Good Distribution Practice – what is it and who does it apply to?

Every medicine that reaches a pharmacy, hospital or a patient passes through a distribution chain that must meet strictly defined requirements. Good Distribution Practice – abbreviated to GDP – is a set of standards ensuring that medicinal products retain their quality, efficacy and safety at every stage of this chain, from the manufacturer’s warehouse to the moment they are dispensed to the patient.

Origins and legal basis

GDP has been part of Polish and European pharmaceutical law for over a decade, but its current form is primarily defined by two documents. At EU level, these are the European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01). In the Polish legal system, these requirements were implemented by the Regulation of the Minister of Health of 13 March 2015 on the requirements of Good Distribution Practice, issued pursuant to Article 79 of the Pharmaceutical Law.

Supervision of compliance with GDP requirements in Poland is carried out by the Main Pharmaceutical Inspectorate (GIF) and regional pharmaceutical inspection authorities. It is the GIF that issues licences for the wholesale distribution of medicinal products – without such a licence, no pharmaceutical wholesaler may operate legally. This authorisation also constitutes a commitment to comply with GDP requirements, and its revocation is a serious sanction for identified breaches.

The GDP guidelines are a living document – the European Commission amends them in response to the changing realities of the pharmaceutical market. A key element of the newer regulations is the extension of the scope of requirements to entities previously subject to less stringent supervision: pharmaceutical brokers and transport companies delivering medicines as subcontractors to wholesalers.

Who is subject to the DPD?

A common misconception is that the DPD applies only to large pharmaceutical wholesalers. In reality, the requirements cover a much wider range of entities involved in the trade of medicinal products.

Pharmaceutical wholesalers – entities engaged in the wholesale trade of medicinal products, required to hold a GIF licence and fully implement the DPD requirements. They bear the greatest scope of systemic obligations, including the need to appoint a Responsible Person (RP) to oversee the quality system.

Pharmaceutical intermediaries and brokers – entities involved in the trade of medicinal products without physical contact with the goods, negotiating transactions on behalf of other entities. Since the amendment of the guidelines in 2013, they have been required to register and comply with DPD requirements regarding the qualification of contractors and transaction documentation.

Logistics operators and transport companies – subcontractors of pharmaceutical wholesalers providing storage or transport of medicinal products. Formally, the wholesaler is responsible for ensuring that its subcontractors meet the DPD requirements, which in practice means that any carrier or warehouse operator wishing to operate in this sector must meet the GDP requirements and be qualified by their client.

Manufacturers and importers – in relation to the distribution of medicinal products, which they carry out themselves or outsource to subcontractors.

The role of DPD in the pharmaceutical quality system

DPD does not operate in isolation from other pharmaceutical standards – it is one component of a broader system for ensuring the quality of medicines, which includes Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). All these practices form a coherent network of requirements aimed at protecting the patient at every stage of a medicinal product’s life cycle.

From the perspective of a pharmaceutical wholesaler, DPD is a mandatory and absolute requirement – it is impossible to operate legally without complying with it. At the same time, a well-implemented GDP system is an operational tool that enables the management of quality risks, minimises losses resulting from improper storage and transport, and builds credibility with suppliers and customers in the pharmaceutical supply chain.

For companies outside the pharmaceutical sector – logistics operators, transport firms, and third-party warehouses – implementing GDP requirements is a gateway to a market segment characterised by high margins and stable demand. The pharmaceutical industry values reliability and certainty of supply, and certified logistics partners have a significantly stronger negotiating position than entities without a documented quality system.