Applicable Legislation

Pharmaceutical products in Serbia are regulated in the Medicines and Medical Devices Act of 2010 (as amended) (Medicines Act). The sections of the Medicines Act regulating medical devices have ceased to apply and medical devices are now regulated separately in the Medical Devices Act of 2017. A considerable number of by-laws regulate in more detail different matters governed by the Medicines Act and Medical Devices Act.

Competent Bodies

Competences for implementation and enforcement of pharmaceutical and medical devices legislation are shared between three governmental bodies:

• the Agency for Medicines and Medical Devices (ALIMS), the regulatory body tasked with enforcement of pharmaceutical and medical devices legislation for pharmaceuticals for human and veterinary use. The ALIMS is an independent regulatory body established by law;
• the Ministry of Health has certain competences with respect to the area of pharmaceuticals and medical devices for human use, particularly with respect to licensing and administrative oversight; and
• the Ministry of Agriculture, Forestry and Water Management is competent for matters concerning the pharmaceutical products intended solely for veterinary use.

Right to Appeal

Decisions of the ALIMS can be challenged before the competent ministry – ie, the Ministry of Health with regard to medicines and medical devices for human use, and the Ministry of Agriculture, Forestry and Water Management with regard to medicines for veterinary use.

A party to the proceeding before the ALIMS, or any person whose rights, obligations or legal interest may be affected by the outcome of the proceedings, may submit an appeal. An appeal may also be submitted if the ALIMS fails to adopt a decision within the statutory deadline.

Appeal Procedure

A party may submit an appeal against the ALIMS’s decision to the competent ministry through the ALIMS. The deadline for submitting an appeal is 15 days from adoption of the first-instance decision or, in the case of failure to adopt a decision, within a year from the expiry of the statutory deadline. Decisions of the competent ministry upon appeal, as well as first-instance decisions of the ministries in the matters from their competence, are final and may be challenged only before the Administrative Court.

Classification of Pharmaceuticals

Pharmaceuticals are classified into pharmaceuticals for human use and those for veterinary use. Furthermore, pharmaceutical products are classified into (i) prescription-only, and (ii) over-the-counter (OTC) pharmaceuticals. The ALIMS carries out the classification in the process for issuing marketing authorisations. Prescription-only and OTC pharmaceuticals are subject to different regimes with respect to pricing, advertising, dispensing and sale.

Classification of Medical Devices

Medical devices are classified into (i) general medical devices, (ii) in vitro diagnostic medical devices, and (iii) active implantable medical devices.

General medical devices are classified according to the degree of risk for the users into:

• Class I – medical devices with a low degree of risk for the user;
• Class IIa – a low-to-medium degree of risk for the user;
• Class IIb – a medium-to-high degree of risk for the user; and
• Class III – medical devices with a high degree of risk for the user.

A notified body carries out the classification of medical devices. As an exception, the manufacturer classifies class I medical devices and others as in vitro medical devices.

Clinical Trials for Pharmaceuticals

The Medicines Act is the principal piece of legislation regulating clinical trials of pharmaceuticals. Additionally, the Healthcare Act of 2019 and the Rulebook on Clinical Trials for Medicines for Human Use (2022, as amended), set out detailed rules related to ethics committee approval and performance of clinical trials. In October 2023, the government introduced amendments to the Clinical Trials Rulebook to limit the phase I (I, Ia, and Ib) clinical trials in Serbia only to public healthcare institutions. However, in December 2024, the government introduced further amendments to the Clinical Trials Rulebook. These changes eliminated the requirement for principal investigators to have prior clinical trial experience and removed the restriction that limited private healthcare institutions to conducting only phases II and III clinical trials, allowing them to participate in all three phases. Additionally, import approval for medicines undergoing clinical trials will now be granted simultaneously with clinical trial approval. When reviewing clinical trial documentation, ALIMS will consider decisions from the EMA and other relevant international bodies, such as ICH, to enhance the efficiency of the approval process. To ensure transparency, ALIMS will also publish information on all approved clinical trials on its website.

Clinical trials of pharmaceuticals are conducted in accordance with the Ministry of Health’s guidelines on Good Manufacturing Practice (2017), Good Laboratory Practice (2008), and Good Clinical Practice (2017).

