Licensing

At PharmRE Limited, we take pride in operating with full legal authorization and in strict adherence to all regulatory frameworks governing the pharmaceutical sector. We are officially licensed and registered by the Malta Medicines Authority, operating under Registration Number BR07, as a broker and wholesaler of medicines for human use.

Our licensing is a testament to our unwavering commitment to quality, safety, transparency, and professional excellence.
It confirms that PharmRE meets the highest standards required for the handling, brokering, and distribution of medicines both within Malta and throughout the European Union.

Our Licenses

Broker Licence (Medicines for Human Use)
PharmRE is licensed to broker medicines for human use. As a licensed broker, we act as an authorized intermediary between sellers and buyers, ensuring that every transaction is carried out safely, transparently, and in compliance with all applicable regulations.

Wholesale Dealer Licence (Medicines for Human Use)
In addition to our broker license, PharmRE holds a wholesale dealer license, allowing us to purchase, store, and distribute medicines for human use. This license enables us to support a broader network of healthcare providers, pharmacies, and pharmaceutical companies by ensuring secure access to high-quality medicines.

Both licenses were granted by the Malta Medicines Authority under the supervision of the Ministry for Health in Malta.

The Licensing Process and Requirements

Obtaining a broker and wholesaler license for medicines for human use in Malta involves a rigorous and comprehensive approval process. This includes:

  • Demonstrating full compliance with Good Distribution Practice (GDP) standards, which ensure the quality and integrity of medicines throughout the supply chain.

  • Establishing robust quality management systems that oversee all operational procedures related to the sourcing, handling, storage, and distribution of medicines.

  • Ensuring the employment of qualified personnel with the necessary expertise and training in the pharmaceutical field.

  • Meeting strict infrastructure and facility requirements, including appropriate storage conditions and security protocols.

  • Undergoing thorough inspections and audits by the Malta Medicines Authority to verify operational readiness and regulatory compliance.

  • Demonstrating full adherence to European Union directives, particularly Directive 2001/83/EC and Commission Guidelines 2013/C 343/01 relating to medicinal products for human use.

Our successful fulfillment of these requirements highlights PharmRE’s dedication to maintaining the highest operational standards in all our activities.

Compliance with European Regulations

PharmRE’s licenses also ensure compliance with the broader regulatory environment established by the European Union.
We fully align our operations with the standards and regulations of:

  • The European Medicines Agency (EMA)

  • The European Commission’s pharmaceutical legislation

  • The European Economic Area (EEA) and European Free Trade Association (EFTA) frameworks

This guarantees that our clients across Europe receive services that are safe, compliant, and professionally executed at every stage.

Our Commitment

Holding licenses from the Malta Medicines Authority is not merely a legal requirement for PharmRE — it is a reflection of our business philosophy. We believe that compliance, transparency, and patient safety are non-negotiable pillars of pharmaceutical distribution.
By choosing PharmRE, you are partnering with a company that meets and exceeds the highest regulatory standards in the industry.

PharmRE — Licensed, Trusted, Compliant.