The regulatory regimei Classification
The definitions of 'medicinal product' and 'medical device' under Polish law are essentially the same as those adopted under EU legislation. Polish law also follows the general EU rule regarding 'borderline products' – if a product falls within the definition of a medicinal product and, at the same time, of another type of product (in particular, a food supplement, a cosmetic or a medical device), the medicinal product's regime applies. Most of the aforementioned products are regulated in Poland under separate pieces of legislation; for example, cosmetics are regulated under the Act on cosmetic products of 4 October 2018 (which reconciles Polish legislation with Regulation (EC) No. 1223/2009 on cosmetic products), and dietary supplements and foodstuffs are regulated under the Act on the Safety of Foodstuffs and Nutrition of 25 August 2006 (which needs to be reconciled with Regulation (EU) No. 609/2013 on food intended for infants and food for special medical purposes).ii Non-clinical studies
Non-clinical (i.e., pharmacological and toxicological) studies should be carried out in accordance with the rules of good laboratory practice (GLP), as regulated under the Act of 25 February 2011 on Chemical Substances and their Mixtures and under the Executive Regulation of the MoH of 22 May 2013 on Good Laboratory Practice and Performing Research in Accordance with the Rules of GLP. Consequently, non-clinical studies should be carried out by research entities that have been granted a GLP compliance certificate.
The means of protection of animals used in the course of studies is regulated under the Act of 15 January 2015 on Protection of Animals Used for Scientific and Academic Purposes.
Tests on animals may only be carried out by authorised 'users' and only with consent from the local ethics committee. The register of authorised suppliers, breeders and users is kept by the Ministry of Science and Higher Education (available online). Records of experimental animals must be kept by the research centres.iii Clinical trials
Clinical trials are regulated by the provisions of the PhL. All clinical trials (including bioavailability and bioequivalence studies) should be planned, carried out, monitored and reported in accordance with good clinical practice (GCP), as set out in the regulation of the Ministry of Health on Good Clinical Practice dated 2 May 2012. The sponsor of any clinical trials (a person responsible for initiating, conducting and financing a clinical trial) may be a natural person or an entity with the registered office in the territory of the European Union or the European Economic Area (EEA) – if the sponsor does not have its registered office in the territory of a EEA state, it may act solely through a legal representative with a registered office in this territory. As a principle, clinical trials may start only after obtaining a positive opinion from the bioethics committee and the authorisation of the president of the ORMP – at this stage, the trials are also entered into the Central Register of Clinical Trials. The president of the ORMP may refuse to authorise a clinical trial when submitted documents are incomplete, the trial constitutes a threat to public policy or is contrary to the rules of social conduct, or when the concept of the trial is not compliant with the requirements of GCP.
No financial encouragement should be offered to participants of clinical trials unless they are healthy adults who may give informed consent. This ban does not preclude reimbursement of the costs of participation.
Before conducting a clinical trial, the informed consent of participants is required. The PhL provides for specific requirements in this respect. Additional requirements apply to clinical trials that involve minors or incapacitated individuals.
The sponsor and the investigator are liable for damages caused in connection with clinical trials and are obligated to take out an adequate insurance policy. Specific requirements are set out in the regulation of the Ministry of Finance dated 30 April 2004 on compulsory insurance of the sponsor and investigator.
The products used in the trials should be prepared in accordance with good manufacturing practice. The principal documentation of the trials should be kept by the sponsor and investigator for at least five full years following the end of the study and should be made available to the ORMP upon request.
Medical devices and active implantable medical devices should undergo a clinical analysis based on clinical data. The specific rules for such trials are regulated under the AMD. Clinical trials must be authorised by the bioethics committee and the president of the ORMP and conducted according to the protocol for clinical trials. The informed consent of participants is required. They also have the right to physical and psychological integrity, privacy and personal data protection; they may withdraw from the trials without sustaining damage or injury. The sponsor and investigator are required to obtain a civil liability insurance policy. Restrictions on offering financial incentives apply, similar to those that apply in trials regarding medicinal products.
