Pharmaceuticals | In Principle

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Regulated activity

Production and trade in pharmaceuticals are a domain of administrative law, in particular the Pharmaceutical Law of 6 September 2001 and executive regulations. Polish regulations implement EU counterparts in this area. Production and trade in pharmaceuticals (wholesale and retail) require official authorisation. Entry onto the pharmaceuticals market requires permits issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Minister of Health or pharmaceutical supervisory authorities in the form of an administrative decision. Such permits concern specific forms of market activity (e.g. a permit for production of a specific product, marketing authorisation for a specific product, or a permit for wholesale pharmaceutical trade). Market supervision is conducted by the Chief Pharmaceutical Inspector, who is entitled to inspect businesses and make necessary interventions in their activity. He may, for example, prohibit the sale of certain product batches or the broadcasting of specific advertising. The rules on how pharmaceuticals are paid for from public funds changed when the Reimbursement Act came into force. Currently refunded drugs are entered on the list of refunded drugs through a decision by the Minister of Health based on an evaluation by the Economic Commission and the President of the Agency for Health Technology Assessment in Poland.

Administrative procedure

An applicant seeking a permit, licence, or inclusion of a drug on the list of refunded drugs who is dissatisfied with the resolution may appeal the decision to a second-instance administrative body. Subsequently, the party may seek review of the administrative decision by the administrative court (complaint filed with the province administrative court, possibly followed by a cassation appeal to the Supreme Administrative Court).

Clinical trials

Clinical trials in Poland require an administrative permit and entry in the register of clinical trials, supervised by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Patent protection

Patents for pharmaceuticals are granted by the Polish Patent Office. All proceedings relating to patent registration or invalidation are conducted by patent attorneys at the Patent Office. Commercial courts adjudicate patent infringement disputes, including claims to cease and desist, for damages, and for declaratory relief.