Pharmaceutical Companies & Medical Facilities

Precision defines the pharmaceutical and healthcare industries — not only in science, but in law. The sector operates under an exceptionally detailed regulatory architecture where every product, study, and interaction is closely scrutinized. From laboratory to market, compliance is inseparable from innovation.

Pharmaceutical development, clinical research, and medical-device manufacturing all depend on strict adherence to EU and national rules governing safety, transparency, and ethical conduct. Each step — from clinical-trial authorization and pharmacovigilance reporting to advertising and market access — requires careful legal alignment with constantly evolving European frameworks.

We structure and negotiate agreements across the full product lifecycle: research collaborations, licensing, distribution, and technology transfer between healthcare institutions and private companies. Our work also covers pricing, reimbursement mechanisms, and compliance with healthcare-marketing and interaction codes of conduct. We ensure that relationships between manufacturers, professionals, and regulators remain transparent, compliant, and ethically sound.

The digital transformation of healthcare adds new legal challenges — from the use of patient data to telemedicine platforms and digital therapeutics. We design privacy and data-protection frameworks that allow innovation while safeguarding sensitive information, ensuring full alignment with GDPR and medical confidentiality requirements.

Relevant Legislation

European Legislation

Human Medicines Directive 2001/83/EC & Regulation (EC) 726/2004 (centralised authorisation)

These two instruments form the core legal framework for the authorisation and regulation of medicinal products for human use in the European Union. The Human Medicines Directive establishes the standardised rules for manufacturing, marketing authorisation, distribution, and pharmacovigilance of medicines at national level.

Regulation (EC) 726/2004 complements this framework by introducing the centralised EU authorisation procedure, allowing certain categories of medicines—such as biotechnology products, advanced therapies, and innovative treatments—to be approved through a single, EU-wide process coordinated by the European Medicines Agency (EMA).

For pharmaceutical companies and medical facilities, these rules ensure high standards of safety, quality, and efficacy, while enabling lawful market access and harmonised supervision across Member States. Compliance with this framework is essential for product development, clinical use, and ongoing monitoring of medicinal products throughout their lifecycle.

Clinical Trials Regulation (EU) 536/2014

The Clinical Trials Regulation establishes a single, harmonised EU framework for conducting clinical trials on medicinal products for human use. It replaces the previous directive-based system with directly applicable rules, introducing a centralised EU portal and database for trial applications, approvals, and transparency.

For pharmaceutical companies and medical facilities, the Regulation simplifies and accelerates trial authorisation across multiple Member States, while maintaining strict requirements for patient safety, ethical standards, and data integrity. It also strengthens public transparency by making key trial information accessible, supporting trust in medical research and innovation.

Compliance with this Regulation is essential for the lawful planning, approval, and conduct of clinical trials in the EU, ensuring that research activities meet uniform scientific, ethical, and regulatory standards across borders.

Medical Devices Regulation (EU) 2017/745 & IVDR 2017/746

Тhe MDR and IVDR establish the comprehensive EU regulatory framework for medical devices and in vitro diagnostic medical devices, replacing earlier directives with directly applicable and more stringent rules. They govern the design, manufacturing, conformity assessment, clinical evaluation, market surveillance, and post-market monitoring of devices used in healthcare.

For pharmaceutical companies and medical facilities, these Regulations significantly strengthen requirements related to patient safety, performance, and traceability, including unique device identification (UDI) and enhanced oversight of notified bodies. Medical facilities using, procuring, or developing devices must ensure that products placed on the market or used in clinical settings fully comply with EU standards.

Together, MDR and IVDR enhance regulatory transparency, product reliability, and patient protection, making compliance essential for the lawful development, distribution, and use of medical technologies across the European Union.

Pharmacovigilance Regulation (EC) 726/2004 & Dir. 2010/84/EU updates

The EU pharmacovigilance framework establishes the rules for monitoring the safety of medicinal products after they are placed on the market. Regulation (EC) 726/2004, together with the updates introduced by Directive 2010/84/EU, strengthens obligations related to adverse reaction reporting, risk management, and ongoing safety evaluation.

For pharmaceutical companies and medical facilities, these rules require the continuous collection and assessment of safety data, timely reporting of adverse events, and implementation of risk-minimisation measures when necessary. Marketing authorisation holders must maintain robust pharmacovigilance systems and cooperate closely with regulatory authorities.

By reinforcing post-authorisation surveillance, the pharmacovigilance regime ensures that medicines remain safe, effective, and subject to constant oversight, supporting patient protection and public confidence in the European healthcare system.

GDPR & e-Privacy (health data)

The GDPR and e-Privacy framework regulate the processing and protection of health-related personal data, which is among the most sensitive categories of information under EU law. In the pharmaceutical and healthcare sector, this includes patient records, clinical trial data, genetic and biometric information, and data used for treatment, research, and pharmacovigilance purposes.

These rules require strict legal grounds for processing, enhanced security measures, and confidentiality safeguards, as well as clear transparency toward patients and research participants. The e-Privacy rules further govern the use of electronic communications, cookies, and digital tracking technologies in healthcare platforms and medical services.

Together, GDPR and e-Privacy ensure that medical innovation, patient care, and digital health solutions are conducted lawfully, ethically, and with the highest level of data protection, reinforcing trust in healthcare systems and life-science activities across the EU.

Cross-border Healthcare Directive 2011/24/EU

The Cross-border Healthcare Directive establishes the rights of patients to access healthcare services in other EU Member States and to receive reimbursement under certain conditions. It facilitates patient mobility while respecting national healthcare systems and reimbursement rules.

For medical facilities and healthcare providers, the Directive sets standards on quality, safety, and transparency when treating patients from other Member States. It also regulates the exchange of health information and cooperation between national authorities, ensuring continuity of care and patient protection across borders.

By harmonising patient mobility rules, the Directive promotes access to healthcare, legal certainty, and cooperation within the EU, making it a key framework for providers involved in cross-border medical services and treatment.

Bulgarian Legislation