Pharmaceutical And Medical Device Regulation Comparative Guide

1. Legal and enforcement framework

1.1 Which legislative and regulatory provisions govern (a) pharmaceuticals and (b) medical devices in your jurisdiction?

The main regulation governing pharmaceuticals in Serbia is the Law on Medicinal Products and Medical Devices, in force since 2010.

Medical devices are governed by the Law on Medical Devices, in force since 2017. This law applies to medical devices for solely human use, including:

• in vitro diagnostic medical devices; and
• active implantable medical devices.

Medical devices used in veterinary medicine are regulated by the Law on Medicinal Products and Medical Devices.

Apart from these two main laws, multiple bylaws, regulations and government-issued decisions regulate in detail each stage of making pharmaceuticals and medical devices available to patients.

1.2 Which bodies are responsible for enforcing the applicable laws and regulations? What powers do they have?

The applicable laws are enforced by:

• the Ministry of Health, through its Inspectorate for Medicines and Medical Devices; and
• the Medicines and Medical Devices Agency (ALIMS).

The inspectorate affirms and verifies:

• the employment of various good practice guidelines; and
• the fulfilment of conditions regarding the manufacture, wholesale, retail and testing of pharmaceuticals and medical devices.

The inspectorate has the power to:

• ban manufacturing, marketing and laboratory testing contrary to regulations, either:
• • until the conditions of the ban are met; or
  • permanently;
• ban the release of a product or order a recall;
• order the destruction of defective pharmaceuticals or medical devices;
• halt or ban the conduct of clinical trials;
• ban unlawful advertising;
• inspect documentation in the possession of a marketing authorisation holder or the holder of a registration in the Register of Medical Devices concerning all data regarding pharmacovigilance or vigilance of medical devices; and
• take other measures as necessary.

ALIMS is responsible for:

• issuing marketing authorisations and deciding on variations, renewals, transfers and terminations thereof;
• entering medical devices in the Register of Medical Devices, including variations, renewals, transfer and termination;
• registering traditional herbal and homeopathic medicinal products;
• issuing authorisations for clinical trials;
• monitoring adverse reactions;
• issuing certificates for export and authorisations for import of pharmaceuticals and medical devices for treatment of particular patient/s and scientific and medical research;
• authorising advertising; and
• conducting quality control.

1.3 What is the general approach of those bodies in regulating the pharmaceutical and medical device sector?

The mission of both the Ministry of Health and ALIMS is to provide patients with medicines and medical devices that are efficient, safe and of good quality by monitoring various stages of approval. Pharmaceuticals and medical devices are monitored and controlled with a primary focus on ensuring:

• public health;
• patient safety; and
• the availability of effective therapies.

Although the sector is very much aligned with applicable EU rules and international regulations, both bodies strive to fully apply and harmonise local regulations and practices with best practices applicable in the European Union and worldwide, including implementing the recommendations and standards of:

• the World Health Organization; and
• the European Medicines Agency.

Both bodies have existing cooperations with various countries, including countries in the region, as well as Italy, Japan, Slovakia, the Democratic Republic of Congo and Egypt.

1.4 What other industry codes of conduct or best practices are applicable to the production and distribution of (a) pharmaceuticals and (b) medical devices in your jurisdiction?

• The Good Manufacturing Practice Guidelines;
• The Guidelines on Good Manufacturing Practice for Active Substances;
• The Guidelines on Good Distribution Practice;
• The Guidelines on Good Clinical Practice;
• The Guidelines on Good Laboratory Practice; and
• The Guidance on Good Control Laboratory Practice.

All of the above are based on:

• applicable EU directives; and
• applicable international standards.

2. Manufacturing permit

2.1 What government permits are required to manufacture pharmaceuticals and medical devices in your jurisdiction? Do any exemptions apply?

Manufacturing permits for both pharmaceuticals and medical devices are issued by the Ministry of Health. Different requirements are in place for manufacturing permits for pharmaceuticals and medical devices.

Manufacturing permits are not required for the production of magistral medicinal products and for the production of galenic medical products up to a certain quantity.

Manufacturing permits are issued only for certain classes of medical devices; for others, authorisation is granted through wholesale permits which are issued by the Ministry of Health.

2.2 What are the key features of such permits?

Manufacturing permits for pharmaceuticals are issued for an indefinite period, as long as all conditions for the manufacturing are fulfilled, for:

• a specific manufacturing site; and
• a specific pharmaceutical form manufactured at that site.

The permit can be for the whole manufacturing process or a certain part thereof. Variations are possible.

The Ministry of Health issues a manufacturing permit for:

• Class I medical devices (other than Classes Ir, Is and Im);
• other in vitro diagnostic medical devices;
• medical devices for which no conformity assessment has been performed;
• medical devices that are not covered by a sign of conformity;
• custom-made medical devices;
• medical devices for clinical examination; and
• medical devices that are sold as a system or kit.

The permit is issued for five years, for:

• a specific manufacturing site; and
• a specific medical device.

The permit can be renewed.

2.3 What are the procedural and documentary requirements to obtain such permits? What restrictions apply to applicants?

A request for a manufacturing permit must be submitted to the Ministry of Health. Permits can be granted only to legal persons that fulfil the applicable requirements regarding:

• the production site;
• equipment; and
• staff.

To obtain a manufacturing permit for pharmaceuticals, a manufacturer must have:

• a person responsible for the production process;
• a qualified pharmacist responsible for releasing a batch into circulation;
• appropriate space, equipment and staff for production, testing and quality control;
• a qualified pharmacist or other person with appropriate qualifications responsible for quality control, if the manufacturer has its own control laboratory; and
• qualified pharmacists for warehouse oversight.

The main information to be submitted with the request includes:

• details of the manufacturer and the production site;
• the place where quality control is conducted;
• details of the batch released into circulation;
• a list of pharmaceuticals planned for production;
• a description of the production process or part thereof;
• the persons responsible for overseeing:
• • the production process;
  • the release of a batch into circulation; and
  • quality control;
• a list of production and quality control equipment;
• a sketch and description of the site where the activity will be carried out; and
• information on the handling of waste products and environmental protection.

Similarly, the following information should be submitted when applying for a manufacturing permit for medical devices:

• details of the manufacturer and the place of production;
• a description of the medical devices to be produced;
• a description of the production process or part thereof;
• the persons responsible for overseeing:
• • the production process;
  • the release of a batch into circulation; and
  • quality control;
• a list of equipment used and documentation thereof;
• information on the handling of waste products and environmental protection; and
• a description of the quality assurance system used.

2.4 What does the permitting process involve? How long does it typically take? What costs are incurred?

Once a request for a manufacturing permit with all relevant documents has been submitted, the Ministry of Health has:

• 90 days to make a decision in case of pharmaceuticals; and
• 60 days in case of medical devices.

