State Regulation of Production and Turnover of Ethyl, Cognac and Fruit Alcohol, Alcoholic Beverages and Tobacco Products," 12 — Rules for Retail Trade in Alcoholic Beverages approved by CMU Resolution dated 30.07.1996 No.854, and — Law of Ukraine "On Advertising." 13 PRICING Draft Law on maximum markups for medicinal products — On October 1, 2014 the Parliament of Ukraine registered the Draft Law "On Amendments to the Tax Code of Ukraine and some other Legislative Acts of Ukraine (to reduce prices for medicinal products)" (hereinafter, the Draft Law) under Registration No. 5120. The Draft Law proposes to reduce the VAT rate on transactions for delivery and importation of medicinal products and medical devices to the customs territory of Ukraine from 7% to 3%, and to establish the maximum wholesale and retail markups for all medicinal products and medical devices marketed and sold in Ukraine. Their amount, according to the Draft, should not exceed 3 % of the wholesale price and 5 % of the procurement price, respectively. It should be recalled that the maximum markups for medicinal products are established only for: — medicinal products procured with funds of state or local budgets, — medicinal products and medical devices included in the National List of Basic Medicinal Products and Medical Devices14 (other than narcotic drugs, psychotropic drugs, precursors and medical gases) and 11 dated 01.06.2000 No. 1775-III 12 dated 19.12.1995 No. 481 / 95-VR 13 Article 22 of the Law of Ukraine "On Advertising" dated 03.07.1996 № 270/96-VR 14 Approved by Resolution of the Cabinet of Ministers of Ukraine "Some Issues of State Price Regulation for Medicinal Products and Medical Devices" dated 25.03.2009 No.333 10 Arzinger. Life Sciences & Healthcare Newsletter October 2014 the Mandatory Minimum Range of (Socially Oriented) Medicinal Products and Medical Devices for Pharmaceutical Institutions15, and — medicinal products included in pilot projects for state regulation of pricing for medicines used in patients with hypertension and diabetes. 16 However, as the Draft Law was not passed as a basis on first reading by the Parliament of Ukraine of the 7th convocation, the Parliament of the next convocation will have to register it anew, as under the Parliament’s Regulations the Draft Law is deemed excluded from consideration.17 Draft amendments to the conclusion form of the State Price Inspectorate on the reasonableness of wholesale and retail prices — On October 16, 2014 the MOH published the Joint Draft Order of the MOH and the Ministry of Economic Development and Trade of Ukraine "On Amendments to Annex 2 to Wholesale Price Calculation Procedure for Medicinal Products" (hereinafter, the Draft Order) on its Website. The Draft Order proposes to amend the conclusion form of the State Price Control Inspectorate (hereinafter, the State Price Inspectorate) on the calculation of wholesale and retail prices for medicinal products included in the list of medicinal products of domestic or foreign production that may be procured by healthcare establishments and institutions wholly or partially financed with the state or local budgets18 (hereinafter, the Conclusion). The current version of conclusion form establishes that the document is signed by the Head or Deputy Head of the State Price Inspectorate. As we reported in our previous issue, on September 10, 2014 the Cabinet of Ministers adopted its Resolution "On Optimizing the System of Central Executive Authorities"19 providing for the liquidation of the State Price Inspectorate. Due to this as well as to the fact that, as stated in the supporting documents to the Draft Order, the State Price Inspectorate has no persons authorized to sign conclusions, the Draft Order proposes to abolish their signing exclusively by Chairman or Deputy Chairman of the State Price Inspectorate as well as to establish that a conclusion should state the title (position) of the signatory. 