Marketing, Manufacturing, Packaging & Labeling, Advertising
Key legal info on marketing, manufacturing, packaging & labeling, advertising in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The following authorization procedures are available in the Czech Republic for obtaining market authorization of new drugs:
The national procedure applies if the new drug has not yet been authorized in any other EEA member state, and the applicant for the marketing authorization intends to market the new drug only in the Czech Republic. The relevant authority for issuance of a national authorization is the State Institute for Drug Control. The applicant must submit the relevant application electronically. The State Institute for Drug Control reviews and notifies the applicant whether the application is complete within 30 days after having received it. If the application is considered complete, the State Institute for Drug Control will then decide on the marketing authorization within 150 days after the applicant receives a confirmation that the application is considered complete (for generic drugs) or within 210 days (for other drugs).
The decentralized procedure applies if the new drug has not yet been authorized in any other EEA member state and the applicant for the marketing authorization intends to market the new drug in two or more EEA member states (including the Czech Republic). Identical applications for marketing authorization must be submitted simultaneously to the competent authorities of all concerned EEA member states. The competent authority in the Czech Republic is the State Institute for Drug Control. The application must include a list of all EEA member states to which an application for marketing authorization has been submitted. The applicant requests one of the member states concerned (the so-called reference member state) to prepare an assessment report on the drug. If the Czech Republic is the reference member state with respect to an application, the State Institute for Drug Control prepares a draft of the assessment report and, within 120 days after receipt of the application, provides this report to the other concerned member states for their comments. The final assessment report then serves as a basis for authorization in the respective other member states concerned.
Mutual Recognition Procedure
The mutual recognition procedure is based on the recognition of an existing national marketing authorization (issued in an EEA member state) in one or more other EEA member state(s). The holder of the marketing authorization informs the reference member state that it has submitted an application for mutual recognition to the State Institute for Drug Control. The holder of the authorization also requests the reference member state to prepare an assessment report or to update the report (if it had already been prepared when the original marketing authorization was granted) and to provide it to the State Institute for Drug Control. If the Czech Republic is the reference member state, the State Institute for Drug Control prepares or updates the assessment report, within 90 days of receiving the request to act as the reference member state, and then submits it to the concerned member states for their comments. The final assessment report serves as a basis for authorization in the respective other member states concerned.
Drugs can also be authorized by the European Commission through a single application in all EEA countries via the centralized procedure. This marketing authorization is then valid in all EEA member states, including the Czech Republic and no separate authorization of the State Institute for Drug Control for the Czech Republic is then necessary.
With respect to the authorization process for marketing traditional herbal medicinal products and homeopathic medicinal products please refer to Answer No. 44 of Chapter Traditional Medicines and Over-the-Counter Products.
The Act on Drugs specifically addresses biologics only in connection with the authorization procedure for biologics that are similar to a reference biological drug (biosimilars). For information about this please refer to Answer No. 2 below.
For placement of a medical device on the EU market, the manufacturer must adhere to the MD Regulation requirements. In particular, the device’s risk classification under MD Regulation classification rules must be determined and, depending on the risk classification, a conformity assessment must be carried out by the notified body or by the manufacturer. If the device passes the conformity assessment, a CE (Conformité Européenne) mark must be affixed to the device to demonstrate compliance.
The MD Regulation introduced the UDI (Unique Device Identification) system. The UDI is a standardized medical device identification system representing a unique medical device identifier listed on the label of each medical device, i.e. directly on the label of the medical device or on its packaging, as well as on all higher levels of packaging. An UDI identifier is a series of numeric or alphanumeric characters created through internationally accepted device identification and coding standards, and it allows for unambiguous identification of specific devices on the market.
In addition the MD Regulation established EUDAMED – the European database on medical devices maintained by the European Commission. EUDAMED is currently a work in progress. Once completed, it will consist of six interconnected modules and a public website. As of April 2021 only the module for registration of actors – that is manufacturers, manufacturer’s representatives and importers – was functioning. The European Commission will make the additional modules (device registration, notified bodies and certificates, clinical investigations, etc.) available on a step-by-step basis as soon as they are functional.