If any documents are missing, the government body will ask for them to be delivered within 15 days; otherwise, the request will be considered as withdrawn. During the granting process, the inspector will:

• visit the site to check whether all requirements are met; and
• check the submitted documentation.

The administrative fee is RSD 99.420..

Additionally, a manufacturer of pharmaceuticals can only manufacture pharmaceuticals for which it has received a marketing authorisation, unless the manufacturing is done:

• under a manufacturing agreement for a foreign third party; or
• for drugs under clinical trials.

2.5 What are the ongoing rights and obligations of the permit holder? How is compliance monitored? What penalties may be imposed for breach?

A manufacturer with a manufacturing permit must:

• manufacture the product in accordance with:
• • the permit granted;
  • the Good Manufacturing Practice Guidelines;
  • the Guidelines on the Good Laboratory Practice;
  • the Guidelines on Good Distribution Practice; and
  • the documents submitted to the Medicines and Medical Devices Agency (ALIMS); and
• use active substances produced in line with the Good Manufacturing Practice Guidelines.

Additionally, the manufacturer must regularly notify the competent authority of

• changes to:
• • the place of production;
  • quality control; or
  • the release of a batch of product into circulation;
• changes to its qualified pharmacists; or
• changes to any other information submitted during the application process.

At the beginning of each calendar year, the manufacturer should submit to the competent authority an updated copy of the main documentation for the place of production for which the permit has been issued.

Manufacturers have rights such as the following:

• the right to request the issuance of a certificate of compliance with good manufacturing practice or a certificate of good laboratory practice;
• the right to distribute or export their products upon receiving relevant permits; and
• the right to have their data and intellectual property protected.

Compliance is monitored by:

• the Ministry of Health's Inspectorate for Medicines and Medical Devices through:
• • regular and extraordinary controls; and
  • controls for the issue of certificates of compliance with good manufacturing practice or good laboratory practice; and
• ALIMS, through issuing time-limited marketing authorisations.

The penalties that may be imposed include:

• fines of up to RSD 3 million;
• a prohibition on a legal entity performing certain business activities for between three and 10 years, depending on the breach;
• cancellation of a permit; and
• in certain cases, recall of the product from the market.

2.6 For how long is the permit valid? Are variations to the permit terms possible? How is the permit renewed?

Manufacturing permits are granted:

• for an indefinite period, for pharmaceuticals; and
• for five years, which may be renewed, for medical devices. Permits for medical devices are renewed based on the same conditions as applied to their initial issue.

2.7 Can a permit be transferred? If so, what is the process for doing so?

Manufacturing permits cannot be transferred. However, for any part of the manufacturing process, the manufacturer can enter into a written agreement on production with another manufacturer in line with the Good Manufacturing Practice Guidelines.

3. Clinical trials

3.1 Which legislative and regulatory provisions govern clinical trials for (a) pharmaceuticals and (b) medical devices in your jurisdiction?

The Law on Medicinal Products and Medical Devices and the Law on Medical Devices, respectively regulate clinical trials. Additionally, the following instruments apply:

• the Regulation on Clinical Trials of Human Medicines;
• the Regulation on Clinical Trials of Medical Devices;
• the Guidelines on Good Clinical Practice; and
• Clinical Investigations of Medicinal Products in the Paediatric Population: Guidelines and Addendum, issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and encompassed in the Regulation on Clinical Trials of Human Medicine.

3.2 What ethical requirements apply to clinical trials in your jurisdiction?

The ethical requirements applicable in Serbia are defined by local regulations and in more detail in the Guidelines on Good Clinical Practice. The guidelines are in line with the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Participants and all other international standards, meaning that the highest ethical standards apply as follows:

• The safety and interests of the subject must be prioritised over the interests of science and society as a whole;
• Clinical trials must be planned and conducted in a way that minimises pain, discomfort, fear and any other foreseeable risk to the subject's health;
• The right of the person to physical and psychological integrity and privacy must be ensured, as must the protection of their personal data in the process;
• The benefit of the product being clinically tested must be greater than its potential risk to the life and health of person;
• The subject's consent must be obtained in accordance with the regulations; and
• Approval from the Ethics Committee must be obtained.

Clinical trials relating to gene therapy that cause changes to the genetic structure of the subject's germ lines are forbidden.

3.3 What consent requirements apply to clinical trials in your jurisdiction?

The 'informed consent' of the subject must be provided in a written statement made by the subject, with the date and signature, about their participation in a certain clinical trial. The subject must be capable of giving consent or, if the person is not capable of giving consent, consent must be given by their legal representative. Consent must be given:

• in accordance with the law; and
• voluntarily after being fully informed about the nature, significance and consequences of the trial and health risks.

The subject must be fully informed in writing in a manner understandable to them about:

• the clinical trial; and
• their right to withdraw consent to participate in the clinical trial at any time.

If a person cannot read and/or write, consent can be given verbally in the presence of at least one witness.

3.4 What reporting requirements apply to clinical trials in your jurisdiction?

The sponsor of the clinical trial must:

• provide reports to the Medicines and Medical Devices Agency (ALIMS) and the Ethics Committee every three months during the trial; and
• inform ALIMS and the Ethics Committee that the trial is over within 90 days of it ending.

If the trial is paused or ends early, the trial sponsor must report this to ALIMS and the Ethics Committee within 15 days. The information that this report should contain is prescribed by local regulations.

The sponsor must submit a final report on the clinical trial to ALIMS and the Ethics Committee within one year of the date on which the clinical trial ends. The information that this report should contain is prescribed by local regulations. The sponsor must also prepare a final report setting out the results of non-interventional post-marketing clinical trials.

Any serious breach of good clinical practice or clinical trial protocol must be reported immediately on a prescribed form.

3.5 What steps does the clinical trial process typically involve?

Clinical trials of pharmaceuticals must be planned, conducted and reported in accordance with the Guidelines in Good Clinical Practice in Clinical Trials (GCP); while clinical trials involving the paediatric population must be conducted in accordance with the Guidelines for Clinical Trials of Medicines on Children of the ICH (ICH: E11).

Also, the clinical trials must include:

• post-marketing interventional and non-interventional clinical trials of the drug;
• non-commercial clinical trials of the drug (academic clinical trials of the drug); and
• clinical trials of bioavailability and bioequivalence.

To apply for approval of a clinical trial, the sponsor must have a presence in Serbia. Alternatively, the sponsor can authorise the contractual research organisation to act as the applicant.

The request for approval to conduct a clinical trial and the request for an opinion of the Ethics must be submitted through ALIMS at the same time, electronically and in the Serbian language. The request for approval should contain the information prescribed by law, including details of:

• the clinical trial itself;
• the sponsor;
• the drug being trialled;
• the aim of the trial;
• the phase of the trial;
• the type of trial;
• the location of the trial; and
• the timeline.

