Category: Serbia

  • The Buzz in Serbia with Boris Baklaja of Baklaja Igric Tintor

    “The Government has responded timely to the crisis and I think that the economic measures it has put in place can have positive effects,“ states Boris Baklaja, Partner at Baklaja Igric Tintor in Belgrade. “The Decrees adopted on April 10 provide for legislative follow-through for some of the measures previously announced by the Government are designed to produce two types of effects: support to companies primarily by postponing the regular obligatory payments — such as the tax and social contributions which are due as part of the employee’s gross salaries and advanced payment of profit tax —due in this period, and a direct, minimum wage, non-refundable financial aid for employees’ salaries for March through May.”

    However, these measures do not come without cost, Baklaja says. “Companies that opt to use this state support will have to accept certain restraints as part of the package, such as a moratorium on payment of dividends in 2020.” According to him, this may pose a problem, because “shareholders of private companies and businesses have a right to dividends from previous financial years and it is possible that they would try to dispute the legality of such an executive decision.” This places them in an “unfortunate position,” because “companies, businesses, factories … all of these economic units have planned budgets, term sheets, and so on. Most of them need to receive financial support and aid in order for them to be able to cover the operational costs at all.”

    Baklaja says that the uncertainty of the entire COVID-19 crisis is inhibiting any chances of “getting a new normal going.“ According to him, “this is not likely to be an overnight switch to a new way of doing business, and some clarity and predictability would go a long way to help all those affected begin adapting to the new status quo.“

    Finally, speaking about the legal market in Serbia, Baklaja says that “the first month of the crisis in Serbia was fraught with fear, doubt, and misunderstandings – a very clear adjustment period.“ However, as the second month of the state of emergency begins, “it would appear that clients are beginning to slowly come back to some regular volumes of work.“ As everywhere else, some practices are going to be more active than others. “I think that labor disputes, restructurings, bankruptcies, liquidations, and contract dissolution due to force majeure are probably going to spike and make the most work for lawyers in Serbia in the near future.“

  • JPM Helps German School Belgrade with GDPR Implementation Project

    JPM has advised the German School Belgrade on its implementation of a GDPR program.

    Serbia’s German School Belgrade was established in 1981 and is one of 143 German schools outside Germany. It provides education in accordance with educational programs from the German province of Thuringen for kindergarten, preschool, primary school, and Gymnasium.

    The GDPR program is focused, according to JPM, on “provid[ing] adequate organizational and technical measures to protect the privacy of minors and [the] steps to be taken to implement such measures,” and JPM assisted by “conducting an information security and personal data protection risk assessment.”

    JPM’s team consisted of Partner Ivan Milosevic and Senior Associate Andrea Cvetanovic.

  • State of Emergency / Corona Virus Crisis: What is a Force Majeure Event?

    In the commercial sector, due to corona crisis impact and amid nationwide state of emergency, we are receiving the following questions with reference to a transaction between two commercial entities. In our answers, we have not, however, considered any distinctions which might be necessary if the transaction involved consumers. Nevertheless, distinctions between the treatment of transactions which are principally for the sale of goods and those which are principally for provision of services have been taken into account.

    Force Majeure in Serbia

    • What is the legal definition of Force Majeure in your country?

    There is no explicit definition of Force Majeure under the general contract and tort rules in Serbia.

    However, the Serbian Law on Contracts and Torts (the “Contract Law”) provides that a party “Shall not be liable for damages if it can prove that it could not fulfill its obligation, or that it was late with the fulfillment of the obligations due to circumstances arising after the conclusion of the contract that could not be prevented, eliminated or avoided.”

    To apply the concept of force majeure to contractual relationship, the seller must not cause events defeating the performance, thus, such events must have occurred independent of its will and without its involvement, and were such that the seller could not prevent them, eliminate them or avoid them.

    It is understood that the provision applies both to sellers and buyers. However, due to the specific nature of its performance, the provision protects sellers’ interests in most cases. As a result, for the purposes of this article we would refer to the “seller” further on in the text.   