Until EUDAMED becomes fully functional, registration of persons/entities and notification of medical devices before they are placed on the market is to be done under national laws, i.e. the Act on Medical Devices, in its wording valid prior to 26 May 2021, will continue to apply. In order to be able to place a medical device on the Czech market in accordance with the Act on Medical Devices, the manufacturer, its representative, importer, or distributor is obliged to register itself with the State Institute for Drug Control before commencing its activities. Once the State Institute for Drug Control issues its registration confirmation, the person or entity will obtain a registration number. The registration is valid for five years and can be repeatedly extended, always by another five years.
In order to place a medical device on the Czech market in accordance with the Act on Medical Devices, the medical device must be notified to the State Institute for Drug Control within 15 days after the medical device is placed on the market. The notification is valid for five years and can be repeatedly extended always by another five years. Once notification is completed for a specific medical device, any additional distributor or importer only needs to inform the State Institute for Drug Control that it is also distributing or importing the device; it does not need to submit all the documents and information required for the purposes of the initial notification of the marketing of a medical device.
Once EUDAMED becomes fully functional, it will be necessary to register manufacturers, manufacturer’s representatives, and importers as well as medical devices in EUDAMED in accordance with the MD Regulation instead of registering/notifying under the Act on Medical Devices. As of April 2021, registration of manufacturers, manufacturer’s representatives and importers in EUDAMED has been possible on voluntary basis. Even after EUDAMED becomes fully functional, distributors and persons servicing medical devices will only be required to register in a national database maintained by the State Institute for Drug Control.
Specific rules that differ from the above apply to custom-made devices and investigational devices.
2. What is the authorization process for the marketing of generic versions of these products?
A generic version of a drug also requires a marketing authorization issued by the State Institute for Drug Control. For generics, the applicant must prove that the product is bioequivalent to the reference drug that has been authorized in at least one EEA member state for at least eight years. In addition, the applicant must provide the State Institute for Drug Control with all information and documents as required in the authorization procedure for new drugs, except for the results of toxicological, pharmacological and clinical tests. The holder of the marketing authorization for the generic drug may not place this product on the market until a lapse of 10 or, under certain conditions, 11 years after issuance of the marketing authorization for the reference drug.
If a biological product does not meet the definition of a generic drug, in particular due to differences in the starting material used or technological differences in the production process, only the results of the relevant toxicological and pharmacological tests and the clinical trials related to these differences have to be submitted. It is not necessary to submit to the State Institute for Drug Control results of toxicological and pharmacological tests or already-conducted clinical trials in connection with the reference biological drug.
3. What are the typical fees for marketing approval?
The approximate fees for marketing authorizations are:
- National Registration: approx. EUR 3,000 to approx. EUR 11,000;
- Mutual Recognition Procedure: approx. EUR 11,000;
- Decentralized Procedure: approx. EUR 13,000 to approx. 16,500.
The fees above as well as fees for other types of proceedings are stipulated in Decree No. 427/2008 Coll.
4. What is the period of authorization and the renewal process?
The marketing authorization of a drug is valid for five years. The State Institute for Drug Control may extend the validity of the authorization on the basis of a written application submitted no later than nine months before the expiry date of the authorization, and on the basis of a review of the risk-benefit balance of the drug.
With respect to medical devices, the registration of the medical device in the Register of Medical Devices is valid for five years and can be extended by another five years on an ongoing basis. The extension request must be delivered to the State Institute for Drug Control no earlier than six months but no later than two months before the registration expires. Once the EUDAMED module for registration of medical devices becomes functional, registration of the medical device in EUDAMED will be required. There is no time limit for validity of the EUDAMED registration, but the information submitted to the database upon registration must be regularly updated and confirmed; initially one year after submission of the information to EUDAMED and then every other year.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The marketing authorization holder is obliged to maintain a pharmacovigilance system that complies with the pharmacovigilance system of the Czech Republic. Under this system the marketing authorization holder (i) collects data on risks related to the drugs for which it holds a marketing authorization, (ii) evaluates this data in order to decrease or prevent potential risks and (iii) adopts appropriate measures. Among other responsibilities, the marketing authorization holder has to report any suspected adverse drug reactions to the EudraVigilance database and keep documents related to pharmacovigilance for 10 years from the date it was obtained. The marketing authorization holder is also obliged to appoint a qualified person to be responsible for the pharmacovigilance agenda; this person must permanently and continuously available.