Appropriate documentation must be submitted, such as:

• the clinical trial protocols;
• a brochure for investigators;
• investigational medicinal product dossier, case report form and good manufacturing practice certificates; and
• a list of countries in which:
• • the clinical trial has been approved and/or rejected; and/or
  • the drug has been approved.

A decision on approval will be issued within 60 days of submission of all documentation. Phases I, Ia and Ib of clinical trials can only be conducted in government-owned healthcare institutions.

Before the clinical trial begins, the sponsor must obtain adequate insurance for the participants of the clinical trial.

A similar procedure applies to clinical trials for medical devices. The request must be submitted to ALIMS and approval is required only for Class IIa, IIb and III medical devices (ie, all medical devices with higher risk for users).

3.6 How are clinical trials monitored in your jurisdiction?

Clinical trials are monitored by the sponsor and controlled by ALIMS and the Ministry of Health.

The sponsor must designate a person with appropriate qualifications and knowledge to monitor the clinical trial. The monitor should be either:

• a citizen of Serbia; or
• a foreigner with a work permit in Serbia and knowledge of the Serbian language.

ALIMS will ensure that clinical trials are conducted in line with Serbian regulations and the Guidelines on Good Clinical Practice. The sponsor can also request ALIMS to conduct controls at the location of the clinical trial. ALIMS must inform the sponsor of controls in advance and issue a final report to the sponsor. In case of any observed irregularities, ALIMS will specify a 60-day timeframe within which they must be rectified. If the irregularities are not rectified, ALIMS may propose:

• controls by the Ministry of Health; and
• the subsequent suspension or termination of the trial.

If, on the basis of the performed controls, ALIMS determines that it is not necessary to immediately suspend the clinical trial in order to protect the health of participants, the interests of science and society as a whole, it will ask the sponsor for additional data on the conduct of the clinical trial.

The sponsor must submit all requested data to ALIMS within eight days of the date of such request, on the basis of which ALIMS will inform the sponsor and the Ethics Committee about the proposed measures.

3.7 What other best practices should be followed in relation to clinical trials?

The best practices that should be followed include those set out in:

• the Guidelines on Good Clinical Practice; and
• the Guidelines for Clinical Trials of Medicines on Children of the ICH.

4. Marketing authorisation

4.1 What are the procedural and documentary requirements to obtain marketing authorisation for (a) pharmaceuticals and (b) medical devices? What exemptions and/or restrictions apply?

Marketing authorisations can be obtained:

• on the basis of full or abbreviated documentation; or
• under a special procedure if a product has already obtained a marketing from the European Medical Evaluation Agency.

Full documentation includes the following:

• administrative data, such as:
• • the name of the drug;
  • the international non-proprietary name of the drug;
  • the generic name or active substance; and
  • the pharmaceutical form and strength;
• a summary of the drug's characteristics;
• the proposed packaging leaflet;
• details of the applicant, the manufacturer, the manufacturing site and batch release;
• proof that the manufacturer has a production licence;
• a proposal for packaging;
• proof that the product:
• • has or is in the process of obtaining marketing authorisation in the country of origin; and
  • is on the market, or the reasons for its withholding;
• a list of countries in which marketing authorisation is held;
• a certificate of good manufacturing practice;
• qualitative and quantitative pharmaceutical, chemical and biological data – for example, on:
• • the drug's composition;
  • the technological production process;
  • quality control of all raw materials;
  • quality control in the production process;
  • stability studies; and
  • the assessment of medicinal product environmental safety);
• pharmacological and toxicological data on the drug's:
• • pharmacodynamic and pharmacokinetic properties;
  • toxicity;
  • impact on reproductive function;
  • embryonic, foetal and perinatal toxicity;
  • mutagenic and carcinogenic potential; and
  • local tolerability; and
• clinical data – that is, general information about:
• • clinical trials;
  • trial results;
  • clinical and pharmacological data;
  • biological availability or biological equivalence;
  • clinical safety and efficacy;
  • unexpected events during trials; and
  • the experience in other countries.

Additional documents and inspection of the manufacturing process may be required.

The abbreviated procedure is available when obtaining marketing authorisations for:

• generics;
• generic hybrids; and
• biologically similar medicinal products.

For medical devices, the following documents are generally required:

• a declaration of conformity;
• an EU certificate;
• if the manufacturer is not based in an EU member state or is from a country that has not signed mutual recognition agreements and protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products:
• • ISO 13485, SRPS EN ISO 13485 and/or EN ISO 13485 certificates; and/or
  • proof that medical device is on the market in an EU member state (eg, under an EU certificate of quality system);
• a letter of authorisation of the foreign manufacturer;
• the labelling in English and/or Serbian; and
• instructions for use in English and Serbian.

4.2 What steps does the process of obtaining marketing authorizations typically involve? How long does it take? What costs are incurred?

An application for marketing authorisation for pharmaceuticals may be filed by:

• the manufacturer;
• its agent or representative;
• an entity to which the manufacturer will transfer the marketing authorisation; or
• a representative of an entity that holds a marketing authorisation in:
• • an EU member state; or
  • another country that has the same requirements as Serbia.

The application must be filed electronically with the Medicines and Medical Devices Agency (ALIMS) together with the prescribed documents. ALIMS will carry out a formal assessment of the documentation within 30 days of receipt of the application. If the application is not complete, ALIMS will:

• inform the applicant in writing of the missing documents; and
• request it to complete the application with the required data within 30 days.

ALIMS will decide whether to issue a marketing authorisation or reject the application within 210 days of receipt of the complete application, based on the opinion and assessment of the commission with regard to quality, safety and efficacy. An accelerated procedure applies to:

• medicinal products of greatest interest for the protection of public health; and
• products for which a licence has already been issued under the centralised procedure.

In this case, ALIMS will issue its final decision within 150 days of receipt of the complete application with all necessary documents.

The administrative fees are as follows:

• Application with full documentation: RSD 542,800.
• Application with abbreviated documentation: RSD 383,500

Other additional costs may be incurred for the following, among other things:

• additional pharmaceutical types;
• different strengths;
• inner packaging; and
• different packaging sizes.

The process is similar for medical devices, with documents being electronically submitted to ALIMS. ALIMS will:

• inform the applicant within 15 days of submission if the application is not complete; and
• give it 30 days to complete the application.

ALIMS will register a medical device that complies with the basic requirements within 30 days of the date of submission of the request. The costs vary depending on the class of medical device, ranging from RSD 13,450 for Class I to RSD 67,300for Class III. The following additional costs may be payable:

• Assessment of the conformity of the medical device:RSD 283,000..
• Recognition of foreign documents: RSD 14,200.

4.3 What are the ongoing rights and obligations of the marketing authorization holder once the product has been placed on the market? How is compliance monitored? What penalties may be imposed for breach?

Once a product has been placed on the market, the market authorisation holder (MAH) must:

• conduct post-market surveillance; and
• take any necessary field safety corrective action.

