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.
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 won a double victory before the Regional Court in Krakow, successfully defending the interests of our clients against (as confirmed by the Court) unjustified claims of the National Health Fund. Both cases concerned the obligation of the National Health Fund to reimburse pharmacies for the sale of medicinal products. These medicines contained highly potent substances in their composition and were ...
SO Krakow: NFZ will not penalise pharmacies for selling drugs by technicians Read More »
Transferring a license to operate a pharmacy is a process that requires great precision in view of the very stringent requirements of the Pharmaceutical Law. From legal conditions, through preparation of documentation, to consequences for the new owner - every step is important. Find out how to take over a pharmacy efficiently and legally, avoiding violations and delays. If you have any doubts, we, as lawyers, are happy to...
Introduction Running a pharmacy involves a number of responsibilities and the need to meet a number of legal requirements. The basic one is obtaining a permit to run a pharmacy, issued by the provincial pharmaceutical inspector. When running a pharmacy, for various reasons, sooner or later - but usually there is a need to sell or make other ownership changes, which include transferring...
How to obtain a transfer of the license to operate it without closing the pharmacy? Read More »
In February 2024, the Sejm began work on an act amending the Pharmaceutical Law, the aim of which is to introduce wide access to emergency contraception (the so-called "morning-after" pills) without a prescription. Currently, such a preparation can only be obtained after receiving a prior prescription (e-prescription) from a doctor. What does the bill already adopted by the Sejm, which is being processed in the Senate and which…
Running a pharmaceutical wholesaler is an activity subject to extremely detailed legal requirements. Obtaining the appropriate permit is not an easy task. Unfortunately for entities holding such permits, there are a number of situations in which such a permit to operate a wholesale store may be lost. This article describes the basic conditions for starting the described business activity and, more extensively, the circumstances in which the permit…
Losing a license to run a pharmaceutical wholesale store - mistakes you should avoid Read More »
New entitlement of a pharmacist-employee With the entry into force of the Act of December 10, 2020 on the profession of pharmacist (consolidated text: Journal of Laws of 2022, item 1873) - hereinafter referred to as UZF, i.e. from April 16, 2021, new employment law for pharmacists who fulfill the obligation of continuous professional development already imposed on them. We're talking about permission...
Paid training leave for a pharmacist – basic rules. What about unused leave? Read More »
Introduction Recently, more and more owners of public pharmacies and pharmacy outlets have been contacting our office, seeking help in the unequal fight against the National Health Fund, which, as a result of inspections, often imposes huge financial sanctions on them, consisting in the obligation to return the refund received or pay a contractual penalty. , which for many of them means...
A loud topic in the broadly understood pharmaceutical environment are changes in the issuance of e-prescriptions - in this case, we are talking about, among others, limits on their issuance, as well as additional restrictions on the issuance of drugs of a specific category. In this article, we describe the latest rules regarding prescriptions. Limits on the number of prescriptions issued – is it legal? From July 3…
The pharmacy community is watching with astonishment the work on the draft of a new regulation of the Minister of Health on the detailed requirements that should be met by the premises of an entity carrying out activities in the field of supplying medical devices available on request. The main problem is, among others, the planned obligation to organize fitting rooms in pharmacies. Will imposing such an obligation be feasible in practice? We invite you …
The following article describes the role of lawyers specializing in pharmaceutical law and the benefits we try to bring to society. In particular, the pharmaceutical industry and its employees. Pharmaceutical law is one of the most complex areas of law today. It is practically a separate area of law. It is in this field that the legislator adopts and the executive power intensively implements…
The role of a lawyer in pharmaceutical law cases Read More »
Note: This article has been partially outdated due to legislative changes. Below is a link to the entry describing the changes introduced in July 2023: Fitting rooms in pharmacies - is it necessary or even possible? Discussion of the proposed requirements for the premises of entities supplying medical products. On November 18, 2022, the implementing regulation of the Minister of...
On February 24, 2022, the proceedings before the Supreme Administrative Court ended - all due to the amendment to the Pharmaceutical Law Act, which entered into force on June 25, 2017, and yet still causes problems with the interpretation of its provisions. The judgment in question (reference number II GSK 477/20) turned out to be positive for entrepreneurs who owned ...
How to sell a pharmacy? – part two of the article [article taking into account changes that occurred in the practical application of the law after the Supreme Administrative Court's judgments from 2022, link to part one of the article here] How can a pharmacy be sold? Who can purchase a pharmacy? How can we help you? You will find the answer to these and other questions in the article below. In life …
Inspection by the National Health Fund – what does the inspection of reimbursed prescriptions look like? What to do when the National Health Fund demands a refund? In recent years, the pharmaceutical and medical community has heard justified complaints about the control proceedings conducted by the National Health Fund regarding the prescription and implementation of reimbursed prescriptions. First of all, they concern contractual penalties imposed by the National Health Fund. The practice of the National Health Fund regarding imposing penalties and…