Clinical Trials for Medical Devices

The Medical Devices Act and the Rulebook on Clinical Trials for Medical Devices of 2018 (as amended) regulate clinical trials for medical devices.

Clinical trials of medical devices are conducted in accordance with the guidelines of the Good Clinical Practice.

Clinical Trials Subject to Approval

Sponsors must request simultaneous authorisations for conducting a clinical trial from the ALIMS and the Ethics Committee of Serbia, a government-appointed expert body that takes care of the provision and implementation of healthcare at the national level, in the case of:

• clinical trials for medicines which do not have a marketing authorisation or for which a different use from the one prescribed in the approved summary of product characteristics is proposed, or medical devices for which a conformity assessment has not been carried out; and
• an interventional post-marketing clinical trial, where the medicinal product is applied in accordance with the conditions prescribed in the marketing authorisation, but requires additional diagnostic procedures, as well as the monitoring procedures defined by the clinical trial protocol, or where a medical device has been subject to conformity assessment, but the clinical trial is conducted for a purpose that is absent from the conformity assessment.

Clinical Trials Subject to Notification Only

Sponsors must only notify the commencement of a trial to the ALIMS if they wish to conduct a non-interventional post-marketing clinical trial of a pharmaceutical or a medical device in accordance with an approved summary of product characteristics of a pharmaceutical for which a marketing authorisation has already been issued, or a clinical trial of a medical device for which a conformity assessment has already been carried out.

Clinical Trials Database

Basic information on all clinical trials conducted at a given moment in Serbia are publicly available within the database kept by the ALIMS on the e-government Portal. The information includes the date and number of the relevant decision on approval of the clinical trial, the protocol number, the names of the sponsor and the client, and the title of the trial, as well as its basic description.

Publication of Clinical Trial Results

Sponsors of clinical trials do not have an obligation to make the results of clinical trials publicly available. They must submit to the ALIMS, within one year of completion of the clinical trial, the report containing detailed results, both positive and negative, obtained through the trial.

There are no restrictions for using online tools to support clinical trials, either for recruiting or monitoring purposes. Sponsors must, however, undertake all adequate measures to provide information to, and secure the consent of, the subjects and to protect their personal data.

In accordance with the Data Protection Act (2018), data resulting from clinical trials is personal data, specifically special category data (health data), as long as a particular individual is identifiable from that data. As it follows from an opinion of the Data Protection Commissioner, expressed in its ninth publication Protection of Personal Data: Opinions and Stances of the Commissioner (2024), the Commissioner considers clinical trial data identifiable (and therefore, personal) as long as any party, whether the controller or a third party, can identify the data subject.

Data processing of the resulting data, including sharing the data with third parties or affiliates, may be permitted, however, the supervisory authority and courts have not given any clarification as to which legal bases and conditions for the processing are applicable. In particular, the Commissioner has not opined on whether consent from clinical trial participants can be freely given and thus serve as a legal basis for the processing of their personal data.

Clinical trial data may be transferred abroad to countries that are members of the Council of Europe Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data, and to countries determined by the European Union to provide an adequate level of protection. Transfer to other countries is allowed if the data exporter applies one of the prescribed safeguards, such as the conclusion of controller-to-processor standard contractual clauses, adopted by the Commissioner, with the data importer. Controller-to-controller clauses are not available in Serbia because the Data Protection Act does not authorise the Commissioner to adopt them. Alternatively, data transfer may occur in specific situations outlined in the Data Protection Act, such as transfer based on explicit and informed consent.

Creation of a database with the resulting data from the clinical trials would require carrying out a data protection impact assessment, in line with the Decision of the Serbian Data Protection Commissioner on the list of categories of data processing activities for which a data protection impact assessment must be carried out.

An assessment of whether a product should be classified as a pharmaceutical or as a medical device is carried out by the ALIMS in the process of issuing of a marketing authorisation for a pharmaceutical product or registration of a medical device. The Medicines Act and the Medical Devices Act contain the criteria for classification.