    It is important to add that the Republic of Serbia is a member of UN Convention on Contracts for International Sale of Goods (CISG). In case contract falls within CISG sphere of application, definition stemming from Article 79 of the CISG would govern the question of Force Majeure.

    • Absent any contractual provision, will relief be granted under the law of your jurisdiction if performance of contractual duties is delayed or prevented by events beyond the control of the affected party?

    Generally, yes.

    Namely, the seller shall be relieved from a duty to perform if obligation have been “prevented” by an event that the seller cannot be held liable for under the Contract Law, including (but not limited to) events “arising after the conclusion of the contract that could not be prevented, eliminated or avoided.”

    Other grounds for excused non-performance are liability of other party to the agreement, or third party liability, or any impediment for which a party cannot be held liable for.   

    Furthermore, as explained under the answer to the question (a), the seller shall not be liable for damages if it can prove that a “delay” of performance was (i) “due to circumstances arising after the conclusion of the contract”, (ii) “that could not be prevented, eliminated or avoided.”

    However, if the performance was not conditioned by the fix deadline, the contract remains valid even in the case of a delay, while the defaulting party is relieved only from the damages that arise in connection to the impediment beyond its control.  Therefore, depending on the circumstances of the case, it may be in the seller’s interest to specify within the contract how long an impediment should be permitted to last to qualify it as force majeure before the contract may be avoided.

    In any case (e.g. prevented or delayed), if the qualifying event occurs following the seller’s default, the seller cannot claim relief from liability for performance of services.

    Nevertheless, when it comes to the performance of contracts on sales of goods, the seller may claim relief under condition that it can show that contracted goods would be lost due to the events beyond its control even in case of a due performance. 

    If so, does the law take into account the reasonability or commercial practicability of the effort necessary to overcome these events, or is any possible effort required to have been expended before claiming relief?

    Generally, no.

    The Contract Law assumes a liability of a non-performing party to a contract. Therefore, it is upon the party claiming the relief from contractual obligation (and from liability) to prove existence of the circumstances that were beyond its control (events “that could not be prevented, eliminated or avoided”).

    We underlie that that the Contract Law presumes only ordinary negligence of non-performing party. It is upon a non-breaching party to the agreement to prove gross negligence or wilful misconduct. Therefore, it is wise to consider excluding ordinary negligence from liability by means of contract.

    However, the Contract Law and pertaining case law does not recognize and apply standard of “reasonability” or “commercial practicability of the effort necessary to overcome these events”.

    Furthermore, although the Serbian case law is not steady on the matter, it suggests that so called “economic impediments” linked to the performance should not qualify as grounds for relief in terms of the force majeure but rather as grounds for right to terminate the contract under provisions governing change in circumstances (hardship).

    Therefore, in order to qualify for relief from liability for non-performance, the standards such as “reasonability” or “commercial practicability of the effort” must be explicitly contracted as elements of the definition of force majeure agreed by parties. 

    • Can the relief afforded by the provisions described above be broadened or extended by agreement of the parties?

    Generally, yes.

    However, statutory limitations to freedom of contract shall apply as follows:

    • The liability based on willful misconduct or gross negligence (culpa lata, culpa magna) cannot be excluded nor capped by contract, and such provision would be void ipso iure.
    • The court may also annul the contractual provision on the exemption of liability for ordinary negligence (culpa levis), should such agreement result from dominant position of the debtor or, otherwise, of unequal mutual positions of the contracting parties.

    Furthermore, in relation to the liquidated damages clauses, the specific safeguards apply, as follows:

    • A provision of a contract by which the maximum amount of compensation is determined shall be valid, unless such amount is in obvious disproportion to the actual harm and unless the law provides otherwise for the specific case;
    • In case of limiting the amount of compensation, the creditor shall be entitled to full redress if the impossibility of performance is caused by willful misconduct or gross negligence of the debtor.

    In light of the above, the relief rule can be modified by a contract to include situations not covered by statutory formula for release of debtor from liability as well as limitation of maximum amount of compensation (liquidated damages).  