The MAH must submit periodic safety update reports:

• every six months for the first two years; and
• annually for the following two years.

The MAH must:

• implement a pharmacovigilance system to:
• • monitor any adverse reactions, side effects or safety issues; and
  • report on them to ALIMS;
• ensure that each batch of the product released onto the market complies with the approved quality standards;
• ensure that the labelling, package inserts and patient information leaflets for the product remain accurate; and
• if new risks are identified or the benefit-risk profile changes, inform ALIMS and update the relevant information accordingly.

The MAH must apply to ALIMS for approval of any variations to the marketing authorisation, including:

• changes to:
• • the manufacturing process;
  • the product formulation;
  • the dosage forms; or
  • the packaging; and
• new therapeutic indications or contraindications.

The MAH must ensure that all advertising and promotional activities comply with local regulations. If safety concerns arise or the product is found to be defective, the MAH is responsible for initiating a product recall or withdrawal. The MAH must notify ALIMS and work with health authorities to ensure that affected products are promptly removed from the market. The MAH must further ensure the continuous supply of the medicinal product or medical device to the market.

Compliance is monitored by ALIMS and the Ministry of Health through its health inspectors. The prescribed penalties are primarily monetary in nature, but can also include:

• injunctive relief against the company performing business activity for between three and 10 years;
• repossession of products; and
• in severe cases, criminal charges.

4.4 For how long is the marketing authorisation valid? Are variations to the terms possible? How is the marketing authorisation renewed?

A marketing authorisation for pharmaceuticals is valid for five years. It is issued for a specific strength, pharmaceutical form and packaging. All places of production and release to the market in the territory of Serbia must be listed on the authorisation.

A conditional marketing authorisation is also available, for which certain other obligations must be fulfilled. A conditional licence may be issued:

• for pharmaceuticals used for the treatment, prevention or diagnosis of serious and life-threatening diseases;
• for pharmaceuticals used in emergency cases;
• for pharmaceuticals for which a marketing authorisation has been issued under the centralised procedure;
• for orphan drugs;
• when public health is threatened (ie, for drugs used to treat infectious diseases, according to the list of infectious diseases of the World Health Organization); and
• for drugs used for the treatment rare diseases.

A conditional marketing authorisation is valid for 12 months.

ALIMS can, exceptionally, issue a marketing authorisation under special circumstances for a medicinal product which is of special public health interest. This is valid for 12 months and requires the applicant to:

• fulfil all obligations relating to the safety of the medicinal product; and
• inform ALIMS of:
• • any undesired events that occur when using the medicinal product; and
  • all security measures undertaken.

In special circumstances, ALIMS can extend the marketing authorisation for an additional 12 months if the necessary requirements are met.

For renewal, the MAH must submit a request to ALIMS that includes:

• expert reports on the product's quality, safety and efficacy; and
• a list of any variations which have previously been approved by ALIMS.

The request must be submitted to ALIMS no later than 90 days and no earlier than 180 days before the marketing authorisation is due to expire. ALIMS will issue its decision on renewal within 90 days of the date of submission of all relevant documentation. Additionally, the applicant may request the grant of a permanent marketing authorisation, which ALIMS may issue if it determines that the pharmaceutical for which marketing authorisation has been granted is safe, based on the pharmacovigilance data for the five-year period from the date of issuance or renewal of the pharmaceutical.

For medical devices, ALIMS will issues its decision within 60 days of the expiry date of an EC certificate. For Class I medical devices and other in vitro diagnostic medical devices that are marketed based on a declaration of conformity decision, registration is issued for a period of five years. The applicant must apply for renewal at least 30 days before the date of expiry, and ALIMS will issue a decision on renewal within 15 days of submission of the application with all relevant documents. ALIMS must inform the applicant if the application is incomplete within 10 days of submission.

4.5 Can a marketing authorisation be transferred? If so, what is the process for doing so?

A marketing authorisation can be transferred with the approval of ALIMS. The transferee must fulfil all conditions that apply to the transferor. The transferee becomes the new MAH as of the date of the transfer.

The request for a transfer must be submitted to ALIMS, which will conduct a formal assessment of the documentation within 15 days of receipt. Within 60 days of receipt of the complete request for transfer, ALIMS will issue a decision approving the transfer or rejecting the request. The new MAH must put the drug on the market in accordance with the approved transfer within 12 months of delivery of the decision.

5. Specific types of products

5.1 What specific provisions and requirements apply to the following types of products in your jurisdiction?
(a) Biologicals and biosimilars
(b) Controlled substances
(c) Orphan drugs
(d) Paediatric medicines
(e) Traditional and complementary medicines

The following substances fall under distinct regulatory frameworks:

• biosimilars;
• traditional herbal and homeopathic medicines;
• paediatric medicines;
• controlled substances; and
• orphan drugs.

These frameworks ensure product safety, efficacy and accessibility while accommodating the unique characteristics of each category. Key regulatory considerations applicable to these medicinal products include:

• marketing authorisation procedures;
• special exemptions; and
• additional oversight measures.

Marketing authorisation for biosimilars may be granted through an abbreviated procedure.

Traditional herbal and homeopathic medicinal products are generally exempt from the requirement to obtain marketing authorisation and may be issued without prescription. They must be registered in corresponding registers held by the Medicines and Medical Devices Agency of Serbia (ALIMS).

For paediatric medicines, the most notable specific provisions relate to case clinical trials, where higher standards for the protection of underage subjects apply.

Controlled substances containing narcotic or psychotropic substances fall under the Law on Psychoactive Controlled Substances and certain controlled substances may be issued with a special medical prescription. In certain cases involving the import or wholesale of controlled substances, the police department is involved in the process.

In the case of orphan drugs, the administrative fees levied for procedures before ALIMS do not apply and a conditional marketing authorisation under the accelerated procedure may be issued with a validity period of 12 months.

6. Packaging and labelling

6.1 What regulatory provisions and requirements apply to the packaging and labelling of (a) pharmaceuticals and (b) medical devices? Do these vary depending on the type of product? What exemptions and/or restrictions apply?

• The Law on Medicinal Products and Medical Devices;
• The Law on Medical Devices;
• The regulations on the content and labelling of outer and inner packaging of medicine, additional labelling and instructions for use; and
• The regulations on the labelling and instructions for use of medical devices.

The outer packaging of a pharmaceutical must be labelled both in Serbian Cyrillic and in the Roman alphabet, in accordance with the marketing authorisation and the summary of product characteristics. The data must be:

• easily legible;
• comprehensible; and
• undeletable.