The main criterion for differentiating between pharmaceuticals and medical devices is the following: pharmaceuticals are applied to humans or animals with the intention to restore, improve or modify physiological function by pharmacological, immunological or metabolic action, or by setting up a medical diagnosis; however, medical devices do not fulfil their principal intended purpose in or on the human body by pharmacological, immunological or metabolic means, but the medical device may be assisted in its function by such means.

Biological medicinal products must meet the same quality, safety and efficacy criteria as other medicinal products to receive marketing authorisation. Biosimilars, however, may benefit from the short-form procedure for the granting of marketing authorisation, equivalent to the one available to generic medicinal products.

Validity and Renewal of Marketing Authorisation

Marketing authorisation is valid for five years. It may be renewed based on the reassessment of the risk/benefit ratio of the medicine. If, on the basis of the available pharmacovigilance data, the ALIMS determines that a pharmaceutical is safe, it grants a permanent marketing authorisation. In the event that the ALIMS determines that the pharmaceutical product is not safe, it will refuse to grant a permanent authorisation. Instead, the ALIMS will decide on whether to renew an authorisation for an additional period of five years. A marketing authorisation may be renewed for an additional period of five years only once. If the ALIMS still has justified doubts with respect to product safety, it will terminate the already issued marketing authorisation.

Revoking of a Marketing Authorisation

The ALIMS will revoke a marketing authorisation if it determines that the product is not safe for the life and health of humans and animals. The ALIMS will revoke the marketing authorisation if:

• the medicinal product is harmful under normal conditions of use;
• the medicinal product has no therapeutic efficacy;
• the risk-benefit ratio is not favourable under typical application conditions;
• the qualitative and quantitative medicinal product composition does not match the declared composition of the medicinal product;
• the marketing authorisation was issued on the basis of incomplete or false information, or if data is not amended in accordance with the law;
• the marketing authorisation-holder no longer meets the prescribed requirements; and/or
• the medicinal product was not marketed in Serbia for three years from the date of marketing authorisation issuance or was withdrawn from the market in Serbia for three consecutive years.

The ALIMS may vary, suspend, or revoke a marketing authorisation on the basis of data on adverse drug reactions collected within the scope of its pharmacovigilance activities.

Medical Devices

If the Ministry of Health determines that a medical device constitutes an unacceptable risk to public health and/or safety, or does not meet the statutory requirements, the Ministry may order the manufacturer or its authorised representative to take all appropriate and justified preventive or corrective measures. The Ministry may also prohibit or restrict the placing of a medical device on the market, set specific requirements for the placement of a medical device on the market, or order the withdrawal of a medical device from the market.

Pharmaceuticals

The Medicines Act and a series of implementing by-laws govern the granting of a marketing authorisation. The ALIMS is the competent authority for issuing marketing authorisations. A medicinal product may be granted a marketing authorisation after undergoing pharmaceutical (pharmaceutical, chemical, and biological), pharmaco-toxicological and clinical trials and provided that it has the required quality, safety and efficacy. The ALIMS conducts a formal review of an application for marketing authorisation within 30 days. The substantive review must be completed within 210 days. If the ALIMS requests additional documents from the applicant, the deadline is paused until submission of those documents. There is also an accelerated procedure for obtaining a marketing authorisation, for a medicinal product which obtained a marketing authorisation in accordance with the EU centralised procedure, and for medicines for human use of utmost importance for public healthcare. The accelerated procedure may last no longer than 150 days from receipt of a complete application.

Medical Devices

Medical devices are not subject to marketing authorisation and may be placed on the market or in use if they comply with essential requirements set out in the Medical Devices Act regarding conformity assessment, labelling and supporting documents, if they are properly procured, installed and maintained, and used in accordance with their purpose. A manufacturer or its representative must submit the application for registration of a medical device to the ALIMS before placing it on the market or putting it to use. The Medicines Act contains a limited list of medical devices which do not need to be registered in order to be placed on the market or put to use (ie, medical devices for approved clinical trials or research and development, custom-made devices, devices for the personal use of a patient previously treated abroad, devices imported on a temporary basis for medical fairs, and those manufactured in medical institutions for in-house use).