    By Miomir Stojkovic, Principal, and Zoran Sretic, Legal Counsel, Stojkovic Attorneys

  • Corona Crisis and its Impact on Public-Private Partnerships Market

    Every day we are hearing news from all around the world about coronavirus and countries are in lockdown situation with no economic activity. Magazine Economist predicts we could see a drop in GDP of 5% and a loss of a quarter of the global GDP forecast for 2020.

    If we put into concern the crashing oil market and the temporary cessation of stock trading as an indicator of the coronavirus’ ancillary economic impacts, global public and private sectors leaders need to embrace mitigation strategies immediately.

    The virus’ economic impacts on PPPs will place a tremendous burden on project stakeholders, users, the private corporate sector, and the public sector for months and years to come. 

    With reduced economic activity, PPP projects (especially in the transportation sector) will experience considerable revenue generation challenges. In most instances, the vulnerability scope and extent to this force majeure risk was not foreseen in PPPs that rely on revenues generated by user fees: maritime ports (loss of shipping and service fees), airports (loss of gate fees, refueling fees, airport commercial concessions), tolls roads (no users due to city-wide quarantines), and hospitals (new patients with uncertainty of how they will pay their medical bills).

    PPPs that receive revenue through availability payments might suffer in the long term as governments face contracting economies that result in declining tax revenues and less treasury and budget resources to honor their availability commitment payments.

    Additionally, the day-to-day operations and management of PPP projects will be affected, with special purpose vehicle (PPP project companies) employees being incapacitated, especially when it comes to project operations and maintenance project knowledge.

    It’s important to monitor what the impact of the coronavirus will have on risk insurance for PPPs. If pandemic insurance becomes expensive and unaffordable the question of impacts on project bankability will need to be addressed.

    If the finance sector becomes less liquid, the question needs to be addressed whether it will have the financial resources in the short and medium term to participate in PPPs with governments in future projects.

    It’s critical the private sector be assured that, as soon as problems arise, they can approach their public sector partners and share project impacts without fear of punitive actions that could unilaterally blame them for impacts.

    It’s also important that recovery plans are harmonized with national strategic priorities. Strategic recovery plans must focus on a win-win recovery tactic that is inclusive of the needs of both the public and private sectors.

    The Public Private Partnership Market Recovery Plan in Serbia should focus equally on the interests of both parties in the partnership.

    Existing contracts that will certainly suffer from the occurrence of force majeure risks should be maintained with active mediation by all parties and a fairer division of the resulting difficulties in order to avoid termination of contracts and court epilogue.

    To revive the public-private partnership market in the aftermath of this crisis, any potential public partner can use the time of crisis to prepare potential public-interest projects that can be implemented in the form of a public-private partnership.

    It is about developing a so-called Public Private Partnership Calendar, a development document that presents all projects of public importance that can be implemented in some form of PPP, as well as the proposed model, risk matrix and financing model. PPP Calendar is a kind of public sector marketing and an instrument for attracting private equity.

    On the other hand, in accordance with the PPPs and Concessions Law, any potential private partner can use the time of this crisis and come up with a PPP Self-Initiative Proposal that will be sent to the potential public partner when the crisis passes.

    The PPP proposal should include a Feasibility Study with the economic and financial analysis of the possible future project, the calculation of the value for money of the project, calculation of the public sector comparator, the suggested risk matrix and the PPP contract proposal.

    If the corona crisis and economic downturns are utilized in this way, PPP market in the World and Serbia will feel much less of present growing vacuum which will certainly affect the real, financial and fiscal sectors.

    By Vladimir Vasiljev, Special Counsellor, Stojkovic Attorneys

     

  • Update on Measures Concerning the Limitation and Prohibition of Movement

    The worldwide pandemic of the COVID-19 has forced governments to undertake actions in order to fight the rapid spread of this infectious disease. Since March 15, 2020, Serbian authorities have been imposing various kinds of measures for the purpose of protecting its citizens and preventing the spread of the COVID-19.

    The measures that affect daily life and work-related activities the most are the ones concerning the limitation and prohibition of movement. The first order imposing full lockdown to the elderly and partial lockdown to other citizens was rendered on 18 March 2020 and has been amended several times since.

