FINANCIAL LAW NEWS. This Measure became effective on 1 February 2012.

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1 JANUARY 2012 NEW FORM OF EMISSION ALLOWANCES TAX RETURN page: 1 INTERNET SALE OF DRUGS AND MEDICAL DEVICES page: 1 INVESTMENT PROMOTION BETWEEN CANADA AND SLOVAKIA page: 1 NATIONAL BANK OF SLOVAKIA REGULATIONS page: 2 OTHER SIGNIFICANT LEGAL REGULATIONS page: 3 PREPARED LEGISLATION page: 4 NEW TEMPLATES OF FORMS FOR SUBMISSION OF APPLICATIONS TO COMMERCIAL REGISTRY page: 4 PROPOSED CHANGES IN NEW ACT ON DRUGS page: 4 JUDICIAL DECISIONS page: 6 LEGAL CONSEQUENCES OF FILING ACTION FOR EXCLUSION OF THING FROM EXECUTION ON FURTHER COURSE OF EXECUTION page: 6 Štúrova Bratislava, Slovak Republic tel.: (421-2) fax: (421-2) office@cechova.sk branch: Avenue d Auderghem 36 B-1040, Brussels, Belgium Tel.: +32 (0) fax: +32 (0) brussels@cechova.sk NEW FORM OF EMISSION ALLOWANCES TAX RETURN (Notification of the Ministry of Finance of the Slovak Republic No. 22/2012 Coll. on Issuance of Measure establishing the Form of Tax Return to the Emission Allowances) The Ministry of Finance of the Slovak Republic issued pursuant to the empowering provision of the Act on Tax Administration (Tax Procedure Code) the Measure establishing a form of tax return to emission allowances. The Measure is published in the Financial Bulletin No. 1/2012 and is available for inspection at the Ministry of Finance of the Slovak Republic and in electronic form at the website This Measure became effective on 1 February INTERNET SALE OF DRUGS AND MEDICAL DEVICES (Decree of the Ministry of Health of the Slovak Republic No. 1/2012 Coll. establishing Details on Internet Sale of Drugs or Medical Devices, Manner of Publishing of Information about Internet Sale, Manner of Packaging of Shipment and its Transportation and Manner of Claim) The Ministry of Health of the Slovak Republic under empowering provision contained in the Act on Drugs and Medical Devices, after agreement with the Ministry of Agriculture and Rural Development of the Slovak Republic issued the Decree stipulating details of the internet sale of drugs and medical devices pursuant to the Act on Drugs, on manner of publishing of information on internet sale, on manner of packaging of shipment and its transportation and on manner of claim. The internet sale includes publication of information about internet sale, ordering of package via electronic order form, registration of electronic order, packaging of shipment and assurance of its transportation, handling of the claim and return of drugs and medical devices. Requirements of good pharmacy practice in accordance with the Act on Drugs apply also to the internet sale. This Decree cancels Decree of the Ministry of Health of the Slovak Republic No. 74/2010 Coll. establishing Details of the Mail Sale of Drugs and Medical Devices. This Decree became effective on 1 February INVESTMENT PROMOTION BETWEEN CANADA AND SLOVAKIA (Notification of the Ministry of Foreign Affairs of the Slovak Republic No. 26/2012 Coll. on Conclusion of the Agreement between the Slovak Republic and Canada for the Promotion and Protection of Investments) In terms of the Notification, the Agreement between the Slovak Republic and Canada for the Promotion and Protection of Investments was signed on 20 July The National Council of the Slovak Republic gave its consent with the Agreement on 29 March 2011 and decided that it is an agreement which in accordance with the Constitution of the Slovak Republic prevails over acts. President of the Slovak Republic ratified the Agreement on 13 May Promotion and protection of investments of investors of one party to the Agreement in the territory of the other party to the Agreement should contribute to stimulation of business initiatives and development of their economic cooperation. The parties to the Agreement committed themselves to promote creation of favourable conditions for investors of the other party to carry out investments on its territory. The Agreement also addresses other issues to ensure protection of investments, possible damage indemnification as well as issues relating to the expropriation. Each party to the Agreement is under the Agreement required to guarantee to investor of the other party unrestricted transfer of investments and returns. The Agreement also provides for resolution

