Pharmaceutical & Medical Devices 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 domestic legislative acts are the Medicinal Products in Human Medicine Act (MPHMA) and the Medical Devices Act (MDA), which govern pharmaceuticals and medical devices respectively.

The Act on Control of Narcotic Substances and Precursors governs medicinal products containing narcotic substances.

The Health Act and the Health Insurance Act regulate certain aspects of public funding of pharmaceuticals and medical devices; while the Public Procurement Act governs the applicable public procurement procedures regarding public expenditure for such products.

In addition to the MPHMA and the MDA, numerous ordinances and regulations also govern pharmaceuticals and medical devices, in relation to matters such as:

• price regulation;
• product registration; and
• advertising.

EU law governing pharmaceuticals and medical devices also applies.

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

The main bodies responsible for enforcing the applicable laws and regulations are:

• the Ministry of Health;
• the Bulgarian Drug Agency (BDA);
• the National Health Insurance Fund (NHIF);
• the National Pricing and Reimbursing Council; and
• the Transparency Committee.

The Ministry of Health's main powers are:

• legislative (drafting bills and adopting secondary legislation); and
• financial (organising public tenders).

The BDA's main powers include:

• issuing:
• • manufacturing, wholesale and retail permits;
  • market authorisations;
  • permits with respect to parallel imports; and
  • clinical trial permits;
• monitoring pharmaceutical advertising; and
• exercising control over and sanctioning manufacturers, wholesalers and retailers.

The NHIF's main functions are financial and relate to the reimbursement of pharmaceuticals and medical devices to insured persons.

The National Pricing and Reimbursement Council's powers relate to the registration and regulation of prices of medicinal products; its resolutions can be appealed before the Transparency Committee.

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

These bodies mainly focus on:

• compliance with domestic and EU law;
• product quality;
• safety and efficiency; and
• lawful and transparent public tenders.

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?

Pharmaceuticals: Industry codes apply to the respective organisations' members – for example:

• the European Federation of Pharmaceutical Industries and Associations Code of Practice; and
• the Association of the Research-Based Pharmaceutical Manufacturers in Bulgaria Consolidated Code of Ethics.

Medical devices: No such industry codes of conduct exist.

2. Manufacturing permit

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

Pharmaceuticals: A permit is required to manufacture:

• all sorts of medicinal products under the Medicinal Products in Human Medicine Act; and
• medicinal products intended for clinical trials within the territory of Bulgaria.

The requirement applies even if the products are intended for export only.

A manufacturing permit is also required for persons that simultaneously or separately carry out full or partial manufacturing, or various processes of portioning, packaging, repackaging, labelling, quality control and release, of batches of medicinal products and medicinal products intended for clinical trials.

As an exemption, no manufacturing permit is required where the processes of portioning, mixing or packaging are performed under magistral or pharmacopeial prescription in a pharmacy.

Medical devices: There is no 'permit' per se, but a registration/notification obligation with the Bulgarian Drug Agency (BDA) applies.

Persons that place on the market Class I medical devices or custom-made active implantable medical devices should apply for registration with the BDA no later than 14 days after the product is placed on the market and/or put into operation in the territory of Bulgaria.

A permit for conformity assessment of medical devices, including assessment of clinical data, is issued to a natural or legal person registered under the Commerce Act by the executive director of the BDA.

The BDA is competent to issue permits for wholesale trade in medical devices.

2.2 What are the key features of such permits?

Pharmaceuticals

Medical devices

Manufacturing activities and pharmaceutical forms, and medicinal products intended for clinical trials. The premises where the manufacturing, control and storage will be carried out. The qualified person (responsible for certifying the release of each batch of pharmaceuticals as compliant with the marketing authorisation). The managers of production and quality control of medicinal products in manufacturing enterprises.

N/A

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

Pharmaceuticals	Medical devices
A standard form application must be submitted by the applicant to the BDA, accompanied by the following documents: higher education diplomas, medical specialisation documents, employment records and employment contracts between the applicant and the qualified person and the managers of production and quality control; copies of outsourcing contracts, if any manufacturing and/or control stages are outsourced to another facility in Bulgaria or abroad; commercial registration data/certificate of good standing of foreign entities; the manufacturing activities to be carried out and the pharmaceutical forms to be manufactured; schemes of manufacturing, control and storage premises and a dossier of the manufacturing facility; an environmental impact assessment (if applicable); a permit from the Nuclear Regulation Agency (if the application refers to the manufacture of radiopharmaceuticals or pharmaceuticals exposed to ionising radiation during their manufacture); and a state fee payment slip.	N/A
In addition, the requirements of the Act on Control of Narcotic Substances and Precursors apply to the manufacture of narcotic substances and pharmaceutical forms which contain such substances.
The applicant (natural person or legal entity) must be registered as a merchant under the jurisdiction of an EU member state.	N/A

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

Pharmaceuticals: The permitting process involves the submission of a standard form application accompanied by certain documents, as outlined in question 2.3.

The BDA will review the application and documentation and perform in-situ checks of the manufacturing, control and storage premises. If documentary insufficiencies and/or factual discrepancies are identified during this process, the applicant will be instructed in writing to correct them. In this case, the 60-day term is suspended until the instructions are fulfilled.

Within 60 days of the application's submission, the executive director of the BDA will either issue a manufacturing permit or reject the application. (The 60-day period is stayed until the fulfilment of any written instructions issued by the BDA.)

The BDA's rejection of the application is subject to court appeal.

The state fee for review of the manufacturing application is between €2,500 and €10,000, depending on the type of product. If more than one type of manufacturing is permitted simultaneously, the applicable fees are deducted by 25%.

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

The permit holder is entitled to manufacture the pharmaceutical forms as set forth in the permit.