    The latest update concerning lockdown is contained in the Order on Limitation and Prohibition of Movement on the Territory of the Republic of Serbia rendered on 2 April 2020 by the Minister of Interior with Minster of Health’s consent and which entered into force on the following day (henceforth: the Order).

    In accordance with the latest, as well as all previous orders concerning lockdown, movement outside living space is prohibited at all times to persons older than 65 in settlements with more than 5,000 inhabitants, as well as to persons older than 70 in settlements with 5,000 or fewer inhabitants. The amendment from the latest Order concerns the time when the said prohibition does not apply. Namely, the period when elder citizens are allowed to leave their living space has been changed to Saturdays from 4 AM to 7 AM.

    With regard to other persons, the prohibition of movement from 5 PM to 5 AM remains in force on working days. However, the Order introduced full lockdown during the weekend, i.e. prohibition of movement to all persons from 1 PM on Saturdays to 5 AM on Mondays starting from 4 April 2020.

    The exception from lockdown has been made for pet owners, who are allowed to take their pets for a 20-minute walk from 23 PM to 1 AM every day and from 8 to 10 AM on Sundays, whilst not going further than 200 meters from their homes.

    Finally, the Order imposes one new limitation with regard to the period when movement in public places is allowed. Namely, outside the lockdown period, it is prohibited to move in groups consisting of more than two persons, with the exception of parents with children. Further, funerals can be attended by up to 10 persons, whilst they must keep the distance of a minimum of 2 meters between them.

    The violation of described prohibitions implies both criminal responsibilities in accordance with the Criminal Code, and the responsibility for a misdemeanor in accordance with the Minister of Interior’s Regulation on Misdemeanor for Violating the Order on Restriction and Prohibition of Movement of Persons on the Territory of the Republic of Serbia with the penalty for the latter ranging from RSD 50,000 to 150,000.

    The described prohibitions do not apply to licensed healthcare workers, army, police, and security service officers on duty, persons granted movement certificates, crew members of vehicles, cargo ships, trains and aircraft and persons in urgent need of medical care with maximum two persons in escort.

    By Ivana Petkovic, Senior Associate, JPM Jankovic Popovic Mitic

  • Patrolling the Edge of Legit and Legal in Employment Relationship

    After the declaration of the state of emergency in Serbia, caused by the global outbreak of the coronavirus, businesses introduced and implemented a series of extraordinary requirements, conditions and measures, some of which significantly affect and challenge the continuation of the traditional concept of employment relationship.

    Under these circumstances, standard employment regulation has been, inter alia, altered by the adoption of Regulation on Organizing the Work of the Employer during the State of Emergency, which explicitly prescribes the duty of employers to enable employees to perform work outside the premises of the employer (teleworking and work from home), in all employment relationships where such work style could be organized and implemented. Taking this under consideration, the initial response from numerous employers was to follow the regulation and instruct their employees to work from home.

    I) Employers’ Adjustments to the Newly Emerged Extraordinary Circumstances

    Work from home is a type of engagement and labor that is identical, in terms of its material aspect and content, to the work performed at the employer’s premises. Therefore, employees are obliged to honor work discipline and perform work duties as contracted/required, and employers are obliged to fully compensate them for such conduct/performance (excluding certain items, such as travel expenses), in the same manner as if employees worked under regular conditions, in the office or elsewhere.

    However, there is a real risk that business affairs would be obstructed by private life while working from home, in a manner that employees may end up losing efficiency, which in turn leads to the “gray zone” of mistaking work from home with vacation.

    Delineation between work and vacation is also less present or even non-existent when employees need to withdraw from their job obligations for the sake of procuring the essentials, which can usually be done until 15:00 when most shops shut down, but anyhow before the total curfew which is enforced at 17:00 on each work day.

    Work from home also implies that the employees are required to be available to their employers and clients through modern means of communication during the work hours, regardless if they have immediate work tasks to do or not.

    On the other hand, if it is not possible to work from home, then it is up to the employer to decide whether to continue such operations, by adjusting the work process in accordance with the circumstances (reducing the number of workers in a shift, providing protective equipment to all employees, reducing the number of employees staying in the same office premise, etc.).

