{"id":5535,"date":"2026-02-16T12:59:43","date_gmt":"2026-02-16T12:59:43","guid":{"rendered":"https:\/\/healthcaremagazine.bg\/mag-pharm-bogdan-kirilov-market-registration-regimes-and-dynamics-in-the-sector\/"},"modified":"2026-05-09T22:02:34","modified_gmt":"2026-05-09T22:02:34","slug":"mag-pharm-bogdan-kirilov-market-registration-regimes-and-dynamics-in-the-sector","status":"publish","type":"post","link":"https:\/\/healthcaremagazine.bg\/en\/mag-pharm-bogdan-kirilov-market-registration-regimes-and-dynamics-in-the-sector\/","title":{"rendered":"Mag.-Pharm. Bogdan Kirilov: Market, Registration Regimes, and Dynamics in the Sector"},"content":{"rendered":"\n

Master Pharmacist Bogdan Kirilov<\/em><\/strong> is among the most recognizable experts in drug policy and regulations in our country. Having graduated in Pharmacy from the Faculty of Pharmacy at MU \u2013 Sofia, and specialized in “Public Health and Health Management” at the Faculty of Public Health, he successfully combines scientific training with management experience. His career in drug regulation began rapidly: from November 2017 to August 2018, he was the Deputy Executive Director of the Bulgarian Drug Agency, and subsequently took the helm of the institution during a period of key changes for the sector. At the European level, Kirilov represents Bulgaria as a member of the Management Board of the European Medicines Agency. In his professional activities, he also maintains a commitment to ethical standards in pharmacy \u2013 in 2016\/2017, he was a member of the Central Ethics Committee of the Bulgarian Pharmaceutical Union.<\/em><\/p>\n\n

How many new companies received marketing or import authorizations during<\/strong> <\/strong>the past year, and in which<\/strong> <\/strong>therapeutic areas is the greatest interest observed?<\/strong><\/p>\n\n

Bogdan Kirilov:<\/strong> The primary activity of the Bulgarian Drug Agency (BDA) involves procedures for the marketing authorization of medicinal products on the territory of the Republic of Bulgaria based on an expert assessment of their quality, safety, and efficacy, the renewal of marketing authorizations, and the respective types of variations to existing marketing authorizations for medicinal products.<\/p>\n\n

In 2024, the BDA received a total of 6,299 applications for marketing authorizations, renewals, and variations via national and international (decentralized, mutual recognition, and repeat-use) procedures, as well as for parallel imports, concerning 9,637 medicinal products. <\/p>\n\n

Of the applications received, 518 were for the issuance of a marketing authorization, 57 for the issuance of a marketing authorization for medicinal products from parallel import, 187 for the renewal of marketing authorizations, and 5,501 applications for variations to the marketing authorizations of 8,933 medicinal products, along with 36 applications for variations to parallel import authorizations.<\/p>\n\n

Compared to the previous two years (2022 and 2023), an increase in the number of submitted applications for the issuance of marketing authorizations (395 \u2013 341 \u2013 518) for medicinal products was established in 2024. The same trend is observed in applications for the issuance of marketing authorizations for medicinal products from parallel import (75 \u2013 33 \u2013 57). <\/p>\n\n

Conversely, how many companies have ceased operations or withdrawn products from the Bulgarian market? Are<\/strong> <\/strong>there large international manufacturers among them, and what are the most common<\/strong> <\/strong>reasons for these decisions?<\/strong><\/p>\n\n

Bogdan Kirilov:<\/strong> In 2024, at the request of the marketing authorization holders, 152 marketing authorizations for medicinal products were terminated. All marketing authorizations for which termination orders were issued were withdrawn from the market for commercial reasons. A comparison of data from 2020 to 2024 shows that the past year had the lowest number of terminated marketing authorizations. <\/p>\n\n

The medicinal products with terminated marketing authorizations belong to various anatomical-therapeutic groups. The motives of pharmaceutical companies to withdraw medicines are primarily of a commercial and economic nature, largely related to the characteristics of the domestic market and the specifics of price regulation. <\/p>\n\n

The excessive number of products containing the same active substance often leads to those with the lowest demand ceasing sales. There are cases where some original products also leave the market due to significantly lower generic prices, which makes them uncompetitive. <\/p>\n\n

In certain cases, it involves the discontinuation of one type of dosage form or the replacement of an administration device with a new, more advanced, and patient-friendly form \u2013 pens for one month of treatment are replaced by pens for two months of treatment; single-use insulin pens are replaced by vials to be used with reusable pens; packs with one number of tablets are replaced by packs with a different number. Due to the introduction of new groups of medicines with a better efficacy and safety profile, older medicines are gradually being phased out. <\/p>\n\n