The permit holder must notify the BDA upon the commencement of manufacturing of each new medicinal product with market authorisation.

The permit holder must ensure that it has hired personnel with appropriate qualification (depending on the specifics of the manufactured pharmaceuticals and pharmaceutical forms). At any time:

• there should be at least one qualified person; and
• the premises for the manufacturing, control and storage of pharmaceuticals should be equipped with the necessary technical equipment and control laboratories.

The executive director of the BDA may cancel a manufacturing permit if:

• any of the above requirements is not satisfied; or
• good manufacturing practice requirements are not observed.

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

The validity of a pharmaceuticals manufacturing permit is not limited by term.

Variations are possible and required by law upon a change to any of the following:

• the qualified person;
• the managers of production and quality control;
• the location of the manufacturing, control or storage premises, or their reconstruction;
• the manufacturing activities;
• the manufactured pharmaceutical forms; or
• commercial registration.

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

Pharmaceuticals: A pharmaceutical manufacturing permit cannot be transferred.

Medical devices: As there is no formal manufacturing permit for medical devices, the concept of transferring a permit does not directly apply. However, the transfer of manufacturing operations involves:

• a change of legal manufacturer (eg, due to acquisition or outsourcing);
• re-registration/notification to the BDA under the new manufacturer's name;
• submission of an update to the European Database on Medical Devices (for EU visibility and compliance); and
• amendment of the CE certificate, if a notified body is involved.

3. Clinical trials

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

(a) Pharmaceuticals

Clinical trials for pharmaceuticals in Bulgaria are governed by:

• the EU Clinical Trials Regulation (CTR) (536/2014);
• the Medicinal Products in Human Medicine Act (MPHMA);
• Ordinance N-1 of 25 May 2022 on the terms and order for submission of data and information to the EU Portal under Article 80 and for access to the EU Database under Article 81 of the CTR; and
• Ordinance 31 dated 12 August 2007 setting out rules on good clinical practice.

(b) Medical devices

Clinical trials for medical devices in Bulgaria are governed by:

• the EU Medical Devices Regulation;
• the Medical Devices Act (MDA);
• the Ordinance on the essential requirements and procedures for conformity assessment with the essential requirements of medical devices under Article 2(1) 3 of the MDA, adopted by the Council of Ministers through Decree 186/2007; and
• Ordinance 10/2008 on the documentation submitted by the main/coordinating investigator or the contracting authority to obtain an opinion from the relevant ethics committee and on the procedure for monitoring the safety of medical devices in the course of the clinical trial and the evaluation of clinical data from the trial.

The following instruments apply to clinical trials for both pharmaceuticals and medical devices:

• the General Data Protection Regulation;
• the Healthcare Establishments Act;
• the Health Act; and
• the Regulation on the Terms and Conditions of Operation of the Ethics Commission for Clinical Trials under the MPHMA.

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

A clinical trial may be conducted in Bulgaria only if:

• the rights, safety, dignity and wellbeing of subjects are protected and prevail over all other interests; and
• the trial is designed to generate reliable and robust data.

A clinical trial may be conducted only where all conditions of the CTR/MDA are met:

• The anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored.
• The subjects or, where a subject is unable to give informed consent, their legally designated representative have been informed in the way prescribed by law.
• The subjects or, where a subject is unable to give informed consent, their legally designated representative has given informed consent compliant with applicable legal requirements.
• The rights of the subjects to physical and mental integrity, to privacy and to the protection of the data concerning them are safeguarded.
• The clinical trial has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the protocol and constantly monitored.
• The medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner.
• The subject or, where the subject is unable to give informed consent, their legally designated representative has been provided with the contact details of an entity where further information can be received in case of need.
• No undue influence, including that of a financial nature, is exerted on subjects to participate in the clinical trial.

The scientific research making use of the data outside the protocol of the clinical trial must be conducted in accordance with the applicable law on data protection.

Consent and information requirements are discussed in question 3.3.

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

The following principles apply to consent for participation in clinical trials for pharmaceuticals or medical devices:

• Only a person who has given their written informed consent may participate in a clinical trial.
• Meaningful and understandable information on the trial and the potential risks and benefits must be provided personally to the participant before they give their consent (or consent is given for them).
• Consent can be withdrawn at any time without:
• • any detriment to the participant; or
  • any need for justification.
• The explicit wish of a legally incapacitated person/underage person to refuse participation or to withdraw at any time from the clinical trial should be considered by the investigator and, if necessary, by the principal investigator.
• Only a legally capable person who understands the nature, significance, scope and potential risks of the clinical trial can give informed consent.
• With respect to legally incapacitated persons over the age of 18, consent is given by their legal representative or by a court-appointed representative (if compulsory treatment was ordered by the court).
• Consent for participation of persons between the age of 14 and 18 must be given by them personally and by both parents/guardians.
• Consent for participation of persons under the age of 14 must be given by both parents/guardians, who are legally obliged to represent the presumed will of the participant to participate in the trial.

The detailed requirements on informed consent of Chapter V of the CTR and Chapter IV of the MPHMA apply to clinical trials for pharmaceuticals; while the requirements on informed consent for participation in clinical trials for medical devices are governed by the MDA.

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

The CTR and the EU Medical Devices Regulation govern clinical trial reporting requirements.

Under the CTR, sponsors must report:

• suspected unexpected serious adverse reactions;
• unexpected events;
• urgent safety measures;
• serious breaches; and
• annual safety reports.

Under the EU Medical Devices Regulation, sponsors must report:

• serious adverse events;
• device deficiencies that might have led to a serious adverse event; and
• new findings in relation to any of the above.