    Furthermore, some employers may decide to reduce the scope of work, or even completely terminate work during this period, according to the Article 116 of the Serbian Labor Law. If the latter occurs, in this period employees are entitled to a salary compensation of at least 60% of their average salary of the previous 12 months, provided that it is not below the minimum wage. Therefore, it is entirely up to employers to set wages between 60% and 100% of the employees’ average salary for the previous 12 months.

    II) The Complication of the Annual Leave

    But, adjusting business operations to the extraordinary circumstances is not the only difficulty employers are encountering. 

    Some employers may be concerned that, when the pandemic and emergency is over, and when regular work process finally gets restored, the employees would trigger their rights on annual leave. The justification for such requests could be found in the fact that stopping / reducing of work in the previous period was not their fault, and that during the summer and holiday season work is traditionally carried out in reduced capacity. From the employers’ point of view, absence of employees during summer holidays could result in additional adverse effects and further blows to their business, which have already suffered significant losses due to the extraordinary circumstances in the previous period.

    For this reason, some employers have referred their employees (all of them, or employees working in the organizational units who are unable to perform business activities due to the state of emergency) to collective vacation during this period, which would de facto deprive those employees of their right to enjoy regular annual leaves during summer. In this case, the employer does not have the right to immediately send the employees on vacation, but is obliged to publish the decision on collective vacation on the noticeboard at least 15 days before the day designated for the use of such vacation, whereby the day of publishing is considered as the day of the handover of such decision to the employees.

    However, there is no danger to employers in this regard, since the employee cannot solely decide when he or she will use the vacation, but this matter depends on the employer’s work requirement, therefore this is a decision of the employer. For the same reason, the employer may even change the time allocated for the annual leave use, determined unilaterally within the previously published decision, provided that the needs of the employer’s business activity require so. In this case, the employer is obliged to make this change no later than five working days before the day designated for the annual leave use.

    III) Work Engagement During Vacation

    Regardless of the latter, it appears that a new form of “latent” work from home is emerging, disguised as “forced” vacation, which is the least favorable position for employees. This implies that the employees shall be on “annual leave” beyond their will until the emergency state is over, while the employer expects them to work from home as they have done so far.

    This is a regular practice exercised by some employers even under regular circumstances, whereby they (whether a supervisor or some other colleagues) continue to call and demand employee’s services via e-mail or telephone, despite the fact that she/he is on vacation, for seemingly insignificant reasons or non-time consuming tasks which in fact often turn into hours of work during vacation, which ipso facto constitutes work outside the premises of the employer.

    Sending an employee on vacation by definition implies that the employer, during that period, has organized work in such fashion that the employee’s services are not required (either a temporary replacement is found, or the employer stopped delegating work tasks to that employee during the vacation). If the employer is unable to organize work processes in a manner that enables the employee to take annual leave, the employer owes the employee a compensation for the unused annual leave in case of termination of employment, within the meaning of Article 76 of the Serbian Labor Law.

    However, the most common situation in reality is sending an employee on vacation, while subtly expecting the employee to engage in work when needed, regardless of the fact that she/he is on vacation.

    This expectation is no longer an exception, triggered by extreme urgency or exigent business, but with many employers has become a regular state of affairs.

    In the West, the situation in this regard is different – predominantly because holidays are taken seriously and in the true sense of that word, while in the Balkans’ region most employers are pushing the boundaries of the legislation, justifying such behavior as legit (for they have still allowed the employee to use the vacation).

    Is this kind of behavior and treatment permissible? What are the rights of employees in these circumstances, and what are the risks for employers that act in such way?

    The provisions of the Serbian Labor Law are not aligned with the modern manner of working highly leveraged on contemporary means of communication, which enable an employee to work in the same way at the seaside, as she/he would do in the office, and allow the employer to contact the employee at any time, even when the employee is on vacation. This is a legal loophole in the current labor regulation that is often abused by some employers. Therefore, the issue of employee’s availability to the employer during the period when the employee is on vacation (daily, weekly and annual vacation) should be regulated by the employment contract itself, or by the employment rulebook with the employer.