15 Approved by Resolution of the Ministry of Health of Ukraine dated 29.12.2011 No.1000 16 Provided for by Resolution of the Cabinet of Ministers of Ukraine "On Implementing the Pilot Project Introducing State Price Regulation for Medicinal Products to Treat Patients with Hypertension" dated 25.04.2012 No.340, Resolution of the Cabinet of Ministers of Ukraine " Implementation Issues of the Pilot Project Introducing State Price Regulation for Insulin Preparations" dated 05.03.2014 No.73 17 Part 1 Article 95 of the Law of Ukraine "On Regulations of the Parliament of Ukraine" dated 10.02.2010 No.1861-VI 18 List of medicinal products of domestic or foreign production that may be procured by healthcare establishments and institutions wholly or partially financed with the state or local budgets approved by Resolution of the Cabinet of Ministers of Ukraine dated 05.09.1996 No.1071 "On Medicines Procurement Procedure for Healthcare Institutions Financed by the State" 19 Resolution of the Cabinet of Ministers of Ukraine "On Optimizing the System of Central Executive Authorities" No.442 dated 10.09.2014; 11 Arzinger. Life Sciences & Healthcare Newsletter October 2014 PUBLIC PROCUREMENT AMCU’s notice on considering complaints in the public procurement of medicinal products — On October 13, 2014 the AMCU reported about the current state of appeal proceedings against customers’ actions in the public procurement of medicinal products and medical devices. Thus, as at October 10, 2014 the AMCU has accepted about 130 complaints about customers’ violations in the public procurement of medicinal products and medical devices, including 36 complaints about the actions of the Ministry of Health. Decisions on the merits have been passed on most of the complaints. The AMCU notes that, having considered the complaints regarding discriminatory requirements established in bidding documents, it has found the following violations: 1) Bidding requirements (technical, quality and quantity characteristics of the object of procurement) were established to match the products of only one manufacturer and thus to restrict the competition among bidders; 2) Customers did not specify the required quantity of the object of procurement in the bidding documents, in particular: information about its to-be-procured quantity in accordance with the release and dosage forms established by it in the bidding documents and thus prevented the tender participants from preparing their bids appropriately; 3) unrelated goods were unreasonably combined in one lot; as a result, only entities able to offer the whole procurement lot could participate in the tender; 4) customers included requirements contrary to the current legislation of Ukraine and violating the rights of tender participants (e.g. obliging suppliers to cover the costs of the customer’s authorized company supplying goods to end recipients (healthcare institutions) and other costs associated with the arrangement of the customer’s contractual performance) in the essential conditions of procurement contracts. It should be noted that including the obligations stated in Par. 4) above into bidding documents is the common practice of the Ministry of Health, as the latter has no appropriate logistic capacities and is limited in funds for organizing the logistics. However, Ukrainian public procurement legislation does not allow customers to impose additional obligations on tender participants in connection with the further transportation of the procured object after its delivery. Also, the laws envisage20 that services related to the delivery of goods (in particular, transportation services) should be procured separately, or may be procured jointly with goods, however, unless the price of such procurement (of such services) exceeds the cost of the goods proper. 20 Par. 2.5 of Procedure for Determining the Object of Procurement approved by Order of the Ministry of Economic Development and Trade dated 26.07.2010 No.921 12 Arzinger. Life Sciences & Healthcare Newsletter October 2014 21 Letter No.6875/7/99-99-19-03-02-17 dated 09.10.2014 "On Value Added Tax" 22 List of Medical Devices in transactions for the supply in the customs territory and importation to the customs territory of Ukraine subject to value added tax at the rate of 7% approved by Resolution of the Cabinet of Ministers of Ukraine dated 01.07.2014 No.216 23 Technical Regulations of Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No.753, Technical Regulations of Medical Devices for in vitro diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No.754, Technical Regulations of Active Implantable Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No.755 24 Par. 187.8 Article 187, Par. 198.2 Article 198 of the Tax Code of Ukraine 25 Par. 