Variations

A request for a variation is submitted to the ALIMS. Marketing authorisation-holders are obliged to:

• report IA-type variations within 12 months from the moment of application (“do and tell” procedure);
• report IAIN variations without delay following their application for the purpose of continuous monitoring of the medicinal product;
• request the ALIMS’s approval for IB-type and type-II variations before their application (“tell, wait and do” procedure); and
• submit a new request for marketing authorisation for variations related to changes of the active ingredient or changes in strength, pharmaceutical form, or manner of application of the medicine, and for variations of veterinary medicines for animals used in human alimentation.

The ALIMS conducts a formal assessment of the application within 15 days from the day of the application and the substantive review within 90 days from the day when the application is deemed complete. The pharmaceutical product must be marketed in accordance with the approved variation at the latest within 12 months from the delivery of the ALIMS’s act on approval of the variation.

Transfer of a Marketing Authorisation

A marketing authorisation may be transferred to a new marketing authorisation-holder at the request of the existing one submitted to the ALIMS. The ALIMS will assess whether the prospective new holder meets the requirements prescribed by the law. The ALIMS conducts a formal assessment of the application within 15 days from the day of the application and the substantive review within 60 days from the day when the application is deemed complete. 

General Conditions

An importer may submit to the ALIMS a request for importation of a pharmaceutical for which a marketing authorisation was not issued in Serbia if:

• there is no registered pharmaceutical of the same international non-proprietary name (INN), strength, pharmaceutical form and packaging size on the market in Serbia;
• the pharmaceutical is intended for treatment of rare diseases in humans;
• it is necessary to ensure sufficient quantities and types of a pharmaceutical in the case of epidemics, natural disasters, or other emergency situations; or
• when the safe provision of healthcare is impeded, meaning when there are insufficient quantities and types of medicines on the market for which a marketing authorisation has been issued due to production or distribution problems, if in Serbia there are insufficient quantities of a medicine with the same INN, strength, pharmaceutical form, and packaging size as the medicine for which an import request has been submitted.

Compassionate Use Programme

In addition to the import of unregistered pharmaceuticals under the general conditions previously described, import is also permitted on the basis of a compassionate use programme. The purpose of such a programme is to treat specific patients or a group of patients who are afflicted by life-threatening diseases such as AIDS, cancer and other malignant or auto-immune diseases. Import is organised as a donation or humanitarian aid to a health institution, provided that such pharmaceuticals are not subject to clinical trial in Serbia at the moment of the submission of request for import, and provided that they:

• are undergoing an advanced stage (Phase III) of clinical trial procedure in an EU country or in a country with similar requirements to Serbia regarding issuance of a marketing authorisation;
• have completed a clinical trial procedure in that country;
• are currently subject to a centralised marketing authorisation procedure in the EU; or
• have received a marketing authorisation in the EU centralised procedure.

Exceptionally, a patient or a group of patients who are not eligible to participate in the ongoing clinical trial for that medicinal product in Serbia may receive a donation or humanitarian aid in the form of unregistered pharmaceuticals or registered pharmaceuticals for an unregistered indication, which are at that time subject to clinical trial in Serbia.

Import of Unregistered Medical Devices

The ALIMS may also authorise the import of a medical device not registered in Serbia. This is permissible if that import is intended for a particular patient or group of patients, or comes as a donation or humanitarian aid, or the subject-matter of the import is a medical instrument for scientific research or for emergency situations. In order to be imported, these medical devices must have undergone a conformity assessment.

Pharmacovigilance of Medicinal Products

In the post-marketing phase, marketing authorisation-holders must ensure continuous monitoring of adverse drug reactions to a pharmaceutical product (pharmacovigilance), namely:

• the continued monitoring of adverse drug reactions (ADRs), and have a full-time employee with adequate qualifications responsible for pharmacovigilance;
• keep records on all suspected ADRs notified in Serbia, EU countries or any third country, and provide the ALIMS with electronic reports;
• keep records of all suspected serious ADRs reported by health or veterinary professionals, or records of ADRs that MAHs can reasonably be expected to be aware of, and to report this information promptly to the ALIMS, no later than 15 days following the receipt of information;
• submit to the ALIMS periodic drug-safety reports at six-month intervals if the marketing authorisation was conditional or under special circumstances; and
• submit periodic drug-safety reports every six months for a period of two years following the placing of the pharmaceutical on the market, then annual reports for another two years and finally submit reports at three-year intervals.