    Of particular interest to both employers and employees is the qualification of work performed during the vacation – is such work considered a part-time job, or perhaps an overtime?

    In fact, it is neither.

    Namely, the employer is not obliged to financially remunerate the employee for performance of this type of work, since such employee is sent on vacation by virtue of the employer’s decision and, in legal terms, “she/he is not working“. Therefore, performing work while on vacation is considered voluntary activity, and represents only a “gift” the employee gives to the employer. So, the only remaining hope is that the employer will remember and appreciate such a “gift”, and reward accordingly such a loyal employee with a bonus, promotion, or at least fairness or understanding during her/his tenure.

    The positive thing is that refusing to complete a work assignment while on vacation is not a justified reason for termination of employment, because the employer’s decision on annual leave “protects” the “disobeying” employee from getting fired. But, unfortunately, this does not mean that in the coming period some employers cannot search and find a new reason for dismissal and terminate employment contract on that grounds, even though the real motive for dismissal is declining a work assignment received while enjoying a cocktail on the beach. Of course, such termination may be challenged before the court which would be obliged to establish whether the reason for dismissal in such a case was justified or not, which usually takes up considerable time to end.

    For that reason, turning off a business phone and computer while on vacation is not the best solution for employees.

    But, what is, in these situations, the best solution for both employers and employees?

    It is our view that the best solution is communication, i.e. that the employee, in agreement with the employer, plans and organizes his duties in such a way that the work process is not hindered nor halted during the vacation, or that the employer does not need such employee during his absence whatsoever. This is doable, but the specifics will depend on a particular line of work. Generally, an employee should be efficient enough to complete all priority tasks before vacation, informing the employer and colleagues in detail about other assignments, deadlines for executions and any specificities that may be of significance in that regard.

    Yet, if the employer, despite the demonstrated efficiency, continues to harass the absent employee for no valid or justifiable reason, there is a real risk of litigation in which, if such approach is qualified as mobbing and employer is found guilty, the court may order measures and award damages against the employer and in favor of the employee.

    By Ivana Cvetkovic Diafa, Senior Associate, and Miomir Stojkovic, Principal, Stojkovic Attorneys

     

  • Serbia Proposes a Set of Economic Measures in Response to the COVID-19 Outbreak

    The Government announced on 1 April 2020 its proposal of a Program of economic measures to reduce the negative effects caused by the COVID-19 pandemic and an attempt to support the economy of Serbia, split into four categories.

    Tax policy measures

    • Payroll tax and social security contributions payments for the private sector during the state of emergency are postponed, with a subsequent repayment of the taxes in installments beginning at the earliest from 2021 (with a possibility of further deferral in the following 24 months, under conditions which will be subsequently prescribed);
    • Payments of advances on corporate income tax in second-quarter earnings of this year are postponed;
    • Donation contributors are exempt from the VAT payment obligation.

    Direct help to the private sector

    • Direct assistance to flat-rate entrepreneurs and to those who pay real income tax, micro, small and medium-sized enterprises in the private sector, in the form of payment of minimum wage for 900 thousand employees during the state emergency;
    • Direct assistance to large private sector companies with payment of 50% of the net minimum wage for employees whose work has been terminated by a resolution in accordance with the Labor Act.

    Measures aimed at the preservation of liquidity

    • Development Fund for Development of Entrepreneurship, micro, small and medium-sized enterprises, agricultural holdings and cooperatives’ program of financial support through subsidized working capital loans valued at 200 million euros;

    The repayment term is set at 36 months including a 12-month grace period, with a prescribed maximum amount for each category of commercial entities:

    • Entrepreneurs and micro businesses – up to 5 million dinars,
    • Small businesses – up to 25 million dinars, and
    • Medium businesses – up to 50 million dinars.

    Received funds may not be used for organizing betting, lottery and similar activities, as well as trade activities, oil production, or any other activity prescribed as forbidden under the relevant Serbian laws.

    • Guarantee scheme to support the economy in the conditions of the COVID-19 crisis for credits to maintain liquidity and working capital for entrepreneurs, micro, small and medium enterprises, agricultural holdings through commercial banks.