2 JANUARY of disputes between investor and host party, as well as disputes resolution between parties to the Agreement. Consultations and exchange of information between parties to the Agreement are regulated as well. The Agreement supersedes currently valid Agreement between the Government of the Czech and Slovak Federal Republic and the Government of Canada for Promotion and Protection of Investments of 15 November The Agreement shall become effective on 14 March NATIONAL BANK OF SLOVAKIA REGULATIONS (Notification of the National Bank of Slovakia No. 25/2012 Coll. on Issuance of Measure on Submission of Statements by the Management Companies and Depositaries of Mutual Funds for the Purpose of Supervision over Financial Market; Notification of the National Bank of Slovakia No. 24/2012 Coll. on Issuance of Measure on Submission of Statements by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Securities Dealers for Statistical Purposes; Notification of the National Bank of Slovakia No. 23/2012 Coll. on Issuance of Measure on Submission of Statements by Management Companies for Mutual Funds or Sub-funds for Statistical Purposes; Notification of the National Bank of Slovakia No. 10/2012 Coll. on Issuance of Measure amending and supplementing Measure of the National Bank of Slovakia No. 6/2009 on Submission of Statements, Notifications and other Reports by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Security Dealers for Purposes of Supervision and on amendment of Measure of the National Bank of Slovakia No. 26/2008 on Submission of Statements by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Security Dealers for Statistical Purposes in wording of Measure of the National Bank of Slovakia No. 4/2011; Notification of the National Bank of Slovakia No. 9/2012 Coll. on Issuance of Measure amending and supplementing Measure of the National Bank of Slovakia No. 4/2007 on Own Sources of Funding of Banks and Requirements on Own Sources of Funding of Banks and on Own Sources of Funding of Securities Dealers and Requirements on Own Sources of Funding of Securities Dealers as amended) The National Bank of Slovakia issued on the basis of empowering provisions of the Act on Collective Investment, Act on Banks, Act on Securities and Investment Services, Act on Supervision over Financial Market mentioned measures. Submission of Statements by Management Companies and Depositories of Mutual Funds for Purpose of Supervision over Financial Market This Measure provides for structure, scope, content, form, classification, terms, manner, methods and place of submission of statements, notifications, summaries and other reports submitted to the National Bank of Slovakia by management companies and depositories of mutual funds for the purpose of supervision over financial market and method for their preparation. The Measure cancels Measure of the National Bank of Slovakia No. 9/2008 on Submission of Statements by Entities ensuring Distribution of Securities of Foreign Collective Investment Undertakings for the Purposes of Supervision. Submission of Statements by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Securities Dealers for Statistical Purposes The Measure provides for content, classification, terms, form, manner, method and place of submission of statements by banks, branches of foreign banks, securities dealers and branches of foreign securities dealers to the National Bank of Slovakia for statistical purposes. The Measure cancels Measure of the National Bank of Slovakia No. 26/2008 on Submission of Statements by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Securities Dealers for Statistical Purposes. Submission of Statements by Management Companies for Mutual Funds and Sub-funds for Statistical Purposes This Measure provides for content, classification, terms, form, manner, method and place of submission of statements by management companies for mutual funds or sub-funds to the National Bank of Slovakia for statistical purposes. The Measure cancels Measure of the National Bank of Slovakia No. 23/2008 on Submission of Statements by Management Companies for Mutual Funds for Statistical Purposes.