Vigilance of Medical Devices

A manufacturer of medical devices or its authorised representative must employ a person responsible for vigilance and continuously monitor the medical device on the market, with the aim of identifying any need for corrective or preventive measures.

The Agency and the competent Ministries must treat as confidential all the data in the documentation enclosed within an application for the issuance of a marketing authorisation, variation or a renewal. This obligation applies in particular in relation to trade secrets – ie, when the following cumulative conditions are met:

• the data is confidential – ie, not generally known or easily available to persons usually dealing with that kind of information;
• the data has commercial value due to its confidentiality, during the period of confidentiality; and
• an applicant for a marketing authorisation, variation, and/or renewal, under the circumstances, takes reasonable measures to keep that data confidential.

Information from the documentation submitted during the procedure of obtaining a marketing authorisation, as well as in other procedures handled by the Agency and/or relevant Ministries, may only be disclosed to third parties with the consent of the applicant, or if the data is already available to the general or professional public for the purpose of providing information necessary for use or handling of a pharmaceutical or a medical device, or required for the protection of health in humans and animals.

The Medicines Act provides for a fast-track procedure for obtaining a marketing authorisation for (i) medicines for human use of utmost importance for public healthcare, particularly with respect to therapeutic innovations, and (ii) for a medicinal product which obtained a marketing authorisation in accordance with the EU centralised procedure.

The Rulebook on the content of application and documentation and the method of obtaining a marketing authorisation for placing the medicine on the market lays down the conditions for issuing the marketing authorisation through fast-track procedure. For medicinal products for human use of utmost importance for public healthcare, particularly with respect to therapeutic innovations, the applicant must first obtain an opinion on priority determination from a special commission formed by ALIMS, determining whether a medicinal product is of the highest public health interest in order to apply through the accelerated marketing authorisation procedure. A request on this basis may be submitted for:

• the first generic application of a medicinal product or the next generic application if a generic medicinal product with the same INN has marketing authorisation in Serbia but is not on the market, with a limit of three generic applications based on the order of priority requests or marketing authorisation applications;
• applications related to the transfer of medicinal product manufacturing in Serbia;
• applications for products manufactured in Serbia that are intended exclusively for export;
• applications for medicinal products whose unavailability in Serbia poses a public health risk, particularly vaccines for mandatory immunisation;
• applications for medicinal products included in the Positive List of medicines reimbursed from the national health insurance fund, but without a marketing authorisation in Serbia (D List) at the time of the priority determination request;
• applications for medicinal products developed, manufactured or marketed with state funding; and
• applications for medicinal products of strategic importance as determined by official acts of Serbia and programmes implemented by the Ministry of Health, where applicable.

With respect to conditions and documentation for fast-tracking of medicines approved through the EU centralised procedure, please see the answer to 4.2 Regulatory Reliance.

The Agency is required to issue a decision on granting the marketing authorisation through the fast-track procedure, or a decision on rejecting the application, no later than 150 days from the date of receipt of a complete application, based on the evaluation of the documentation regarding the quality, safety and efficacy of the medicinal product. If the application for a marketing authorisation under the fast-track procedure is incomplete, the Agency notifies the applicant in writing, requesting the submission of the missing information within 30 days from the date of receipt of the written notification. The request for outstanding information stops the clock until the applicant completes the application.

Since 2023, Serbia has been progressively introducing the concept of regulatory reliance. The reliance strategy employed by the ALIMS is based on a risk- and science-driven approach, carefully selecting where to apply reliance while considering public health needs and priorities, available resources and expertise, the type and source of the evaluated product, and the opportunities for reliance.

Regulatory reliance for centrally authorised medicinal products (CP) was introduced in January 2023, both for the issuance of initial marketing authorisations and for post-approval changes (ie, renewals and variations). In 2024, ALIMS initiated a pilot project aimed at expanding the reliance framework to cover medicines previously approved in the EU via the decentralised procedure (DCP) and mutual recognition procedure (MRP).