The outer packaging of a medicinal product that is on the market must include at least:

• the name and international non-proprietary, generic or chemical name of the substance;
• the active pharmaceutical ingredients, expressed qualitatively or quantitatively per dosage unit;
• the pharmaceutical dosage form;
• the strength (relating to the mass, volume or number of doses);
• the packaging;
• a list of excipients with proven effects;
• all excipients for:
• • medicinal products in the form of injections;
  • medicinal products for local application; and
  • preparations for eyes;
• the route of administration of the medicinal product;
• a warning that the product must be kept out of the reach of children;
• other necessary warnings;
• the expiry date;
• storage conditions;
• special precautionary measures for disposal and destruction;
• details of the marketing authorisation holder;
• the marketing authorisation number;
• the batch number and European Article Number code; and
• the method of administration for the over-the-counter medicinal products.

The name of the product should also be written in Braille, unless the marketing authorisation specifies that the product will be exclusively used in:

• in-patient medical institutions; or
• medical institutions under the control of physicians.

Similar rules apply to medical devices. The wording on the safe and proper use of the medical device should:

• take into account the training and knowledge of potential users;
• include data that identifies the manufacturer;
• be written in Serbian; and
• fully correspond to the original text of the manufacturer's instructions in case of translation.

The content and labelling on the outer and inner packaging, as well as the instructions, must:

• be:
• • legible;
  • understandable;
  • undeletable; and
  • in the Serbian language, with other languages if necessary, all with identical content; and
• include:
• • the series or lot number,
  • the name;
  • the validity; and
  • any special markings (eg, if used for clinical trials or scientific purposes, or if custom made).

Exceptionally, instructions for use are not required:

• for medical devices in Classes I and IIa; and
• in justified cases, for in vitro diagnostic medical devices if they can be used safely without instructions for use.

Additionally, if a medical device is used only by medical experts, the instructions may be provided in electronic form only.

6.2 How is compliance with these provisions and requirements monitored? What penalties may be imposed for breach?

All labelling and packaging elements must be approved by the Medicines and Medical Devices Agency (ALIMS) before the medicinal product is put on the market, after which compliance will be monitored by ALIMS and the Ministry of Health. Imposed penalties may include:

• fines of up to RSD 3 million;
• a prohibition of the conduct of certain business activities for between three and 10 years, depending on the breach;
• cancellation of the permit; and
• in certain cases, recall of the product from the market.

6.3 What other best practices should be followed in relation to the packaging and labelling of (a) pharmaceuticals and (b) medical devices?

In Serbia, the packaging and labelling of pharmaceuticals and medical devices must adhere to local regulations, which are aligned with EU standards in many respects. The packaging should be child safe and user friendly. The language used should be:

• adjusted to the target audience;
• clear; and
• concise.

The instructions for use and patient leaflet should be detailed and understandable, including:

• detailed instructions;
• potential side effects; and
• actions to take in case of adverse events or overdose.

Serial numbers and tamper-evident seals should be included; and QR codes or other track-and-trace technologies should be used for supply chain security in order to combat counterfeiting.

7. Advertising and promotions

7.1 What regulatory provisions and requirements apply to the advertising and promotion of (a) pharmaceuticals and (b) medical devices? How do these vary depending on:
(a) The type of product?
(b) The target (ie, healthcare professionals or consumers)?
(c) Whether the activity takes place online or offline?

The prior permission of the Medicines and Medical Devices Agency (ALIMS) is required for the use of promotional materials and other documentation for both pharmaceuticals and medical devices. ALIMS will ensure that these materials are accurate and consistent with the product's approved use.

The advertising of prescription-only medicines to the general public is strictly prohibited. These products can only be promoted to:

• healthcare professionals such as doctors and pharmacists; and
• other relevant medical personnel.

Promotional materials must be supported by scientific data and clinical trials. In order to inform healthcare professionals about the characteristics of a new medicine which has been put into circulation, it is possible to provide them with the smallest package of the new medicine with a note on the packaging stating: "Free sample, not for sale."

Over-the-counter medicines can be advertised to the general public, but strict requirements apply to ensure that consumers are not misled. Ads:

• should:
• • be clear and objective;
  • promote rational use; and
  • comply with ALIMS's strict guidelines; and
• should not:
• • exaggerate the benefits; or
  • encourage unnecessary consumption.

Only medical devices that are intended for independent use by consumers may be advertised to the general public (mostly devices in Classes I and IIa). The claims made in ads:

• must not be misleading; and
• must adhere to ALIMS's guidelines.

All classes of medical devices can be promoted to healthcare professionals. Ads must:

• include technical and clinical information on the device's:
• • usage;
  • risks; and
  • benefits;
• be scientifically accurate; and
• comply with the regulatory requirements.

The following are not permitted:

• giving samples to general public; and
• advertising pharmaceuticals or medical devices that are issued under compulsory health insurance.

The same rules apply to both offline and online promotion.

7.2 What safeguards are in place to prevent inducements from being offered to healthcare professionals to promote the use of specific pharmaceuticals or medical devices?

Both pharmaceutical companies and medical device manufacturers must adhere to legal and ethical standards prescribed by local regulations. Promotional gifts or inducements for healthcare professionals are generally prohibited, and any sponsorships or collaborations must be transparent. Serbian law specifies the types of promotions to healthcare professionals that are allowed. It is prohibited to advertise a pharmaceutical or medical device:

• for the purpose of encouraging the prescription, dispensing or sale of the product; or
• by giving or promising financial, material or other benefits.

Free samples may be given to healthcare professionals, although the number of samples that may be given is limited.

Professional associates who promote a pharmaceutical or medical device may provide gifts healthcare professionals only if those gifts:

• have no greater value; and
• are related to medical, dental or pharmaceutical practice (eg, pens, notebooks, calendars and other similar low-value items).

In terms of the law, this is not considered to constitute advertising.

Pharmaceutical companies and medical device manufacturers can sponsor scientific conferences or provide educational materials. However, the regulations:

• closely define the scope of the sponsorship; and
• prescribe transparency.

Finally, the law expressly provides that healthcare professionals may not request or accept any material or non-material contribution as an incentive for prescribing, issuing, purchasing or consuming a product.

7.3 What provisions and requirements apply to the promotion of off-label use?

In Serbia, the promotion of off-label use of pharmaceuticals and medical devices is strictly prohibited. The applicable regulations explicitly prohibit the promotion of any pharmaceutical or medical device for purposes that are not aligned with approved indications and intended uses. Companies that promote medical devices for off-label use can face:

• significant monetary fines;
• revocation of marketing authorisation;
• suspension of business activities; and
• in case of severe violations, criminal sanctions.

7.4 How is compliance with these provisions and requirements monitored? What penalties may be imposed for breach?

Compliance is monitored by ALIMS and the Ministry of Health through the Inspectorate for Medicines and Medical Devices. The Ministry of Health may ban advertising which is carried out contrary to the law and the use of advertising materials and other documentations, based on information submitted to it by ALIMS. In case of breach, penalties may include:

• fines of up to RSD 3 million; and
• a prohibition on the conduct of certain business activities for between three and 10 years.

7.5 What other best practices should be followed in relation to the advertising and promotion of (a) pharmaceuticals and (b) medical devices?

The advertising and promotion of pharmaceuticals and medical devices in Serbia require:

• careful adherence to local regulations and ethical considerations; and
• a commitment to providing accurate, evidence-based information.

The prioritisation of transparency, accuracy and patient safety will ensure that promotional efforts align with legal requirements.

8. Product liability and safety

8.1 What regulatory provisions and requirements apply to the safety and quality of (a) pharmaceuticals and (b) medical devices in your jurisdiction?

The following instruments apply:

• the Law on Medicinal Products and Medical Devices;
• the Law on Medical Devices; and
• various bylaws, including regulations on:
• • the method of quality control of medicines and medical devices;
  • the manner of reporting, collecting and monitoring adverse drug reactions;
  • suspensions and withdrawals; and
  • the technical evaluation of a medical device on the market.

The Medicines and Medical Devices Agency (ALIMS) conducts safety and quality control of pharmaceuticals and determines whether quality standards are met. Quality control may take the form of:

• laboratory quality control; and/or
• quality documentation assessment.

Quality control is carried out in accordance with:

• the European or national pharmacopoeia;
• other recognised pharmacopoeias or verified methods of analysis; and/or
• magistral formulae.

Quality control may be carried out:

• prior to the grant of marketing authorisation; or
• post the grant of marketing authorisation.

Prior to marketing a product, a wholesale licence holder must submit to ALIMS:

• samples of the imported products batch; and
• the manufacturer's certificate of analysis or a certificate of analysis of a professional body for quality control of medicinal products from another country.

8.2 What is the typical process for conducting product recalls in your jurisdiction? Are these generally voluntary or mandatory?

Pharmaceuticals manufacturers must inform the Ministry of Health of:

• any accident or error in the manufacturing process; and
• any other occurrences that may affect the safety or quality of a product.

A wholesaler must inform the Ministry of Health of any incident that may compromise the safety, quality or efficacy of the product. The Ministry of Health may:

• order a product recall; and/or
• prohibit further manufacturing of the product.

Pharmaceutical recalls are mandatory in certain cases specifically defined by law, including where:

• a specific product is harmful when applied in normal conditions; or
• no therapeutic efficiency is noted.

Recalls are ordered by the Ministry of Health either:

• on its own initiative; or
• if recommended to do so by ALIMS.

The Ministry of Health may decide either to:

• recall a certain product series that does not meet requirements; or
• completely withdraw a product from the market.

Recalls of medical devices generally follow the same path, with the law prescribing certain cases in which the Ministry of Health is required to issue a recall – for example, where:

• a medical device:
• • is harmful under normal conditions of use; or
  • fails to perform; or
• the qualitative and quantitative composition of a medical device does not correspond to that prescribed by the manufacturer in:

• the technical documentation;
• the certificate of conformity; or
• any other certificate for that medical device.

The manufacturer of a medical device or its representative may voluntarily withdraw the product from the market, in which case ALIMS must be promptly informed.

Products are generally recalled voluntarily. Usually, there is no more than one mandatory recall per year (if any).

8.3 What reporting requirements apply to product recalls in your jurisdiction?

Marketing authorisation holders (MAHs) must report adverse reactions and any quality defects that may necessitate a product recall to ALIMS. Periodic safety update reports must be submitted to ALIMS:

• every six months for the first two years of product marketing;
• annually for the following two years; and
• once every three years thereafter.

A safety update report must also be submitted immediately upon obtaining information about all adverse reactions to a medicine. The reports should contain a professional assessment of the risk-benefit ratio of a particular medicine.

ALIMS may also require MAHs to:

• conduct post-marketing safety studies in order to identify previously unknown safety risks;
• investigate potential and identified risks;
• confirm the known safety profile of a medicine in its approved use;
• assess the frequency of adverse reactions;
• identify risk factors; and
• report back to ALIMS accordingly.

These studies may also be initiated by MAHs.

Healthcare professionals are also required to report any adverse reactions promptly to ALIMS.

Manufacturers of medical devices and their authorised representatives must report any incidents or potential risks associated with a medical device to ALIMS without delay. If a recall is deemed necessary, a detailed notification must be submitted, including:

• the reasons for the recall; and

• the actions to be taken to ensure that all affected products are effectively removed from the market.

8.4 What other best practices should be followed with regard to product recalls in your jurisdiction?

MAHs, manufacturers, wholesalers, sponsors of clinical trial and importers of unregistered pharmaceutical must:

• have detailed procedures that describe the actions taken after receiving a recall notice;
• take appropriate steps to inform all users to which they have supplied batches of the drug that are covered by the recall;
• check whether they have stocks of drugs that are covered by a quality defect and place these in quarantine; and
• keep documentation related to the distribution of drugs in order to facilitate the withdrawal of the drug from circulation.

Wholesale licence holders, including importers, must have in place an urgent product withdrawal plan that will help to ensure an efficient product withdrawal based on a request for recall issued by:

• the Ministry of Health;
• the manufacturer; or
• a licensee.

8.5 What regulatory provisions and requirements apply to medical product liability in your jurisdiction?

Medical product liability in Serbia is regulated through a combination of industry-specific laws and general consumer protection laws, including:

• the Law on Medicines and Medical Devices;
• the Law on Medical Devices;
• the Law on General Product Safety;
• the Law on Consumer Protection;
• the Law on Contracts and Torts; and
• the Criminal Law.

Serbia's regulatory framework holds manufacturers and distributors strictly liable for damages caused by defective medicinal products and medical devices. Compliance with safety and quality standards is essential to minimise liability risks. If a defective product causes harm, affected individuals have the right to seek compensation through legal channels.

8.6 What are the respective liabilities of the various parties in the supply and distribution chain under this regime?

Generally, both manufacturers and distributors must:

• ensure that products meet safety standards; and
• inform consumers about potential risks.

During clinical trials, the law requires the sponsor of a clinical trial to insure the subjects in the clinical trials in case damage occurs to their health which is caused by the clinical trial of the medicinal product or medical device.

8.7 Who has standing to bring a medical product liability claim in your jurisdiction? What is the process for bringing a claim?

Medical product liability is primarily governed by the Law on Obligations, which outlines the general principles of liability for damages. Under this law, manufacturers and distributors can be held strictly liable for harm caused by defective medicinal products and medical devices. The injured party – which in most cases will be the patient – can bring a medical product liability claim. There is no special process for these types of cases, meaning that the standard process for the filing of a lawsuit with the competent court will apply.

Additionally, criminal proceedings may be enacted by competent public prosecutor if a violation could be categorised as a criminal offence.