3.5 What steps does the clinical trial process typically involve?

Duly authorised clinical trials for pharmaceuticals in Bulgaria typically involve four phases:

• Phase I: Evaluation of safety on a limited group of healthy volunteers.
• Phase II: Investigation of safety and effectiveness of the investigated product as a potential therapy on a limited group of patients.
• Phase III: Effectiveness of the investigated product compared to available pharmaceuticals on a larger group of patients.
• Phase IV: Post-marketing studies.

3.6 How are clinical trials monitored in your jurisdiction?

Clinical trials conducted in Bulgaria are monitored by the experts and inspectors of the Bulgarian Drug Agency.

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

The International Council for Harmonisation guidelines on good clinical practice referred to in the CTR apply.

The World Medical Association Declaration of Helsinki's principles are relevant to medical device clinical trials.

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?

(a) Pharmaceuticals

Marketing authorisations for pharmaceuticals are issued under a centralised, mutual recognition/decentralised or national procedure pursuant to the Medicinal Products in Human Medicine Act (MPHMA) or EU Regulation 726/2004 (as applicable).

Under the national procedure, the applicant submits to the Bulgarian Drug Agency (BDA) a standard form application accompanied by a dossier, containing, among other things:

• data on the pharmaceutical (eg, composition, international non-proprietary name, dosage, form, therapeutic indications, contraindications, adverse reactions);
• the results from pharmaceutical and pre-clinical tests and clinical trials;
• a summary of the pharmacovigilance system;
• a summary of product characteristics;
• a description of manufacturing and control methods; and
• a mock-up of primary and secondary packaging.

Specific domestic regulations apply to the mutual recognition and decentralised procedures.

With respect to homeopathic and traditional herbal pharmaceuticals, only a certificate for registration is issued.

Тhe marketing authorisation/registration certificate holder must be established in an EU member state and non-Bulgarian holders must appoint local authorised representatives.

Medical devices: In Bulgaria (and across the European Union), medical devices do not require a national marketing authorisation in the same way as pharmaceuticals. Instead, they are placed on the market based on CE marking in accordance with the EU Medical Device Regulation. Medical devices must undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The CE mark signifies that the device meets EU safety, performance and quality standards. The entity responsible for the CE marking is the legal manufacturer.

An authorised representative located in the European Union is required for manufacturers based outside the European Union to place their devices on the EU market.

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

The BDA will review the pharmaceutical's dossier for completeness and prima facie compliance within 15 days of submission:

• If there are discrepancies, the applicant will be instructed to rectify them with 14 days; where the applicant fails to do so, the BDA will return the application as invalid and reimburse 75% of the prepaid state fee.
• If no discrepancies are identified (or if any discrepancies are duly rectified), the applicant will be notified of the commencement date of the marketing authorisation issuance procedure (to be completed within 210 days).
• When assessing the documentation, the BDA may, among other things:
• • test the finished or intermediate product or the starting materials; and
  • perform documentary or in-site checks for compliance of third-country manufacturers' manufacturing and/or control methods with the dossier descriptions.
• Within 200 days of receiving valid documentation, the BDA will:
• • assess the pharmaceutical's quality, safety and efficiency; and
  • compose an assessment report with comments on:
  • • pharmaceutical and pre-clinical tests results;
    • clinical trials;
    • risk management; and
    • pharmacovigilance systems.
• The BDA may require additional information or clarification of identified insufficiencies and discrepancies from the applicant within 180 days of notification. The 210-day term is suspended until fulfilment of the instructions; if they remain unfulfilled by the deadline, the marketing authorisation procedure will be terminated.
• Within 10 days of completion of the assessment report, the BDA's executive director will issue a marketing authorisation or reject the application. The rejection is subject to court appeal.

State fees are due for the submission of application and in-site checks.

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

The main obligations relate to pharmacovigilance – the marketing authorisation holder (MAH) must:

• have a pharmacovigilance system in place; and
• designate a qualified person.

Compliance is monitored and sanctioned by the BDA.

As an example, where the MAH infringes an obligation related to pharmaceutical safety indicators set forth in the MPHMA or Delegated Regulation (EU) 2016/161, a monetary sanction of approximately €2,500 to €5,000 is imposed. In case of repeated infringement, the sanction ranges from €12,500 to €25,000.

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

The marketing authorisation for pharmaceuticals is valid for an initial period of five years.

The marketing authorisation can be renewed upon application by the MAH submitted no later than nine months prior to the expiry of the initial validity.

The marketing authorisation may be renewed by the BDA on the basis of a benefit/risk assessment. The BDA's rejection of the renewal application is subject to court review.

After its renewal, the marketing authorisation becomes unlimited by term. As an exception, for product safety reasons, the BDA may request the MAH to apply for renewal for another five years.

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

Pharmaceuticals: The marketing authorisation can be transferred to another legal entity or to associations based in another EU member state. The process entails the submission of a standard form application accompanied by documents specified in secondary legislation.

The BDA will review the application within 30 days of submission and issue a transfer permit. Any documentation discrepancies identified by the BDA during the review will be corrected by the MAH within a further 30 days (the main 30-day term is stayed).

The new MAH fully undertakes the rights and obligations of the previous MAH as of the date indicated in the transfer permit. The transfer of the marketing authorisation does not alter its term.

Medical devices: What can be transferred is the legal manufacturer's responsibility, typically through:

• acquisition or assignment of the technical documentation and CE certificate;
• notification of the BDA of changes (if the manufacturer is changing or if the authorised representative changes); and
• updating of the registration in the European Database on Medical Devices, if applicable.

