Marketing, Manufacturing, Packaging & Labeling Advertising
DLA Piper / Poland
All about marketing, manufacturing, packaging & labeling, advertising in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
a) Medicinal products
Chapter 2 of the Pharmaceutical Law sets forth the rules relating to the marketing of medicinal products (including new drugs, biologics, over-the-counter medications and medicinal products in general). As a rule, medicinal products may be placed on the Polish market only if marketing authorization has been granted by the URPL or European Commission. Marketing authorizations may be granted in one of the following procedures:
- National procedure – national authorization granted by the URPL valid in Poland only;
- Mutual recognition procedure – national authorization granted by the URPL based on the recognition of a marketing authorization already issued by another member state of the European Economic Area (“EEA”);
- Decentralized procedure – national authorization granted in Poland by the URPL and one or more other EU member state in parallel if no authorization had been previously granted in the EU;
- Centralized procedure – marketing authorization granted by the European Commission based on EMA’s recommendation and valid in all EU member states as well as in the EEA. This procedure is mandatory for some medicines (e.g. medicines containing a new active substance to treat HIV, AIDS, cancer or other diseases; medicines derived from biotechnology processes such as genetic engineering) and optional for others.
In order to receive a marketing authorization the pharmaceutical company has to gather scientific data, which will be included in a dossier of medicinal product, and submit an application. In the case of generic products there may be made a reference to the dossier of the other, already registered, medicine (please see also answers to questions 3 and 6, on Regulatory, Pricing and Reimbursement Overview).
Traditional herbal medicinal products are subject to a simplified marketing authorization procedure. The homeopathic medicinal products:
- which are administered orally or externally,
- whose therapeutic indications are not given on the labelling or package leaflet,
- which have a sufficient degree of dilution to guarantee the safety of the medicinal product, i.e. they do not contain more than l/10,000th of the mother tincture or more than l/100th of the smallest dose of an active substance contained in a medicinal product issued on prescription
– are also subject to a simplified marketing authorization procedure.
There are no special rules for the marketing authorization process for biologics and OTC medicines.
b) Medical devices
Medical devices do not require any marketing authorization to be placed on the market. However, the notification to the URPL must be made (please see answer to question 3, on Regulatory, Pricing and Reimbursement Overview).
2. What is the authorization process for the marketing of generic versions of these products?
Generic versions of these products are subject to essentially the same authorization rules, save that certain exemptions may apply regarding the submission of documentation (please see question 6, on Regulatory, Pricing and Reimbursement Overview).
3. What are the typical fees for marketing approval?
Please see above (question 4, on Regulatory, Pricing and Reimbursement Overview).
4. What is the period of authorization and the renewal process?
Please see above (question 5, on Regulatory, Pricing and Reimbursement Overview).
5. What are the requirements, if any, for post-approval pharmacovigilance?
Chapter 21 of the Pharmaceutical Law sets forth post-approval pharmacovigilance requirements. It imposes a number of pharmacovigilance obligations on the marketing authorization holder, including:
- appointing a qualified person responsible for pharmacovigilance who satisfies the requirements set forth in Pharmaceutical Law;
- recording all suspected adverse reactions;
- complying with the notification obligations towards the URPL and / or EMA concerning any suspected serious adverse reaction;
- presenting studies on the benefit-risk balance of the use of the medicinal product;
- notifying the URPL of the need to make immediate changes to the Summary of Product Characteristics
– and others.
The URPL is the authority competent in regard of the post-approval pharmacovigilance. Its obligations include:
- collecting reports of individual cases of adverse reactions from healthcare professionals, patients and their representatives;
- collecting and analyzing documents relating to the safety of medicinal products, in particular studies on the safety of post-authorization studies, periodic safety reports on medicinal products, risk management plans for medicinal products and other studies on the safety of medicinal products;
- issuing safety information for a medicinal product, intended for and addressed directly to medical professionals or the general public
– and others.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorizations are not recognized in Poland. However, under a mutual recognition procedure it is possible to obtain a marketing authorization in Poland on the basis of an authorization granted in another EEA country. There is no similar procedure for recognizing marketing authorizations issued by countries outside the EEA.