    Other measures

    • Moratorium on dividend payment until the end of the year, except for public enterprises;
    • Stimulus to increase domestic demand in the amount of EUR 100 per each citizen of legal age.

    It is important to note that the measure applies to all commercial entities, except those that reduced the number of employees for more than 10% (excluding the employees whose employment agreement expires during the state of emergency) and those that temporarily ceased business prior to the proclamation of the state of emergency (i.e. prior to 15 March 2020).

    The measures are expected to have a total effect of RSD 608.3 billion (approx. EUR 5.1 billion). Further clarifications and conditions under this program are expected and we will provide all updates as soon as the proposed measures are adopted.

    By Milica Savic, Partner, and Branimir Rajsic, Senior Consultant, Karanovic & Partners

  • CMS Helps EBRD Prepare Tender Process for PPP Project in Serbia

    CMS, in cooperation with GFA Consulting Group, has helped the EBRD prepare a tendering process for the Serbian City of Pirot for the selection of a private partner in a PPP project titled “Reconstruction and Maintenance of the Public Lighting System in the City of Pirot.”

    According to CMS, “the tender was launched on March 13, 2020, and the deadline for submission of bids is 60 days.”

    CMS’s team included Partners Ivan Gazdic and Maja Stepanovic and Attorneys Igor Djordjevic and Srdjan Jankovic.

  • Status of Foreign Citizens in the Republic of Serbia During the COVID-19 Pandemic

    The Republic of Serbia has officially closed its border crossings for passengers in road, rail, air and water traffic at 8.00 a.m. on 20 March 2020. The passing of humanitarian aid and crossings of national importance that are approved by the competent authority are still allowed. International passenger traffic to and from the Nikola Tesla Airport has been suspended in accordance with the Government of Serbia’s decision on 19 March 2020 from 12.00 p.m. onwards.

    As a result of those measures, the question of the status of foreign citizens has arisen.

    The Government of the Republic of Serbia consequently enacted the decision regulating the status of foreign citizens who were on the territory of the Republic of Serbia when the state of emergency was declared – Decision on status of foreign citizens in the Republic of Serbia during the state of emergency dated 24 March 2020.

    According to this decision, all foreign citizens who were lawfully on the territory of the Republic of Serbia when the state of emergency has been declared (15 March) or who had valid residence permits issued on this date, may lawfully remain in the Republic of Serbia while the state of emergency is in effect without the obligation to initiate proceedings to further determine their status.

    Furthermore, identification cards provided for foreign citizens and the asylum seekers will be considered as valid during the state of emergency, even if they expire during this period.

    Finally, the Government also adopted Decision on the validity of work permits issued to foreign individuals during the state of emergency on 27 March 2020, which states that all issued work permits shall be deemed as valid during the state of emergency, regardless of whether they expired during this period.

    All the above-mentioned measures above are temporary, and after the state of emergency is terminated, all regular procedures will be effective.

    By Milena Jaksic Papac, Partner, in cooperation with Karanovic & Partners

  • Registration Procedure for Tests for Viruses and Vaccines in Serbia

    Registration Procedure for Tests for Viruses and Vaccines in Serbia

    After declaration of the state of emergency to prevent further spread of corona virus, health care sector in Serbia saw a number of corresponding measures that naturally affected regular state of affairs.

    This article focuses on providing an overview of the general legal framework and principles of registration for medical products and medical devices, with reference to the special regime introduced during the state of emergency.

    General framework

    The Law on Medicinal Products and Medical Devices (the “Law”), inter alia, regulates the conditions for placing on the market of medicinal products and medical devices, the conditions for production, marketing and testing of medicinal products and medical devices used in human and veterinary medicine, and regulates supervision in these fields.

    The registration procedure takes place before the Medicines and Medical Devices Agency of Serbia (ALIMS) (the “Agency“), which was established by the Law.

    According to the Law, tests are considered as medical devices, while vaccines are considered as medicinal products.

    The condition for placing medical devices on the market in Serbia is the registration of medical devices in the Register of Medical Devices (the “Register”), which is performed at the Agency.