198.3 Article 198 of the Tax Code of Ukraine 26 Par. 198.3 Article 198 of the Tax Code of Ukraine TURNOVER OF MEDICAL DEVICES State Fiscal Service clarified some VAT issues regarding medical devices — On October 9, 2014 the State Fiscal Service of Ukraine (hereinafter, the SFS) clarified21 some VAT issues regarding medical devices. As we wrote in our August issue, on September 3, 2014 the CMU approved its Resolution "On Approving List of Medical Devices in Transactions for the Supply in the Customs Territory and Importation to the Customs Territory of Ukraine subject to Value Added Tax at the Rate of 7%" (hereinafter, Resolution No.410). In terms of structure, Resolution No.410 represents a list of medical devices under UKTZED Codes (hereinafter, the List). Earlier, based on Resolution No.21622 (that was in effect before Resolution No.410 came into effect) the 7% VAT rate applied to all medical devices, medical devices for in vitro diagnostics, and active implantable medical devices within the meaning of the Technical regulations of Medical Devices. 23 Given the above mentioned, the SFS explained that upon the entry into force of Resolution No. 410 only medical devices defined in the List shall be subject to VAT at the rate of 7%, with due regard to the relevant labeling for the headings specified in the List, regardless of the tax rate applied to their purchase or import to the customs territory of Ukraine. At the same time, the companies that have already imported the now listed medical devices at the rate of 20% before the entry into force of Resolution No.410 and thus have to pay VAT at the rate of 7% on the delivery of the same in the territory of Ukraine, have the right to include VAT amount paid in imports into the tax credit in full (20%), as the Tax Code of Ukraine (hereinafter, the Tax Code) links this right to the following conditions existing in total: — a properly executed import customs declaration and the payment of VAT on import 24; — the goods are purchased to be used in transactions that are subject to VAT25 and — as part of business activities of the VAT payer.26 13 Arzinger. Life Sciences & Healthcare Newsletter October 2014 At the same time, the Tax Code of Ukraine contains no conditions that would make the inclusion of VAT amounts paid on imports dependent on the VAT rate. Proportionate allocation of tax amount to the tax credit is only possible, if some part of the purchased goods is used in VAT-exempt transactions. In turn, medical devices that have not been included into the List shall be subject to VAT at the rate of 20% upon the entry into force of Resolution No.410, both in customs clearance procedures in case of their importation to Ukraine and in case of their delivery in the customs territory of Ukraine. The stated rate shall be applied regardless of the rate applied in the calculation of tax amounts on their purchase in the customs territory of Ukraine or their importation to the customs territory of Ukraine. 14 Arzinger. Life Sciences & Healthcare Newsletter October 2014 CUSTOMS ISSUES Customs declaration in the movement of goods across borders of the Free Economic Zone "Crimea" — Due to the introduction of the Free Economic Zone "Crimea" (hereinafter, the FEZ) based on the relevant law27 in force as of 27.09.2014 (hereinafter, Law No.1636-VII), which we detailed in our relevant issue, the SFS explained some issues of customs formalities in the movement of goods and commercial vehicles across borders of the FEZ in its relevant letter28. The letter explains the types and procedure for filling customs declarations that should be submitted, if goods are moved to / from the territory of the FEZ, depending on their place of origin, destination, method of movement etc. Also, the letter explains that the customs clearance of goods imported to the FEZ shall be carried out at the following authorities: 1. In the movement of Ukrainian goods from elsewhere in Ukraine to the FEZ "Crimea" – at the relevant customs clearance units of Kherson or Zaporizhzhya Customs; 2. In the movement of foreign goods through another territory of Ukraine with their subsequent importation to the FEZ "Crimea": 1) in cases of transit – at the point of entry (pass) to another territory of Ukraine; 2) if goods are placed under the free customs zone regime – at the relevant customs clearance units in