The national regulation on clinical trials is still in force but it will be replaced by Regulation (EU) No. 536/2014 on Clinical Trials, which is expected to become applicable in 2020. The draft amendment of the PhL is ready and should be made available soon.iv Named-patient and compassionate use procedures
The PhL allows for importation of medicinal products that have no MA in the territory of Poland, where it is necessary to save the life or health of a patient. A medicinal product must be authorised in the country from which it is imported (country of origin) and have a valid MA in that country (a targeted import procedure). The basis for a targeted import procedure is the requisition of a hospital or a physician carrying out therapy outside the hospital, confirmed by a national or regional medical consultant qualified in the relevant field of medicine. Detailed rules governing the distribution of medicinal products imported through the targeted import procedure were set out in the MoH regulation dated 21 March 2012 but, on 31 December 2016, the regulation was revoked and no new regulation has been enacted.
The following cannot be placed on the market under the targeted import procedure:
- medicinal products in respect of which a decision refusing an MA, non-extension of the validity period of an MA or revocation of an MA was issued in Poland;
- medicinal products containing the same active ingredients, dose and form as products that have already obtained MAs in Poland; and
- products that, owing to the safety of use or the volume of import, should be placed on the market in accordance with the general provisions of the PhL.
Pursuant to Article 39 of the ARM, medicinal products imported under the targeted import procedure may be reimbursed.
Poland has not expressly implemented legislation specific to compassionate use in the meaning set out in Article 83 of Regulation (EC) No. 726/2004. Currently, the proposal of specific regulations is included in the bill amending the ARM. This draft is at the stage of governmental work and it is difficult to assess when the new regulation will enter into force.
The PhL also provides extraordinary procedures for the importation of medicinal products applicable in the event of a natural disaster (or other similar life- or health-threatening events).
The AMD allows for the introduction into the Polish market of single medical devices that have not yet undergone a compliance assessment procedure if they are necessary to achieve required preventive, diagnostic or therapeutic purposes. Devices may be marketed on the basis of a decision of the president of the ORMP issued when it is necessary to protect the life or health of a patient, or for the protection of public health. A request for a decision may be filed by a healthcare provider, national, regional or military healthcare consultant, the president of the Health Technology Assessment Agency or the president of the NHF.
Moreover, custom-made devices may be distributed without a CE marking provided that the device is accompanied by a statement by the manufacturer or its authorised representative that it fulfils its essential requirements (or indicating which requirements are not fulfilled and why).v Pre-market clearance
Medicinal products covered by a Polish national MA and products covered by an MA issued by the EU Council or the European Commission are eligible to be marketed in Poland. There are four ways of obtaining an MA that is effective in Poland: through a national procedure, a centralised procedure, a decentralised procedure and a mutual recognition procedure.
The marketing authorisation holder (MAH) may be an entrepreneur in the meaning outlined in the Polish Entrepreneurs' Law, or an entrepreneur conducting business activity in the European Union or the EEA.
The national procedure is regulated under the PhL. The authority competent to issue an authorisation is the president of the ORMP. The authorisation should be issued within 210 days of submission of the application for a period of five years (which may be subsequently extended). The authorisation may be issued following verification of an application by the ORMP and after preparing an assessment report with a scientific opinion on the medicinal product. The application for authorisation must include extensive documentation, which reflects the requirements provided in Directive 2001/83/EC. The expedited path for generic products also reflects EU legislation (as a rule, eight years' data exclusivity and 10 years' market exclusivity periods apply). The results of non-clinical and clinical studies are not required for products with active substances that have a well-established use or well-established effectiveness and an acceptable level of safety and use in EU or EEA Member States.
The PhL provides for a simplified authorisation procedure for traditional herbal medicinal products and homeopathic products.
Some products do not require MAs to be distributed in Poland, including magistral formulae, officinal formulae, selected radiopharmaceutical products, whole blood, plasma and blood cells of human origin, advanced therapy medicinal products (according to Regulation (EC) No. 1394/2007); neither are authorisations required for products used solely for scientific research, products used by manufacturers, products used in registered clinical trials and intermediate products to be used by manufacturers. The PhL also regulates a parallel import procedure.