8.8 What defences to medical product liability claims are available in your jurisdiction? Can liability be limited?

Manufacturers and distributors must prove that they did not cause the harm by demonstrating that:

• they did not market the medical product;
• the product was marketed in accordance with the requirements of a competent body;
• the defect did not exist when the product was put on the market; or
• the injury occurred due to the fault of the injured party or a third party.

Liability cannot be limited.

8.9 What remedies can claimants seek? Are punitive damages available?

Claimants can seek civil procedure remediates, meaning that monetary claims are possible. Additionally, administrative and monetary measures may be imposed by the Ministry of Health and ALIMS, in line with their competences.

Punitive damages are not available.

9. Sale and distribution

9.1 What regulatory provisions and requirements apply to the dispensing, sale and distribution of (a) pharmaceuticals and (b) medical devices? How do these vary depending on:
(a) The type of product?
(b) The target (ie, healthcare professionals or consumers)?
(c) Whether the activity takes place online or offline?

In Serbia, the regulatory framework for pharmaceuticals and medical devices is governed primarily by the Law on Medicines and Medical Devices and the Law on Medical Devices, and their corresponding bylaws. These regulations address wholesale and retail separately.

The wholesale of pharmaceuticals may be conducted by legal entities:

• only with permission from the Ministry of Health; and
• only for pharmaceuticals for which permission, including marketing authorisation, has been granted.

A manufacturer may distribute pharmaceuticals to a wholesaler without permission.

In order to obtain a permit, a wholesale distributor must fulfil certain requirements relating to:

• storage conditions;
• personnel; and
• equipment.

A request must be submitted to the Ministry of Health, which will grant a permit within 90 days if all requirements are met. The permit will be granted for an indefinite period. The permit can be modified and recalled under certain conditions.

Retail of both prescription and over-the-counter drugs is possible only in licensed pharmacies by authorised pharmacists. Prescription drugs may be sold only with a valid prescription issued by a healthcare professional. Pharmaceuticals cannot be sold online.

The wholesale of medical devices by both legal entities and individuals is possible under a permit obtained from the Ministry of Health. The procedure for obtaining a permit is similar to that for obtaining a wholesale permit for pharmaceuticals. A permit will be issued within 60 days once all necessary documentation has been submitted and remains valid for five years. The permit can be modified, renewed and recalled under certain conditions.

Both manufacturers and wholesalers may distribute medical devices only to:

• registered wholesalers;
• pharmacies;
• other health institutions;
• private practices; and
• specified stores selling medical devices.

Retail sales must be made through:

• pharmacies;
• private practices; and
• specified stores selling medical devices.

9.2 How is compliance with these provisions and requirements monitored? What penalties may be imposed for breach?

Compliance is monitored by:

• the Ministry of Health; and
• the Medicines and Medical Devices Agency.

Penalties include:

• fines of up to RSD 3 million;
• a prohibition on conducting certain business activities for between three and 10 years, depending on the breach; and
• confiscation of goods.

9.3 What other best practices should be followed in relation to the advertising and promotion of pharmaceuticals and medical devices?

The Guidelines on Good Distribution Practice.

10. Price regulation

10.1 How are the prices of (a) pharmaceuticals and (b) medical products regulated in your jurisdiction?

The government sets the criteria for determining the price of prescription-only pharmaceuticals. These include:

• the current wholesale price in Serbia;
• the wholesale price in comparable countries (Slovenia, Greece and Italy);
• the results of pharmacoeconomic studies; and
• the wholesale costs.

The retail price of prescription-only medicines that are included on the Positive List of the Republic Fund of Health Insurance (ie, subsidised by the state) may be increased by 12% in comparison to the wholesale price; while the retail price of prescription-only medicines that are not on this list may be increased by up to 25%, depending on the wholesale price.

The price of the over-the-counter drugs is determined by the marketing authorisation holder, which must inform the Ministry of Health before 31 March of the current year of the price for the previous year.

10.2 Does the government subsidise the cost of pharmaceuticals and medical devices in your jurisdiction? If so, what is the process for doing so?

The Serbian government subsidises the cost of pharmaceuticals and medical devices. To benefit from a subsidy, a pharmaceutical must be included on the Positive List of the Republic Fund of Health Insurance. A request for inclusion on the list must be submitted to the Republic Fund of Health Insurance, which will conduct a health technology assessment to determine whether the medicine meets the necessary standards. The general criteria considered in this regard are:

• the pharmacotherapeutic and pharmacoeconomic justification of the pharmaceutical; and
• the budget allocated by the Financial Plan of the Republic Fund of Health Insurance.

If the allocated budget cannot cover the cost of all pharmaceuticals that fulfil the general criteria, the Central Commission for Medicines will determine their priority based on the following criteria:

• a lack of medicines from the same pharmacotherapeutic group on the Positive List for a particular medical indication;
• the medicine's significance to public health;
• ethical aspects; and
• any special agreements between the Republic Fund of Health Insurance and the applicant for including the medicine on the Positive List, such as:
• • a value cap;
  • a volume cap; and/or
  • risk and cost-sharing agreements.

With regard to medical devices, the Republic Fund for Health Insurance prescribes the highest amount to be reimbursed for certain medical devices that are included on the list. The difference must be paid by patients.

11. Import and export

11.1 What requirements and restrictions apply to the import and export of (a) pharmaceuticals and (b) medical devices in your jurisdiction?

Pharmaceuticals may be imported and exported only:

• by legal entities that hold a wholesale licence from the Ministry of Health; and
• where marketing authorisation has been issued for the pharmaceutical.

A manufacturer may import and/or export pharmaceuticals from its manufacturing portfolio, as well as raw materials, interim products and semi-finished products, in accordance with the manufacturing licence and marketing authorisation, without an additional import/export permit.

In order to obtain a permit, an importer/exporter must fulfil certain requirements relating to:

• storage conditions;
• personnel; and
• equipment.

A request must be submitted to the Ministry of Health, which will grant a permit within 90 days if all the requirements are met. The permit will be granted for an indefinite period. The permit can be modified and recalled under certain conditions.

In certain cases, the Medicines and Medical Devices Agency (ALIMS) may exceptionally approve the import of unregistered medicines for:

• treating specific patients; or
• conducting scientific and medical research.

Wholesale medicine distributors must submit an import request to ALIMS. Imported quantities must not exceed a one-year supply for healthcare institutions, while research imports must match the project needs. ALIMS may also approve the import of unregistered medicines and medical devices for Serbian military needs, as determined by the Defence Ministry.

Medical devices may be imported and exported by both legal entities and individuals. The same rules apply as for obtaining a wholesale permit. A permit will be issued by the Ministry of Health within 60 days once all necessary documentation has been submitted and is valid for five years. The permit can be modified, renewed and recalled under certain conditions.

11.3 What other issues from an import and export perspective should pharmaceutical and medical device manufacturers bear in mind?

