Overview of the guide

The Bulgarian pharmaceutical legal framework is mature, robust and closely aligned with EU law in the context of the entire product lifecycle – from clinical trials and market authorisation to manufacturing, distribution, advertising and pharmacovigilance. Although no significant legal reforms have been implemented recently, our observations are that the system is adapting to the typical industry risks of today: supply chain unpredictability, drug shortages, digital health/health (sensitive) data management and advances in manufacturing. The sector is also increasingly seen as critical to national security – considering the EU Defence Preparedness Roadmap, the pharmaceutical industry has its chances to access investment support in the development of new products/materials and the development of shorter and more sustainable supply chains.

In parallel, the pharma sector is already heavily discussing and bracing to meet the expected changes that the EU pharma package will eventually bring. However, actual modifications to the EU level and national legislation may be delayed for various political and economic reasons. While the pharma package will undoubtedly have a significant impact on the pharma sector in the future, there are other pressing issues that will affect the business in the upcoming months. As one case in point, the sector may expect a rising number of international patent disputes to arise over the next year. Several EU blockbuster medicines patents expire in 2025-2026 with more on the line in the next few years. The large volume of upcoming changes will have a downstream impact on competition and supply of and access to pharmaceuticals, while an ongoing background effort to keep market exclusivity will persist.

In the meantime, the Bulgarian market is facing its own unique challenges. The introduction of the euro currency brings a specific range of practical and regulatory issues. A negative factor for the business is undoubtedly the temporary price fixing for consumer goods, including medicinal products, until August 2026 provided for in the Euro Introduction Act. Although limited in time, it could open the door for a normalisation of the approach to wider public intervention in prices, which would cripple the normal market processes.

Current legal framework in Bulgaria

The Medicinal Products in Human Medicine Act (MPHMA) is the main legislative act in Bulgaria regulating medicines in human medicine. It implements and aligns with the EU level rules. Together with secondary legislation, the MPHMA regulates the full product life cycle. The Bulgarian Drug Agency (BDA) is the competent authority for authorising, supervising and enforcing the legislation, working in conjunction with the Ministry of Health and other authorities responsible for pricing, reimbursement, etc.

Market authorisation is carried out through EU harmonised procedures (centralised, decentralised, mutual recognition and national). Clinical trials are regulated according to EU and national rules, with ethical oversight and approvals by the BDA, if applicable. Manufacturing, import and wholesale are subject to licensing, Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements, including safety and anti-counterfeit characteristics. Pharmacovigilance obligations apply throughout the supply chain, with risk management plans, periodic updating of safety information and adverse event reporting. Pricing and reimbursement remain central to market access. Administrative pricing controls and reference pricing determine market access and availability, with a significant impact on competition in the market.

The Euro Introduction Act provides for a temporary conditional price fix on consumer goods until August 2026. During Bulgaria’s dual price display period — part of the euro-adoption transition — retailers are required to form prices in good faith and transparently, with any increase justified by objective economic factors. These factors are defined as external, documentable circumstances such as changes in production, delivery, storage or sales costs, new regulatory requirements, or force majeure events that have a direct and material impact on cost price. Upon request, traders must provide evidence of these factors to the authorities, notably the Commission for Consumer Protection. The rule aims to prevent unjustified price hikes, protect consumers, and maintain market integrity during the transition period. Additionally, the Council of Ministers is provided with additional powers to adopt temporary countermeasures in the event of a significant increase in the prices of essential goods such as medicinal products. This specifically applies to essential prescription only medicinal products that are not reimbursed. Although of limited duration, the measure is not perceived positively by the business community, which believes that it may create expectations in regulators of wider intervention and, therefore, requires close monitoring by market participants.

