KIELTYKA GLADKOWSKI advises on the full scope of Polish pharmaceutical law in the entire area of pharmaceutical law, understood as the preparation, control, storage and distribution of all kinds of medicinal products.
The focus of legal cases concerning pharmaceutical law are:
The specialization of KIELTYKA GLADKOWSKI in Polish and EU pharmaceutical law takes into account the specificity of the legal environment of the pharmaceutical sector in Poland.
When advising our foreign clients, we keep in mind that the comprehensive subject of Polish pharmaceutical law is not only to define the rules and procedures for marketing medicinal products, taking into account the quality, effectiveness and safety of their use. Pharmaceutical law regulates the issues of names, packaging and labeling of medicinal products. In addition, it defines the conditions and requirements for conducting clinical trials, manufacturing and marketing medicinal products. The Pharmaceutical Law specifies the requirements that apply to facilities that store and sell medicinal products. Moreover, it determines the method of organization and functioning of the supervision system, including control over the safety of medicinal products and monitoring the safety of their use, including the tasks of the regulatory body, i.e. the so-called Pharmaceutical Inspection and its powers.
In addition, legal assistance within pharmaceutical law covers the issues of:
KIELTYKA GLADKOWSKI has extensive experience in the issues of biological activity of medicinal products (expressed in units of potency of the active substance or active substances of the medicinal products), safety studies conducted after granting a marketing authorization for a medicinal product, which aims to identify, describe or determine the risk, safety and efficacy of an authorized medicinal product. In addition, it is also a matter of clinical trials conducted in order to discover the effects or identify adverse effects of medicinal products.
KIELTYKA GLADKOWSKI focuses on cases whose core is the legal problem of the so-called “MEDICAL PRODUCT”, i.e. a drug within the meaning of the legal definition in Polish pharmaceutical law.
When talking about a medicinal product, it is usually a substance or a mixture of several substances, which is defined as having properties for the prevention or treatment of diseases occurring in humans or animals, or which is administered for the purpose of making a diagnosis or restoring, correcting or modifying the physiological functions of the body resulting from pharmacological, immunological or metabolic action.
Pharmaceutical law defines unexpected, severe and undesirable effects of a medicinal product. Additionally, adverse medical events as well as unexpected adverse reaction issues due to a medicinal product. It is also the subject of falsification of medicinal products and active substances, in terms of their identity, origin and history.
Our law firm offers assistance in the area of legal aspects of trading in medicines in Poland – full legal assistance, regardless of the type of medicine products.
The Polish legislator distinguishes the following types of drugs – pharmacy products, ready-made products, prescription products and types of medicinal products – homeopathic, immunological, blood-derived, medicinal plant products, advanced therapy products or radiopharmaceutical products. Similarly, there can be specified substances that may be of human, animal, plant, chemical origin and their types – active or auxiliary.
Pharmaceutical law regulates the issues of medicinal products used exclusively in animals and related research, adverse effects or good veterinary clinical practice.
Poland as a member state of the European Union is subject to the legal regulations of the European Union. The field of pharmaceutical law is no exception, which is why KIELTYKA GLADKOWSKI advises on the basis of such acts of EU law as:
Of additional importance for pharmaceutical law is the Agreement on the European Economic Area in the matter of distribution by entities operating in the territory of the Member States of the European Union or the Member States of the European Free Trade Association, import from outside the territory of the Member States of the European Union or the Member States of the European Free Trade Association ( European Free Trade Association).
We advise on the marketing authorization of drugs that do not require a permit, for example prescription, pharmacy or pharmaceutical drugs. We assist in legal issues of borderline products. We support Clients in meeting the conditions for the admission of medicinal products from abroad – target import, as well as in submitting applications for a parallel import permit. We help in communication and setting up an account in the Target Import Service System.
We supervise the correctness of procedures and the development of a marketing strategy for the medicine, including the correctness of the signature and the content of the requisition for a medicinal product – the value of data of the entity performing medical activity submitting the requisition, the physician issuing the requisition, the person authorized to represent it, the data of the patient, information on the medicinal product and the correctness notification of the need to grant consent for a temporary marketing authorization of a medicinal product. We provide support during the consideration and implementation of the demand for a medicinal product and notification of the need to grant consent for a temporary marketing authorization of a medicinal product.
We advise on obtaining consent for the foreign language content of orphan drug packaging labeling under Regulation (European Community) No. 141/2000 of the European Parliament and of the Council of December 16, 1999 on orphan medicinal products.