Furthermore, doctors, dentists, pharmacists, and other healthcare practitioners are obliged to report to the State Institute for Drug Control all suspicions of any serious or unexpected effects related to the use of a drug, which could have serious consequences for the health of patients.
Medical devices are divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Manufacturers are required to establish and maintain a post-market surveillance and vigilance system for each device in a manner that is proportionate to the risk class and appropriate for the type of device. Manufacturers are required to have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
Manufacturers are obliged to report:
- any serious incident involving the device, except side-effects that are expected and documented or subject to trend reporting (see below);
- any field-safety corrective action, including those undertaken in a third country, in relation to a device that has also been made available on the EU market, if the reason for the field-safety corrective action is not limited to the device that was made available in the third country.
Manufacturers are also required to produce a trend report describing any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects.
Importers, distributors, healthcare providers, service persons, dispensers and sellers are not obliged to report suspected incidents. However, healthcare providers have certain obligations that are related to the suspected incidents – e.g. obligation to take measures to mitigate negative effects of the incident and to cooperate with the manufacturer and regulator in order to establish the cause of the incident.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorization of a drug is recognized in the Czech Repu-blic if it had been obtained through the European Medicines Agency under the European Union’s centralized authorization procedure. Otherwise, foreign marketing authorizations other than those mentioned in the previous sentence must be recognized by and registered in the Czech Republic, with the State Institute for Drug Control, e.g. via the mutual recognition procedure (recognition of an existing national marketing authorization by one or more EEA member states) or the decentralized procedure (the application for marketing authorization is submitted simultaneously in several EEA member states). In these cases, a separate authorization issued by the State Institute for Drug Control is still required.
Medical devices to be placed on the European Union market must fulfill requirements described above in Answer No. 1, including notification to the State Institute for Drug Control or, once EUDAMED becomes fully functional, registration of the medical device in EUDAMED.
7. Are parallel imports of medicines or devices allowed?
Authorization for the parallel import of medicines may only be granted to the authorization holder for the wholesale distribution of medicines under the following conditions:
- the medicine is authorized in the EEA member state and in the Czech Republic and the medicine is not being distributed by the marketing authorization holder in the Czech Republic;
- the medicine will be distributed in the Czech Republic with a quantitatively and qualitatively identical composition and dosage form as that of the medicine authorized in the Czech Republic;
- the medicine has identical therapeutic effects as the product authorized in the Czech Republic, it does not constitute a risk to public health and it is being used in accordance with the marketing authorization of the reference product.
Parallel trade in medical devices already placed on the market is a lawful form of trade within the internal market of the European Union. The MD Regulation stipulates the conditions under which importers and distributors of medical devices traded in parallel must fulfill obligations that otherwise apply to manufacturers of medical devices. This is the case when the importer/distributor:
- makes a device available on the market under its name, registered trade name, or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified on the label as such and remains responsible for meeting the requirements placed on manufacturers under the MD Regulation;
- changes the intended purpose of a device already placed on the market or put into service;
- modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. The following actions do not qualify as such modification: (i) provision, including translation, of information supplied by the manufacturer, and of additional information that is necessary in order to market the device in the relevant Member State and (ii) changes to the outer packaging of a device, including a change in the package size, if repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such a way that the original condition of the device cannot be affected by it.
Distributors and importers must have in place a quality management system that, inter alia, ensures that the distributor or importer is informed of any corrective action taken by the manufacturer of the device in question in order to respond to safety issues or to bring the device into conformity with applicable regulations.
For further information please refer to Answer No. 1 above.
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?
Any gifts, promises, offers or other incentives made to healthcare professionals in relation to the advertising of drugs for human use are not allowed, unless they are of negligible value and, at the same time, relate to the specific professional’s activity. Accordingly, healthcare professionals may not require or accept such benefits. Under Czech law, only professionals authorized to prescribe or dispense drugs or medical devices are considered healthcare professionals.
Samples of drugs and medical devices can only be provided to healthcare professionals in a limited quantity and they must be marked as “not for sale”. As regards drugs, each sample must correspond to the smallest available packaging of the product. Samples of drugs containing narcotic and/or psychotropic substances are not allowed at all.
Sponsorship of meetings and conventions for experts, including related travel and accommodation costs, is allowed provided that the sponsorship is proportionate to the main purpose of the meeting / convention and that such sponsorship (or any reimbursement of costs) is only provided to healthcare professionals.