The EU is introducing a new regulatory framework for<\/strong> <\/strong>monitoring and managing shortages<\/strong> <\/strong>of medicines,<\/strong> <\/strong>including enhanced<\/strong> <\/strong>coordination between national regulators and the EMA. How is the BDA preparing <\/strong> <\/strong>for<\/strong> <\/strong>these changes? Which internal processes will need to be adapted, and which elements of the European <\/strong> <\/strong>framework \u2013 early warning, strategic reserves, shared data, and<\/strong> <\/strong>centralized response mechanisms<\/strong> <\/strong>\u2013 will require the greatest effort from<\/strong> <\/strong>the Bulgarian side?<\/strong><\/p>\n\n

Bogdan Kirilov:<\/strong> Medicine shortages are a public health issue affecting countries in the EU and worldwide. They can be due to numerous reasons, including manufacturing problems leading to delays or interruptions in production, raw material shortages, increased demand and use of certain medicines, and distribution issues. <\/p>\n\n

The specifics of price regulation, as well as the possibilities for parallel export, are also factors that can lead to the absence or shortage of certain medicinal products. <\/p>\n\n

In recent years, this problem has affected more than one EU Member State and is primarily due to the fact that some manufacturers of active substances (in India and China) find it necessary to temporarily reduce or cease production due to problems arising from the restructuring or relocation of the production process.<\/p>\n\n

Thus, to compensate for the resulting shortage, the usual consumption of products from competing manufacturers increases. This, in turn, leads to shortages or even total absences for them as well. Usually, they are not prepared in advance to expand production or do not initially have sufficient capacity to respond to the sudden increase in demand. Over the past 2 years, the European Medicines Agency (EMA) has been actively working with Member States to address critical cases of shortages. <\/p>\n\n

The European Shortages Monitoring Platform (ESMP) is already active, featuring its core functionalities. The launch of the ESMP represents an important step in efforts to tackle medicine shortages and ensure the availability of the most necessary medicines for patients. This will enable centralized automated data collection regarding medicine shortages, thereby providing competent authorities with access to comprehensive real-time information, which will facilitate the prevention, monitoring, and management of this serious problem within the EU and EEA. <\/p>\n\n

The platform was developed by the EMA as part of its extended mandate in accordance with Regulation (EU) 2022\/123, with the aim of facilitating information exchange, leading to more effective prevention, identification, and management of shortages, as well as better communication between the EMA, NCAs, and industry stakeholders to ensure the availability of medicines for patients during public health emergencies and major events.<\/p>\n\n

It is the obligation of marketing authorization holders to plan the quantities delivered to the Bulgarian market, taking into account the current situation in the country regarding the consumption of their products, production cycles, company policy, and their business plan.<\/p>\n\n

The Ministry of Health and the BDA provide maximum assistance to marketing authorization holders (MAHs) in fulfilling their obligation to deliver the necessary quantities for the Bulgarian market. Priority is also given to the assessment of applications for parallel import, as well as those related to the marketing authorization of medicinal products where difficulties in production and supply are observed. <\/p>\n\n

Measures for access to medicinal products that are not distributed on the territory of the country are provided for under the special procedure for the delivery of unauthorized medicinal products or those included in the list under Art. 266a, para. 2 of the LMPHM (Ordinance No. 10\/2011 on the terms and conditions for treatment with medicinal products not authorized for use in the Republic of Bulgaria, medicinal products applied outside the terms of the marketing authorization, and medicinal products for compassionate use, as well as the terms and conditions for inclusion, variations, exclusion, and delivery of medicinal products from the list under Art. 266a, para. 2 of the LMPHM) or via exceptional import.<\/p>\n\n

The online sale and delivery of<\/strong> <\/strong>medicines is a topic of great public<\/strong> <\/strong>interest. Is it possible for<\/strong> <\/strong>a regulation<\/strong> <\/strong>that allows for safe deliveries<\/strong> <\/strong>to compensate for the lack of physical<\/strong> <\/strong>pharmacies in<\/strong> <\/strong>certain areas?<\/strong><\/p>\n\n

Bogdan Kirilov:<\/strong> According to the current regulatory framework, internet trade in medicinal products can be carried out by a person who holds a retail trade authorization for medicinal products in a pharmacy (issued by the BDA) or a registration certificate for a drugstore (issued by the RHI). Only non-prescription medicinal products may be sold over the internet. Given the legal framework, every retailer of medicinal products registered by the BDA to sell non-prescription medicinal products over the internet also possesses a brick-and-mortar facility (pharmacy or drugstore) with the corresponding authorization for it. <\/p>\n\n

Since 2015, a common logo has been introduced in the EU for persons engaged in the retail trade of medicinal products over the internet. The common EU logo identifies legitimate internet retailers of medicinal products and aims to increase citizen awareness of the risk of purchasing medicinal products from illegal sources on the internet. <\/p>\n\n