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

Under Bulgarian law, a "product whose active substance is a biological substance" is a biological medicinal product. This group includes:

• immunological medicinal products and medicinal products derived from human blood or human plasma;
• products under Item 1 of the annex to EU Regulation 726/2004 (ie, developed by recombinant DNA technology; controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes, including transformed mammalian cells, or hybridoma and monoclonal antibody methods); and
• modern therapy products included in secondary legislation.

Biosimilars are products which cannot be determined as generic to a reference biological product but are highly similar to it.

(b) Controlled substances

The Act on Control of Narcotic Substances and Precursors Narcotic substances and precursors and secondary legislation regulate controlled substances.

Bulgarian law divides controlled substances into three categories:

• List 1: High-risk plants and substances prohibited in human and veterinary medicine.
• List 2: High-risk substances applicable in human and veterinary medicine.
• List 3: Risk substances.

All stages of the distribution chain are regulated.

The production, processing, storage and wholesale trade in Bulgaria, retail, import, export and transit, carriage and transport of narcotic substances and medicinal products containing narcotic substances from Lists 2 and 3 must be carried out with a licence for activities, buildings and premises issued by the Ministry of Health.

A licence may be issued only to an individual or entity which holds a manufacturing or wholesaling permit or, respectively, a retailing permit (pharmacy) under the Medicinal Products in Human Medicine Act (MPHMA).

Pharmaceuticals containing narcotic substances cannot be advertised to the public and samples of such products may not be distributed.

(c) Orphan drugs

The MPHMA defines a 'medicinal product intended for the treatment, prevention and diagnosis of rare diseases' as:

The criteria on orphan drugs set out in EU Regulation 141/2000 apply. Marketing authorisations are issued under the procedures set out in EU Regulation 726/2004.

(d) Paediatric medicines

EU Regulation 1901/2006 on medicinal products for paediatric use and amending EEC Regulation 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and EC Regulation 726/2004 applies.

(e) Traditional and complementary medicines

Under Bulgarian law, traditional plant medicines and homeopathic products may only be over-the-counter medicines. Among other requirements, they can be registered only if they are intended:

• for oral or external administration; or
• in the case of traditional plant medicines, for inhalation.

No specific therapeutic indications can be presented on the product's packaging or otherwise.

Traditional plant medicine may be registered if scientific data demonstrates that it or an equivalent product has no less than a 30-year use in world healthcare practice, of which at least 15 years is in the territory of an EU member state.

A registration certificate is issued under a simplified procedure of the MPHMA.

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?

(a) Pharmaceuticals

Pharmaceuticals packaging consists of:

• primary and/or secondary packaging; and
• the patient leaflet.

All information provided on the packaging and the leaflet must fully comply with the summary of product characteristics approved by the Bulgarian Drug Agency (BDA) upon issuance of the marketing authorisation.

Where various language versions of the information are provided:

• one of them must be Bulgarian; and
• the contents of all language versions must be identical.

The pharmaceutical's name must be written in Bulgarian.

The information on the packaging and in the leaflets must be understandable to the patient, legible and indelible.

Further regulations on packaging and leaflets are set forth in secondary legislation.

Medical devices: Pursuant to the Medical Devices Act, the manufacturer must pack and label the medical device in conformity with the legal requirements set forth in the secondary legislation.

The EU Medical Device Regulation prohibits labelling that uses text which may mislead users regarding the intended purpose, safety or performance of a device. Specifically, it forbids:

• ascribing functions and properties to the device which it does not have;
• creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
• failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; or
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

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

Pharmaceuticals: Compliance is monitored by the BDA.

The following constitute administrative infringements:

• the sale of pharmaceuticals in packaging or with leaflets which do not comply with the Medicinal Products in Human Medicine Act;
• the sale of pharmaceuticals without any leaflet; and
• the sale of pharmaceuticals with damaged primary/secondary packaging.

These are punishable with monetary sanctions ranging:

• between approximately €1,125 and €2,250; and
• in case of the repeated commission of the same infringement, between approximately €2,250 and €4,500.

Medical devices: If competent employees of the BDA establish that a medical device has been placed on the market and/or put into operation without instructions for use and/or without a label, that the content of the label does not comply with the requirements of the regulations on the application of the law, or that the name and address of the manufacturer or its authorised representative and importer are not affixed on the device, they will issue a prescription to the manufacturer or its authorised representative with a deadline to remedy the established violation.

If the violation is not remedied within the specified period, the inspectors will prepare an opinion for the executive director of the BDA with a proposal for issuing an order for blocking and withdrawing the device from the market. The penalties may vary:

• from €500 to €1,500; and
• in case of repeated commission of the same violation, from €1,500 to €2,500.

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

Bulgaria is a member of the World Health Organization (WHO). The WHO's guidelines on packaging and labelling of both pharmaceuticals and medical devices should be followed as best practices.

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:

1. The type of product?
2. The target (ie, healthcare professionals or consumers)?
3. Whether the activity takes place online or offline?

(a) Pharmaceuticals

Only pharmaceuticals with marketing authorisation may be advertised.

Advertising must:

• comply with the summary of product characteristics; and
• present only the indications specified upon market authorisation.

Advertising may not contain an offer/promise of gift and/or another monetary or non-monetary benefit.

A healthcare professional or a person posing as a healthcare professional may not directly or indirectly advertise medicinal products in print and/or electronic media or online.

The advertising of prescription pharmaceuticals to the public is prohibited. As an exception, marketing authorisation holders (MAHs) may implement offline and/or online advertising campaigns on vaccination, after the Bulgarian Drug Agency (BDA) has approved the advertising materials.

Only over-the-counter products may be advertised to the public offline and/or online following the BDA's approval of the advertising materials.

Medical representatives may not provide product samples directly to the public.