Reliance for Medicinal Products Approved Through CP in the EU

As at the time of writing, no legislative amendments have been made to formally incorporate reliance into Serbia’s regulatory framework. Instead, reliance for centrally authorised medicinal products has been introduced through an interpretation of the existing provisions governing the accelerated procedure for initial marketing authorisations (which has a 150-day timeline, as outlined in 4.1 Fast Track Registration Routes).

ALIMS employs the European Medicines Agency (EMA) as its reference regulatory authority, relying on EMA assessment reports while retaining full independence, responsibility and accountability in its decision-making process. The reliance procedure involves requesting various EMA assessment reports to enable an informed reliance approach, taking advantage of EMA’s transparent evaluation processes.

ALIMS applies reliance to both issuance of marketing authorisations and post approval changes (renewals and variations) for centrally authorised medicinal products. The reliance-based regulatory pathway follows three key steps: (i) verification of the sameness of dossier submitted to Serbia and approved in the centralised procedure before EMA; (ii) confirmation of the applicability of the assessment outcomes of EMA for regulatory decision-making in the national context; and (iii) abridged review.

The reliance pathway is detailed in the ALIMS Internal procedures and Standard Operating procedures (SOPs), which outline the steps for processing reliance applications, the corresponding regulatory procedures, and the requirements that applicants must meet. ALIMS also employs a distinct template for abridged review applications, separate from full review applications.

Documentation Required for Initial Marketing Authorisation Through Reliance

Documentation to support reliance for initial marketing authorisations includes:

• confirmation of approval (Commission Decision; Approval Letter/CHMP Opinion; eCPP);
• statement regarding product sameness submitted in Serbia and approved in CP;
• list of variation submitted and approved in CP;
• questions and answers, interim assessment reports and unredacted final CHMP assessment report (before publishing) generated by EMA;
• approvals (acknowledgement of receipt/notification/CHMP Opinion) and assessment reports (type IB i II) for all variations implemented in submitted dossier;
• the complete product dossier (CTD M2-5) as approved by EMA; and
• the latest set of documents approved in the centralised procedure for the initial MA or variations, including the composition of the medicinal product with specification for the active substance(s), SPC, PIL, text for inner and outer packaging, EURMP (European Risk Management Plan), finished product specifications, specification release and shelf-life for the product, and flow chart approved in the centralised procedure).

Documentation Required for Post-Approval Changes Through Reliance

Documentation to support reliance for post approval changes incudes the package of variation documentation approved in the centralised procedure, variation approval in centralised procedure, and assessment report in centralsied procedure for variations type IB and II.

Reliance Pathway on DCP/MRP Approved Medicines Pilot Project

In 2024, ALIMS launched a pilot project to refine and expand the reliance strategy to cover medicines approved under the DCP and MRP. This project focuses on initial marketing authorisations and post-approval changes for recently approved medicines (no later than 2022) to incorporate the latest scientific and regulatory requirements, such as risk assessments for nitrosamine and elemental impurities.

Currently, there are no national regulations explicitly governing reliance for medicines approved via the DCP/MRP. However, upcoming legislative changes in Serbia’s medicinal product regulations are expected to introduce formal provisions for this type of reliance. In the meantime, the documentation required for reliance on DCP/MRP-approved medicines aligns with that for CP-approved medicines.

Other Projects Regarding Reliance and International Co-Operation

ALIMS actively participates in the WHO Regulatory Systems Strengthening (RSS) programme for National Regulatory Authorities (NRAs) under WHO Resolution 67.20. Serbia’s regulatory system underwent benchmarking in 2019 and was classified as Maturity Level 3 (stable, well-functioning, and integrated) for vaccines. By the end of 2025, ALIMS aims to achieve Maturity Level 4 (advanced level of performance and continuous improvement) for vaccines and expand this evaluation to cover other medicines.

ALIMS is also striving to be designated as a WHO Listed Authority (WLA), which recognises regulatory agencies operating at an advanced level of performance as globally trusted authorities for reliance and work-sharing procedures. As part of these efforts, in 2024, ALIMS participated in its first pilot project for post-approval changes (CMC variation), with the objective of reducing global approval and implementation timelines while minimising country-specific regulatory requirements.

