What constitutes a medicinal product?
The starting point is crucial, because misclassifying a product determines everything that follows.
The definition of a medicinal product in Poland derives from Article 2(32) of the Pharmaceutical Law and implements Article 1(2) of Directive 2001/83/EC. A medicinal product is any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or administered with a view to restoring, correcting or modifying physiological functions.
The definition operates in two ways simultaneously. Satisfying either one is sufficient.
The presentation criterion — the product is advertised, described or offered as having therapeutic properties. This applies to both direct therapeutic claims and indirect suggestions arising from the name, appearance of the packaging or method of distribution. The CJEU established this principle as early as its judgment in Case 227/82 Van Bennekom.
The function criterion — the product can significantly modify physiological functions, regardless of how it is presented. Here the mechanism of action is decisive. In Case C-140/07 Hecht-Pharma, the CJEU indicated that even the absence of proven clinical efficacy does not preclude pharmacological classification — a significant potential to affect the functions of the body is sufficient. In Cases C-319/05 and C-27/08, the Court clarified that not every effect on the body determines pharmaceutical status, but any product with a significant pharmacological effect is a medicinal product, even if sold as a food supplement.
Misclassification at this stage — assuming that a product is not a medicinal product when it in fact is — means that all activities relating to manufacture, import and distribution are carried out without the required authorisation and expose all participants in the supply chain to criminal liability under Article 124 of the Pharmaceutical Law.
flowchart TD
A[Product] --> B{Presented\nas medicinal?}
B -->|YES| C[Medicinal product]
B -->|NO| D{Significantly modifies\nphysiological functions?}
D -->|YES| C
D -->|NO| E[Not a medicinal product\n- supplement / cosmetic / device -]
style C fill:#ef4444,color:#fff
style E fill:#22c55e,color:#fff
Named patient import
Named patient import (Article 4 of the Pharmaceutical Law) is a mechanism that allows a medicinal product authorised abroad to be brought into Poland where it does not hold a Polish marketing authorisation but is registered in another country.
The conditions are strict. The product must hold a marketing authorisation in the country of export. A justified medical need must exist for a specific patient or group of patients. Importation requires the consent of the Minister of Health and must be carried out through a responsible entity or a licensed importer.
Expert Tip: Named patient import is not a route to commercialisation. It serves to meet an individual clinical need, not to build a sales model. The key condition — authorisation in the country of export — is frequently overlooked in practice, which renders an apparently lawful import actually unlawful. A product not authorised anywhere does not satisfy the requirement under Article 4.
Parallel import
Parallel import is a separate legal institution, entirely distinct from named patient import. It concerns products already registered in Poland that are sourced from another EU Member State where the same product (or its equivalent) is available at a lower price.
The legal basis is the principle of free movement of goods (Articles 34–36 TFEU) and CJEU case law, which recognises parallel import as permissible even without a separate marketing authorisation, provided the products are identical in composition and manufacturer and essentially identical in form and indications. Under Directive 2001/83/EC (Article 76), authorisation from the national competent authority is required — in Poland, the URPL issues decisions granting parallel import licences.
Expert Tip: Parallel import is a market mechanism, not a humanitarian exception. It is used by distributors and pharmaceutical wholesalers for the purpose of price arbitrage between EU markets. It carries its own risks — repackaging must meet stringent requirements regarding product identity information and must not damage the reputation of the trade mark, which has been the subject of repeated disputes before the CJEU (including Case C-348/04 Boehringer Ingelheim).
Advanced Therapy Medicinal Products (ATMPs) and the hospital exemption
ATMPs (Advanced Therapy Medicinal Products) are a distinct category of medicinal products regulated by Regulation 1394/2007/EC. They include gene therapy products, somatic cell therapy products and tissue-engineered products. Given the complexity and individualised nature of these products, the Regulation provides for a special exception: the hospital exemption (in Poland: Article 38a of the Pharmaceutical Law).
The hospital exemption allows ATMPs to be manufactured and used without a centralised EMA marketing authorisation, provided the product is manufactured on a non-routine basis, on prescription for an individual patient, by an entity subject to national pharmaceutical supervision, and used exclusively in the same Member State in which it was manufactured. This last condition — the territorial requirement — is absolute: an ATMP manufactured abroad cannot benefit from the hospital exemption in Poland.
A common error is to assume that every therapeutically advanced biological product is an ATMP. The EMA and national competent authorities (EOF, AGES) have on numerous occasions classified oligonucleotide, RNA and similar products as non-ATMPs, because they do not satisfy the definition in Directive 2009/120/EC — in particular the requirement for a recombinant nucleic acid for gene therapy products. Incorrectly assuming ATMP status leads to pursuing a pathway that does not in fact exist.
Compassionate use
Compassionate use (Article 83 of Regulation 726/2004) is a mechanism for exceptional access to an unauthorised product for patients with a serious or life-threatening disease where no satisfactory authorised treatment exists. In Poland it requires the consent of the Minister of Health.
There is one entry condition, but it is not immediately obvious: the product must be the subject of an ongoing clinical trial or a submitted marketing authorisation application. Without either of these elements, compassionate use is unavailable — even if the product is effective and is being manufactured. Under compassionate use it is possible to charge patients, which distinguishes this mechanism from participation in a clinical trial, where the investigational medicinal product (IMP) is provided free of charge.
The procedure is not swift. The application is submitted to the Minister of Health, who may seek an opinion from the URPL. In practice, processing times are measured in weeks rather than days. Nevertheless, it is the only pathway that combines lawful access for a patient paying for therapy with the absence of full marketing authorisation.
graph LR
A[Named patient import] --> A1[Requirement: authorisation\nabroad]
B[Parallel import] --> B1[Requirement: authorisation\nPL + EU]
C[ATMP hospital\nexemption] --> C1[Requirement: domestic\nmanufacture]
D[Compassionate use] --> D1[Requirement: clinical trial\nor application]
style A fill:#2196F3,color:#fff
style B fill:#FF9800,color:#fff
style C fill:#9C27B0,color:#fff
style D fill:#4CAF50,color:#fff
Expert Tip: Selecting the correct pathway requires first correctly classifying the product — and only on that basis assessing which mechanisms are available at all. Errors at the classification stage cannot be corrected by choosing an appropriate distribution pathway.