The activity of selling on the internet is carried out by the registered person through their own website, on which the common logo, recognizable throughout the European Union, is published. The requirements for the common logo are defined by a delegated act of the European Union. <\/p>\n\n

A list of Bulgarian retailers who can engage in internet trade of non-prescription medicinal products, along with the corresponding electronic address of the sales site, is maintained on the BDA website at www.bda.bg. Control over this activity is exercised by the Bulgarian Drug Agency. <\/p>\n\n

Upon detecting advertisements for the sale of medicinal products outside registered online sites, the BDA works in coordination with various structures of the Ministry of Interior to track IP addresses, take down advertisements, and shut down sites, to identify and locate the persons carrying out this activity, as well as in cooperation with the Customs Agency for the physical tracking of deliveries, as it does not have independent competence to perform these activities. The LMPHM does not regulate the internet sale of medicinal products outside the legal framework mentioned above. <\/p>\n\n

Unregulated internet trade primarily concerns medicinal products not authorized for use in the country with packaging and leaflets in a foreign language, often of unclear origin or counterfeit medicinal products. These medicinal products do not have guaranteed quality, efficacy, and safety regarding both their production and their storage method, which is why they pose a serious risk to the life and health of citizens. <\/p>\n\n

What are the main risks associated<\/strong> <\/strong>with the unregulated online market, and<\/strong> <\/strong>what does the BDA’s monitoring<\/strong> <\/strong>show<\/strong> <\/strong>regarding sites that offer medicines without authorization?<\/strong><\/p>\n\n

Bogdan Kirilov:<\/strong> In September 2025, the EMA and the Heads of Medicines Agencies (HMA) warned the public about the growing threat of illegal medicines advertised and sold online in the European Union (EU).<\/p>\n\n

In recent months, there has been a sharp increase in the number of illegal medicines sold as GLP-1 receptor agonists, such as semaglutide, liraglutide, and tirzepatide, for weight loss and diabetes. These products, often sold through fraudulent websites and promoted on social media, are not authorized for use and do not meet the necessary standards for quality, safety, and efficacy. <\/p>\n\n

Such illegal products represent a serious risk to public health. They may not contain the declared active substances at all, or they may contain other substances in harmful quantities. Consequently, people who use these products are at a very high risk of treatment failure, unexpected and serious health problems, and dangerous interactions with other medicines. <\/p>\n\n

Competent authorities have identified hundreds of fake profiles, advertisements, and e-commerce listings on Facebook, many of which are outside the EU. Some of these fraudulent websites and social media advertisements misuse the official logo and use fake testimonials to mislead consumers. <\/p>\n\n

Illegal medicines are promoted online in the EU through fraudulent websites and social networks, typically featuring false claims and testimonials. It is important for people to know that the EMA and national competent authorities do not endorse or promote specific products or brands. Any claim suggesting otherwise is false. Prescription medicines should be dispensed by a qualified medical professional and a pharmacy that holds a retail trade authorization for medicines. <\/p>\n\n

Can you share specific<\/strong> <\/strong>data on the volume of inspections, the sanctions imposed, or the frequency<\/strong> <\/strong>of<\/strong> <\/strong>established violations? What tools do you plan for strengthening<\/strong> <\/strong>control?<\/strong><\/p>\n\n

Bogdan Kirilov:<\/strong> In 2024, officials \u2013 inspectors and experts \u2013 exercised direct control over the activities of storage and trade of medicinal products and medical devices carried out by persons holding authorizations\/certificates for wholesale and retail trade of medicinal products and medical devices, to establish compliance with the requirements of Good Distribution Practice, the LMPHM, the LMDA, and the secondary legislation for their implementation.<\/p>\n\n

A total of 927 inspections were carried out on the territory of the Republic of Bulgaria. Within the scope of the inspections, data were also collected on the availability of certain medicinal products, the distribution of their quantities to other wholesalers and pharmacies, as well as information on their planned deliveries. The collected information was provided monthly by the BDA to the Ministry of Health for analysis and decision-making for the purposes of the orders issued by the Minister of Health to ban the export of specific medicinal products. <\/p>\n\n

In 2024, BDA inspectors carried out follow-up inspections at facilities (pharmacies and wholesale warehouses for medicinal products) that had been given prescriptions, instructions, and guidelines in the previous year, 2023, to bring their activities into compliance regarding their connectivity with SESPA and the National Verification System. In cases where non-compliance with the given prescriptions was established, actions were taken to initiate administrative penalty proceedings. <\/p>\n\n

During the inspections, violations of the legal and regulatory framework were established, which for retail trade facilities are summarized as follows:<\/p>\n\n