Manufacturing of Pharmaceuticals

The manufacturing of pharmaceuticals is subject to a licence issued by the Ministry of Health to legal entities. The application for a manufacturing licence must contain information and documents regarding the location and premises of the manufacturing site, equipment, personnel, medicines to be produced, relevant procedures, as well as other information required by the law. The Ministry issues a licence for a particular manufacturing site and certain forms of pharmaceutical manufactured at that site. The licence may include an entire manufacturing process or only a part of the process. The licence is valid for an indefinite period.

Manufacturing of Medical Devices

Manufacturers of medical devices may be both legal entities and individuals. A manufacturing licence is necessary only for class I medical devices (other than Is and Im class), other in vitro diagnostic medical devices, medical devices for which no conformity assessment has been performed, those not covered by the sign of conformity, custom-made devices for a particular patient, and medical devices for clinical trials, as well as a system or a kit. The Ministry of Health issues a manufacturing licence for medical devices, which is valid for five years.

Wholesale of medicines and medical devices includes purchase, storage, distribution, imports and export. A wholesale licence is issued by the Ministry of Health for an indefinite period for pharmaceuticals, and for medical devices for a period of five years.

The exception from obtaining a wholesale licence applies to (i) manufacturers of medicines for products from their production programme, (ii) manufacturers of medical devices with a registered seat in Serbia, who must obtain a manufacturing licence for medical devices from their production programme, and (iii) entities performing only import or export activities on behalf of and for the account of a medicines wholesale licence-holder.

Applicants for a wholesale licence must provide information and documents regarding the legal entity, location and premises, supply territory, products for which the wholesale licence is sought, personnel, equipment, a plan for an urgent withdrawal of products from the market, as well as the other information of relevance for the issuance of the wholesale licence.

See 1.3 Product Classification: Pharmaceuticals or Medical Devices relating to different categories of pharmaceuticals.

The import and export of pharmaceutical and medical devices in Serbia are governed by the Medicines Act and the Medical Devices Act, respectively. Import and export constitute the wholesale of medicines and medical devices and as such are additionally regulated in the rule books governing the wholesale of medicines and medical devices.

Depending on whether the product is intended for human or veterinary use, the Ministry of Health or the Ministry of Agriculture issues a pharmaceutical wholesale licence. The ALIMS issues (i) opinions on the import of cell or tissue samples for clinical trials’ procedures of medicinal products, (ii) approvals for the import of medicines for clinical trials, and (iii) approvals for the import of medicines without a marketing authorisation.

Customs officials check if all the conditions are met in each case.

An importer of record for pharmaceuticals or medical devices may be a legal person with a relevant wholesale licence.

Furthermore, a pharmaceutical or a medical device manufacturer may import products from its production programme, raw materials and substances for production, interim products, and semi-finished products, in accordance with the manufacturing licence, medicinal products marketing authorisation, or a subcontracting agreement.

Manufacturers of medical devices with a registered seat in Serbia who do not need a manufacturing licence must obtain a wholesale licence for medical devices from their production programme.

The import and export of pharmaceuticals and medical devices is subject to a prior issuance of a medicinal product wholesale licence, subject to exceptions described under 7.2 Importer of Record of Pharmaceuticals and Medical Devices.

A legal entity that performs only the activities of import and export may perform these activities without a medicinal product wholesale licence if it conducts the import and customs clearance activities on behalf of and for the account of a wholesale licence-holder to the site of the goods’ free marketing, in accordance with the customs regulations.

Generally, only medicinal products with a valid marketing authorisation and medical devices registered in the ALIMS’s registry of medical devices may be imported. Exceptionally, the ALIMS may approve import of medicinal products without a marketing authorisation in Serbia or unregistered medical devices under conditions prescribed for compassionate-use programmes, donation or humanitarian aid, or the emergency situations described in 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations. 

Persons entering or leaving Serbia may carry medicinal products in the amount not exceeding their six-month requirement within one calendar year, for their personal usage or for an animal travelling with them, depending on the type and length of the underlying illness. They have to provide to the Customs Authority the approval of a competent Serbian ministry for bringing in or carrying out medicinal products for personal use.