Pharmaceutical and medical devices companies in the Czech Republic usually also adhere to ethical codes of the professional associations they belong to, which regulate marketing practices in more detail, such as the codes of the European Federation of Pharmaceutical Industries and Associations (EFPIA) (e.g. the EFPIA HCP Code).
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The main supervisory authority for the manufacturing of medicines and medical devices is the State Institute for Drug Control.
The State Institute for Drug Control issues approvals for the manufacturing of medicines and their distribution and issues certificates confirming that the conditions of good manufacturing practice, good distribution practice etc. have been fulfilled. In addition, the Ministry of Health issues the Czech Pharmacopoeia, which sets out procedures for the manufacture of active substances and excipients used in the manufacture and preparation of medicinal products and for their testing and storage.
As regards medical devices, the manufacturer needs to obtain a relevant trade license, which is issued by the Trade Office, and to register itself as a manufacturer in the relevant database. For more details please refer to Answer No. 1 above. The other relevant authorities concerned with the regulation of the manufacturing of medical devices are the Ministry of Health, the Institute of Health Information and Statistics of the Czech Republic, the Czech Office for Standards, Metrology and Testing, the State Office for Nuclear Safety and local trade authorities.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food and Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
The Czech Republic is a part of the European Union; therefore, the GMP regulations of the European Medicines Agency apply. The EU and the US have entered into a mutual recognition agreement on GMP inspections. The US FDA approved the capability of the Czech Republic to carry out GMP inspections at a level equivalent to that of the United States in March 2018.
11. What is the inspection regime for manufacturing facilities?
The State Institute for Drug Control has jurisdiction over inspections of manufacturing facilities for drugs in the Czech Republic. Inspections of manufacturing facilities are carried out by the State Institute for Drug Control to monitor and ensure compliance with the obligations under the Act on Drugs and the requirements of GMPs.
In addition, internal inspections of manufacturers’ premises are also required. According to the guidelines of the State Institute for Drug Control, the following are to be inspected on a regular basis: employees, buildings, facilities, documents, manufacturing procedures, inspections of quality and distribution, how complaints are dealt with, and how goods are removed from the market.
Internal inspections are to be carried out comprehensively and independently by a qualified employee of the relevant manufacturer or by external experts. A written report containing all information identified during the inspection must be produced in relation to every internal inspection and, where appropriate, a solution to the findings should also be proposed.
The State Institute for Drug Control also has jurisdiction over inspections of manufacturing facilities for medical devices. Inspections are carried out to ensure compliance with the obligations under both the MD Regulation and Czech legislation regulating medical devices.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the US FDA/EMA?
Inspections of manufacturing facilities for medicines and medical devices are carried out by the employees of the State Institute for Drug Control. Generally, foreign inspectors are not allowed, but competent authorities of EU member states are required to cooperate with each other when conducting supervision over drugs and medical devices. With respect to drugs, upon request by the competent authority of another EU member state, the State Institute for Drug Control may inform the authority of the contents of its inspection report. With respect to medical devices, regulatory authorities of EU member states are required to share the results of these activities with each other in order to ensure a harmonized and high level of market surveillance in all member states.
Internal inspections can be carried out by the manufacturer’s employees or an external expert engaged by the manufacturer.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Specific requirements for storage, packaging, and handling of medicinal products are regulated by the Decree of the Ministry of Health and the Ministry of Agriculture No. 229/2008 Coll., on Manufacturing and Distribution of Medicines, which stipulates Good Manufacturing Practice (GMP) Requirements and Good Distribution Practice (GDP) Requirements. Additional requirements are found in Decree No. 84/2008 Coll., on Good Pharmacy Practices (GPP) as well as in relevant guidelines of the State Institute for Drug Control.
Every drug package must contain a package leaflet, unless all the required information is stated on the package itself. The information on the package must be legible and comprehensible, it must be in Czech and the name of the medicinal product must also be written in Braille. The information is approved by the State Institute for Drug Control during the marketing authorization process for the drug. For requirements regarding the information to be provided on the outer packaging please see Answer No. 14 and 15 of Marketing, Manufacturing, Packaging & Labeling Advertising.