Kherson or Zaporizhzhya Customs; 3. In the movement of goods from the FEZ "Crimea" to another territory of Ukraine: 1) at the relevant customs clearance units in Kherson or Zaporizhzhya Customs, or 2) at any tax authority elsewhere in Ukraine upon delivery to such authority under a customs declaration of "ТР 81 АА" type or a document used to declare goods and commercial vehicles in the customs regime of transit in accordance with Article 94 of the Customs Code of Ukraine; 4. In the movement of goods from the FEZ "Crimea" across the other territory of Ukraine with their subsequent exportation from the other territory of Ukraine (including goods of Ukrainian origin with due regard to provisions of Par. 12.4 Article 12 of Law No.1636-VII) – at the relevant customs clearance units in Kherson or Zaporizhzhya Customs. 27 Law of Ukraine "On Establishing the Free Economic Zone "Crimea" and specifics of economic activities in the temporarily occupied territory of Ukraine" dated 12.08.2014 No.1636-VII 28 Letter of the State Fiscal Service of Ukraine dated 26.09.2014 No.5626/7/99-99-24-01-06-17 15 Arzinger. Life Sciences & Healthcare Newsletter October 2014 CURRENCY REGULATION The National Bank of Ukraine amended the previously passed resolutions to steady Ukrainian currency market — On 30 October 2014 the NBU by its Resolution No. 685 (the "Resolution No. 685") amended Resolution No. 540 dated 29 August 2014 and canceled the ban on the following transactions in foreign currency: — settlements under import transactions without actual importation of goods to Ukraine; — payments under import contracts, under which products have been imported to Ukraine under customs clearance carried out on the basis of an import customs declaration with the date of clearance exceeding 180 days. Besides, amendments were introduced to the NBU Resolution No.597 dated 30 December 2003, regarding the price of services (work, IP rights), payment of which requires obtaining of an act of pricing expertise from the National Research and Information Center for Monitoring International Commodity Markets. Respective amount has been decreased from 100,000 to 50,000 euros. The Resolution No. 685 came into effect on 3 November 2014. Kind regards and best wishes, Timur Bondaryev, Managing Partner, Attorney-at-law, Head of Life Sciences and Healthcare Practice Lana Sinichkina, Partner, Head of Life Sciences and Healthcare Practice 16 Arzinger. Life Sciences & Healthcare Newsletter October 2014 Related Publications by Arzinger: — The Law of Ukraine “On Medicines” has been changed (in Ukrainian) Leonid Cherniavskyi, Associate /Yurydychna gazeta, № 31-32 / — mHealth is Taken under Control: Software and Mobile Applications of the "Health" Category will Fall under State Regulation in 2015 (in Russian) Leonid Cherniavskyi, Associate /IT Expert, 29.10.2014 / — Market Access in Ukraine Lana Sinichkina, Partner, Leonid Cherniavskyi, Associate / PharmExecBlog, 13.10.2014 / — New wave of information requests from the Antimonopoly Committee of Ukraine (in Russian) Lana Sinichkina, Partner, Svitlana Malynovska, Senior Associate / Apteka.ua, 07.10.2014 / — Direct involvement of pharmaceutical companies in public procurement of medicines: background and perspectives (in Russian) Lana Sinichkina, Partner, Svitlana Malynovska, Senior Associate, Igor Svitlyk, Associate / Apteka.ua, 23.09.2014 / — Comment: Clinical trials of medicines: the consequences of changes to the Procedure for Patients (in Ukrainian) Lana Sinichkina, Partner Apteka.ua, No.950 (29) 28.07.2014 — Marketing vs Charity (in Russian) Svitlana Malynovska, Senior Associate / Analytical Issue "Yurist & Zakon", 25.07.2014 – 31.07.2014, No. 29 — Comment: Full value compliance (in Russian) Igor Svitlyk, Associate / Yurydycheskaya Praktika, April 2014/ — Removal of the State Service on Medicinal Products of Ukraine out of control of the Minister of Healthcare is illegal (in Russian) Lana Sinichkina, Partner / «Yurliga», 12.05.2014 г. / — Getting the Deal Through – Pharmaceutical Antitrust 2014 Timur Bondaryev, Managing Partner, Svitlana Malynovska, Senior Associate / Law Business Research Ltd, Getting the Deal Through – Pharmaceutical Antitrust 2014 / 17 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — Comment: Representative office of the pharmaceutical company in Ukraine vs full entity: what