In order to obtain the BDA's approval, the MAH or its authorised representative must submit the proposed ad and the scientific source of used citations, tables and other materials (if any), accompanied by relevant auxiliary documents. The term for review and approval or explicit rejection of the advertising materials is one month after submission. The BDA's failure to respond within this timeframe is deemed to constitute tacit approval of the advertising materials. The BDA's explicit refusal is subject to court review.

Advertising to healthcare professionals: Advertising intended for healthcare professionals may be disseminated after its notification to the BDA.

The information provided to healthcare professionals must at all times correspond to the data in the product's summary of product characteristics. Ads may contain:

• the product's price; and
• conditions for full or partial reimbursement by the National Health Insurance Fund.

No data from unpublished research or with no proven clinical significance can be presented.

Advertising materials for healthcare professionals may not be made available in places accessible by patients.

MAHs must ensure that online advertising for healthcare professionals is accessible exclusively by healthcare professionals.

Medical sales representatives may, as an exception, provide free samples to healthcare professionals authorised to prescribe pharmaceuticals. The following restrictions apply:

• No more than two samples of the same dosage form may be provided in one calendar year;
• Each sample must not be larger than the smallest package authorised for use; and
  Each sample must bear the inscription: "Free sample – not for sale."

MAHs must maintain a sample reporting and control system. The BDA may require data from this system.

Healthcare professionals who prescribe pharmaceuticals may not request or accept any financial or other benefits from:

• manufacturers;
• MAHs;
• holders of registration certificates;
• medical sales representatives; or
• medicinal product traders.

Sponsors or organisers of promotional meetings, scientific congresses, symposiums or other scientific events may cover the travel expenses, accommodation and registration fees of healthcare professionals. Such expenses must be strictly limited:

• to the professional and scientific purposes of the event; and
• to persons who are medical professionals.

Coverage of such expenses is prohibited for:

• persons holding public office;
• members of the National Pricing and Reimbursement Council;
• members of the Transparency Commission; and
• members of the High Council of Pharmacy.

(b) Medical devices

No specific requirements are set out in the Medical Devices Act.

General provisions of the Competition Protection Act and the Consumer Protection Act apply with respect to the advertising of medical devices. The Competition Protection Act ensures that advertising practices do not distort market competition. The Consumer Protection Act protects consumers from misleading ads.

Article 7 of the EU Medical Device Regulation (2017/745) is directly applicable. It is prohibited to use in advertising text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

• ascribing functions and properties to the device which it does not have;
• creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
• failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; or
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

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?

In Bulgaria, several legal and ethical safeguards are in place to prevent inducements from being offered to healthcare professionals to promote specific pharmaceuticals or medical devices. These measures aim to ensure that medical decisions are based on patient welfare and scientific evidence rather than commercial incentives.

The Medicinal Products in Human Medicine Act prohibits offering material or non-material benefits to healthcare professionals that could influence their prescribing behaviour. The advertising of medicinal products to healthcare professionals requires prior notification of the BDA, including submission of the advertising materials for review. Sanctions for violations include fines ranging from approximately €5,000 to €10,000, applicable to both advertisers and publishers.

While Bulgaria lacks specific national regulations on medical device advertising, it adheres to the EU Medical Device Regulation, which prohibits misleading advertising of medical devices.

The Code of Professional Ethics for Physicians explicitly forbids physicians from entering agreements with pharmaceutical companies that could result in material or other benefits in exchange for prescribing specific medications or consumables.

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

The off-label use – that is, use not approved by the relevant regulatory authorities – of pharmaceuticals cannot be advertised/promoted. Off-label treatment is provided to patients on a case-by-case basis, subject to detailed legislation.

The promotion of medical devices for off-label use is generally prohibited. Manufacturers and distributors must ensure that all promotional activities align with the approved indications of the device. Bulgaria adheres to the EU Medical Device Regulation, which prohibits misleading advertising and mandates that promotional materials must not promote uses beyond the device's intended purpose.

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

Pharmaceuticals: Compliance is monitored and sanctioned by the BDA.

Breaches of the provisions on the advertising of pharmaceuticals are sanctionable with fines and monetary sanctions, ranging from:

• €5,000 to €15,000 for individuals; and
• €15,000 to €30,000 for legal entities.

Persons that allow the broadcasting, publishing and distribution of advertising in breach of the law will be subject to the same sanctions.

Healthcare professionals or persons posing as healthcare professionals who directly or indirectly advertise pharmaceuticals in print/electronic media or online can be fined between €500 and €5,000.

The quantum of the sanctions will be based on the gravity of the committed breach.

Where competition rules are affected, the Commission on Protection of Competition may impose fines.

Medical devices: While there is no specialised authority overseeing medical device advertising, general regulatory bodies such as the BDA, the CPC and the Consumer Protection Commission monitor compliance:

• The Consumer Protection Commission can impose fines of up to €7,500 for violations related to unfair commercial practices, including misleading advertising.
• The CPC can:
• • impose fines of up to 10% of the infringer's total Bulgarian turnover for the financial year preceding the violation;
  • order the suspension of the misleading ad; and
  • require the offender to publish the decision at its own expense.

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

In Bulgaria, beyond strict legal compliance, best practices for the advertising and promotion of pharmaceuticals and medical devices are guided by:

• ethical standards;
• transparency; and
• industry self-regulation.

These practices aim to preserve the integrity of healthcare and public trust.

With respect to pharmaceuticals:

• compliance with the Association of the Research-Based Pharmaceutical Manufacturers in Bulgaria Consolidated Code of Ethics requires that all promotional activities be accurate, balanced and not misleading; and
• all transfers of value to healthcare professionals and organisations must be disclosed in line with the European Federation of Pharmaceutical Industries and Associations Disclosure Code.