3 JANUARY Measure on Submission of Statements, Notifications and Other Reports by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Securities Dealers for Purposes of Performance of Supervision and Amending Measure on Submission of Reports by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Securities Dealers for Statistical Purposes This Measure amends and supplements Measure of the National Bank of Slovakia No. 6/2009 on Submission of Statements, Notifications and other Reports by Banks, Branches of Foreign Banks, Securities Dealers and Foreign Branches of Securities Dealers for Purposes of Performance of Supervision and on amendment of Measure of the National Bank of Slovakia No. 26/2008 on Submission of Statements by Banks, Branches of Foreign Banks, Securities Dealers and Branches of Foreign Securities Dealers for Statistical Purposes, which takes into account matters resulting from application practice. The Measure also cancels Article II. of Measure of the National Bank of Slovakia No. 24/2008 amending and supplementing certain Measures of the National Bank of Slovakia in connection with introduction of euro currency in the Slovak Republic. Amendment of Measure on Own Sources of Funding of Banks and on Requirements on Own Funding of Banks and on Own Sources of Funding of Securities Dealers and on Requirements on Own Sources of Funding of Securities Dealers The Measure shall ensure full and correct transposition of the Directive 2010/76/EU of the European Parliament and the Council of 24 November 2010 amending Directives 2006/48/EC and 2006/49/EC as regards capital requirements for the trading book and for re-securitisations, and the supervisory review of remuneration policies into Slovak law. All above mentioned measures were published in Bulletin of the National Bank of Slovakia No. 27/2011, 1/2012 and 3/2012 and are available for inspection at all organisational units of the National Bank of Slovakia. These Measures became effective on 31 January Other significant legal regulations published in the Collection of Laws in January 2012 are as follows: - Notification of the Ministry of Foreign Affairs of the Slovak Republic No. 15/2012 Coll. to the Convention Abolishing the Requirement of Legalization for Foreign Public Documents on Supplementing of Fully Updated List of Authorities of Parties to the Convention under Article 6 of the Convention Abolishing the Requirement of Legalization for Foreign Public Documents of 5 October 1961, - Notification of the Ministry of Finance of the Slovak Republic No. 14/2012 Coll. on Issuance of Measure of the Ministry of Finance of the Slovak Republic of 8 November 2007 No. MF/20414/ , Establishing Organisation, Content Definition, Method, Date and Place of Submission of Accounting Information and Data Needed for Evaluation of Implementation of Budget of Public Administration, as amended, the Slovak Republic No. 12/2012 Coll. amending and supplementing Decree of the Ministry of Transport, Posts and Telecommunications of the Slovak Republic No. 351/2010 Coll. on Transportation Order of Rails, - Decree of the Ministry of Interior of the Slovak Republic No. 8/2012 Coll. amending Decree of the Ministry of Interior of the Slovak Republic No. 599/2006 Coll. on Expenses out of the State Budget for Civil Protection of Population, as amended, - Decree of the Ministry of Interior of the Slovak Republic No. 7/2012 Coll., establishing Details of Professional Competence in the Field of Civil Protection of Population, the Slovak Republic No. 6/2012 Coll. amending and supplementing Decree of the Ministry of Transport, Posts and Telecommunications of the Slovak Republic No. 245/2010 Coll. on Competency, Medical and Psychological Fitness of Persons in the operation of Railway and Track Transport,

4 JANUARY the Slovak Republic No. 3/2012 Coll., amending the Decree of the Ministry of Transport, Posts and Telecommunications of the Slovak Republic No. 29/2006 Coll. on Template and Requirements of Forms, Inspection Stickers, Stamps and on Forms of Marking of the Technical Control Station, Workplace of the Emission Control, Originality Check Workplace and Workplace of Assembly of Gas Appliances and on Form and Requirements of Licence of Inspector authorized to Perform State Professional Supervision in wording of Decree No. 353/2009 Coll., the Slovak Republic No. 2/2012 Coll., amending and supplementing Decree of the Ministry of Transport, Posts and Telecommunications of the Slovak Republic No. 578/2006 Coll. establishing Details of Some Provisions of Act No. 725/2004 Coll. on Conditions of Operation of Vehicles in the Road Traffic and on amendments and supplements of Certain Acts, as amended. PREPARED LEGISLATION This part contains current selected proposed legal regulations that are in the legislative process at the time of closing this issue. NEW TEMPLATES OF FORMS FOR SUBMISSION OF APPLICATIONS TO COMMERCIAL REGISTRY (proposal of Decree of the Ministry of Justice of the Slovak Republic, amending and supplementing Decree of the Ministry of Justice of the Slovak Republic No. 25/2004 Coll. Stipulating Specimen of Forms for Submission of Petition for Registration in the Commercial Registry and List of Documents that Have to be Attached to the Petition for Registration, as amended) The Ministry of Justice of the Slovak Republic proposes issuance of new Decree establishing standard forms for petitions for registration in the Commercial Registry and list of documents that shall be attached to the petitions for registration. The proposal of Decree follows new platform of the Commercial Registry administrated by the Ministry of Justice of the Slovak Republic. Purpose of new standard forms to the Commercial Registry is an automatic transfer of data directly contained in the electronic application to the judicial system, which should inter allia be enabled by modification of standard forms in such manner that the web forms could be saved in XML format. It is also proposed to introduce functions as control of correctness of filling of mandatory data in order to avoid errors in completing the forms by users, filing of items municipalities (in the Slovak Republic) and state for registration should only be possible by selection of codelist values under special regulation. Current electronic form of standard form for submission of petition in RTF format should be used for filling in electronic form until 31 October The effectiveness of this Decree is proposed from 1 April PROPOSED CHANGES IN NEW ACT ON DRUGS (Proposal of Act amending and supplementing Act No. 362/2011 Coll. on Drugs and Medical Devices and on Amending and Supplementing Certain Acts) The aim of the proposal amending and supplementing the Act on Drugs and Medical Devices and some other acts is to implement Directive 2010/84/EU of the European Parliament and the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community Code relating to medicinal products for human use. It is proposed to tighten supervision over medicinal products for human use, market surveillance and sanctions for failure to comply with relevant provisions, requirements for all entities handling with medicinal products for human use and supplementing competencies of the SIDC. Supplementing of definition of professional and promotional event in the Act is also proposed. Part of the professional event should in adequate extent form also accompanying activities and it is also proposed to allow organisation of promotional events subject to statutory conditions. It is proposed to clarify notification obligation of

5 JANUARY holder of the permission for manufacturing of medicinal products, holder of the permission for wholesale of the medicinal product and the holder of the registration of medicinal product for human use towards the National Health Information Centre immediately after any professional event. The amendment proposes to modify the definition of natural discounts. The definition of other non-monetary performance for purposes of discounts should be also modified and should state that provision of hospitality at professional event or promotional event is not considered other non-monetary performance. Changes should also affect clinical trials, including shifting of notification obligation regarding submission of the list of participants in clinical trials to the health insurance company from sponsor to the investigator. Membership of the participant in the health insurance company should be decisive at the time of completion of enrolment of participants in clinical trials. In connection with obligation of sponsor to cover the costs connected with clinical trials is proposed to cancel costs connected with treatment of the disease, to which the clinical trial is aimed and its replacement by obligation to cover the costs associated with clinical trials including costs for tested human products, tested medicinal products for human use stated in the protocol and costs connected with laboratory tests listed in the protocol. This proposal also contains new regulation concerning the adverse effects of medicinal products for human use. In this context, it is proposed to specify in detail surveillance over medicinal products for human use, transparency and provision of information regarding on supervision of medicinal products for human use, recording and reporting of suspicions of adverse reactions (Eudravigilance), update of report on safety of medicinal products for human use, signal detection, an urgency procedure of the European Union and supervision over study on safety of medicinal products for human use after registration. Upon this proposal, also Act on Administrative Fees shall be amended in connection with supplementing of related administrative fees and increase of their amounts. Definition of advertising of medicinal products in the Act on Advertising is proposed to be supplemented by provision of the medicinal products for human use. At the same time, it is proposed to extent the prohibition of advertising also to the OTC medicinal products which contain same drug or same combination of drugs as Rx medicinal products or medicinal products reimbursed from the public health insurance under special regulation. It is proposed to change provisions relating to hospitability at promotional events to hospitability at professional events. In the Act on Income Taxes it is proposed to include into incomes exempted from tax also non-monetary income provided in connection with active participation of health care provider, his employee or health care professional at professional event; in terms of the explanatory report active participation should be e.g. presentation of lecture or contribution. In the Act on Scope and Condition of Payment for Drugs, Medical Devices and Dietary Food via Public Health Insurance, it is proposed to amend effectiveness of decisions of the Ministry of Health of the Slovak Republic, introduce the mechanism enabling the Ministry of Health of the Slovak Republic to modify the price of drugs, medical devices and dietary food in case of change of value added tax or maximal price of commercial performance under the special regulation, introduce a fiction of deletion of the medicinal product or medical device from the list upon moment of termination of validity of its registration, to eliminate possibility of inclusion into system of food that by its form could correspond to medicinal products or nutritional supplements, cancel so-called rule of fixed surcharge of patient in case of decrease of the price of drugs, medical devices and dietary food with determined special method of payment. The effectiveness of the Act is proposed from 21 July 2012.