to choose? (in Russian) Svitlana Malynovska, Senior Associate, Anna Demchenko, Associate / Pharma.net.ua, 08.04.2014 / — Comment: How to avoid the disappearance of drugs from pharmacies (in Russian) Timur Bondaryev, Managing Partner / LigaBuisnessInform, 27.02.2014 / — Conclusion of an agreement between the sponsor and health care facilities to conduct clinical trials of drugs (in Ukrainian) Igor Svitlyk, Associate / "Upravlinnya Zakladom Ohorony Zdorovia", №1/2014 / — Turnover of a study drug: expected changes in legal regulation (in Ukrainian) Svitlana Malynovska, Senior Associate, Igor Svitlyk, Associate / "Medychna praktyka", №3 - 2013 / — Interview with Lana Sinichkina for Yurydychna Gazeta (in Ukrainian) / "Yurydychna Gazeta", No.51-52, 17 December 2013/ — Payment for the services of health facilities for conducting clinical trials of new drugs (in Ukrainian) Svitlana Yazykova, Senior Associate / "Upravlinnya Zakladom Ohorony Zdorovia", No.12, 2013 / — Getting the Deal Through - Life Sciences 2014 Timur Bondaryev, Managing Partner, Lana Sinichkina, Partner, Svitlana Malynovska, Senior Associate /Law Business Research Ltd., Getting the Deal Through – Life Sciences 2014/ — Clinical Trials in Ukraine: Execution of Contracts and Budgeting (in Ukrainian) / Pharmaceutical courier, No.12, December 2013 / — Comment: Low level of protection of IP rights in Ukraine holds back supply of innovative medicinal products (in Russian) Lana Sinichkina, partner /IA "Interfax-Ukraine", 20 November 2013 / — Clinical Trials in Ukraine: what to remember while concluding the contracts (in Russian) /Online newspaper «apteka.ua», 18 November 2013 / — Comment: Requirement to own production facilities in Ukraine complicates participation at the public procurement procedures for global pharmaceutical companies (in Russian) Lana Sinichkina, partner /IA "Interfax-Ukraine", 8 November 2013 / — Legislation on clinical trials needs reforms Lana Sinichkina, Partner /IA "Interfax-Ukraine", 24 October 2013 / — In order to implement the concept of insurance medicine a political will is required – a lawyer Svitlana Malynovska, Senior Associate / IA "Interfax-Ukraine", 22 October 2013/ 18 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — Comment: MOH approved promotion rules for medicinal products. Loopholes in the document may be used by pharmaceutical companies Lana Sinichkina, Partner /newspaper "Capital", 14 October 2013 / — Comment: a new scandals boils up on the pharmaceutical market Vitaly Kasko, Partner /korrespondent.net, 11 October 2013 / — Comment: special attention was given to medicinal products Vitaly Kasko, Partner /"Kommersant Ukraina", 11 October 2013/ — Investigators’ Legal Status in Entering Clinical Trial Services Agreements: Should They be Registered as Entrepreneurs or Not? Lana Sinichkina, Partner; Igor Svitlyk, Associate /Journal for Clinical Studies, September 2013/ — Restrictions on Advertising of Certain Product Groups: State Control, Practice, Sanctions and Prospects (in Russian) Lana Sinichkina, Partner /Online portal “Jurliga”, 26 September 2013/ — Interview with Lana Sinichkina (in Russian) Lana Sinichkina, Partner /“Pharmaceutical Courier”, No. 9, September 2013/ — Comment: Lawyer Recommends the Pharmacies to Stop Using Advertising Information in Their Names (in Russian) Svitlana Malynovska, Senior Associate /"Interfax-Ukraine", 4.09.2013/ — Peculiarities of health insurance in Ukraine (in Ukrainian) Svitlana Malynovska, Senior Associate; Аndriy Datskiv, Associate /“Medical Practice”, August 2013/ — Shadow of Health (in Russian) Svitlana Malynovska, Senior Associate; Rodion Teslya, Associate /“Yurydychna Praktyka”, No. 24 (807), 11 June 2013/ — Licensing the Economic Activity on Circulation of Medicinal Products (Ukrainian) Svitlana Malynovska, Senior Associate; Anna Serb, Associate /“Medical Practice”, May 2013/ — Interview by Svitlana Malynovska about Medicinal Products in Pharmacies and Their Re-registration (in Ukrainian) Svitlana Malynovska, Senior Associate /program “Hot Topic”, Gamma channel, 03.06.2013/ — Mandatory Character of GMP in Ukraine (Ukrainian) Lana Sinichkina, Partner; Dmytro Zaitsev, Associate /”Yurydychna Gazeta”, No 21, 21.05.2013/ 19 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — Comment on clinical trials in the absence of accreditation of health facilities (in