With respect to medical devices:

• the promotion should be strictly within the scope of their CE-marked indications and intended use; and
• off-label promotion or unsubstantiated claims should be avoided pursuant to the EU Medical Device Regulation.

The MedTech Europe Code of Ethical Business Practice provides guidance on interactions with healthcare professionals, including on:

• transparency of sponsorship and grants; and
• non-direct sponsorship of individual healthcare professionals for third-party conferences.

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?

(a) Pharmaceuticals

The Bulgarian Drug Agency (BDA) organises and maintains a pharmacovigilance monitoring system. All reports of suspected adverse drug reactions occurring in the territory of Bulgaria from healthcare professionals and patients are registered in this system.

The marketing authorisation holder (MAH) must:

• have a pharmacovigilance system in place; and
• designate a qualified person responsible for pharmacovigilance.

All reports of suspected adverse reactions observed in the European Union or in third countries reported to the MAH spontaneously by healthcare professionals or by patients or arising in the process of post-marketing studies must be documented.

The MAH and, respectively, the BDA must notify any severe suspected adverse reactions to EudraVigilance within 15 days of receiving the report. Other suspected adverse reactions must be notified within 90 days.

(b) Medical devices

The manufacturer must:

• establish and maintain a documented system for monitoring the safety of the medical devices that it has manufactured, placed on the market and/or put into service in:
• • EU member states;
  • European Economic Area countries; and
  • third countries; and
• be able to implement the necessary corrective actions.

The manufacturer must notify the BDA of:

• any malfunction or deterioration of the characteristics of a device and/or of its performance, as well as of incomplete or inaccurate information on the label or in the instructions for use, which caused or could cause death or serious injury to a patient, medical professional or third party in Bulgaria; and
• any technical or medical reason related to the characteristics or performance of the device which for the same reasons leads to a systematic market recall of devices of the same type.

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

Pharmaceuticals: The BDA will block the pharmaceutical through an order which has mandatory application for all of the following in Bulgaria:

• MAHs/registration certificate holders;
• parallel import holders;
• manufacturers;
• importers;
• wholesalers;
• pharmacies;
• drugstores; and
• medical and health establishments.

Upon receiving the blocking order:

• all persons must immediately discontinue the sales and dispensing of the blocked pharmaceutical/batch indicated in the order; and
• the manufacturer, importer or wholesaler must:
• • immediately discontinue the sale of the available quantities; and
  • within 24 hours:
  • • instruct in writing all persons to which it has delivered quantities of the product/batch of the discontinuation of sales and use; and
    • inform the BDA of the measures taken and of all persons to which it has delivered the product/batch and the number of supplied packages.

Pharmacy managers must immediately inform patients to whom they have dispensed quantities of the blocked pharmaceutical.

Within 30 business days of the blocking order, and on the basis of performed checks/laboratory testing to confirm the level of risk and benefit/risk assessment, the BDA will instruct the MAH/registration certificate holder or the parallel import holder of the release or recall of the blocked product/batch. A recall must be completed by the MAH/parallel import permit holder within another 30 business days.

Medical devices: The manufacturer must:

• submit an initial report to the BDA:
• • within 10 days of receipt of information of an event which leads to death or serious injury ('incident'); or
  • within 30 days if the event could have led to death or serious injury which was prevented by chance or medical intervention ('potential incident');
• immediately inform its authorised representative, wholesaler and the notified body of an incident/potential incident; and
• submit a final report with corrective measures (eg, device/batch of devices recall) within three months of submission of the initial report.

The BDA's executive director will order the blocking and recall of the device/batch of devices if the manufacturer did not perform corrective measures or recall the device/batch of devices by the deadline specified therefor in the final report.

The terms and procedure for the blocking, recall and/or destruction of devices are regulated in secondary legislation.

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

Within five working days of completion of a recall, the MAH/registration certificate holder, or the parallel import permit holder, must submit to the BDA and the regional health inspectorate:

• a summary report on its results; and
• a proposal for subsequent measures related to the pharmaceutical.

The BDA publishes on its website a list of medical devices included in blocking and recall orders. The executive director of the BDA will prepare a report of the incident/potential incident and send a copy to the European Commission and to member state regulators.

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

EU legislation and guidelines on good manufacturing practice and good distribution practice with respect to pharmaceuticals apply in Bulgaria and must be observed by stakeholders.

EU guidance documents on medical devices assist stakeholders in implementing the medical devices regulations.

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

The Medicinal Products in Human Medicine Act (MPHMA) and the Medical Devices Act do not contain special provisions on liability for a defect in a medical product.

The Consumer Protection Act (CPA) regulates the liability of manufacturers, distributors and traders for damage caused by a defect in goods as a special legal act in relation to the general legal regulation of torts in the Obligations and Contracts Act.

Under the CPA, the injured party can seek compensation only for material damages – that is, incurred losses and lost profits. Compensation for non-material damage sustained by the injured person, or respectively their legal heirs in case of death, can be sought under the general legal regulation of torts under the Obligations and Contracts Act.

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

According to Article 130(3) of the CPA, a 'manufacturer' is:

• any person or entity which:
• • by profession produces finished goods, raw materials or components, included in the production of other goods; or
  • is identified as a manufacturer by labelling its name, trademark or another distinctive mark on goods; and
• every person or entity which by profession imports to the territory of the European Union goods for the purpose of selling, lending, leasing or using any other form of distribution of the goods in the territory of the European Union.

A 'distributor' according to Article 130(4) of the CPA is any person or entity, other than a manufacturer, that releases goods into circulation.

A manufacturer or importer in the territory of the European Union will be liable for defective goods. If the manufacturer cannot be identified or, even though it is identified by the distributor, it is located outside the territory of Bulgaria, the distributor will be liable for defective goods under the CPA.