6 JANUARY JUDICIAL DECISIONS In this part are stated quotations from opinions of selected judicial decisions and statements in civil, business and labour law matters which were recently published in the journal From Court Practice (in Slovak: Zo súdnej praxe): LEGAL CONSEQUENCES OF FILING ACTION FOR EXCLUSION OF THING FROM EXECUTION ON FURTHER COURSE OF EXECUTION (Resolution of the Supreme Court of the Slovak Republic, File No. 3 MCdo 20/2010, published in the journal Zo súdnej praxe 6/2011, No. 56) Section 33 (1), Section 36 (5), Section 55 (1), Section 56 and Section 140 (2) of Act No. 233/1995 Coll. on Court Executors and Execution Activities (Execution Order) Filing of action for exclusion of thing from execution pursuant to Section 55 (1) of Act No. 233/1995 Coll. on Court Executors and Execution Activities (Execution Order) does not itself result in suspension of enforcement proceedings [Section 36 (5) of Act No. 233/1995 Coll. on Court Executors and Execution Activities (Execution Order)] or postponement of execution [Section 56 of Act No. 233/1995 Coll. on Court Executors and Execution Activities (Execution Order)]. The court executor may also after filing of action for exclusion of thing from execution continue in performance of tasks of execution activity and perform sale of things at auction even if the proceedings on exclusion of things have not been finally concluded.

7 JANUARY The information contained in this publication is not a legal advice. For any questions regarding the contained information, please consult the contact person for the respective topic. The Financial Law News is not a printed periodical and is avai lable in electronic format only as a marketing product distributed to a selected group of addressees. If you do not wish to receive the Financial Law News, or wish to be inclu ded in our mailing list, please notify the editor at the below address. You can find more information on our website: where the online versions of Financial Law News are available. For information on European Union and European Community law, you may obtain the European Community Law News, available under the same conditions as the Slovak Financial Law News. Editor Financial Law News: Mgr. Zuzana Gaálová, zuzana.gaalova@cechova.sk Čechová & Partners. Unauthorised copying not permitted Advokátska kancelária Čechová & Partners Združenie advokátov: JUDr. Katarína Čechová (evidenčné číslo v zozname advokátov vedenom Slovenskou advokátskou komorou: 0339/ ) poverená vedením úč tovníctva združenia pod IČ DPH SK , JUDr. Simona Haláková (5503/ ), Mgr. Ing. Michaela Jurková (4286/ ), Mgr. Tomáš Maretta (1601/ ), Mgr. Tomáš Rybár (3988/ ). Členovia združenia advokátov Čechová & Partners sú zapísaní v zozname advokátov ve denom Slovenskou advokátskou komorou (SAK) so sídlom Kolárska 4, Bratis lava a advokátske povolanie vykonávajú v zmysle príslušných advokátskych predpisov dostupných na internetovej stránke umožňujúcej trvalý prístup k infor máciám o tejto stavovskej organizácii. Členovia združenia advokátov nadobudli akademic ké tituly v Slovenskej republike. Štúrova 4, Bratislava Slovak Republic tel: +421 (2) , fax: +421 (2) office@cechova.sk, Branch Office: Avenue d Auderghem 36 B-1040 Brussels, Belgium tel.: +32 (0) , fax: +32 (0) brussels@cechova.sk,