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This guide explains the legal framework that applies to drugs and medical devices for people in Kolbuszowa, a town in the Podkarpackie region of Poland. Rules that govern pharmaceuticals and medical devices are set mainly at the national and European Union level, and they are implemented locally through regional and county offices. Whether you are a patient, caregiver, pharmacist, healthcare professional, manufacturer, distributor, or business owner, the same national statutes and EU regulations shape how medicines and devices are authorized, manufactured, marketed, sold and monitored.
Key legal areas include authorization and registration of medicines, product safety and conformity for medical devices, pharmacovigilance and device vigilance, prescription and dispensing rules, advertising restrictions, clinical trial approval, and criminal or administrative liability for illegal activities such as unauthorized sale of controlled substances. Local bodies in the Podkarpackie region and Powiat Kolbuszowski enforce these rules, investigate breaches and handle complaints.
You may need legal help in the drugs and medical devices field for many reasons. Legal matters in this area are often technical, time-sensitive and involve public authorities, regulated processes and potential civil or criminal liability. A lawyer with experience in pharmaceutical and medical device law can explain your rights, represent you before administrative authorities or courts, and help manage risk.
Common situations where legal help is useful include:
- Disputes with manufacturers or distributors over defective medicines or devices that caused harm or failed to perform as promised.
- Adverse event or injury claims where you seek compensation for harm allegedly caused by a drug or device.
- Administrative proceedings before national regulators such as the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, or appeals against fines and enforcement actions by regional inspectorates.
- Criminal investigations or prosecutions related to illegal trade in controlled drugs, counterfeit medicines, or improper clinical practices.
- Regulatory compliance for businesses - obtaining market authorization, CE marking for devices, ensuring Good Manufacturing Practice and proper labeling and advertising.
- Issues around reimbursement, reimbursement appeals with the National Health Fund, or disputes over prescribing and dispensing rules.
Although EU law influences many requirements, the main national building blocks you should know are:
- Pharmaceutical Law (Prawo farmaceutyczne): This act regulates authorization, manufacturing, distribution, wholesale, retail sale and pharmacy practice for medicinal products. It specifies prescription rules, dispensing obligations of pharmacists and penalties for illegal distribution.
- Medical Device Regulation and In Vitro Diagnostic Regulation: EU Regulation 2017/745 for medical devices and 2017/746 for in vitro diagnostics set conformity, clinical evaluation, CE marking and post-market surveillance rules. In Poland these are implemented by national authorities and supervised by regional inspectorates.
- Act on Counteracting Drug Addiction and related criminal provisions: These regulate controlled substances, their prescription, possession and penalties for illegal trafficking.
- Acts and regulations on advertising, clinical trials, pharmacovigilance and good manufacturing and distribution practices - these set obligations for manufacturers, importers and healthcare institutions.
Key local and regional authorities that enforce these rules and provide oversight include entities at the county and voivodeship level in Podkarpackie, such as the regional pharmaceutical inspectorate, the provincial sanitary-epidemiological station, and local units of national agencies. Administrative decisions from these bodies can be appealed to higher administrative courts, and some matters permit civil litigation or criminal proceedings in ordinary courts.
If you suspect an adverse reaction, report it immediately to the prescribing physician or the pharmacist, and ask them to record and report the event. You or the healthcare provider can notify the national regulator through the system managed by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Locally, you can also inform the regional sanitary inspectorate or your healthcare facility. Keep copies of medical records, the product name, batch number and any packaging or photographs.
First, stop taking the medicine and contact your doctor or emergency services if you have symptoms. Keep the dispensed package and receipt, and ask the pharmacy to record the incident. You may file a formal complaint with the pharmacy, and if you believe negligence occurred, you can report the matter to the regional pharmaceutical inspectorate. A lawyer can advise on civil claims for harm or costs and on filing complaints with regulatory bodies.
Buying medicines online is legal when purchased from a licensed EU pharmacy or a verified supplier operating under Polish law. Avoid unverified foreign or anonymous sites that sell prescription-only medicines without a prescription. Illegal or counterfeit products risk personal harm. If you suspect an online seller is unlawful, report it to the regional authorities and consider seeking legal advice, especially if you suffered harm or financial loss.
Liability may fall on the manufacturer, importer, distributor or healthcare provider depending on the facts. Under product liability rules, a producer can be liable for defective products that cause damage. Administrative sanctions or recalls may be initiated by regulators. A lawyer can help identify responsible parties, collect evidence and bring a civil claim for damages or coordinate with authorities conducting an investigation.