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

This will typically be the directly aggrieved patient, although in certain cases the patient's heirs might bring a claim.

The 'injured party' is defined by the CPA as any individual who has suffered material damages from defective goods.

Consequently, under the terms of the CPA, only material damages must be compensated – for example:

• expenses for treatment (eg, for hospitalisation, examinations, medicines, follow-up therapy, rehabilitation); and
• lost profits due to being out of work because of the injury.

Compensation for non-material damage sustained by the injured person, or respectively their legal heirs in case of death, can be sought under the general legal regulation of torts under the Obligations and Contracts Act.

A claim is brought through the submission of a statement of claim to the court.

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

Monetary damages stemming from death or bodily injury, or damage or destruction of an item other than the defective product worth not less than €500, where the item is intended primarily for personal use and is used by the injured person for its intended purpose, are compensated under the CPA.

Liability is strict (the manufacturer's fault is irrelevant). Liability cannot be excluded if the product was:

• manufactured in compliance with existing standards or good practices; or
• released into circulation on the grounds of a permit issued by an administrative authority.

The manufacturer is not liable if it can demonstrate the following:

• It never put the product into circulation;
• On the balance of probabilities, it is possible that the defect did not exist when the product was placed into circulation or appeared afterwards;
• It did not manufacture the product for sale or another form of commercial distribution and did not manufacture or distribute the product within its professional activities;
• The defect is due to the product's compliance with mandatory requirements determined by state authorities; or
• The state of scientific and technical knowledge at the time that the product was put into circulation did not allow the defect to be identified.

Liability can be excluded or limited if:

• the damage was caused simultaneously by the defective product; and
• the action/omission of the injured party/a person for whom the injured party is liable.

A three-year limitation period from the date on which the claimant knew or had to know about the damage, the defect and identity of the manufacturer applies (but no later than 10 years from the date on which the manufacturer released the product into circulation).

Compensation for non-monetary damages can be sought under the Obligations and Contracts Act. Depending on the case, liability for damages caused by objects or liability of the contracting entity may be sought.

The defendant may rely on the following arguments:

• the five-year limitation period as from identification of the liable party;
• the absence of causality; or
• that the damage was due entirely to the behaviour of a third party.

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

The typical remedy is monetary compensation for:

• monetary damages (eg, for treatment, loss of income), which are adjudicated to the amount proven by the claimant; and
• non-monetary damages (eg, physical or psychological discomfort, pain, fear), which are adjudicated by the court ex aequo et bono.

The Bulgarian legal system does not recognise punitive damages.

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:

1. The type of product?
2. The target (ie, healthcare professionals or consumers)?
3. Whether the activity takes place online or offline?

(a) Pharmaceuticals

Pharmaceuticals may be sold on a retail basis only in pharmacies and drugstores.

As an exception, in settlements without pharmacies, physicians and dentists holding the required permit may store and sell pharmaceuticals.

Prescription pharmaceuticals may be sold only in pharmacies and only offline.

Over-the-counter (OTC) pharmaceuticals may be sold in both pharmacies and drugstores; they can be sold online if the pharmacy or drugstore holds a permit for online sales.

Only OTC product types that are explicitly enumerated in secondary legislation (eg, antiacids, laxatives, analgesics, antipyretics) can be sold via vending machines; these machines may be owned only by pharmacies or drugstores.

The occasional sale of pharmaceuticals and the return of bought pharmaceuticals are prohibited.

The wholesaling of pharmaceuticals is subject to a permit issued by the Bulgarian Drug Agency (BDA). Manufacturers and importers can wholesale only products included in their manufacturing/import permit. Wholesalers may not retail products.

(b) Medical devices

Medical devices may be retailed by pharmacies or drugstores.

Certain medical devices enumerated in orders issued by the minister of health (ranging from orthopaedic shoes to toothpaste) may also be sold in other commercial establishments.

The wholesale of medical devices is subject to a permit issued by the BDA. Manufacturers based in Bulgaria can wholesale only devices included in their manufacturing permit.

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

The BDA and the regional health inspectorates monitor compliance. Monetary sanctions may be imposed in the event of breaches. As set forth in the applicable legislation, in certain cases the breaching entity's permit may be cancelled.

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

Please see question 7.5.

10. Price regulation

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

(a) Pharmaceuticals

The prices of pharmaceuticals are regulated by primary and secondary domestic legislation. The National Pricing and Reimbursement Council:

• regulates the prices of prescription pharmaceuticals included in the Positive Drug List and paid with public funding, in compliance with the lowest reference prices in EU member states;
• regulates the price limits of prescription pharmaceuticals, other than those discussed above, in compliance with the lowest reference prices in EU member states; and
• registers the maximum retail price of over-the-counter products.

Secondary legislation also regulates applicable mark-ups at the wholesale and retail levels.

With respect to medical devices, prices are generally determined by the market; the National Health Insurance Fund sets maximum values up to which it pays for medical devices for insured persons.

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 government buys certain pharmaceuticals and medical devices outside the scope of mandatory health insurance, such as:

• vaccines for mandatory immunisations and re-immunisations;
• vaccines for special indications and in emergency circumstances;
• specific serums, immunoglobulins and other bioproducts related to the prevention of infectious diseases;
• HIV products;
• tuberculosis products;
• products for the treatment of mental and behavioural disorders due to opioid use or addiction syndrome; and
• medical devices (eg, related to transplantations, radiopharmaceuticals, radionuclide generators, kits and radionuclide precursors, which are medical devices and are included in the relevant list under the Medical Devices Act).

Procedures under the Public Procurement Act apply.

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?