7. Is parallel import of medicines or devices allowed?
Medicinal products subject to parallel import for which a parallel import authorization has been obtained can also be approved for sale. Parallel import of medicinal product is understood as any activity involving bringing in from member states of the European Union and member states of the European Free Trade Association (EFTA) – parties to the Agreement on the European Economic Area, a medicinal product that meets all the following conditions:
- the imported medicinal product has the same active substance (active substances), at least: the same features for the 3rd level of the ATC/ATCvet code (Anatomical Therapeutic Chemical Classification Code), the same strength, the same route of administration and the same form as a medicinal product approved for sale in the territory of the Republic of Poland or a similar form that does not give rise to therapeutic differences in relation to the medicinal product approved for sale in the territory of the Republic of Poland,
- the imported medicinal product and the medicinal product approved for sale in the territory of the Republic of Poland are also either reference medicinal products or equivalents of reference medicinal products in the state from which the product is imported and in the Republic of Poland respectively.
Parallel import of medical devices is not regulated under Polish law.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
Under the Pharmaceutical Law it is prohibited to advertises f medicinal products HCPs by giving gifts, making offers and promising material benefits, handing in presents and other inducements, prizes, offering trips and organizing and financing meetings to promote medicinal products during which hospitality exceeds the main purpose of the meeting. Accepting the benefits referred to above is prohibited.
The above-mentioned prohibitions do not apply to gifts that meet the following conditions:
- their value does not exceed PLN 100 (gross value),
- they are related to medical or pharmaceutical practice,
- they bear the mark advertising the specific company or medicinal product.
The Polish Act on Reimbursement prohibits entities that manufacture or sell reimbursed medications, foodstuffs intended for particular nutritional uses or medical devices from providing material or personal benefits to HCPs and patients. It is commonly understood that this prohibition does not apply to the advertising tools allowed by the Polish Pharmaceutical Law (e.g. giving gifts in observance of the standards set forth in the Pharmaceutical Law, giving samples, sponsoring HCPs to attend conferences, etc.).
Pursuant to the Polish Criminal Code, it is not permitted to provide or promise any material or personal benefit to HCPs performing public functions if the benefit is provided or promised in relation to performing their function (i.e. in relation to spending public funds or exercising public powers).
Interactions between pharmaceutical companies and healthcare organizations/professionals are also subject to voluntary self-regulation codes e.g. Code of Good Practices for the Pharmaceutical Industry prepared by INFARMA that is based on the Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA). With regard to medical devices the most relevant ethical code is the MedTech Code.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
a) Medicinal products
Manufacturing of medicines is regulated in Chapter 3 of the Pharmaceutical Law. The manufacturing of medicinal products require an authorization from GIF. GIF enters the information on issued authorizations for the manufacture of a medicinal product into the European EudraGMDP database. GIF is also the competent authority for compliance with all applicable requirements and inspects the manufacturing sites.
In order to receive a manufacturing authorization it is required to submit an application and undergo an inspection conducted by GIF. Marketing authorization may be granted if an applicant:
- has appropriate premises as well as equipment necessary for the manufacture or import, inspection and storage of medicinal products;
- employs a Qualified Person that meets the criteria set forth in the law.
The manufacturer of medicinal products is subject to numerous obligations and, among others, is obliged to abide by GMPs.
b) Medical devices
The manufacturing of medical devices does not require a formal authorization under Polish law. However, the manufacturer of medical devices or its authorized representative that has its registered seat on the territory of Poland has to notify the URPL of the first placing of a medical device on the market. The manufacturer is responsible for ensuring that the medical devices are compliant with the applicable regulatory and safety requirements.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
The Pharmaceutical Law expressly requires the manufacturer to comply with the standards of good manufacturing practice for medicinal products that are set forth in the Polish secondary legislation and mirror EU GMPs. Polish medical device laws do not expressly require compliance with GMPs.
11. What is the inspection regime for manufacturing facilities?
a) Medicinal products
GIF is the authority competent in regard of monitoring compliance in manufacturing facilities. GIF can carry out inspections, whether ex officio or at manufacturer’s request, at production sites.
When carrying out an inspection, GIF, within periods not exceeding 3 years, verifies whether the manufacturer of the medicinal product meets the obligations under the Pharmaceutical Law and GMPs. The manufacturer of the medicinal product has to be informed of the date of commencement of the inspection at least 30 days prior to the planned date of the inspection. It is also possible for GIF to conduct ad hoc inspection if there are serious doubts as to the quality and safety of products. Inspection results in preparing a compliance report.
GIF, by way of a decision, may suspend the manufacture or import of a medicinal product completely or until the deficiencies identified in the report are remedied. If the results of the inspection confirm that the manufacturer of a medicinal product meets the GMPs requirements, GIF issues, within 90 days from the date of completion of the inspection, a certificate confirming the compliance of the manufacturing or import conditions of the medicinal product with the GMPs requirements. GIF immediately introduces information on the issuance of the certificate to the European EudraGMDP database.
b) Medical devices
According to the Act on Medical devices URPL may conduct inspections at the premises of the manufacturer. Inspectors may in particular:
- check the production and storage rooms and their equipment;
- demand that the samples necessary for testing and verification of the product be made available.
Inspection results in preparing a compliance report.
URPL may, in order to protect the life, health or safety of patients, users or other persons or to counteract a threat to health, safety or public order, may, in relation to a product or group of products, issue an administrative decision to subject to specific requirements, prohibit, withhold or limit the introduction of placing on the market, putting into service, putting into service or using these devices, withdrawing them from the market or from use, or undertaking to undertake an FSCA or issue a safety notice.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Inspections at production sites for medicinal products can only be performed by GIF with or without the support of duly appointed third parties. However, inspections may also be carried out upon request from the European Commission, EMA or an EU member state.
The FDA also can carry out inspections in the EU. However, in November 2017, a Mutual Recognition Agreement (MRA) on GMP inspections between the EU and FDA came into effect, with a transitional phase until July 2019 during which the FDA has been conducting capability assessments of the national regulatory authorities in each EU member state on a rolling basis. Polish authority is now recognised as competent by the FDA. It means that FDA should rather avoid duplication of inspecting Polish manufacturers.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Regulation of Ministry of Health of 13 March 2015 on the requirements of Good Distribution Practice and Regulation of Ministry of Health of 3 December 2015 on the requirements of Good Distribution Practice of active substances (“GDPs”) provides for guidelines on the proper storing, packaging and handling of medicinal products and their active substances in wholesale trade. The manufacturer must comply with the requirements set forth therein and is required to perform quality checks and keep proper records of the results therein. There are no GDPs for storage, packaging and handling of devices.
Requirements for storage and handling of medicines and devices in a pharmacy are set forth in the Regulation of the Minister of Health of 18 October 2002 on the basic conditions for running a pharmacy. According to it medicinal products and medical devices must be stored carefully and protected against dust, dirt and damage; stored medicinal products and medical devices must not come into direct contact with the walls and floors of the storage area. Rooms in which medicinal products and medical devices are stored must be clean, dry, adequately ventilated, and medicinal products and medical devices must be protected against sunlight. Pharmacy must keep the proper records regarding the prepared / stored / handled / destroyed products.
14. What information must be included in medicine and device labeling?
a) Medicinal products
Requirements for medicines labelling are set forth in the Regulation of the Minister of Health of 20 February 2009 on the requirements for labeling the medicinal product packaging and the content of the leaflet. The outer packaging of the medicinal product, and if the product has no outer packaging, the direct packaging, must include the following information:
1. in this order:
a) the name of the medicinal product and the common name of the active substance, if the product contains only one active substance; if the product contains two or three active substances, the common names of all these substances shall be provided, separated by the “+” sign,
b) the strength of the medicinal product, if the medicinal product contains only one active substance; if the product contains two or three active substances, the strength of the product should be given for each of these substances, separated by the “+” sign,
c) specification of the pharmaceutical form,
d) information whether the product is intended for infants, children or adults, if applicable,
e) specification of the size of the package, indicating the weight, volume or number of dosage units of the medicinal product,
2. content of active substances defined qualitatively and quantitatively per dosage unit, volume or weight, using commonly used names,
3. a list of excipients with recognized action and effect, specified pursuant to art. 65 of Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Journal of Laws EC L 311 of 28 November 2001, p. 67, as amended) d .; Official Journal of the EU, Polish special edition, chapter. 13, vol. 27, p. 69, as amended), and in the case of parenteral, topical and ophthalmic medicinal products – a list of all excipients,
4. the method of use and, if necessary, the route of administration,
5. warning about keeping out of the reach and sight of children,
6. warnings regarding the place and method of storage, if any,
7. other special warnings, if necessary,
8. the category of availability,
9. expiry date (month and year), and for ready-made drugs that require special treatment immediately before their use – also, if necessary due to the properties of the medicinal product, the shelf life after the drug has been brought into a suitable form for use,
10. special precautions that should be observed during the disposal of an unused medicinal product or waste derived from medicinal products, if any,
11. name and address of the responsible entity and, if applicable, name and address of the representative of the responsible entity,
12. marketing authorization number,
13. batch number,
14. instructions for use, if the medicinal product is dispensed without a doctor’s prescription,
15. EAN UCC barcode,
a) in the case of the medicinal product referred to in Art. 54a paragraph. 1 of Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, the security features,
16. in the case of a traditional herbal medicinal product:
a) information that its indication is based solely on long-term use,
b) recommendation that the user should consult a doctor if the symptoms persist while using the product or if there are side effects not listed in the leaflet.
The outer packaging, and if the product does not have an outer packaging the direct packaging, must contain the following information in Braille:
1. name of the medicinal product;
2. the strength of the medicinal product, if the product is available in several strengths;
3. pharmaceutical form, if the product is available in several forms.
Regulation also sets froth mandatory information that should be included on the blisters and other inner packaging of medicinal products as well as on packaging of the homeopathic medicinal products.
b) Medical devices
CE mark must be placed on the labelling of the medical device. The CE mark must be affixed in such a way as to be visible, legible and indelible in the instructions for use of the device and on the commercial packaging of the device and on:
1. packaging ensuring sterility of an active implantable medical device;
2. a medical device for in vitro diagnostics – if possible;
3. a medical device or its packaging ensuring sterility – if possible.
There are also many rules regulating certain mandatory disclosures and indications, including the language to be used, which must be affixed to the packaging, depending on the type of the product.
15. What additional information may be included in labeling and packaging?
a) Medicinal products
Symbols or pictograms may be placed on the outer packaging and in the leaflet, in order to make the mandatory information more clear. Additional information may be placed on the medicinal product, consistent with the data contained in the Summary of Product Characteristics, if useful for health promotion purposes and does not contain advertising elements. The symbols or pictograms placed must be approved in the process of authorizing the medicinal product to market.
b) Medical devices
No specific regulations in this regard.
16. What items may not be included in labeling and packaging?
Packaging of a medicinal product may not include advertising elements and items that ae not approved in the process of authorizing the marketing of the medicinal product. Labelling and packaging of any products may not be misleading.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
a) Medicinal products
Advertising of medicinal products is regulated in the Chapter 4 of the Pharmaceutical Law and the Regulation of the Minister of Health of 21 November 2008 on advertising of medicinal products.
In a nutshell, Pharmaceutical Law provides for a broad definition of “advertising of medicinal products” which includes activities consisting in informing or encouraging the use of a medicinal product, aimed at increasing: the number of prescribed prescriptions, the supply, sale or consumption of medicinal products. Advertising of a medicinal product may be carried out only by or on behalf of the MAH.
The advertising of medicinal products, may consist in particular of:
- advertising a medicinal product to the public;
- advertising of a medicinal product addressed to persons authorized to issue prescriptions or persons trading in medicinal products (HCPs);
- visiting HCPs through sales or medical representatives;
- providing samples of medicinal products;
- sponsoring promotional meetings for HCPs;
- sponsoring conferences, conventions and scientific congresses for HCPs.
The following are not considered advertising of medicinal products:
- information on the packaging and attached to the packaging of medicinal products in accordance with the marketing authorization;
- correspondence accompanied by non-promotional information materials necessary to answer questions about a specific medicinal product;
- non-public informational notices regarding, in particular, packaging changes, warnings about adverse effects, provided that they do not contain content relating to the properties of medicinal products;
- commercial catalogs or price lists containing only the proper name, commonly used name, dose, form and price of a medicinal product, and in the case of a medicinal product covered by the refund – the official retail price, provided that they do not contain content relating to the properties of medicinal products, including therapeutic indications;
- information concerning human and animal health or diseases, provided that they do not even indirectly refer to medicinal products.
Advertising of a medicinal product must not:
- be misleading, it should present the medicinal product objectively and inform about its rational use.
- consist in offering or promising any benefits directly or indirectly in return for the purchase of the medicinal product or providing evidence that it has been purchased.
- be directed to children or contain any element that is directed at them.
There are numerous rules on mandatory content of the advertising of medicinal products (traditional and herbal) directed at the general public and at HCPs, which are set forth in the Regulation on advertising medicinal products referred to above.
Advertising of a medicinal product that is a reminder of full advertising, apart from its proper name and commonly used name, may only contain a trademark not containing references to therapeutic indications, pharmaceutical form, dosage, advertising slogans or other advertising content.
It is forbidden to advertise to the public medicinal products:
- dispensed only on the basis of a prescription;
- containing narcotic drugs and psychotropic substances;
- included in the lists of reimbursed drugs, in accordance with separate regulations, and admitted to be dispensed without prescriptions, with the name identical to that on these lists.
Advertising of a medicinal product to the public may not consist of:
- presenting a medicinal product by people known to the public, scientists, persons with medical or pharmaceutical education, or persons suggesting such education;
- referring to the recommendations of people known to the public, scientists, people with medical or pharmaceutical education or suggesting such education.
Advertising of a medicinal product to the public may not contain content that:
1. suggest that:
a. it is possible to avoid medical advice or surgery, especially by making a diagnosis or prescribing treatment by correspondence,
b. even a healthy person taking the medicinal product will improve their health,
c. not taking the medicinal product may aggravate the state of health of the person;
d. the medicinal product is a food, cosmetic or other consumer product,
e. the efficacy or safety of the medicinal product is due to its natural origin;
2. ensure that taking the medicinal product guarantees the proper effect, is not accompanied by any side effects or that the effect is better or the same as in the case of another method of treatment or treatment with another medicinal product;
3. may lead to erroneous self-diagnosis by citing detailed descriptions of cases and symptoms of the disease;
a. refer in an inappropriate, disturbing or misleading form to the therapeutic indications;
4. they contain inappropriate, disturbing or misleading definitions of graphically presented lesions, injuries of the human body or effects of a medicinal product on the human body or its parts.
Please see above also answer to question 8, in regard of incentives and self-regulation of advertising.
b) Medical devices
Advertising of medical devices can’t be misleading. There are no other specific rules on advertising of medical devices, however general rules on advertising apply. What is more, the bill of a new act on medical devices that is now in the legislative process provides for more detailed rules on advertising of medical devices.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
a) Medicinal products
Please see above answer to question 14, on Regulatory, Pricing and Reimbursement Overview). The retail sale of OTC medicinal products can be carried on by the following:
- pharmacies,
- pharmacy dispensaries,
- herbal medicine shops,
- specialist medical supply shops,
- shops open to the public (general shops).
Mail-order sales of medicinal products dispensed without medical prescription (OTC) by pharmacies and pharmacy dispensaries are allowed, with the exception of medicinal products dispensing of which is limited by the patient’s age.
b) Medical devices
There are no restrictions on channels / ways of sale and delivery of medical devices. They may be sold and delivered also via post.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
The same restrictions and requirements apply as are discussed in the answers to the above Questions. Additionally, the requirements for electronic marketing stemming from the general provisions of law apply (applicable to all types of products, not only health-related).
20. May medicines and devices be advertised or sold directly to consumers?
a) Medicinal products
Please see answer to question 17, in regard of advertising medicinal products directly to consumers (to the public). As regards sale directly to consumers, there are various categories of availability of medicinal products in Poland – certain medicines are available only for hospital use and others are available to patients, without prescription or only on prescription. Medicinal products released onto the market are classified in one of the following availability categories:
- dispensed without a doctor’s prescription – OTC;
- dispensed on a doctor’s prescription – (Polish abbreviation – Rp);
- dispensed on a doctor’s prescription for restricted use – (Polish abbreviation – Rpz);
- dispensed on a doctor’s prescription containing narcotic drugs or psychotropic substances specified in separate regulations – (Polish abbreviation – Rpw);
- only for hospital use – (Polish abbreviation – Lz).
Only the medicinal products indicated in points 1-4 may be sold directly to
b) Medical devices
Medical devices may be sold and advertised directly to consumers provided that generally applicable rules on sale and advertising of medical devices are met.
21. How is compliance monitored?
Compliance with sales and advertising regulations is monitored, and infringements prosecuted, by GIF in relation to medicinal products and URPL in relation to medical devices. As some penalties are of criminal nature also criminal authorities are competent in case of non-compliance for both types of products.
Due to the fact that many companies are members of industry associations the infringements of the ethical codes are often subject to proceedings initiated by a competitors before private courts of these associations.
22. What are the potential penalties for noncompliance?
In case of medicinal products penalties for non-compliance with sales and advertising regulations are of financial character (administrative financial penalty or criminal fine) or personal character (restriction of liberty, imprisonment). Non-compliance may also result in decision of GIF on prohibition to disseminate an advertisement or on withdrawal of the pharmacy license.
Non-compliance with the regulations on medical devices may be punished by criminal fine, restriction of liberty or imprisonment. If there is a need to protect the life, health or safety of patients, it may also result in decision of URPL on obligation to abide by specific requirements, prohibition, suspension or restriction on placing on the market, putting into service or using these devices, withdrawing them from the market or from use, or undertaking an FSCA or issuance of a safety notice.