KG LEGAL KIELTYKA GLADKOWSKI assists in submitting applications for marketing authorization for medicinal products, radiopharmaceutical drugs, medicinal products derived from human or animal blood, so that they contain the necessary elements. We support Clients in the preparation of the characteristics of a medicinal product and the characteristics of a veterinary medicinal product, risk assessment report for the use of a product containing or consisting of genetically modified organisms (GMOs).
We help in the admission of equivalents of reference medicinal products, veterinary medicinal products or products containing active substances with well-established medical use, veterinary medicinal products containing active substances with well-established effectiveness and an acceptable level of safety, without the need to submit the results of non-clinical or clinical trials.
We support our clients in product safety testing and documentation of test results so that they are conducted in accordance with the law, including assistance in supplementing the deficiencies identified during the formal examination.
KG LEGAL KIELTYKA GLADKOWSKI operates in the case of a decentralized procedure – submitting, simultaneously in several countries that are parties to the agreement on the European Economic Area, an application for marketing authorization for the same medicinal product that is not authorized in any Member State of the European Union or in a Member State of the European Free Trade Agreements. We also provide support during the mutual recognition procedure, when the application for marketing authorization concerns a medicinal product that has an authorization issued by the competent authority of a Member State of the European Union or a Member State of the European Free Trade Association.
We help with the procedure and the simplified procedure for marketing traditional herbal medicinal products, homeopathic medicinal products and submitting applications for their marketing authorization along with attachments.
Medicinal products admitted to the market receive the category of availability – dispensed without a doctor’s prescription, dispensed with a doctor’s prescription, dispensed with a doctor’s prescription for restricted use, dispensed with a doctor’s prescription, containing narcotic drugs or psychotropic substances, used only in inpatient treatment. KG LEGAL KIELTYKA GLADKOWSKI advises on the request to change the availability category of a medicinal product.
KG LEGAL KIELTYKA GLADKOWSKI assists with the request to conduct post-authorisation testing of the product, responding to such a request, completing the necessary formalities, and during the control of the system for monitoring the safety of use of medicinal products.
KG LEGAL KIELTYKA GLADKOWSKI advises on meeting the quality requirements, testing methods for medicinal products and their packaging as well as pharmaceutical raw materials specified by the European Pharmacopoeia, as well as requirements for packaging, markings, information leaflet, name of the drug in Braille.
We assist in extending or shortening the validity period of the authorization for a medicinal product or veterinary medicinal product and in submitting an application to change the data covered by the authorization, changing the documentation being the basis for issuing the authorization or changing the entity that obtained the marketing authorization for the medicinal product (marketing authorization holder). We advise on the appointment and responsibility of the responsible entity’s representative.
In Polish pharmaceutical law, adverse reactions to medicinal products should be reported to the President of the Office of Medicinal Products or to the marketing authorization holder, in particular concerning: medicinal products containing a new active substance – admitted for the first time to the market in any country within 5 years preceding the notification, medicinal products containing a new combination of active substances, medicinal products containing a known active substance, but administered in a new way, therapy with new pharmaceutical forms of medicinal products, medicinal products with a new indication, cases where an adverse reaction of a medicinal product led to the use of another medicinal product, medical procedures or treatment given to the patient, the occurrence of an effect during pregnancy or immediately after delivery.
Our law firm formally supports the reporting of a single case of an adverse reaction. In addition, it supports the MAH in terms of its obligations, for example, having a full description of the pharmacovigilance system for medicinal products or conducting regular audits of the system to ensure that information on reports of individual cases of adverse reactions, which are sent to this entity, will be collected and compiled in one place, or submitting reports of adverse reactions to the European Medicines Agency, submitting periodic safety reports to the European Medicines Agency – including a request to change the frequency of submitting reports or to set an EU reference date.
The marketing authorization holder and entrepreneurs dealing with wholesale trade in medicinal products are obliged to ensure the availability of medicinal products and to place orders for medicinal products on demand.
We assist Clients in initiating an EU pharmacovigilance procedure and submitting and amending a post-authorisation safety study protocol.
We help with issues related to the principles of conducting clinical trials – resignation from participation in trials and consent to them (also among minors and people with disabilities), also in connection with the principles of Good Clinical Practice. Our law firm provides services in the scope of duties and responsibilities of the research sponsor and researcher, the transfer of rights to the product, non-commercial clinical trials and the rules of research funding. We help in submitting an application to start research and in legal issues of their organization, and we provide support during research inspections.
KG LEGAL supports clients during activities covered by permits – obtaining and maintaining a promise to conduct business activity subject to a permit, inspection and control of business activity.