Imports: All types of pharmaceuticals and pharmaceuticals intended for clinical trials may be imported only by merchants registered under the legislation of an EU member state who have received an import permit from the Bulgarian Drug Agency (BDA).

The applicant must at all times have at least one qualified person, a quality control laboratory and storage premises equipped with the necessary technical equipment that essentially meet the Medicinal Products in Human Medicine Act's respective requirements regarding manufacturers.

The import authorisation holder must ensure compliance with the requirements of Delegated Regulation (EU) 2016/161 on:

• affixing safety features to the pharmaceutical's packaging; and
• entering each package's individual identification mark in the system of registers.

An import permit has indefinite validity but is issued only for:

• the pharmaceuticals specified in the application;
• their forms of active substances;
• specified pharmaceuticals intended for clinical trials; and
• the premises at which control and storage will be carried out.

Importers may place on the EU market only medical devices that conform with the EU Medical Devices Regulation – that is, CE-marked devices with:

• an EU declaration of conformity;
• an identified manufacturer;
• a designated authorised representative;
• a label that accords with the Medical Devices Regulation and is accompanied by the required instructions for use; and
• where applicable, a unique device identifier assigned by the manufacturer.

The requirements of Article 13 of the Medical Devices Regulation on the importer's identification, storage and transport, vigilance and document retention apply.

Exports: Pharmaceuticals may be exported by the holder of a wholesale or a manufacturing permit. A manufacturing permit holder may export only pharmaceuticals manufactured by it. Intra-community delivery within the European Union is also treated as an export by the Medicinal Products in Human Medicine Act (MPHMA).

Pharmaceuticals included on the Positive Drug List affected by shortages cannot be exported for the period for which they are included on the shortage list.

11.2 Are parallel imports permitted in your jurisdiction?

Pharmaceuticals: Parallel imports of pharmaceuticals in Bulgaria may be carried out by a natural or legal person registered under the Commerce Act, or under the law of an EU member state, after obtaining a parallel import permit from the BDA.

A pharmaceutical authorised for use in another EU member state may be imported in parallel in Bulgaria where it is identical or similar to a pharmaceutical authorised for use in Bulgaria under the MPHMA.

If the importer repackages and/or labels a medicinal product in the territory of Bulgaria, it must hold a manufacturing permit issued by the BDA.

Medical devices: Parallel trade in medical devices that have already been placed on the market is a lawful form of trade within the internal market as per Recital 37 of the EU Medical Devices Regulation, subject to the limitations arising from the need to:

• safeguard health and safety; and
• protect IP rights.

The conditions specified in the EU Medical Devices Regulation – in particular, the requirements for relabelling and repackaging – apply.

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

EU customs legislation (eg, tariff measures) and EU sanctions may apply in certain cases.

12. Protecting and incentivising innovation

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

Pharmaceuticals: To the extent that no IP rights are infringed, an applicant for marketing authorisation need not submit results from pre-clinical tests and clinical trials if it can prove that the product specified in the application is a generic of a reference product that is or was authorised for use in an EU member state not less than eight years ago.

The generic pharmaceutical cannot be placed on the market before 10 years have elapsed since the reference product's authorisation for use. This 10-year period can be extended by up to one year if, during the first eight years from issuance of the marketing authorisation for the reference product, the holder received an authorisation for a new therapeutic indication for the same product whose significant clinical advantages over existing treatment options are scientifically justified.

If the applicant can attest (under conditions set forth in secondary legislation) that the active substance has a well-established use in medical practice, recognised efficacy and an acceptable level of safety, the applicant may provide relevant scientific publications instead of results from pre-clinical tests and clinical trials, provided that no IP rights are infringed.

Medical devices: Bulgarian law does not regulate generic medical devices.

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

Pharmaceuticals: Data on clinical trials and the marketing authorisation process is not made public. The Bulgarian Drug Agency publishes its assessment report with motives for its resolution without such data, which constitutes a trade secret.

The conduct of necessary studies and tests for the purpose of preparing documentation for a marketing authorisation for generics or biosimilars does not constitute infringement of the patent or supplementary protection certificate of the reference product.

Medical devices: Officials and persons who enforce the Medical Devices Act (MDA) and secondary legislation must not disseminate information obtained during and in connection with the performance of their duties.

Confidentiality does not encompass information:

• for the registration of persons that place medical devices on the market under the MDA;
• that is provided to consumers by the manufacturer, its authorised representative or a wholesaler in connection with measures taken under the procedure for the notification and assessment of incidents; or
• that is contained in:
• • issued, modified, supplemented or withdrawn certificates; or
  • certificates whose validity is temporarily suspended.

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

Where the requirements of laws aimed at promoting investment are met, investors may benefit from advantages such as:

• expedited and/or individualised administrative service; and
• various forms of financial support.

The Ministry of Innovation and Growth is the main administration which implements state policy in this field.

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?

The scope of patients eligible to receive a free human papillomavirus (HPV) vaccination was expanded under the government's recent 2025-2030 National HPV Programme. For the first time, boys have been included in the programme; the scope of eligible girls and women has also been expanded. In Bulgaria, the HPV vaccination is voluntary.

The Ministry of Health has prepared a draft bill with national measures for the implementation of the EU Medical Device Regulation and EU Regulation 2017/746 on in vitro diagnostic medical devices. Public consultations have already closed and the next step is the proposal of the bill to Parliament.

Members of Parliament have also proposed bills on:

• the further digitalisation of healthcare processes; and
• the exchange of healthcare information.

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?

• The pharmaceutical sector in Bulgaria is heavily regulated.
• In addition to EU law and domestic legislation, numerous ordinances providing detailed and complicated secondary regulation apply.
• Pharmaceutical pricing is compulsory; limitations on mark-ups at different levels of the supply chain apply.

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.