Medical devices may generally be marketed only if they have a CE marking (see the European Union chapter). The essential requirements for devices, as well as the specific procedure for compliance assessment, are set out in a number of executive regulations of the MoH. The manufacturer is responsible for compliance assessment and introduction of medical devices to the market. The manufacturer must be domiciled or have registered offices in the European Union or appoint an authorised representative who is responsible for a given product. When the manufacturer does not appoint a representative, or the manufacturer or representative is not responsible for introducing the product to the market, the entity that places the product on the market bears responsibility for its compliance with law.
Medical devices should be notified to the ORMP by the manufacturer or its representative, domiciled or with registered offices in Poland, at least 14 days before the product is first put on the Polish market. Distributors and importers with a domicile or registered office in Poland who introduce medical devices to the Polish market must notify the ORMP without delay, and certainly no later than seven days following the first introduction of the products on the market.vi Regulatory incentives
Supplementary protection certificates for medicinal products are granted in Poland according to Regulation (EC) No. 469/2009 (executive measures are implemented into the Polish Industrial Property Law).
Article 15 of the PhL implements into Polish law the data exclusivity and market exclusivity periods (eight and 10 years, respectively) provided by EU law.
The Polish government is still planning to introduce the Innovative Development Mode – a reward programme for pharmaceutical companies that conduct their economic activity and run the research and development centres in Poland and employ Polish nationals. The details of the Innovative Development Mode are still not specified. As a principle, qualifying companies could rely on easier reimbursement negotiations and other reimbursement-related incentives. The Innovative Development Mode has been included in the Polish Medicine Policy announced in 2018.vii Post-approval controls
The obligations stemming from the EU pharmacovigilance system apply in Poland. The Polish implementation of the EU Directive on Falsified Medicines for Human Use entered into force on 8 February 2015.
After the lapse of a five-year period of validity of an MA, the authorisation may be indefinitely extended after examination of documents regarding the product's quality, safety and effectiveness, as well as any side effects. At this stage, the ORMP may refuse to extend the authorisation or extend it only for a further five years (if, for safety reasons, the ORMP deems prolongation of the authorisation for an indefinite period to be inappropriate).
Any amendments to an MA may be made upon request of the MAH and requires a decision by the president of the ORMP. The procedure varies depending on the type and scope of the amendments.
The MA may be withdrawn because of, inter alia, serious adverse reactions related to the product, insufficient therapeutic effectiveness, infringement of provisions of the medicinal product's marketing or failure to notify required new information regarding the product. Violations not resulting in a direct threat to public health may result in suspension of the authorisation. Furthermore, the MA expires if the product is not marketed for three years.
The AMD uses the term 'medical incident' for malfunctions, defects, improper labelling or contents of any manuals as well as other technical or medical causes related to medical devices that may result in death or deterioration of the health of a patient. Healthcare providers are obliged to report any such incidents without delay to the device manufacturer or its representative, and to send a copy of that notification to the ORMP. The manufacturer (or its representatives) must carry out field safety corrective action. The president of the ORMP may issue a decision prohibiting or suspending the marketing of unsafe medical devices.viii Manufacturing controls
The manufacturing of medicinal products is understood broadly and requires a permit from the MPI. There are certain exceptions to the obligation to obtain a permit; these exceptions are generally consistent with EU legislation.
Manufacturers of medicinal products must comply with provisions of good manufacturing practices (set out in the MoH regulation, reflecting the respective EC guidelines). Manufacturing permits may cover the manufacturers' own products and any products manufactured for third parties (as a contractor). A manufacturing permit allows a manufacturer to undertake any of the activities expressly mentioned in the permit and with respect to the products listed in the permit. If the manufacturer wishes to expand the list of medicinal products or the scope of its activities, it must apply for the relevant amendment of the permit. The processing of controlled substances requires additional authorisation (see Section II.xiii).
Manufacturing permits are issued for an unspecified period of time. The MPI also issues a separate certificate confirming compliance of the manufacturing facility with the GMP requirements, which is valid for three years from the date of the latest inspection carried out by the MPI (the date of the inspection is stated on the certificate).