The transfer of medicinal products across the border in the amount not exceeding the 15-day requirement of an individual is not subject to any approval.

Although Serbia is not yet an EU member state, nor a member of the World Trade Organization (WTO), Serbia has, to a large extent, harmonised its legislation with the EU acquis and WTO agreements. Therefore, non-tariff restrictions are rare and imposed only in particularly justified situations, in line with the general principles of the EU and WTO to limit the use of non-tariff restrictions.

Non-tariff regulations and restrictions are imposed based on the Harmonized Tariff Schedule (HTS) Code. The products that are subject to those restrictions (usually quotas) are listed for example in specific international agreements which Serbia has concluded.

Serbia is a party to the Stabilisation and Association Agreement with the EU, the Central European Free Trade Agreement, and the Agreement with EFTA, as well as a number of bilateral free-trade agreements.

The prices of pharmaceuticals are controlled by the government only with respect to prescription-only pharmaceuticals. The government determines the criteria for the pricing of pharmaceuticals, and calculates their maximum prices at the joint proposal of the ministries competent for health and trade. The Ministry of Health calculates the maximum wholesale price for prescription-only pharmaceuticals.

The pricing of prescription-only medicines is governed by the Medicines Act, the Decree on Criteria for Forming of Prices of Prescription-Only Pharmaceuticals for Human Use, and the Decision on Maximum Prices of Prescription-Only Pharmaceuticals for Human Use. Prescription-only pharmaceuticals for which the government did not determine the maximum wholesale price may not be placed on the market.

Once the government decides on the maximum permitted wholesale price of the pharmaceutical, marketing authorisation-holders may apply to include the pharmaceutical into the positive reimbursement list of medicines (“Positive List”), to be prescribed and issued at the expense of the compulsory health insurance. Wholesalers of pharmaceuticals, as well as pharmacies, must align the prices of pharmaceuticals that they have in stock with the maximum prices determined by the government on the same day as the relevant decision on maximum prices enters into force.

However, marketing authorisation-holders are free to determine the prices of over-the-counter medicines and must only notify the Ministry before March 1st of the current year of the price for the previous year.

The Ministry of Health calculates the maximum wholesale price for prescription-only pharmaceuticals based on a number of criteria. One of these criteria is price parity – ie, the comparable wholesale prices of pharmaceuticals in reference countries, namely, Slovenia, Greece and Italy, and the current wholesale price in Serbia, in addition to other applicable criteria.

For the cost of a pharmaceutical to be reimbursed, the product must be included in the Positive List. The general criteria for adding a pharmaceutical to the List are, as follows:

• pharmaco-therapeutic justification of the pharmaceutical;
• pharmaco-economic justification of the pharmaceutical; and
• financial resources provided by the annual financial plan of the National Health Insurance Fund.

In cases when there are not sufficient resources to include in the Positive List all pharmaceuticals which comply with the general criteria, the National Health Insurance Fund further considers two special factors: (i) the existence, if any, of a managed entry agreement, and (ii) the priority for adding the pharmaceutical to the list according to the following criteria:

• the lack of a pharmaceutical from the same pharmaco-therapeutic group on the Positive List for a particular medical indication;
• the significance of a pharmaceutical for public health; and
• ethical aspects.

Within the scope of the process for inclusion of pharmaceuticals into the Positive List of pharmaceuticals to be reimbursed from the national health insurance, the Central Medicines Commission established by the National Health Insurance Fund conducts the health technology assessment of medicines when reviewing the applications for inclusion of pharmaceuticals on the List.

Dispensing and sale of pharmaceuticals is regulated only with respect to prescription-only medicines. The ALIMS decides whether a medicine is to be dispensed only on prescription in a marketing authorisation procedure. Prescriptions and dispensing of pharmaceuticals are regulated in the Rulebook on Form and Content of Medical Prescription, Manner of Issuing and Prescription of Pharmaceuticals. Healthcare professionals are obliged to observe the recommendations from Good Practice in Prescribing of Pharmaceuticals.

A pharmacy may replace the prescribed brand-name medicine with its generic equivalent only if the patient consents after being adequately informed by the pharmacist, and under the condition that the physician did not prohibit replacement on the prescription.