Russian) Igor Svitlyk, Associate /"Interfax-Ukraine", May 2013/ — Comments on Prohibition to Send Dietary Supplements (Ukrainian) Svitlana Malynovska, Senior Associate; Andriy Datskiv, Associate /”Yurydychna Gazeta”, No. 19-20, 14.05.2013/ — Clinical Research Involving Children - Legal and Ethical Aspect (in Ukrainian) Lana Sinichkina, Partner; Igor Svitlyk, Associate /magazine “Pharmaceutical Courier”, No. 5 May 2013/ — “Investigator’s Legal Status in Concluding a Service Agreement in Clinical Trials: Register or Not?” (in Ukrainian) Lana Sinichkina, Partner; Igor Svitlyk, Associate /magazine “Pharmacist Practitioner”, 13.05.2013 (http://fp.com.ua/)/ — Getting the Deal Through - Pharmaceutical Antitrust 2013 Timur Bondaryev, Managing Partner; Svitlana Malynovska, Senior Associate /Law Business Research Ltd., May 2013/ — Pharmacy Business Regulation (in Ukrainian) Svitlana Malynovska, Senior Associate; Аnna Serb, Associate /“Yurydychna Gazeta”, No. 16, 16.04.2013/ — Importing Medicines in a New Way: Will Importers' (Manufacturers') Trade Secrets Become Public? (in Russian) Lana Sinichkina, Partner; Dmytro Zaitsev, Associate /“PharmazevtPraktik”, 15.04.2013 (http://fp.com.ua/)/ — Procedure for Inspections before Issuing an Import License for Medicinal Products (in Russian) Svitlana Malynovska, Senior Associate; Аndriy Datskiv, Associate /Analytical publication “Yurist&Zakon”, No. 27, 09.04.2013 – 11.04.2013/ — Import of Unregistered Medical Devices for Conducting Clinical Trials (in Ukrainian) Lana Sinichkina, Partner; Igor Svitlyk, Associate /Analytical publication “Yurist&Zakon”, No. 27, 09.04.2013 – 11.04.2013/ — Compulsory Licenses for the Use of Patented Inventions Relating to a Medicinal Product (in Ukrainian) Lana Sinichkina, Partner; Vira Batova, Associate /“Medychna Praktyka”, April 2013/ — Concept and Specifics of the Term Parapharmaceutical Product (in Ukrainian) Lana Sinichkina, Partner; Vira Batova, Associate /magazine “Pharmaceutical Courier”, No. 4 April 2013/ — Attention! Registration of medical products (in Russian) Lana Sinichkina, Counsel; Anna Serb, Associate /PharmazevtPraktik No. 3, 2013/ — Legal Analysis of the Law of Ukraine No. 5038-VI regarding Licensing of Import of Drugs (in Russian) Svitlana Malynovska, Senior Associate; Dmytro Zaitsev, Associate /Weekly Digest “Apteka”, March 2013 (http://www.apteka.ua)/ 20 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — Interview with Svitlana Malynovska regarding the Short Supply of Medicines in Ukraine (in Russian) Svitlana Malynovska, Senior Associate /“Vlasnyy Poglyad”, TV Rada, 30.01.2013/ — Changes in the Legal Regulation of Medicines Containing Tryptamine Derivatives (in Ukrainian) Lana Sinichkina, Partner; Igor Svitlyk, Associate /“Medychna Praktyka”, January 2013/ — Getting the Deal Through - Life Sciences 2013 Timur Bondaryev, Managing Partner; Svitlana Malynovska, Senior Associate /Law Business Research Ltd., December 2012/ — Spheres of Restraint (Chemical Industry and Healthcare) (in Russian) Lana Sinichkina, Partner /“50 leading companies in Ukraine”, Publishing House “Kommersant-Ukraina”/ — Interview with Svitlana Malynovska on the Introduction of Electronic Patient Registry (in Russian) Svitlana Malynovska, Senior Associate /”Vlasnyy Poglyad”, TV Rada, 16.11.2012/ — Clinical Trials in Ukraine. Recent Changes: Legal and Practical Aspects Lana Sinichkina, Partner, Head of Life Sciences and Healthcare Practice at Arzinger; Sergei Mikhailov, Chairman of the EBA Subcommittee on Clinical Trials /Journal for Clinical Studies No. 121101 - 01/11/2012/ — The Ministry of Health of Ukraine Proposes to Limit the Sale of Combined Medicinal Products (in Russian) Igor Svitlyk, Associate /“Yurydychna Gazeta”, No. 41-42, 16.10.2012/ — Last Changes as to Declaration of Wholesale and Retail Prices for Medicinal Products and Medical Devices Purchased for Public Funds (in Ukrainian) Svitlana Malynovska, Senior Associate; Vira Batova, Associate /“PharmazevtPraktik”, 25.10.2012 (http://fp.com.ua/)/ — Flaws of the Reimbursement for Antihypertensive Drugs (in Ukrainian) Svitlana Malynovska, Senior Associate; Vira Batova, Associate /Weekly Digest “Apteka”, 18.10.2012 (http://www.apteka.ua)/ — Illegal Benefits (in Ukrainian) Lana Sinichkina, Partner /magazine “Vashe Zdorovie”, 21.10.2012/ — Changes in the Procedure for Importing Unregistered