Depending on the legal form of the transfer of ownership of a manufacturing facility, manufacturing permits may be transferred with the facility (e.g., in the event of a merger). New permits may be required in the event of the sale of the facility to another entrepreneur.ix Advertising and promotion
Advertising of medicinal products is regulated under the PhL and under the MoH executive regulation dated 21 November 2008. Applicable restrictions for advertising and promotion are generally consistent with the applicable EU legislation. Only the MAH (or a parallel importer) and any entity authorised by the MAH may undertake advertising of medicinal products (in practice written authorisation is required by the MPI). Reimbursed medicinal products cannot be publicly advertised. Violation of the applicable rules may trigger various sanctions, including criminal sanctions or a fine.
The regulations regarding advertising of medical devices are very limited. Under the AMD, promotional materials, presentations and information on devices may not be misleading as to the properties and operation of devices by:
- attributing properties, functions and operations to a device that are non-existent;
- giving the impression that treatment or diagnosis with the device is guaranteed to be successful;
- failing to inform of the expected risks connected with using the device in accordance with its intended use or for a period longer than intended; and
- suggesting use or properties other than those declared during the conformity assessment.
The ARM prohibits manufacturers and distributors of reimbursed products (including medicinal products, medical devices and reimbursed foodstuffs) to offer any encouragement regarding such products to patients or healthcare professionals authorised to issue prescriptions. In particular it is prohibited to offer conditional sale, rebates and bonuses, packages, loyalty programmes, donations, prizes, small gifts, trips, lotteries, any form of lending, tied transactions, facilitations, acquisitions or sponsored services, vouchers, coupons or other benefits not expressly named. Various sanctions apply for violation of this ban.
Pharmacies in Poland may not advertise. This prohibition includes a broad range of promotional activities such as loyalty programmes and the publication of price lists.x Distributors and wholesalers
Wholesale is defined in accordance with EU legislation. Wholesale trade may be undertaken by pharmaceutical wholesalers and pharmaceutical manufacturers (in the latter case, limited to their products). Before 8 February 2015 (when the amendments to the PhL entered into force), customs and consignment warehouses had also been authorised to carry on a wholesale trade in medicinal products. However, by operation of the new amendment to PhL, such entities were automatically transformed into pharmaceutical wholesalers. Wholesalers must obtain an authorisation issued by the MPI, except for manufacturers (a manufacturing permit already encompasses authorisation for the sale of manufactured products). All wholesalers are required to follow the rules of good distribution practice (as regulated under the MoH Regulation dated 13 March 2015). The regulation implements EC Guidelines of 2013, but the Polish implementation is more strict than the requirements stemming directly from the Guidelines. Also the findings of pharmaceutical inspectors prove that the interpretation of law is not consistent and changes quite often. Under the new supervision system, periodic inspections are carried out in each wholesale premises at least once during a three-year period. There is also rather limited understanding of the pharmaceutical authorities for the more advanced business models (e.g., logistic operators running wholesale premises or transporting medicinal products for third parties); in most cases they tailor their expectations based on the 'regular' buy-sell business model. As a result, the standard for running a pharmaceutical wholesale business in Poland is set much higher than in most other EU countries.
In 2018 there was further limitation of the entities eligible for running wholesale activity. Namely, the authorities will deny permits for running wholesale pharmaceutical operations if an applicant simultaneously runs (or applied for a permit to run) a pharmacy, is brokering with regard to medicinal products or is entered into the register of medicinal activity.
Retail trade may be undertaken by pharmacies (the PhL distinguishes between generally accessible pharmacies and hospital pharmacies) and pharmacy outlets. Some over-the-counter products may also be sold in herbal medicine stores, medical supplies stores and general stores.
Distribution of medical devices does not require any specific authorisation and may be undertaken by any entrepreneur (provided they comply with the requirements of the AMD).xi Classification of products
Under the PhL there are the following categories of dispensing medicinal products:
- those dispensed over-the-counter without a physician's prescription (OTCs);
- those dispensed on a physician's prescription;
- those dispensed on a physician's prescription for restricted use;
- those dispensed on a physician's prescription, containing narcotic agents or psychotropic substances defined in separate regulations; and
- those for hospital use only.
The criteria for classifying medicinal products into one of the categories are specified in the MoH executive regulation dated 14 November 2008. The dispensing category must be indicated in the MA and may only be changed by an amendment of the MA. The main consequences of classification are limitations on the allowed channels of distribution (only OTCs may be sold in general stores) and limitations on the advertising of products other than OTCs directed to patients.
Medical devices are classified as Class I, IIa, IIb or III depending on the risk connected with their use. The factors relevant to classification are the time of contact of the device with an organism, the place of contact, the level of invasiveness, local and systemic effects, and the function and technologies used. Medical devices for in vitro diagnostics are classified as Class A or B in accordance with Directive 98/79/EC.xii Imports and exports
The import of a medicinal product from third countries (non-EEA) requires an import authorisation that is issued in a procedure similar to the granting of a manufacturing authorisation by the MPI.
The parallel import of products authorised to be marketed in Poland requires the importer to obtain an authorisation for the import of each specific product. This authorisation is valid for five years and may be renewed for subsequent five-year periods.
In order to remedy problems with shortages of state-reimbursed medicines, Poland has introduced new restrictions on the export of some products listed as being in danger of shortages (the list is compiled on the basis of product availability data gathered from the market by the MPI and is published by the MoH). A parallel exporter must file a notification to the MPI 30 days prior to the export of any listed products. The MPI may then issue an objection to the export. If such object is issued, the wholesaler is obliged to sell the products in Poland. If the MPI does not issue an objection to the export, the exporter may export medicinal products within 30 days. The entrepreneur shall inform the MPI within seven days about actual export.
The same rules apply to medical devices listed as being in danger of shortage. However, importers of medical devices are obligated to ensure that the compliance assessment for the device was performed, that the manufacturer has appointed an authorised representative and that the CE marking, with the identification number of a notified body, are included in the product's labelling (if required). An importer domiciled or with a registered office in Poland is also obliged to keep a declaration of conformity or required statements and certificates regarding the device. The president of the ORMP, at the request of a manufacturer or authorised representative domiciled or with a registered office in Poland, may issue a certificate of free sale to facilitate the export of devices with a CE marking or custom-made devices.xiii Controlled substances
The marketing of narcotic drugs and psychotropic substances (controlled substances) is governed by the CDA. Drug precursors are additionally governed by EU regulations.
Under the CDA, the importation and exporting (from or to EU and non-EU Member States) of controlled substances may be carried out only by businesses with authorisation to manufacture or wholesale trade. These authorisations are issued by the MPI. As a general rule, the importation and exporting of controlled substances require consent from the MPI and the competent authorities in the country of export. When the controlled substances are in transit through Poland, they must be accompanied by an export authorisation granted by the authorities in the country of origin and they cannot be stored in customs warehouses. There are exceptions to these rules with regard to controlled substances imported for personal medicinal needs.
The wholesale trade in controlled substances and drug precursors also requires authorisation granted by the MPI. The retail trade in these products (which are also medicinal products) may be undertaken by pharmacies and pharmacy outlets.
There are further specific requirements regarding storage, handling and issuance of controlled substances, keeping pertinent records and documentation, and so on.xiv Enforcement
The MPI supervises the manufacture, importation, quality and distribution of medicinal products and the marketing of medical devices. When an instance of non-compliance is detected, the MPI generally issues a decision ordering the contravener to remedy the breach. If there is a direct threat to life and health of the population, the MPI may immediately close the manufacturer's or distributor's operations.
The president of the ORMP is the competent inspection authority for medical devices manufactured, marketed, used and assessed in Poland. The president of the ORMP may issue decisions prohibiting, suspending or restricting the marketing and use of devices for reasons regarding patients' safety, public health, safety and order, etc.
The PhL and the AMD provide for criminal liability for infringement of some of the rules regarding labelling, compliance assessment, marketing or failure to perform some duties by the entities responsible for product compliance. In such a situation, enforcement is carried out by the police, public prosecutors and courts.