Clinical trials in Poland must be approved by the national authority and a local ethics committee. The sponsor must notify and get approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and comply with Good Clinical Practice. Participants must provide informed consent and have access to information about risks. If you have concerns about trial conduct or consent, contact the ethics committee, the regulator or seek legal advice.
Do not purchase or use the suspected products. Preserve any packaging and receipts and notify the pharmacy inspectorate, regional sanitary inspectorate or the police. Regulators can investigate and order seizures or recalls. You may also need legal help if you suffered harm or to cooperate with an investigation.
Yes. Pharmacies must hold proper licenses and operate under Pharmaceutical Law. Pharmacists must follow dispensing rules, keep accurate records, and adhere to restrictions on selling certain medicines. Regional inspectorates carry out inspections and can impose sanctions for breaches. Patients who feel harmed by pharmacy errors can file complaints with the inspectorate and consider civil claims.
If a medicine is not reimbursed by the National Health Fund, patients are generally responsible for payment. You can ask your physician about alternative reimbursed treatments or apply for individual reimbursement processes when applicable. Disputes about reimbursement decisions may be appealed through administrative channels; a lawyer can guide you through appeals or complaints to the payer.
Limitation periods depend on the type of claim. For civil claims under the general civil code, standard limitation periods apply and can vary with circumstances. For administrative appeals, strict statutory deadlines apply for filing appeals. Because time limits can prevent legal action, consult a lawyer quickly to preserve your rights and evidence.
Healthcare professionals can consult regional inspectorates, professional chambers such as the National Medical Chamber for physicians or the National Pharmaceutical Chamber for pharmacists, and the relevant departmental units at the voivodeship level. Private legal counsel with experience in healthcare regulation can provide tailored compliance advice, prepare policies, and represent professionals in administrative or disciplinary proceedings.
Relevant national and regional bodies and organizations that can provide information or handle complaints include:
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products - national regulator for approval, vigilance and market surveillance of medicines and devices.
- Główny Inspektorat Farmaceutyczny and Wojewódzki Inspektorat Farmaceutyczny - pharmacy inspectorates supervising pharmacies and distribution.
- Państwowa Inspekcja Sanitarna - regional sanitary-epidemiological stations that handle public health issues and local inspections.
- Narodowy Fundusz Zdrowia - National Health Fund responsible for reimbursement decisions.
- Naczelna Izba Lekarska and Naczelna Izba Aptekarska - professional chambers for doctors and pharmacists that handle professional conduct issues and can advise members.
- Local county office - Starostwo Powiatowe w Kolbuszowej - for information about public services, local administrative contacts and free legal aid points run under national programs.
- Police and prosecutor's office - for criminal matters such as illegal distribution, counterfeiting or trafficking in controlled substances.
- Bioethics committees and regional clinical trial oversight bodies - for questions about research ethics and study approvals.
If you need legal assistance in Kolbuszowa about drugs or medical devices, use the following practical steps:
- Preserve evidence: keep medicine or device packaging, receipts, prescriptions, photos, medical records and any correspondence with sellers or manufacturers.
- Seek immediate medical care if harmed and ensure the adverse event is documented in medical records.
- Report the incident to the relevant authority as appropriate - the prescribing physician, the pharmacy, regional inspectorate, or the national regulator - and get written confirmation of any reports you make.
- Find an experienced lawyer: look for a lawyer or law firm with experience in pharmaceutical law, medical device regulation, administrative law and personal injury or product liability. Ask about their track record, fees and whether they offer a free initial consultation.
- Prepare for the first meeting: bring identification, copies of medical documents, product information, receipts, timelines of events and contact details for witnesses. Prepare a clear summary of what happened and what outcomes you seek.
- Consider remedies: a lawyer can advise whether to pursue administrative appeals, civil damages, consumer complaints, criminal reports or alternative dispute resolution. They can also guide compliance for businesses or healthcare providers facing regulatory action.
- Check availability of free or low-cost legal help: ask the Starostwo Powiatowe w Kolbuszowej about local free legal aid points or social services that may assist if cost is a barrier.
Taking timely action and consulting legal and medical professionals early will help protect your rights and preserve evidence. Local and national authorities exist to enforce safety rules and to investigate breaches, and lawyers can help you navigate the procedures and pursue the remedy you need.