KG LEGAL supports clients in monitoring the transport of medicinal products, foodstuffs for particular nutritional uses and medical devices.
We deal with matters related to the export or sale of medicinal products outside the territory of Poland. We assist in enforcement proceedings in connection with fees for guarding and storage of seized goods and in cases of court proceedings regarding their forfeiture.
KG LEGAL supports clients in the manufacture and import of medicinal products.
We help in running a business dealing with the manufacture or import of medicinal products – obtaining a permit, also for the manufacture of advanced therapy medicinal products, and in fulfilling the obligations after obtaining the consent.
We deal with matters related to the obligations of manufacturers and importers and in matters related to safeguards against counterfeiting of medicinal products that are not radiopharmaceuticals.
We provide services in the field of obtaining the CPP (Certificate of Pharmaceutical Product) certificate, which is issued on the basis of the guidelines of the World Health Organization by the relevant authorities in the member countries of this organization, the GMP (Green Project Management) certificate, which confirms compliance with the requirements of Good Professional Practice, and the position of Qualified Person.
We provide support in the process of concluding contracts for production or import with other manufacturers or importers.
We provide assistance during the process of entering into the National Register of Manufacturers, Importers and Distributors of Active Substances, fulfilling statutory obligations in this regard and obtaining a certificate confirming the compliance of the active substance manufacturing conditions with the requirements of Good Manufacturing Practice.
KIELTYKA GLADKOWSKI, as one of the few law firms in Poland, has experience in advising foreign clients in the marketing of pharmaceutical raw material in the form of medical cannabis, sold in special pharmacies in Poland for palliative treatment procedures.
We specialize in matters related to restrictions and prohibitions in advertising medicinal products. In addition, we provide support for entities involved in the advertising of medicinal products.
The scope of services of KG LEGAL KIELTYKA GLADKOWSKI includes support in the trade in medicinal products – rules, obligations, prohibitions applicable to entities, facilities and pharmacy points. We help in compliant retail and wholesale trade in medicinal products.
We provide support for activities related to the purchase and sale, delivery or possession of medicinal products or other forms of control over medicinal products. We help in obtaining an entry in the National Register of Intermediaries in Medicinal Products, in matters related to the obligations of intermediaries in medicinal products, and in submitting an application for inspection in order to obtain a certificate confirming the compliance of the terms of trading with the requirements of Good Distribution Practice in the field of intermediation.
We assist in obtaining the authorization of the Chief Pharmaceutical Inspector to operate a pharmaceutical wholesale store, along with submitting an application for authorization and an application for inspection in order to issue a certificate, which is a certificate confirming the compliance of trading conditions with the requirements of Good Distribution Practice.
We help Clients in meeting the requirements and obligations when running pharmaceutical wholesalers. We provide services in the field of drawing up contracts for the storage and distribution of medicinal products and in disputes related to the prohibition of supplying medicinal products to legally unacceptable entities.
We provide support in the withdrawal of a permit to run a pharmaceutical warehouse and in the procedure of selling medicinal products, foodstuffs for particular nutritional uses and medical devices.
We provide support in setting up generally accessible pharmacies, hospital pharmacies and company pharmacies – obtaining a permit to run a pharmacy, meeting the premises requirements and legally permissible distribution of drugs from pharmacies. We deal with issues related to running pharmacies and hiring employees, including meeting statutory minimum employment standards, the obligation to appoint a pharmacy manager and regulating working hours of pharmacies, and issues related to the qualifications of a pharmaceutical technician.
We deal with cases related to the ban on advertising pharmacies and pharmacy outlets, as well as prescriptions (issuing prescriptions, cross-border prescriptions, electronic prescriptions) and dispensing drugs from pharmacies. We have experience in legal matters related to the refusal to provide pharmaceutical services or dispense a medicinal product, medical device or food for particular nutritional uses.
We help Clients in the event of refusal, withdrawal, expiration or transfer of a license to operate a pharmacy.
We provide support during the Inspection’s supervision over the manufacture and circulation of medicinal products and medical devices, quality tests of new medicinal products, proceedings in the event of a violation of the requirements: manufacturing or import or marketing of medicinal products or active substance, storage and transfer of vaccines, quality of a medicinal product in entity performing medical activity. In addition, we support in issuing decisions to suspend the marketing of a series of medicinal products, decisions to prohibit the introduction or withdrawal of a medicinal product or active substance from the market, and in the procedure related to control activities.
Our law firm supports Clients in proceedings concerning: