Overview of Health Market

Commercialisation of healthcare in Poland: overview, Practical Law Country Q&A...
Commercialisation of healthcare in Poland:

overview
by Marcin Matczak, Tomasz Kaczyński and Agata Kruczyk, Domański Zakrzewski Palinka
Sp. k.
Country Q&A | Law stated as at 01-Feb-2018 | Poland
Regulatory overview
Legislation
Regulatory authorities
Private parties
Drugs
Manufacturing
Advertising
Sale
Medical devices
Manufacturing
Advertising
Sale
Biological products
Manufacturing
Advertising
Sale
Natural health products
Manufacturing
Advertising
Sale
Traditional herbal medicinal products
Homeopathic medicinal products
© 2019 Thomson Reuters. All rights reserved. 1

Dietary supplements
Homeopathic medicinal products and traditional herbal medicinal products
Dietary supplements
Dietary supplements
Reform
The regulatory authorities
Ministry of Health
Office for the Registration of Medicinal Products, Medical Devices and Biocides
(Registration Office)
National Health Fund
Main Pharmaceutical Inspector (MPI)
Main Sanitary Inspector (MSI)
Online resources
Internet system of legal acts (ISAP)
Office for the Registration of Medicinal Products, Medical Devices and Biocides
(Registration Office)
Office for Competition and Consumers’ Protection
Main Sanitary Inspectorate (MSI)
English translation of the Pharmaceutical Law
Contributor profiles
Marcin Matczak, Partner
Tomasz Kaczyński, Partner
Agata Kruczyk, Associate, Life Sciences Practice
A Q&A guide to the commercialisation of healthcare in Poland.
This Q&A provides an overview of the regulatory framework for the commercialisation of medical
products in Poland. It covers the key requirements for manufacturing, advertising and selling
drugs, medical devices, biological products and natural health products.
To compare answers across multiple jurisdictions, visit the commercialisation of healthcare

Country Q&A tool.
This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of
jurisdictional Q&As visit global.practicallaw.com/healthcare-guide.
Regulatory overview
1. What is the regulatory framework for medical products?
Legislation
The main laws regulating medical products in Poland are the:
0• Pharmaceutical Law of 6 September 2001, which is the main law regulating the
medicinal products’ market and is largely based on EU law. The Pharmaceutical Law contains
legal provisions concerning medicinal products, homeopathic medicines and traditional
herbal products.
0• Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular
Nutritional Uses and Medical Devices of 12 May 2011, which contains the rules on
reimbursement of medical products.
0• Act on Medical Devices of 20 May 2010, which regulates medical devices.
0• Act on Food Safety and Nutrition and secondary legislation adopted under the Act,
which regulate dietary supplements and foodstuffs for special dietary purposes.
Regulatory authorities
The key institutions regulating the medical products’ market include the:
0• Ministry of Health, which issues decisions on reimbursement of medicinal products.

0• Office for the Registration of Medicinal Products, Medical Devices and Biocides,
which issues decisions on marketing authorisations.
0• National Health Fund, which funds the national healthcare system.
0• Main Pharmaceutical Inspector, which, among other things, supervises the
manufacturing and marketing requirements relating to medicinal products.
0• Main Sanitary Inspector, which is responsible for the supervision of the foodstuff

market (including dietary supplements).
Private parties
The role of private parties in the medical product regulatory system in Poland is limited.
Pharmaceutical sector representatives can participate in the process of developing the law under
public consultation. They can submit informal applications, arguments and opinions.
Pharmaceutical companies are also taking steps for the self-regulation of the sector, including:
0• The adoption of the Code of good marketing practice in the pharmaceutical sector.
0• Co-operation with health service representatives and patients’ organisations.
2. What types of medical products are regulated?
The following types of medical products are regulated:
0• Medicinal products. These are regulated by the Pharmaceutical Law of 6

September 2001, which is largely based on EU law. The Pharmaceutical Law contains legal
provisions on medicinal products, homeopathic medicines and traditional herbal products.
0• Medical devices. These are mainly regulated by the Act on Medical Devices of 20
May 2010.
0• Dietary supplements. Dietary supplements and foodstuffs for special dietary
purposes are regulated by the Act on Food Safety and Nutrition, and secondary legislation
adopted under the Act.
Drugs
3. What are the general requirements for a drug to be manufactured,

advertised and sold?
Under Polish law, separate permits must be obtained for manufacturing/importing and marketing
a drug. There are various requirements to obtain these permits, which are issued by different
entities.

Manufacturing
An entity applying for a manufacturing permit or a permit for the import of a medicinal product
from outside the EU/European Free Trade Area must:
0• File a permit application.

0• Supply details of quality assurance, including fulfilment of good pharmaceutical
manufacturing practice requirements.
0• Have the appropriate premises and technical and control equipment to
manufacture, control and store the medicinal products listed in the application.
0• Hire a qualified person responsible for ensuring that every batch of a medicinal
product has been manufactured and controlled in compliance with all necessary legal
regulations and documents before introducing the particular batch on the market.
Requirements relating to good manufacturing practice are included in:
0• Polish good manufacturing practice.

0• Directive 2003/94/EC on good manufacturing practice for medicinal products (GMP
Directive).
The Main Pharmaceutical Inspector is responsible for granting manufacturing/import permits for
medicinal products.
Advertising
The advertising of medicinal products is regulated by Chapter 4 of the Pharmaceutical Law. An
advertisement for a medicinal product must:
0• Not mislead its recipients.

0• Present the product in an objective manner.
0• Provide information on use of the product.
In addition, the advertising of medicinal products cannot:
0• Involve offering or promising any benefits, either directly or indirectly, in exchange

for purchasing a medicinal product, or providing proof that a medicinal product was
purchased.
0• Be directed at children or contain any element directed at them.
The advertising of a medicinal product involving the free supply of samples can only be directed to
persons authorised to write prescriptions, subject to conditions specified in the law.
It is prohibited to advertise medicinal products that:

0• Are not authorised for marketing.

0• Are marketed without a mandatory marketing authorisation, under specific
regulations.
0• Contain information that is inconsistent with the summary of product
characteristics.
Additionally, advertisements must contain certain data set out in the Advertising Regulation. Such
data must be expressed using wording that complies with the summary of product characteristics.
Content requirements are regulated separately for the advertising of medicinal products aimed at
persons authorised to write prescriptions and advertising aimed at the general public.
The advertising of medicinal products can only be conducted by the marketing authorisation
holder (see below, Sale) or on its instructions. The MPI is responsible for supervising compliance
with advertising regulations. In the case of breach of legal provisions on advertising, the MPI can,
by way of a decision, order:
0• Cessation of the infringement.

0• Discontinuation of particular advertisements.
0• Publication of the decision in places where the advertisement was shown, together
with a correction of the advertisement.
In addition, the Polish Employers’ Union of Innovative Pharmaceutical Companies (INFARMA) has
issued a self-regulating Code of Good Marketing Practices of the Pharmaceutical Industry with
detailed provisions on the advertising of medicinal products. The Code provides that clinical
assessments and post-marketing monitoring programmes, analysis and authorisation studies
(among others) cannot constitute a hidden advertisement. The Code also regulates the procedure
for providing free product samples.
Sale
To market a medicinal product, a person must apply for a marketing authorisation from the
President of the Office for the Registration of Medicinal Products, Medical Devices and Biocides
(Registration Office). Applications for authorisation are subject to a fee.
To obtain a marketing authorisation, the applicant must file the appropriate application form, with
all elements and documents required under the Pharmaceutical Law, including details of the
packaging, accompanying leaflet and the results of adequate clinical and non-clinical trials. Under
the Pharmaceutical Law, the Registration Office can order a pre-registration control of the place of
manufacture.
Medical products can also be introduced on the market under the centralised procedure in
accordance with Regulation (EC) 726/2004 on the authorisation and supervision of medicinal
products and establishing a European Medicines Agency (EMA Regulation) (see Question 6).
A marketing authorisation is issued for a period of five years.

Products that do not require a marketing authorisation include:
0• Medicinal products intended for clinical trials.

0• Medicinal products used by manufacturers.
0• Pharmaceutical raw materials.
There are no provisions on compassionate use in Poland, as defined under the EMA Regulation.
However, there are extraordinary procedures for introducing medicinal products on the Polish
market, including:
0• Direct import of a specific medicinal product when a patient’s life or health is in

danger, and other treatment methods available on the market are not effective.
0• Conditional authorisation granted by the European Commission in the case of a
disease for which only a small number of therapies are available on the market, when full
clinical data is not yet available.
0• In cases of natural disaster or other danger to the life and health of the population,
and the Minister of Health authorises the import of a medicinal product, subject to the
conditions specified in the Pharmaceutical Law.
4. Are there different requirements for patented and generic drugs?
Although there is no specific legislation on generic drugs, there are certain separate rules for this
category of medicines. The Pharmaceutical Law sets out a streamlined procedure for marketing
authorisations of generic drugs. Under this procedure, reports on mandatory trials are not
required when applying for marketing authorisation, provided that the reference medicinal
product has already received such authorisation.
5.What authority is responsible for regulating the manufacture,

advertising and sale of drugs?
As mentioned in Question 3, there are various procedures for issuing marketing authorisation and
manufacturing permits. Therefore, a number of institutions monitor medicinal products at each
stage of commercialisation, from the production line to the time they are transferred to end-users.

The authority responsible for issuing marketing authorisations for drugs is the President of the
Office for the Registration of Medicinal Products, Medical Devices and Biocides (Registration
Office). Before issuing (or refusing to issue) a marketing authorisation, the President of the
Registration Office can order a medicinal product to be tested and can obtain an opinion of the
Commission for Medicinal Products.
The sale and advertising of medicinal products that obtained a marketing authorisation are
supervised by bodies operating under the State Pharmaceutical Inspectorate, including the Main
Pharmaceutical Inspector (MPI) and regional Pharmaceutical Inspectors. The duties of the State
Pharmaceutical Inspectorate include:
0• Inspecting the conditions in which drugs are manufactured and verifying that they
are imported in accordance with the requirements of good manufacturing practice, and
inspecting the conditions of transport, reloading and storage of medicinal products.
0• Inspecting the quality of medicinal products that are sold on the market.
0• Inspecting pharmacies and other entities conducting retail and wholesale trade in
medicinal products.
0• Inspecting the quality of prescription and over-the-counter drugs prepared in
pharmacies.
0• Inspecting the proper labelling and advertising of medicinal products.
0• Inspecting intoxicating and psychotropic substances that are traded on the market.
0• Giving opinions on the suitability of premises designated as a pharmacy, warehouse
or non-pharmacy trade outlet.
0• Keeping a register of generally accessible hospital pharmacies and pharmacy
outlets.
0• Keeping a register of pharmaceutical warehouses and pharmaceutical
manufacturing plants.
Under new amendments to the Pharmaceutical Law, the MPI has new powers to supervise exports
of medicinal products from Poland. These new rules require wholesalers wishing to export
medicinal products from Poland to obtain export clearance from the MPI. The MPI can impose
fines for non-compliance.
For more information on the MPI and Registration Office see box: The regulatory authorities.
6. Are there fewer or different requirements for drugs that have already
been licensed or approved in another jurisdiction?
Foreign marketing authorisations can be recognised in Poland under the following procedures:

0• Centralised procedure. This procedure enables a product to be marketed in all EU

member states at once. The European Commission issues marketing authorisations on
examination of the application by the European Medicines Agency (currently based in
London). The centralised procedure is compulsory for medicinal products for human use that
are:
0• used for the treatment of HIV/AIDS, malignant tumours, diabetes,
neurodegenerative disorders, autoimmune diseases and other immune dysfunctions and
viral diseases;
0• generated through biotechnological processes;
0• used in advanced therapy (for example, gene therapy); and
0• orphan medicines used for the treatment of rare diseases.
0• Decentralised procedure.This procedure applies where a medicinal product is
marketed in the EU and the applicant applies for registration in another member state. The
President of the Office for the Registration of Medicinal Products, Medical Devices and
Biocides (Registration Office) must issue a marketing authorisation within 30 days after
acknowledging an assessment report prepared by the relevant body of the reference country.
0• Mutual recognition procedure. Under this procedure, a previously unregistered
product is registered in a member state specified as the reference state and subsequently
registered in secondary member states where the applicant wants the product to be
marketed. This procedure is used as an alternative to the centralised procedure (see above),
and enables a product to be registered in selected member states at the same time. The
President of the Registration Office must issue a marketing authorisation within 30 days after
acknowledging an assessment report prepared by the relevant body of the reference country.
In addition, it is possible to introduce medicinal products on the Polish market through direct
import, conditional authorisation or in emergency situations (see Question 3, Sale).
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?
The sale and purchase of medicinal products from abroad is permitted once the conditions set out
in the Pharmaceutical Law are met.
The Pharmaceutical Law allows the import of medicinal products, which is defined as any step
taken to import a prepared medicinal product from non-EU member states and countries outside
the European Free Trade Area (EFTA). Importing medicinal products requires a permit from the
President of the Office for the Registration of Medicinal Products, Medical Devices and Biocides
(Registration Office).
The purchase of medicinal products from EU/EFTA wholesalers or manufacturers is possible once
a wholesale permit has been obtained from the Main Pharmaceutical Inspector (MPI) by a Polish
wholesaler. An undertaking wishing to operate a wholesale warehouse must apply for a permit. A
fee is charged for issuing such permits.
An undertaking that operates a pharmaceutical wholesale warehouse must:
0• Have facilities enabling the proper conduct of wholesale trade.

0• Employ a qualified person as warehouse manager.
0• Meet other requirements set out in Article 78 of the Pharmaceutical Law.
Polish pharmacies can obtain supplies of medicinal products from wholesale warehouses within
the EU and EFTA. The operation of a generally accessible pharmacy requires a permit to run a
pharmacy. The Regional Pharmaceutical Inspector is the authority responsible for awarding,
amending, withdrawing or confirming the expiry of a permit to run a pharmacy.
Undertakings operating wholesale warehouses within the EU and EFTA can also import medicinal
products through parallel imports. Parallel import requires a permit issued by the President of the
Registration Office. The permit is issued for a period of five years and is subject to payment of a
fee. Once a parallel import permit is obtained, the entity authorised to import must inform the
following entities of the anticipated date of marketing of the medicinal product in Poland at least
30 days before the planned date of marketing:
0• MPI.
0• President of the Registration Office.
0• Marketing authorisation holder in Poland.
Not all medicinal products can be imported by means of parallel import. A product imported under
this procedure must fulfil all the following conditions:
0• The imported product must have the same active substance (or at the very least the
same medical indications), strength, means of administration and form as a medicinal product
with a marketing authorisation in Poland, or a similar form (with no therapeutic differences)
to that of a medicinal product with a marketing authorisation in Poland.
0• The imported product and medicinal product with a marketing authorisation in
Poland must be reference medicinal products or equivalents of a reference medicinal product
in both the country of import and Poland.
Medicinal products that have obtained a parallel import permit do not require a marketing
authorisation from the President of the Registration Office.
Recent amendments to the Pharmaceutical Law set out new rules relating to export controls over
medicinal products. The amendments require any wholesaler to notify the MPI of its intention to
export medicines or sell medicinal products to an entity operating abroad. The MPI can, within 30
days of the notification, object to such export or sale of medicinal products. If the MPI does not
object within this deadline, the export or sale will be cleared. If the MPI objects to the export or
sale, the wholesaler will be obliged to sell the products in Poland in the same quantity as stated in
the notification. Additionally, a wholesaler that has sold medicinal products abroad must inform
the MPI of such sale within seven days. If a wholesaler does not comply with these obligations, the
MPI can:
0• Withdraw the wholesaler’s permit to operate.

0• Impose fines specified in the Pharmaceutical Law.
8. Is it permitted to advertise drugs to consumers? Are there restrictions

on advertising?
The advertising of medicinal products is mainly regulated by Chapter 4 of the Pharmaceutical Law.
Medicinal products that cannot be advertised to consumers are those that:
0• Are available on medical prescription only.

0• Contain psychotropic or narcotic substances.
0• Have been placed on the lists of reimbursed medicines in accordance with specific
regulations and can be dispensed over the counter with a name identical to those on such
lists.
0• Have a name identical to that of a prescription-only medicinal product.
Preventive vaccinations specified in a communication from the Main Pharmaceutical Inspector

(MPI) can be advertised to consumers.
The Ministry of Health Regulation of 21 November 2008 on the advertising of medicinal products
governs, among other things:
0• The terms and conditions for advertising a medicinal product.

0• The form of the advertisement and the data that it must contain.
0• How the advertisement will be circulated.
These provisions implement Directive 2004/27/EC on the Community code relating to medical
products for human use.
The general rules relating to advertising under the Act on Combating Unfair Competition 1993
also apply.
The MPI monitors compliance with the rules on medicinal product advertising. In cases of breach,
the MPI can order a person to:
0• Cease the medicinal product advertising.

0• Display the decision establishing the breach in the places where the advertisement
was shown, and publish a correction.
0• Rectify the breach.
Medical devices
9. What is the definition of medical device in your jurisdiction?
The definition of medical device is set out in the Act on Medical Devices, which provides that a
medical device is any instrument, apparatus, appliance, software, material or other article, used
alone or in combination, together with any software intended by its manufacturer to be used
specifically for diagnostic or therapeutic purposes and necessary for its proper application. The
factor that determines whether a product is a medical device is the intention of the manufacturer
for the device to be used on human beings for any of the following purposes:
0• Diagnosis, prevention, monitoring, treatment or alleviation of disease.

0• Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or
handicap.
0• Investigation, replacement or modification of the anatomy or of a physiological
process.
0• Control of conception.
Additionally, the device must not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but may be assisted in its function by such
means
Under the Pharmaceutical Law, a medicinal product is a substance or combination of substances

that is either:
0• Presented as having properties for treating or preventing disease in human beings

or animals.
0• Administered with a view to making a medical diagnosis or to restoring, correcting
or modifying physiological functions in an organism by pharmacological, immunological or
metabolic action.
Therefore, a product is held to be a medicinal product if it is presented as having therapeutic or

preventive properties.
While there are no specific legislative provisions on differentiating between medical devices and

medicinal products, the main difference is the mechanism through which they achieve their
therapeutic or preventive purpose. In the case of medical devices, the mechanisms are usually
physical or mathematical in nature, whereas in the case of medicinal products the mechanisms are
pharmacological, immunological or metabolic. The European Commission has issued Guidelines
relating to the demarcation between Directive 90/385/EEC on active implantable medical devices,
Directive 93/42/EEC on medical devices and Directive 65/65/EEC relating to medicinal products
and related directives (MEDDEV.2.1/3 Rev. 5.1 – March 1998), which may be helpful in assessing
whether a product is a medical device or a medicinal product.
There is no procedure to obtain a decision from the regulatory authority as to whether a product is
a medicinal product or a medical device.
10. What are the general requirements for a medical device to be

manufactured, advertised and sold?
Manufacturing
Medical devices must satisfy various requirements set out in the Act on Medical Devices, including
basic requirements regarding design, manufacturing, packaging and labelling. A medical device
must be marked appropriately with the CE mark. The introduction of particular medical devices on
the market is subject to prior notification to the President of the Office for the Registration of
Medicinal Products, Medical Devices and Biocides (Registration Office).
Advertising
The advertising of medical devices is mainly regulated by the Act on Medical Devices. Unlike for
drugs, the Act on Medical Devices does not contain a specific definition of what constitutes
advertising of medical devices, nor a list of permitted forms of advertising. Therefore, the
advertising of medical devices must also be conducted in accordance with general rules, including
the:
0• Act on Combating Unfair Competition 1993.

0• Act on Combating Unfair Commercial Practices 2007.
See also Question 14.
Sale
To market a medical device, the manufacturer or authorised representative must notify the

President of the Registration Office 14 days before the planned date of marketing. Introduction
into use of the device also requires notification. In certain cases, a notified body authorised by the
Minister of Health can decide whether a medical device complies with the requirements for
marketing and use.
Distributors and importers that have their place of residence or registered office in Poland, and
which have marketed a product intended for use in Poland, must notify the President of the
Registration Office of this fact immediately, and at the latest within seven days from the date the
first product is marketed in Poland.
The President of the Registration Office conducts a “negative” supervision, meaning that he/she
can issue decisions prohibiting the trade or use of a given medical device rather than issuing
authorisations.
By way of an exception, the President of the Registration Office can allow the marketing or
introduction into use of a medical device in Poland for which compliance assessment procedures
have not been performed if that device is necessary for specified preventative, diagnostic or
therapeutic purposes.
A medical device that fails to meet the requirements set out in the Act on Medical Devices can be
presented at fairs, exhibitions, demonstrations, presentations and scientific or technical
symposiums, provided that it:
0• Is not used to collect or test samples collected from participants to such events.
0• Includes information stating that it cannot be marketed or used until the
requirements set out in the Act on Medical Devices are met.
11. What authority is responsible for regulating the manufacture,

advertising and sale of medical devices?
The President of the Office for the Registration of Medicinal Products, Medical Devices and
Biocides (Registration Office) is the authority responsible for supervising the marketing and use of
medical devices.
The President of the Registration Office co-operates with other public authorities, including the
Main Pharmaceutical Inspector (MPI) and the Main Sanitary Inspector. These authorities must
inform the President of the Registration Office of any known improprieties relating to medical
devices.
For more information on the President of the Registration Office and the MPI see box: The
regulatory authorities.

12. Are there fewer or different requirements for medical devices that
have already been licensed/approved in another jurisdiction?
There are fewer requirements regarding the notification obligation (see Question 10, Sale) for
medical devices that have already been marketed in another jurisdiction. In the case of the
introduction of a medical device into use, the importer or distributor must notify the President of
the Registration Office of this fact within seven days of the date of introduction, whereas a first
introduction requires notification to the President 14 days before the introduction.
13. Is it possible to sell devices to or buy devices from other jurisdictions?
In principle, it is possible to sell or buy devices from other jurisdictions. Imported medical devices
must satisfy the same requirements as devices manufactured in Poland. A manufacturer that does
not have its place of residence or registered office in an EU member state and which markets a
product under a trade name must appoint an authorised representative for this product. An
authorised representative is an entity that has its registered office in a member state and with
which member state authorities can correspond regarding the manufacturer’s duties set out in the
Act on Medical Devices.
A distributor is an entity that supplies or makes a product available following its marketing within
the EU. An importer is an entity that markets a product originating from non-EU member states.
Importers and distributors must act with due care to ensure the safety of products. In particular,
they must not supply or make available devices that they know or should know, based on the
information and professional experience they hold, do not meet the requirements of the Act on
Medical Devices. Such entities must verify whether the devices they market, introduce into use,
supply or make available are properly labelled and have appropriate instructions for use. In
addition, they must co-operate with the President of the Office for the Registration of Medicinal
Products, Medical Devices and Biocides (Registration Office), for example, with regards to
monitoring the safety of medical devices.
Before marketing a product, an importer must verify whether:
0• The manufacturer or authorised representative has conducted the proper procedure

to assess the product’s compliance.
0• The manufacturer has appointed an authorised representative for the product.

0• The device is labelled with the CE mark and the identification number of the notified
entity that participated in the compliance assessment (if relevant).
0• The information provided by the manufacturer satisfies the basic requirements of
the Act on Medical Devices.
An importer with its place of residence or registered office in Poland must hold and keep, among
other things, a copy of the compliance declaration and copies of compliance certificates for a
period of five years from the date the device is marketed, and make such documents available to
the President of the Registration Office on request. During customs clearance of a device, the
importer must submit copies of the necessary documents, including compliance declarations and
compliance certificates.
In addition, the recent amendments to the Pharmaceutical Law regarding the supervision of the
export or sale of medicinal products also apply to medical devices (see Question 7). Therefore, any
wholesaler must notify the Main Pharmaceutical Inspector (MPI) of its intention to export or sell
medical devices to an entity operating abroad. The MPI can, within 30 days of the notification,
object to such export or sale. If the MPI does not object within this deadline, the export or sale will
be cleared. If the MPI objects, the wholesaler will be obliged to sell the products in Poland in the
same quantity as stated in its notification.
14. Is it permitted to advertise medical devices to consumers? Are there

restrictions on advertising?
It is permitted to advertise medical devices to the public. The advertising of a medical device
cannot mislead recipients by (Act on Medical Devices):
0• Attributing to it properties, functions and actions that it does not possess.

0• Creating the false impression that therapy or diagnosis using the product will
definitely be successful.
0• Failing to provide information on the expected risk associated with use of the device
in accordance with its anticipated period of use, or a period longer than expected.
0• Suggesting administration or properties other than those declared when performing
the compliance assessment.
The general rules on advertising under the Act on Combating Unfair Competition 1993 and the Act
on Combating Unfair Commercial Practices 2007 also apply.
Biological products
15. What are the general requirements for a biological product to be

Manufacturing
The manufacturing/import of biological products requires a permit issued by the Main
Pharmaceutical Inspector (MPI). The procedure is the same as for medicinal products (see
Question 3, Manufacturing).
The requirements for registration through the centralised procedure are set out in detail in the
guidelines issued by the European Medicines Agency (EMA) (see Question 6).
The requirements concerning clinical trials are set out in the Pharmaceutical Law, which
implements EU legislation. In principle, requirements are uniform for all medicinal products.
Advertising
Requirements for the advertising of biological products are the same as for other medicinal
products (see Question 3, Advertising).
Sale
Rules on the registration of biological products vary depending on the type of product. In
principle, biological medicinal products can be marketed once they have been approved under the
centralised procedure by the European Commission through the EMA, in accordance with
Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and
establishing a European Medicines Agency (EMA Regulation).
Biological products that are subject to the mandatory centralised procedure are set out in Annex 1
to the EMA Regulation. If a biological product is not required to be registered centrally, it can
receive a marketing authorisation from the competent national authority (that is, the President of
the Office for the Registration of Medicinal Products, Medical Devices and Biocides). The national
procedure is the only procedure for biological products made from human blood or plasma. Under
the Pharmaceutical Law, blood products must pass an initial batch control before they can be
placed on the market.


advertising and sale of biological products?
The national authorities have exclusive jurisdiction for regulating the manufacture, advertising
and sale of biological products. The Main Pharmaceutical Inspector (MPI) is responsible for
supervision over these areas. The President of the Office for the Registration of Medicinal
Products, Medical Devices and Biocides (Registration Office) is competent for issuing marketing
authorisations. However, the manufacture of biological products that must be introduced into
trade under the centralised procedure is supervised by the European Medicines Agency (EMA).
For more information on the Registration Office and the MPI see box: The regulatory authorities.
17. Are there fewer or different requirements for biological products that
have already been licensed/approved in another jurisdiction?
There are no different requirements for biological products that have already been
licensed/approved in another jurisdiction. The legislation of member states has been harmonised
in accordance with EU legislation.
18. Is it possible to sell biological products to or buy biological devices

from other jurisdictions?
It is possible to sell biological products to, or buy biological products from, other jurisdictions on
the same basis as for other drugs (see Question 7).
19. Is it permitted to advertise biological products to consumers? Are

there restrictions on advertising?
The rules are the same as for other drugs (see Question 3 and Question 8).
Natural health products
20. Is there a category for natural health products (including, for example,
traditional medicines, homeopathic medicines, supplements, vitamins and
minerals)?
There is no concept of natural health products under Polish law. However, the following categories
are recognised:
0• Traditional herbal medicinal products. These are recognised in the

Pharmaceutical Law as a particular type of medicinal product, and are subject to specific
rules, particularly regarding marketing authorisations.
0• Homeopathic medicinal products. These are a particular type of medicinal
product that are subject to different rules on marketing (simplified procedure).
0• Dietary supplements. These include supplements, vitamins and minerals and are
subject to numerous rules under various national regulations and directly applicable EU
legislation.
21. What are the general requirements for natural health products to be
Manufacturing
Traditional herbal medicinal products. The same requirements apply as for other medicinal
products (see Question 3, Manufacturing).
Homeopathic medicinal products. The same requirements apply as for other medicinal
products (see Question 3, Manufacturing).
Dietary supplements. Approval of the State County Sanitary Inspector or the State Border
Sanitary Inspector is required to manufacture:
0• Dietary supplements.
0• Foodstuffs for particular nutritional uses (for example, infant formula and follow-on
formula, dietary foods for special medical purposes and foodstuffs for persons who are gluten-
intolerant).
Production plants for fortified foods must also be approved by the State County Sanitary Inspector
or the State Border Sanitary Inspector.
Obtaining manufacturing approval for dietary supplements is much simpler and faster than
obtaining a permit to manufacture medicinal products. Manufacturers must also apply for entry on
the register of production plants.
Advertising
Traditional herbal medicinal products. The same requirements apply as for other medicinal
Homeopathic medicinal products. The same requirements apply as for other medicinal
Dietary supplements. The advertising of dietary supplements is subject to specific rules under
the following instruments:
0• Act on Food Safety and Nutrition.

0• Ministry of Health Regulation of 9 October 2007 on the composition and labelling of
dietary supplements.
0• Regulation (EC) 178/2002 on the general principles and requirements of food law
and establishing the European Food Safety Authority.
Any nutritional or health claims must comply with the requirements set out in Regulation (EC)
1924/2006 on nutrition and health claims made on foods.
Sale
Traditional herbal medicinal products. Because of their specific properties, these are subject
to the simplified marketing authorisation procedure, regulated mainly by Directive 2004/24/EC on
traditional herbal medicinal products and the Pharmaceutical Law. There is only a national
marketing authorisation procedure for these products. The registration can be processed without

safety tests and clinical trials. The applicant must only provide sufficient evidence of the medicinal
use of the product throughout a period of at least 30 years, including at least 15 years in the EU.
The President of the Office for the Registration of Medicinal Products, Medical Devices and
Biocides (Registration Office) must recognise the registration of traditional herbal medicinal
products granted by other member states whenever it is based on the EU list of herbal substances
and preparations. The decentralised procedure or mutual recognition procedure apply if either:
0• The components of a traditional herbal medicinal product are on the EU list.

0• There is a community monograph for the product.
Homeopathic medicinal products. Like any other medicinal product, homeopathic products
must obtain a marketing authorisation to be sold legally. A marketing authorisation can be
obtained following the submission of an application together with the documentation required by
Article 10 of the Pharmaceutical Law, and with results, summaries and reports of the following
tests:
0• Physico-chemical, biological or microbiological tests.

0• Non-clinical tests: pharmaceutical and toxicological tests.
0• Clinical tests.
However, the full procedure only applies to homeopathic medicinal products that have specified
medicinal indications (that is, which contain information about the medical designation of the drug
and have not yet been applied in therapy, or have not been described in medical literature).
Additionally, there is a specific streamlined registration procedure for homeopathic medicinal

products meeting certain conditions under Article 21 of the Pharmaceutical Law. This can be
applied to homeopathic products that:
0• Are administered orally or externally.

0• Do not contain indications regarding applications on the label or leaflet.
0• Are characterised by the appropriate level of dilution guaranteeing safety of use,
(that is, they must contain no more than 1/10,000 of the parent solution or no more than
1/100 of the smallest dose of active substance contained in a medicinal product issued under
prescription in Poland).
Applications for marketing authorisation under the streamlined procedure require fewer
documents and do not require evidence of therapeutic effectiveness.
Dietary supplements. The marketing of dietary supplements is regulated by the Act on Food
Safety and Nutrition. An entity marketing a dietary supplement for the first time must notify the
Main Sanitary Inspector (MSI) by completing an electronic form available on the MSI’s website.
After receiving notification, the MSI can conduct proceedings to clarify whether a product:
0• Complies with the declared classification.

0• Satisfies the requirements for a given foodstuff.

If such proceedings are conducted, the MSI can either:
0• Obtain the opinion of the Dietary Supplements Unit operating under the Sanitary
and Epidemiology Committee.
0• Require the inspected entity to submit an opinion from a scientific entity or an
opinion of the Registration Office.
Notification to the MSI is also required for dietary foods for special medical purposes.

advertising and sale of natural health products?
For traditional herbal medicinal products and homeopathic medicinal products:
0• The Main Pharmaceutical Inspector (MPI) is responsible for granting manufacturing

permits.
0• The President of the Office for the Registration of Medicinal Products, Medical
Devices and Biocides (Registration Office) is responsible for issuing (and withdrawing)
marketing authorisations, and for conducting inspections.
For dietary supplements:
0• The Main Sanitary Inspector (MSI) and the Regional Sanitary Inspectors are
responsible for issuing manufacturing permits.
0• The MSI is responsible for supervising trade and advertising. The MSI can also
obtain the opinions of other bodies, or order a manufacturer to obtain and submit an opinion.
For more information on the MPI, MSI and Registration Office see box: The regulatory authorities.
23. Are there fewer or different requirements for natural health products
that have already been licensed or approved in another jurisdiction?
Traditional herbal medicinal products

It is easier to obtain a marketing authorisation for traditional herbal medicinal products that have
been used for a period of at least 30 years before the date of the application, including at least 15
years in an EU member state, or a member state of the European Free Trade Area (EFTA) or
European Economic Area (EEA) (see Question 21, Sale).
Although there is also a procedure for granting marketing authorisations to products that have
been used in EU or EFTA member states for less than 15 years, this procedure takes longer and is
less convenient for the manufacturer.
Homeopathic medicinal products

The procedure for registering homeopathic medicinal products is streamlined for products that
satisfy certain requirements. However, there are no additional benefits for products that have
been approved in another jurisdiction. In such a case, the general procedure applies.
See also Question 21, Sale.
Dietary supplements
Dietary supplements and foodstuffs for particular nutritional uses that do not meet the
requirements for marketing authorisation can be authorised if they were either (Article 6(3), Act
on Food Safety and Nutrition):
0• Manufactured or marketed in another EU member state in accordance with the law

of that country.
0• Manufactured in the EFTA or EEA, or marketed in Turkey in accordance with the
law of such countries provided that they:
0• benefit from provisions on free movement of goods under agreements entered into
with the EU; and
0• do not constitute a risk to human health or life.
24. Is it possible to sell natural health products to or buy natural health

products from other jurisdictions and/or electronically?

The rules are the same as for other medicinal products (see Question 7).
It is possible to sell homeopathic and traditional herbal medicinal products electronically, although
the Pharmaceutical Law prohibits the electronic sale of prescription medicinal products. More
specific rules are set out in the Ministry of Health Regulation of 23 March 2015 on the mail order
sale of medicinal products.
Dietary supplements
Dietary supplements imported from EU countries can be marketed in Poland under the principle of
free movement of goods, provided that they meet the requirements applicable to dietary
supplements produced in Poland (see Question 21, Sale).
Importing dietary supplements from third countries is also permitted, although they must also
satisfy the requirements applicable to dietary supplements produced in Poland. In addition,
dietary supplements imported from third countries are subject to sanitary border controls.
Sanitary border controls can also be applied to dietary supplements imported from the EU. These
controls are undertaken on the basis of an application of an entity trading similar goods on the
market, or on the basis of a notice by customs authorities.
Electronic sales of dietary supplements are legal in Poland.
25. Is it permitted to advertise natural health products to consumers? Are

there restrictions on advertising?

The same restrictions apply as for other medicinal products (see Question 8). However, the
advertising of traditional herbal medicinal products must be accompanied by a notice stating: “A
traditional herbal medicinal product with certain indications arising exclusively from long-term
use” (Regulation of the Minister of Heath regarding the advertising of medicinal products).
Dietary supplements
The Act on Food Safety and Nutrition provides that the labelling of dietary supplements cannot:
0• Mislead consumers, in particular:

0• regarding the characteristics of a foodstuff, including its name, type, properties,
composition, amount, longevity, source or place of origin, methods of manufacture or
production;
0• by attributing the foodstuff actions or properties that it does not possess; or
0• by suggesting that the foodstuff has particular properties, if all similar foodstuffs

have such properties.

0• Attribute the foodstuff properties for preventing or curing diseases or refer to such
properties, or contain nutritional or health statements inconsistent with Regulation (EC)
1924/2006 on nutrition and health claims made on foods.
In addition, the labelling, presentation and advertising of dietary supplements cannot contain
information asserting or suggesting that a balanced and varied diet cannot provide sufficient
amounts of nutritional components for the organism (Act on Food Safety and Nutrition).
Preventing producers from including such messages is part of the policy intended to promote
healthy eating habits among citizens and to reduce the irrational consumption of dietary
supplements.
Manufacturers of dietary supplements must also market, present and advertise their products
under the name “dietary supplement”. This name cannot be replaced by an (invented) trade name.
However, it is permitted to use a trade name with the name “dietary supplement” immediately
next to it. This restriction aims to prevent consumers from confusing dietary supplements with
medicinal products.
Reform
26. Are there any plans to reform the rules on the development,
manufacture, advertising and sale of medical products?
Recent and proposed reforms include the following:
0• A significant reform of the regulations on pharmacies. The reform changed the

prerequisites necessary for opening a pharmacy, including the requirement that new
pharmacies can only be opened by pharmacists and a cap of four pharmacies held by one
entity. The changes came into force on 25 June 2017.
0• A full implementation of the Integrated System for the Monitoring of Trade in
Medicinal Products (ISMTMP), which is planned for 2018. A marketing authorisation holder
(MAH) will be required to upload the following information to the ISMTMP:
0• each release of a batch of a medicinal product placed on a list of products that may
become unavailable in Poland, along with information on the batch number, expiry date
and size;
0• each sale of any medicinal product to a business undertaking operating a
pharmaceutical wholesaler, a hospital pharmacy or a hospital formulary department, a
hospital, a treatment centre or another business undertaking;

0• stock levels of all medicinal products; and

0• planned deliveries of any medicinal products intended for sale in Poland, and the
number of unit packages and planned places of delivery.
1• The Ministry of Health has postponed the implementation of the ISMTMP following
an appeal from MAHs.
The regulatory authorities
Ministry of Health
W www.mz.gov.pl/en
Principal responsibilities. The Ministry of Health issues decisions on the

reimbursement of medicinal products.
Office for the Registration of Medicinal Products, Medical Devices and

Biocides (Registration Office)
W http://urpl.gov.pl/pl
Principal responsibilities. The Registration Office issues decisions on marketing

authorisations.
National Health Fund

W www.nfz.gov.pl
Principal responsibilities. The National Health Fund funds the national healthcare
system.

W www.gif.gov.pl

Principal responsibilities. The MPI supervises medicinal product manufacturing and

marketing requirements (among other things).
Main Sanitary Inspector (MSI)

W http://gis.gov.pl/?go=news
Principal responsibilities. The MSI is responsible for the supervision of the foodstuff
market (including dietary supplements).
Online resources
Internet system of legal acts (ISAP)

W http://isap.sejm.gov.pl/
Description. This website is maintained by the lower chamber of the Polish

parliament (Sejm). ISAP contains bibliographic and legal texts published in official
publications, including the Journal of Laws and the Polish Monitor issued by the Prime
Minister. Legal texts are available in Polish only.

W www.gif.gov.pl/pl/decyzje-i-komunikaty/decyzje/decyzje
Descrption. The official website of the MPI provides access to decisions of the MPI
(available in Polish only). The English version of the website does not provide access to
decisions (www.gif.gov.pl/en).

Office for the Registration of Medicinal Products, Medical Devices and

Biocides (Registration Office)
W http://urpl.gov.pl/pl
Description. The official website of the Registration Office provides access to acts,
rules and guidelines regarding the procedures for registration of medicinal products.
Office for Competition and Consumers’ Protection

W https://uokik.gov.pl/home.php
Description. The official website of the Office for Competition and Consumers’
Protection provides access to the main European and Polish legal competition
regulations (in English).
Main Sanitary Inspectorate (MSI)

W http://gis.gov.pl/?go=news
Description. The official website of the MSI provides access to the acts, rules and
guidelines regarding the marketing of food products.
English translation of the Pharmaceutical Law

W www.gif.gov.pl/download/3/5000/PharmaceuticalLaw-June2009.pdf
Description. The translation does not include the latest version (May 2015) of the
Law. Translations of the Act on Reimbursement of Medicines, Foodstuffs Intended for
Particular Nutritional Purposes and Medical Devices are not available online.

Contributor profiles
Marcin Matczak, Partner
Domański Zakrzewski Palinka Sp. k.
T +48 22 557 86 28
F +48 22 557 76 01
E Marcin.Matczak@dzp.pl
W www.dzp.pl
Professional qualifications. Poland, Legal adviser
Areas of practice. Pharmaceutical and biotechnology law; competition law;

administrative law; advertising law; food law; medical law; constitutional law.
Non-professional qualifications. Professor, Warsaw University
Languages. Polish, English, German
Professional associations/memberships. Member of the District Chamber of Legal

Advisers in Warsaw.
Publications. Author of over 40 academic publications, including two monographs.
0• Matczak M., Lobbing w Unii Europejskiej. Reprezentowanie interesów

gospodarczych po akcesji [Lobbying in the EU. Representation of business
interests after accession], Warsaw 2003.
0• Matczak M., Ramy prawne funkcjonowania koszyka świadczeń
gwarantowanych i prywatnych ubezpieczeń zdrowotnych [Legal framework for

the functioning of baskets of guaranteed benefits and private healthcare

insurance] [in:] Ubezpieczenia zdrowotne a koszyki świadczeń [Healthcare
insurance and benefit baskets]. Przegląd rozwiązań, W.P. Kalbarczyk, K. Łanda, M.
Władysiuk (ed.), Kraków/Warsaw 2011.
0• Matczak M., Czarnuch M., Kaczyński T., Poland – Law & Practice [w:]
Legal Practice Guides. Life Sciences 2015, wyd. Chambers & Partners.
Tomasz Kaczyński, Partner
Domański Zakrzewski Palinka Sp. k.
T +48 22 557 86 53
F +48 22 557 76 01
E Tomasz.Kaczynski@dzp.pl
W www.dzp.pl
Professional qualifications. Poland, Legal adviser
Areas of practice. Pharmaceutical and biotechnology law; competition law;

administrative law; advertising law; food law.
Languages. Polish, English
Professional associations/memberships
0• Member of the District Chamber of Legal Advisers in Warsaw.

0• Expert Council Member in the Polish Council for Supplements and
Nutritional Foods (KRSiO).
Publications. Matczak M., Czarnuch M., Kaczyński T., Poland – Law & Practice [in:]

Legal Practice Guides. Life Sciences 2015, wyd. Chambers & Partners.
Agata Kruczyk, Associate, Life Sciences Practice
Domanski Zakrzewski Palinka Sp. K.
T +48 22 557 76 67
F +48 22 557 76 01
E agata.kruczyk@dzp.pl
W www.dzp.pl
Professional qualifications. Poland, Legal adviser trainee; UK, lawyer
Areas of practice. Pharmaceutical and biotechnology law; medical devices;

healthcare entities law; data protection; product liability.
Languages. Polish, English, Czech, German
END OF
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Commercialisation of healthcare in Poland: overview, Practical Law Country Q&A...

Commercialisation of healthcare in Poland:

Country Q&A | Law stated as at 01-Feb-2018 | Poland

© 2019 Thomson Reuters. All rights reserved. 1

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare

© 2019 Thomson Reuters. All rights reserved. 2

Country Q&A tool.

1. What is the regulatory framework for medical products?

0• Ministry of Health, which issues decisions on reimbursement of medicinal products.

© 2019 Thomson Reuters. All rights reserved. 3

market (including dietary supplements).

2. What types of medical products are regulated?

The following types of medical products are regulated:

0• Medicinal products. These are regulated by the Pharmaceutical Law of 6

3. What are the general requirements for a drug to be manufactured,

© 2019 Thomson Reuters. All rights reserved. 4

0• File a permit application.

Requirements relating to good manufacturing practice are included in:

0• Polish good manufacturing practice.

0• Not mislead its recipients.

In addition, the advertising of medicinal products cannot:

0• Involve offering or promising any beneﬁts, either directly or indirectly, in exchange

It is prohibited to advertise medicinal products that:

© 2019 Thomson Reuters. All rights reserved. 5

0• Are not authorised for marketing.

0• Cessation of the infringement.

A marketing authorisation is issued for a period of ﬁve years.

© 2019 Thomson Reuters. All rights reserved. 6

Products that do not require a marketing authorisation include:

0• Medicinal products intended for clinical trials.

0• Direct import of a speciﬁc medicinal product when a patient’s life or health is in

4. Are there different requirements for patented and generic drugs?

5.What authority is responsible for regulating the manufacture,

© 2019 Thomson Reuters. All rights reserved. 7

© 2019 Thomson Reuters. All rights reserved. 8

0• Centralised procedure. This procedure enables a product to be marketed in all EU

7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

An undertaking that operates a pharmaceutical wholesale warehouse must:

0• Have facilities enabling the proper conduct of wholesale trade.

0• Withdraw the wholesaler’s permit to operate.

8. Is it permitted to advertise drugs to consumers? Are there restrictions

Medicinal products that cannot be advertised to consumers are those that:

0• Are available on medical prescription only.

Preventive vaccinations speciﬁed in a communication from the Main Pharmaceutical Inspector

0• The terms and conditions for advertising a medicinal product.

0• Cease the medicinal product advertising.

© 2019 Thomson Reuters. All rights reserved. 11

9. What is the deﬁnition of medical device in your jurisdiction?

0• Diagnosis, prevention, monitoring, treatment or alleviation of disease.

Under the Pharmaceutical Law, a medicinal product is a substance or combination of substances

0• Presented as having properties for treating or preventing disease in human beings

Therefore, a product is held to be a medicinal product if it is presented as having therapeutic or

© 2019 Thomson Reuters. All rights reserved. 12

10. What are the general requirements for a medical device to be

0• Act on Combating Unfair Competition 1993.

See also Question 14.

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11. What authority is responsible for regulating the manufacture,

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13. Is it possible to sell devices to or buy devices from other jurisdictions?

Before marketing a product, an importer must verify whether:

0• The manufacturer or authorised representative has conducted the proper procedure

© 2019 Thomson Reuters. All rights reserved. 15