Medicinal Products for Individual Use to Ukraine (in Russian) Lana Sinichkina, Partner; Nadiya Karlash, Associate /“PharmazevtPraktik”, September 2012 (http://fp.com.ua/)/ — Illegal Benefits and Charges for Them (in Russian) Lana Sinichkina, Partner /Weekly Digest “Apteka”, 12.09.2012 (http://www.apteka.ua)/ 21 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — Clinical Trials in Ukraine: Legal and Practical Aspects (in Russian) Lana Sinichkina, Partner at Arzinger; Sergiy Mykhaylov, Chairman of the EBA Clinical Trials Subcommittee /Weekly Digest “Apteka”, No. 854 (33) 27.08.2012 (http://www.apteka.ua)/ — The International Comparative Legal Guide to: Pharmaceutical Advertising 2012 Timur Bondaryev, Managing Partner; Svitlana Malynovska, Senior Associate /The International Comparative Legal Guide to Pharmaceutical Advertising, издательство Global Legal Group Ltd, London, July 2012/ — Memoranda of Understanding between the Government and National Pharma Producers: Legal Analysis (in Russian) Lana Sinichkina, Partner /Weekly Digest “Apteka”, No. 849 (28) 23.07.2012 (http://www.apteka.ua)/ — Crimes without Punishment (in Russian) Lana Sinichkina, Partner; Maria Baranovych, Associate /“Yurydychna Praktyka”, No. 28 (759), 10.07.2012/ — Enhanced Price Regulation in the Pharmaceutical Market (in Russian) Lana Sinichkina, Partner; Oksana Matsiv, Associate /“Yurydychna Gazeta”, No. 26, 26.06.2012/ — Comments on the Draft Law Limiting HCPs’ Cooperation with Pharmacies (in Russian) Lana Sinichkina, Partner; Nadiya Karlash, Associate /“PharmazevtPraktik”, June 2012 (http://fp.com.ua/)/ — Arzinger Lawyers Answer Readers’ Questions for “Investgazeta” (in Russian) Timur Bondaryev, Managing Partner; Sergiy Shklyar, Founding Partner; Pavlo Khodakovsky, Partner /“Investgazeta”, June 2012/ — Pharmaceutics in the State’s Focus of Attention (in Russian) Timur Bondaryev, Managing Partner /“GVardia”, May 2012/ — The Cabinet of Ministers of Ukraine Proposes to Create an Electronic Register of Patients (in Russian) Lana Sinichkina, Partner /Weekly Digest “Apteka”, 23.05.2012 (http://www.apteka.ua)/ — Processing and Protecting Personal Data in Clinical Trials (in Ukrainian) Svitlana Malynovska, Senior Associate /“Yurydychna Gazeta”, No. (311), 22.05.2012/ — Recent Trends in Developing and Launching Medicinal Products (in Russian) Lana Sinichkina, Counsel /Weekly Digest “Apteka”, 15.05.2012 (http://www.apteka.ua)/ — Getting the Deal Through: Pharmaceutical Antitrust 2012 Timur Bondaryev, Managing Partner; Svitlana Malynovska, Senior Associate /Law Business Research Ltd., May 2012/ 22 Arzinger. Life Sciences & Healthcare Newsletter October 2014 — Development and Market Entry of Medicines: Specifics and Tendencies in Ukraine (in Russian) Lana Sinichkina, Partner /“PharmazevtPraktik”, No. 4_2012 (http://fp.com.ua/)/ — Problems Arising due to Legislative Novelties (in Russian) Lana Sinichkina, Counsel /“Sovremennaya Pharmazia”, No. 3, March 2012/ — Pharmaceutical Market Trends in the World and in Ukraine: Legal Opinion (in Russian) Lana Sinichkina, Partner /Weekly Digest “Apteka”, 19.03.2012 (http://www.apteka.ua)/ — Changes in Legislation to Strengthen Control of Trade in Medicines (in Ukrainian) Timur Bondaryev, Managing Partner; Svitlana Malynovska, Senior Associate /“PharmazevtPraktik”, No. 3 март 2012/ — Ironing Out the Creases Timur Bondaryev, Managing Partner; Svitlana Malynovska, Senior Associate /European Pharmaceutical Contractor, 62 – 01.03.2012/ — Interview with Lana Sinichkina (in Russian) Lana Sinichkina, Partner /”Yurydychna Gazeta”, No. 6, 07.02.2012/ — Marking Given a Start in Life (in Russian) Timur Bondaryev, Managing Partner /“Yurydychna Praktyka”, No. 5 (736), 31.01.2012/ 23 Arzinger. Life Sciences & Healthcare Newsletter October 2014 ARZINGER’S LIFE SCIENCES & HEALTH CARE PRACTICE Arzinger provides legal services to leading international and local pharmaceutical companies doing business on the territory of Ukraine on various legal issues, from planning business in the Ukrainian market to interacting with government agencies; intellectual property; settlement of disputes with monitoring / supervising / regulatory agencies and contractors etc.). Arzinger’s working languages are Ukrainian, Russian, German, and English. Arzinger’s team is a recognized leader on the legal services market in the sphere of