Legal Alert | Is a supervisory revolution coming for the transport of medicines from online pharmacies?
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Mail-order sales of OTC medicinal products have been permitted since 2007. The most recent amendments concerning the manner in which patients place orders were introduced into the implementing regulation in 2025 as part of the deregulation package, expanding the catalogue of channels through which a patient may place an order.
Does the expansion of the catalogue of communication channels with a pharmacy mean that all doubts have been resolved? Not necessarily. The Chief Pharmaceutical Inspectorate (GIF) has received a petition[1] in which the authors challenge the correctness of pharmacies' selection of companies transporting medicines to patients!
The main allegations raised by the petition’s authors:
- Pharmacies select transport providers based on the criterion of price rather than compliance with legal requirements.
- These entities are often not subject to the supervision of the Pharmaceutical Inspectorate and do not possess infrastructure compliant with the requirements of Good Distribution Practice (GDP), such as a qualified means of transport, and transshipment chambers covered by a wholesale distribution authorization.
- This leads to a breach of the legal supply chain of medicinal products to the end recipient, and increases the risk of their falsification.
What steps should GIF take?
The authors of the petition have set out what actions they expect the supervisory authority to take. One of them has already been completed, namely:
- On 12 March 2026, a statement[2] was published on the GIF website regarding the obligation to comply with the rules governing the mail-order sale of medicinal products, in which the authority reiterated the basic rules governing the mail-order sale of OTC medicinal products and emphasised that:
- pharmacies operating a mail-order service are responsible for organising and carrying out the delivery of medicinal products to the recipient in accordance with the regulations,
- verifying that medicinal products are transported under the correct conditions is part of a pharmacy’s responsibilities, even if this task is carried out on behalf of or by a third party.
The authors of the petition are still waiting for:
- Conducting ad hoc inspections of selected online pharmacies with a focus on verifying agreements with logistics operators and temperature mapping protocols in transport.
- Undertaking educational initiatives aimed at raising patients' awareness of the risks arising from the use of deliveries through unregistered transport channels.
If you operate a pharmacy engaged in mail-order sales or a transport entity, please contact us. We will be happy to answer your questions and assist you in reviewing and updating your procedures!
[1] Petycje złożone w 2026 r. - Główny Inspektorat Farmaceutyczny - Portal Gov.pl (access: 06.03.2026)
[2] Komunikat Głównego Inspektora Farmaceutycznego z dnia 12 marca 2026 r. - Główny Inspektorat Farmaceutyczny - Portal Gov.pl (access: 13.03.2026)