    The procedure for registration of medical devices in the Register may vary, and it depends in particular on the fact whether such products carry the CE mark (SE mark) or not.

    For medical devices bearing the CE marking, which implies that the control of these medical devices has been carried out in one of the institutions accredited by the European Union and that these medical devices are in accordance with the EU directives on medical devices, the registration in the Register is done through the administrative procedure, on the basis of appropriate certificates and documents proving compliance with EU directives on medical devices.

    For medical devices that do not have the CE marking, entry in the Register is performed on the basis of an assessment of the quality, safety and efficacy through tests carried out in Serbia, in accordance with internationally accepted standards.

    The procedure for issuing a decision on the registration of a medical device in the Register is in line with the guidelines of the Good Regulatory Practice.

    To place medical devices on the market, a national authorization must be issued in a form of a decision on the registration of a medical device in the Register, whereby the Agency should recognize the relevant foreign certificates and documents, proving compliance with EU directives on medical devices and guaranteeing quality, safety and efficiency of such a medical device.

    The Agency, in accordance with the Law, may also authorize the market of unregistered medical devices only at the request of certain health care facilities for the treatment of life-threatening patients or groups of patients, as well as for certain scientific or medical research.

    The Agency also issues approvals for clinical trials of medical devices and monitors their safety, i.e. vigilance. 

    The Agency publishes a database of medical devices and lists of medical devices, which are registered in the Registry, on the Agency website.

    On the other hand, medical product is, inter alia, a blood product derived from human or animal blood, an immunological drug for human and veterinary medicine (sera, vaccines, specific and non-specific immunoglobulins, toxins and allergens) and a radiopharmaceutical, ready-made or ready-to-use medicinal product, containing one or more radionuclides intended for medical use.

    Applicants that wish to place medical products on the market of medicinal products in Serbia, especially when it comes to innovative medical products or medical products that have not been on the aforementioned market before, should prepare for special expert discussions with representatives of the authorities about the quality of the drug, the ingredients of the drug, effectiveness, indication area, side effects, pharmacoeconomic parameters etc.

    The procedures for obtaining a market authorization are in accordance with the guidelines of the Good Practice, prescribed by the Law.

    As previously implied, a national market authorization for medicinal products is issued in Serbia. But, given that Serbia is not an EU member state, it is still not possible to issue a centralized authorization or market authorization based on a mutual recognition procedure.

    The Agency publishes lists of medicinal products for which a market authorization has been issued and for which a decision on the termination of a market authorization has been issued in the Official Gazette of the Republic of Serbia.

    Temporary regulation

    One of the consequences of the recently introduced state of emergency in Serbia is the Decree on Specific Technical Requirements and Standards and Application of Medical Devices During the Emergency of COVID-19 caused by the SARS-CoV-2 virus (the “Regulation“) issued by the Serbian Government on 24 March 2020.

    The Regulation aims to allow the application of medical devices and medicines, which have proven effective in the treatment of COVID-19, but are not authorized by the Agency.

    Namely, for the duration of the state of emergency, in order to effectively combat the epidemic and treatment of patients with COVID-19 disease, medical devices not manufactured according to the prescribed standards can be procured, put into use and applied in treatments, provided that the manufacturer or distributor with medical device:

    • submits one copy of the description of the technical characteristics and the use of the medical device, with translation into Serbian language;
    • encloses a statement that the use of a medical device ensures its effectiveness in the treatment, that is, that the device meets the conditions of effective treatment as well as the corresponding product manufactured to the prescribed standard;
    • submits a statement that he / she will train health care professionals who will provide health care on that facility;
    • issues a statement by which undertakes obligation to provide service and spare parts for the medical device and to specify the period of validity of such an obligation.

    All foregoing also applies accordingly to medicine products.

    Also, it is very important to mention the provision which stipulates that the procedure of procurement of medical devices and medicines in accordance with the Regulation shall be governed by the provisions of the law governing public procurement in the event of a natural disaster or epidemic of an infectious disease.

    The regulation entered into force on 24 March 2020.

    By Miomir Stojkovic, Principal, and Ela Trisic, Associate,  Stojkovic Attorneys