Additionally, the Euro Introduction Act imposes further obligations on medicinal product retailers. During Bulgaria’s dual price display period, retailers with annual turnover exceeding BGN 10 million engaged in the sale of medicinal products are required to publish daily information on the individual sale prices of goods included in the “large consumer basket” as defined by the Commission for Consumer Protection (CPC). The CPC has published a list of these goods, including the medicinal products with included INN and ATC codes. Retailers without a website will submit the data directly to the CPC. If the same products are sold at different prices across multiple outlets, information must be reported separately for each location. Published price lists must include details such as the store, product name, brand, net quantity, retail price, category, any discounts, duration of discounts, reference price, current discounted price, and the percentage change. The CPC is to maintain a publicly accessible portal to publish all submitted data daily and provide guidance on compliance. Retailers outside the mandatory threshold may voluntarily submit data under the same rules, which will also be published on the portal.

In the meantime, food supplements remain a large and increasingly growing section of the broader healthcare market in Bulgaria. Food supplements are treated as food under EU food legislation, as well as the Bulgarian implementing legislation. However, the less strict regulation on the market entry and distribution of food supplements leave room for bad faith practices. As a result, public pressure is rising, and people are calling for stricter regulation and increased control by the consumer protection and food safety authorities.

Three key tips for clients

1. Develop a full lifecycle regulatory strategy for your products. Clearly define your products portfolio, the types of products and the relevant regulation to each of them. Map out the clinical pathway, authorization pathway, pharmacovigilance system, manufacturing and distribution licenses and networks. Stay on top of data management and be prepared to meet new regulations and requirements early.
2. Be prepared to provide evidence requested by the authorities for a wide range of matters – packaging, advertising, supply chain, pricing and price changes, etc.
3. Strengthen supply chain resilience. Diversify sources, emphasise on shorter regional supply chains, and prepare contingency plans. Integrate traceability and quality agreements between partners and ensure pharmacovigilance and product quality processes remain effective even under expedited or rerouted supply models.

Top threats and opportunities over the next 12 months

Threats include increased supply chain volatility and shortages, litigation pressure and the theoretical risk of expanded public price controls. Conditional price fixing in the Euro Introduction Act until August 2026 creates some uncertainty for similar future measures, even as a temporary measure. This is especially true for the medicinal products market, which is of high public interest and subject to intense regulation.

Tech and health data protection will further define the healthcare market in the near future. The introduction of stricter cybersecurity regulations will have sector wide effects. These include clinical trials projects, manufacturing operations and healthcare providers. Cybersecurity is an ever so current topic given the globally seen increase in ransomware attacks.

Opportunities arise from the strategic importance of pharmaceuticals as critical to national security, which unlocks political attention and potential support for investment in new products, advanced manufacturing and shortening of the supply chains. In combination with scientific advances such as AI target detection, test optimization, and accelerated research timelines, the sector has unmatched potential for growth and investment.

Ensuring high customer satisfaction

We advise prioritising proactive, clearly articulated risk mapping and rigorous documentation throughout the product lifecycle. Early development and implementation of risk management strategies ensures sustainability and adequate response in any situation. Documentation and data and evidence collection for key processes is at the heart of this risk management.

Technological advances are changing pharmaceutical law and customer benefits

Two technological currents are changing the face of practice, namely:

• Scientific research and analytical artificial intelligence are a combination that would transform the workflow in the sector and demand adequate regulatory response. Tools for literature sorting, hypothesis generation, target discovery, optimization, and safety alert detection are shortening timelines and improving the quality of information.
• Digitization of quality and safety systems strengthens safeguards. Identity and access controls protect professional-only systems and sensitive health data, supporting compliant programs and evidence generation. The timely implementation of effective cybersecurity programs is essential here.

In these advances, preplanned management is a constant: strong scientific teams to manage information flows; proper compliance training and meticulous documentation as well as strong oversight.

Concluding observations

In the years ahead, resilience and preparedness should guide decision-making in the sector: plan conservatively for adversity, prepare for tightening regulation and increased litigation, invest in shorter and more transparent supply chains, strengthen your R&D teams, your digital quality and cybersecurity systems. The result is not only regulatory compliance and continuity of supply, but enduring trust from patients, professionals and authorities.