pharmaceutical business of Ukraine. Our life sciences and healthcare practice employs 12 experienced lawyers who have worked as legal advisors (in-house lawyers) to leading pharmaceutical companies, clinical research organizations and medical institutions. At the same time, we are constantly developing and expanding our team to meet our clients’ needs. In addition, if required for a project, we engage lawyers from other Arzinger’s practices specialized in certain areas of law (e.g. intellectual property rights, tax and customs law, public procurement, corporate law, advertising, etc.). Thus we can provide clients with integrated and comprehensive advice on all aspects of doing business in Ukraine. The symbiosis of knowledge of law, a personal-touch approach to each assignment and our practice’s significant experience enables us to offer our clients high-quality legal services. In 2012 and 2013 the Ukrainian rating “Ukrainian Legal Firms. Handbook for Foreign Clients” rated Arzinger highly in the areas of medicine, healthcare and pharmaceutics. Timur Bondaryev, Managing Partner, and Lana Sinichkina, Counsel, were ranked individually in the area of healthcare and pharmaceutics. According to the ranking “Client’s Choice. Top-100 Best Lawyers of Ukraine” conducted by Yurydychna Gazeta in 2010-2011 and 2012-2013, Timur Bondaryev, Managing Partner and Head of Arzinger’s Life Sciences and Healthcare Practice, has been recognized as one of the best lawyers in Ukraine specializing in health and pharmaceutical law. Lana Sinichkina, Counsel and Head of the Life Sciences and Healthcare Practice, was listed by the 2012-2013 rating among 300 Ukrainian lawyers, whose names have been mentioned most frequently by representatives of business, customers and peers. 24 Arzinger. Life Sciences & Healthcare Newsletter October 2014 Arzinger provides legal services in relation to: — Antitrust and competition law — Clinical trials — Advertising and other types of promotion of MPs and medical devices — Registration , protection and transfer of intellectual property rights — Public procurement — Tax and legal advice on business development — Business Restructuring — Public -private partnership — Localization of manufacturing , contract manufacturing — Registration (re -registration ) of MPs, food and dietary supplements as well as functional foods and foods for special dietary use , medical equipment and medical devices — MPs Manufacture — MPs and medical devices import — MPs and medical devices sales in the territory of Ukraine (wholesale and retail , pricing , public procurement etc .) — State accreditation of pharmacies and healthcare institutions — Licensing of medical activities — Obtaining a special license for medical practice in the sector of folk and alternative medicine — Certification of pharmacists , physicians and nurses — Healthcare institutions activity — Legalization and employment of foreign specialists — Representing physicians and patients in conflict situations — Support during regulatory authorities raids — Advising clients on legal issues regarding personal data protection , legal support of registration of personal data bases — Litigation , including disputes with ta x and customs authorities and disputes on debt collection . 25 Arzinger. Life Sciences & Healthcare Newsletter October 2014 The daily consulting of pharmaceutical business clients includes: — Corporate issues — Contract maintenance — Reviewing clients ’ marketing and advertising materials for compliance with advertising and competition laws — Drafting /amending internal documents (policies , procedures , instructions ) — Legal support of HR departments — Protecting clients ’ interests during inspections conducted by state authorities (Security Service of Ukraine , Public Prosecution bodies , AMCU, State Tax Inspection etc .). Arzinger’s lawyers conduct corporate workshops/trainings for employees of pharmaceutical companies on the most topical issues of Ukrainian legislation. As part of Arzinger Academy Legal Days we hold monthly business breakfasts for pharmaceutical representatives to let the participants know experts’ opinions, to discuss current market issues and to share experience. Moreover, Arzinger is a general partner of Pharmaceutical and Medical Law School created by all-Ukrainian public organization Ukrainian Bar Association.