Pharmaceutical and medical device manufacturers should consider several additional factors, as follows:

• Customs requirements and regulatory compliance: Pharmaceuticals and medical devices should be classified under the appropriate customs tariff codes to avoid delays and penalties. All necessary documentation should be properly prepared, including:
• • an invoice;
  • a packing list;
  • a certificate of origin;
  • an import licence (if applicable); and
  • a certificate of analysis or quality certificate.
• Compliance with the Guidelines on Good Distribution Practice is essential for import and export, to ensure proper handling, storage and transportation. Finally, exporters in particular should ensure compliance with destination country regulations – for example, when exporting to the European Union, exports must comply with serialisation requirements under the EU Falsified Medicines Directive.
• Obligation of continuous market supply: Manufacturers must ensure a stable supply of products to the Serbian market to avoid shortages. The obligation to maintain an adequate stock of medicines applies in particular to essential and life-saving drugs. Any anticipated disruption in supply must be reported to ALIMS.
• Medicinal product quality certificate and regulatory inspections: Imported pharmaceuticals must adhere to Serbian and EU good manufacturing practice requirements, including inspections by ALIMS. A medicinal product quality certificate is mandatory for imported pharmaceuticals and must be issued by a recognised authority. The importer/exporter must:
• • keep the copies of certificates of analysis for each pharmaceutical batch for which it has been granted a permit by the Ministry of Health; and
  • indicate on the accompanying documentation that the batch holds a certificate of analysis issued by ALIMS, as well as the certificate number.
• Recalls and reporting: Companies must have a system in place to handle recalls and report adverse drug reactions in line with regulatory requirements.

12. Protecting and incentivising innovation

12.1 What regulatory exclusivities are available to pharmaceutical and medical device manufacturers (both innovators and generics)?

In Serbia, pharmaceutical and medical device manufacturers – including both innovators and generics – can benefit from a range of regulatory exclusivities, which are largely aligned with EU standards. While the regulatory exclusivities in Serbia mirror many of the EU standards, there are nuances depending on:

• the type of product (pharmaceuticals versus medical devices); and
• the market conditions.

Innovators benefit from:

• patent protection;
• supplementary certificates;
• data exclusivity; and
• orphan drug exclusivity.

Generic manufacturers can enter the market only once exclusivity periods have expired.

Medical devices also benefit from some data exclusivity and market protections, but these are less defined and may vary depending on the type of device.

Innovator pharmaceutical companies can secure patent protection for their products, which typically lasts for 20 years from the filing date. Patent extensions may be granted under certain circumstances, such as for paediatric use. Innovators can apply for a special protection certificate, which extends the patent protection for pharmaceutical products for up to five additional years. Serbia offers a six-year data exclusivity period for new pharmaceuticals.

While not as formalised as for pharmaceuticals, innovators in the medical device industry can enjoy some degree of data exclusivity for clinical trial data used to support regulatory approvals in Serbia. Competitors may be unable to use the same data when submitting their own applications for a similar device within a certain timeframe.

12.2 How is the data of pharmaceutical and medical device manufacturers protected during clinical trials, the marketing authorisation process and beyond?

The following persons are obliged to treat as classified all data in the documentation enclosed with an application for marketing authorisation and in all other procedures processed by the Medicines and Medical Devices Agency (ALIMS) and/or competent ministries:

• employees of ALIMS;
• members of the bodies and advisory boards of ALIMS;
• experts from the list of experts; and
• employees of the competent ministries.

This applies in particular if:

• the data is confidential and/or the data – either as a whole or in a precise form and set of its components– is not generally known or easily available to persons that usually deal with information of this kind;
• the data has a commercial value due to its confidentiality, for the duration of the period of confidentiality; or
• the applicant for a marketing authorisation, for variations thereto or for renewal thereof, has taken reasonable measures under the circumstances to keep the data confidential.

This also applies to data:

• that refers to undisclosed tests (examinations) of pharmaceutical products using new chemical solutions; or
• whose generation involved considerable efforts.

Serbia provides patent protection for pharmaceutical innovations, which lasts for 20 years.

In case of violation, apart from compensation for damages in civil proceedings, the Serbian regulations provide for the criminal liability of responsible persons, meaning that criminal charges may be brought against them. The regulations on the protection of industrial property also govern the protection of related data.

12.3 What other incentives are available to encourage innovation in the pharmaceutical and medical device space?

Currently, there are no incentives specific to the pharmaceutical sector. Serbia mostly provides general commercial incentives that do not relate to certain business fields; however, tax breaks – especially in relation to research and development – could be of interest to pharmaceutical companies. Additionally, Serbia's industrial property regulations are mainly aligned with international standards, providing for:

• patent protection for pharmaceutical innovations;
• supplementary protection certificates; and
• protection of inventions under petty patents (ie, utility models).

13. Trends and predictions

13.1 How would you describe the current industry landscape and prevailing trends in your jurisdiction? Are any new developments anticipated in the next 12 months, including any proposed legislative reforms?

Serbia's pharmaceutical industry is experiencing significant growth, driven by increased demand for innovative treatments. Projections suggest a steady annual growth rate of approximately 4.93% between 2025 and 2029. Based on data published by the Medicines and Medical Devices Agency for the last 10 years, the turnover of the pharmaceutical market has doubled. Prescription medications dominate sales, significantly surpassing over-the-counter medicines. Oncology drugs are expected to become the largest segment of the market. The government occasionally includes innovative drugs on the Positive List of the Republic Fund of Health Insurance, although this does not happen nearly as frequently as it should.

In October 2024, the Serbian government adopted the Reform Agenda with the aim of accelerating ongoing reforms as outlined in the EU membership negotiations. This agenda seeks to expedite Serbia's integration into the European Union and will have an impact on the pharmaceutical industry – notably through anticipated regulatory reforms aimed at harmonisation with EU standards.

Finally, Serbia is investing in positioning itself as a research and development hub (R&D) in Europe by:

• establishing multiple science and technology parks – most notably BIO4 Campus Belgrade for biotechnology research and development; and
• partnering with many pharmaceutical companies.

14. Tips and traps

14.1 What are your top tips for pharmaceutical and medical device manufacturers seeking to operate in your jurisdiction and what potential sticking points would you highlight?

While Serbia, as a fairly small market, offers opportunities in the pharmaceutical and medical device sectors, businesses must be prepared to deal with:

• regulatory complexity;
• local market nuances; and
• the potential challenges of working in a developing healthcare system.

To succeed, it is crucial to:

• establish a strong local presence;
• understand the regulatory landscape; and
• navigate the public procurement system.

The government has been investing in the healthcare system, including through the procurement of innovative and orphan drugs; however, research shows that the most expensive medicines are seldom used in Serbia compared to countries with good pharmacotherapeutic practices. The most expensive medicines are those used for specific and rare indications, and large amounts of money are not allocated for them, as they are for some cheaper but more frequently prescribed medicines.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.