Pharmaceutical law, although unpopular in theory, is one of our main areas of activity. We provide comprehensive support for the opening and sale of pharmacies, employee matters, reimbursement disputes and registration processes.
Can one of the most popular civil law relationships, i.e. lease, still have any "secrets"? Is a person even aware that even by not concluding a contract in its most traditional written form, but only by making an oral agreement with another person, he or she is almost entering the realm of civil law?
Operating in the pharmaceutical market is different from "ordinary" running a business. It is subject to additional regulations, and running a pharmacy itself is subject to the procedure of obtaining the appropriate permit - it is therefore a regulated activity. As you can easily guess, the sale of such a pharmacy will be more complicated than the "traditional" procedure of selling an enterprise.
On 20 February 2025, our Law Firm achieved a double victory before the District Court in Krakow, successfully defending the interests of our Clients against (as confirmed by the Court) unfounded claims by the National Health Fund. Both cases concerned the obligation imposed by the NFZ on pharmacies to refund reimbursements for the sale of medicinal products. 💡 The most important conclusions Our Law Firm achieved two victories before the District Court in Krakow…
SO Krakow: NFZ will not penalise pharmacies for selling drugs by technicians Read More »
Transferring a pharmacy licence is a process requiring great precision due to the very stringent requirements of the Pharmaceutical Law. From the legal conditions and preparation of documentation to the consequences for the new owner – every step is important. Learn how to take over a pharmacy efficiently and legally, avoiding infringements and delays. 💡 Key Information The transfer of a licence, consequently the so-called…
Running a pharmacy involves meeting a number of legal requirements. During the operation of a pharmacy, sooner or later the need arises to sell or make other ownership changes, which include transferring the pharmacy operating permit to another person or entity. Find out if this can be done without a long period of pharmacy closure. 💡 Key Takeaways Standard procedures …
How to obtain a transfer of the license to operate it without closing the pharmacy? Read More »
In February 2024, work began in the Sejm on a bill amending the Pharmaceutical Law, aiming to introduce widespread access to emergency contraception (the so-called "morning-after pill") without a prescription. Currently, such a preparation can only be obtained after receiving an e-prescription. What does the project envisage and will it come into effect? 💡 Key takeaways The Pharmaceutical Law amendment project proposes to facilitate access…
Running a pharmaceutical wholesale business is a strictly regulated activity, subject to exceptionally detailed legal requirements. Obtaining the appropriate permit is a difficult task in itself. Unfortunately, for entities on the market, there are a number of situations through which such a permit can be lost rapidly. We will outline the conditions for undertaking this activity and the circumstances in which the GIF may (or must) revoke the permit. 💡 Key takeaways Revocation…
Losing a license to run a pharmaceutical wholesale store - mistakes you should avoid Read More »
The coming into force of the Act on the Pharmaceutical Profession has granted pharmacy employees a new, important employment right – paid training leave of up to 6 days per year, intended for the implementation of continuing professional development obligations. Due to the modest content of the regulations, this new entitlement is raising many doubts in the market. We explain who is entitled to the leave, how to account for it, and whether unused days…
Paid training leave for a pharmacist – basic rules. What about unused leave? Read More »
Recently, we've seen an unprecedented increase in the number of inspections carried out in pharmacies by the National Health Fund (NFZ). Even minor discrepancies in prescription fulfilment are resulting in severe financial penalties – from contractual fines to demands for full reimbursement refunds. For many pharmacy owners, this poses a threat of bankruptcy. We explain why not every NFZ decision is justified and how to defend yourself...
A hot topic in the medical and pharmaceutical circles has become changes regarding the issuing of e-prescriptions. This primarily concerns top-down daily limits on prescribed medications and strict restrictions on the remote issuing of narcotic and psychotropic drugs. We examine the new rules, analysing their purposefulness and legal basis. 💡 Key takeaways From 3 July 2023, a limit has been introduced into the P1 system…
The pharmacy sector is looking with astonishment at the work on the new regulation by the Minister of Health regarding the detailed requirements for premises supplying patients with medical devices on prescription. The main point of contention is the planned obligation to organise fitting rooms in pharmacies. Will it be practically possible to implement such an obligation? 💡 Key conclusions Currently, pharmacies, as entities solely distributing…
Pharmaceutical law is one of the most rigorous and complicated areas of the legal system, where patient safety and the business's existence or non-existence for pharmacies or manufacturers are at stake. We explain why the support of a specialised lawyer is crucial at every stage of the pharmaceutical market – from drug development, through opening pharmacies, to defence against the Provincial Pharmaceutical Inspectorate (WIF) and the National Health Fund (NFZ). 💡 Key takeaways...
The role of a lawyer in pharmaceutical law cases Read More »
In December 2022, a brand-new regulation from the Minister of Health came into force, setting out the basic conditions for operating a pharmacy. It replaced the archaic provisions from 2002. Although the act is intended to improve quality in theory, in practice it imposes a series of costly and rigorous technological, record-keeping, and warehousing obligations on pharmacy owners. What do pharmaceutical entities have to contend with? 💡 The most important…
For over five years since the introduction of the "Pharmacy for Pharmacists" amendment, authorities held the position that its restrictive rules applied even to entities that had been operating on the market long before the regulations changed. A landmark ruling by the Supreme Administrative Court demolishes this interpretation, defending the constitutional acquired rights of entrepreneurs running "old" pharmacies. 💡 Key takeaways The Supreme Administrative Court…
Selling a pharmacy is one of the most complex transactions at the intersection of civil and administrative law. The restrictions of the "Pharmacy for the Pharmacist" act have significantly hindered market turnover, but the latest rulings of the Supreme Administrative Court (NSA) from 2022 have given entrepreneurs new hope and opportunities. We explain how to practically sell shares, transfer an organised part of an enterprise, and who can actually today...
The National Health Fund is increasingly demanding that pharmacies and doctors repay huge sums for drug reimbursements due to microscopic formal errors (e.g. a missing signature next to the stamp). We reveal the NFZ's tactics when selecting a "control sample" and advise on how to win a court battle for your money, citing the latest, favourable case law for medical professionals. ...