July 2025 brought a number of significant legislative developments in Poland’s healthcare sector. Key updates include: (a) Medicinal products: The Sejm passed an amendment to the Reimbursement Act; (b) Pharmacies: A draft amendment to the regulation on detailed requirements for pharmacy premises has been published; (c) Veterinary sector: A draft Act on Animal Health is currently under consultation; and (d) Food sector: A draft amendment to the Act on Products of Animal Origin and the Act on Food and Nutrition Safety has been released.
Status of amendments to the Pharmaceutical Law
Last month, two amendments to the Pharmaceutical Law were published in the Journal of Laws. A third bill amending the Pharmaceutical Law is currently being debated in the Sejm (the lower house of the Polish Parliament). These legislative initiatives form part of the government’s deregulation programme.
Facilitating the providing of medicinal product samples
On 7 July 2025, the Act of 4 June 2025 amending the Pharmaceutical Law was published in the Journal of Laws. The new provisions entered into force on 22 July 2025.
The amendment eases the requirements regarding the form in which a person authorised to issue prescriptions may request a sales or medical representative to provide a sample of a medicinal product. In addition to the existing written form, such requests may now also be made in documentary form.
Relaxation of the information obligations of the marketing authorisation holder
On 10 July 2025, the Act of 24 June 2025 amending the Pharmaceutical Law was published in the Journal of Laws. The new provisions entered into force on 25 July 2025.
The amendment abolished the obligation for the marketing authorisation holder to provide the Integrated System for Monitoring the Marketing of Medicinal Products (ZSMOPL, Zintegrowany System Monitorowania Obrotu Produktami Leczniczymi) with information on the planned place of delivery of medicinal products intended for sale in Poland.
This obligation was deemed unnecessary given the scope of data already available in the ZSMOPL.
Update of requirements for Qualified Persons and Competent Persons
Another bill amending the Pharmaceutical Law is currently being debated in the Sejm. On 22 July 2025, the Deregulation Committee and the Health Committee, following the first reading, recommended its adoption.
The aim of the amendment is to update and increase the flexibility of the requirements for Qualified Persons and Competent Persons, and to relocate the relevant provisions within the Pharmaceutical Law to facilitate future amendments.
The new provisions are expected to enter into force one month after their publication in the Journal of Laws.
Amendment to the Reimbursement Act passed by the Sejm
On 25 July 2025, the Sejm passed the Act amending the Act on the Reimbursement of Medicines, Foodstuffs for Special Nutritional Purposes and Medical Devices (the Reimbursement Act), as well as the Act on Healthcare Services Financed from Public Funds.
The new provisions implement the government’s deregulation measures. Their primary objective is to introduce uniform clinical assessments at European level to the Polish legal system, thereby expediting reimbursement procedures.
Under the amendment, the Agency for Health Technology Assessment and Tariff System (AOTMiT, Agencja Oceny Technologii Medycznych i Taryfikacji) will perform the tasks arising from the European Union Regulation (EU) 2021/2282 on health technology assessment.
The Act has been submitted to the Senate , which passed it without amendments. The Act is expected to enter into force 14 days after its publication in the Journal of Laws.
Draft amendment to the Regulation on the template for an application for a licence to operate a pharmaceutical wholesale warehouse
On 2 July 2025, a draft Regulation of the Minister of Health amending the Regulation on the template for an application for a licence to operate a pharmaceutical wholesale warehouse was published on the website of the Government Legislation Centre (RCL, Rządowe Centrum Legislacji).
Among other things, the draft seeks to align the national application form with the guidelines of the European Medicines Agency (EMA). Key proposed changes include enabling applicants to declare:
- wholesale trade in narcotic drugs or psychotropic substances;
- the temperature range for products requiring low-temperature storage, in line with EMA guidance.
The draft is currently under public consultation. The new Regulation is expected to enter into force 14 days after its publication in the Journal of Laws.
Update of the National List of Critical Medicines
On 14 July 2025, an updated National List of Critical Medicines was published on the Ministry of Health’s website. The new list includes 401 active substances in medicinal products whose unavailability, in the Ministry’s view, could affect national drug security.
According to the Ministry of Health, the update was based on active substances included in the second edition of the European Critical Medicines List, published on 16 December 2024, that were not part of the first national list. Proposals submitted by various authorities, institutions and marketing authorisation holders were also considered.
GIF reminder on XML messages
On 1 July 2025, the Chief Pharmaceutical Inspectorate (GIF, Główny Inspektorat Farmaceutyczny) issued a reminder on how to correctly complete the “SERIA” field in XML messages submitted to the Integrated System for Monitoring the Marketing of Medicinal Products (ZSMOPL, Zintegrowany System Monitorowania Obrotu Produktami Leczniczymi).
GIF clarified which characters may be entered in this field.
If an unauthorised character is used, the system will currently generate a TROSPOZ92 warning: “A prohibited character has been entered in the product serial number.” GIF announced that this warning will soon be replaced by a system error, which will result in the rejection of the entire message.
Draft amendment to the Regulation on detailed requirements for pharmacy premises
On 8 July 2025, a draft Regulation of the Minister of Health amending the Regulation on detailed requirements for pharmacy premises was published on the website of the Government Legislation Centre (RCL, Rządowe Centrum Legislacji).
The proposed amendments are editorial in nature and aim to ensure consistency across the legal framework. Among other things, the draft replaces the term “healthcare facility” (zakład opieki zdrowotnej) with “medical facility of a medical entity” (zakład leczniczy podmiotu leczniczego), and “homeopathic products” (produkty homeopatyczne) with “homeopathic medicinal products” (produkty lecznicze homeopatyczne).
The Regulation is expected to enter into force seven days after its publication in the Journal of Laws.
Bill on Animal Health
On 10 July 2025, a bill on Animal Health was submitted to the Sejm (the lower house of the Polish Parliament) for its first reading.
The bill seeks to implement Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law).
Among other things, the bill sets out:
- the tasks of entities responsible for animal health protection and disease control in Poland (in particular, the Veterinary Inspection);
- the principles of animal disease control;
- the rules on controlling animal diseases in wild animals;
- penalties for violations
The bill provides that, with the exception of Article 126(12), which will apply 14 days after publication, the new provisions will enter into force three months after their publication in the Journal of Laws. The exception is intended to ensure continuity of record-keeping and reporting to the existing database.
Bill amending the Act on Products of Animal Origin and the Act on Food and Nutrition Safety
On 7 July 2025, a government bill amending the Act on Products of Animal Origin and the Act on Food and Nutrition Safety was submitted to the Sejm (the lower house of the Polish Parliament) for its first reading.
The bill is deregulatory in nature. Its primary aim is to allow new operators of establishments producing food of animal origin, supervised by the Veterinary Inspection, to automatically assume the rights and obligations set out in administrative decisions previously issued by the district veterinary officer to the former operator.
The new legislation is expected to enter into force 14 days after its publication in the Journal of Laws.
By Andrzej Balicki, Partner, Jolanta Dabrowicz, Counsel, and Urszula Grebowska, Junior Associate, DLA Piper