The storage location must have sufficient capacity to allow for storage of different kinds of products in a clear manner. It must further meet the conditions of good storage practice – to be clean, dry, and an adequate temperature must be maintained. For products requiring storage at a specific temperature, the temperature must be regularly checked by thermometers strategically placed within the premises. Drugs cannot be stored directly on the floor, near heating devices and cannot be exposed to sunlight. The storage conditions must be checked and monitored on a regular basis.
When handling drugs, specific storage conditions (e.g. in terms of temperature or light) must also be maintained during transport.
Requirements for storage, packaging and handling of medical devices are laid down primarily in the MD Regulation, the New Act on Medical Devices, the Act on Medical Devices (with respect to diagnostic devices in vitro) and in implementing decrees of the Ministry of Health. According to the MD Regulation, each device must be assigned a unique identification, which must be stated in the device’s labeling or on the device packaging. Devices must be packaged so that their characteristics and performance during their intended use are not adversely affected during transport or storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.
Devices supplied in a sterile state must be packaged in accordance with appropriate procedures to ensure that they are sterile when placed on the market and, provided that the packaging is not damaged, that they remain in compliance with applicable transport and storage conditions until the packaging is opened. Packaging systems for non-sterile devices must maintain the integrity and purity of the device and, if the devices are to be sterilized before use, these systems must minimize the risk of microbial contamination. The packaging system must be suitable with regard to the sterilization method specified by the manufacturer. The MD Regulation sets out the information that must be stated on the packaging maintaining the sterile condition of a device.
Manufacturers are obliged to include an indication of any applicable special storage and / or handling conditions in the device labeling as well as in the UDI database. Importers are obliged to ensure that, while a device is under their responsibility, the storage or transport conditions do not jeopardize its compliance with the general safety and performance requirements set out in the MD Regulation. In addition, importers and distributors are obliged to ensure that the storage or transport conditions comply with the conditions set by the manufacturer.
14. What information must be included in medicine and device labeling?
The following information, inter alia, must be included on the outer packaging of a medicinal product:
- the name of the medicinal product followed by its strength and pharmaceutical form and, if applicable, whether it is intended for use by infants, children or adults; if the product contains a maximum of three active substances the international non-proprietary name (the INN) of each such active substance must be included or, if INN is not applicable, its common name;
- the amount (expressed qualitatively and quantitatively) of the active substances in the unit of dosage or in a given volume or weight of the form administered, using their common names in Latin;
- dosage form and pack size;
- manner of administration;
- a warning that the product must be kept out of the sight and reach of children;
- special warnings, in particular the possibility of affecting the ability to drive or to use machinery, if relevant for the product;
- expiry date (month, year);
- special storage requirements;
- special precautions for the disposal of any unused product or any waste derived from the product, if required to limit the adverse effects of the effects thereof on the environment, in accordance with other legislation;
- the business name and the address of the registered office of the marketing authorization holder, for legal persons, or the name or names, surname and place of business of the marketing authorization holder, for natural persons, and, where applicable, the name of any representative appointed by the marketing authorization holder;
- registration number of the product;
- batch number;
- in the case of dispensing without prescription, instructions for the use of the product.
Specific requirements apply to the contents of the Summary of Product Characteristics (SPC) and package leaflet (PIL).
The following basic information, inter alia, must be included on medical device labeling:
- the name or trade name of the device;
- details that are strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
- the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
- if the manufacturer has its registered place of business outside the EU, the name of the authorized representative and address of the registered place of business of the authorized representative;
- where applicable, an indication that the device contains or incorporates (i) a medicinal substance, including a human blood or plasma derivative, or (ii) tissues or cells, or their derivatives, of human origin, or (iii) tissues or cells of animal origin, or their derivatives;
- where applicable, information about dangerous substances (e.g. substances that are carcinogenic, mutagenic or toxic to reproduction, etc.) contained in the device;
- the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER (in Czech) or an equivalent symbol, as appropriate;
- the UDI carrier;
- an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
- where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided that the date is clearly identifiable;
- an indication of any special storage and/or handling condition that apply;
- if the device is supplied sterile, an indication of its sterile state and the sterilization method;
- warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum if more detailed information appears in the instructions for use, taking into account the intended users;
- if the device is intended for single use, an indication of that fact;
- if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
- if the device is custom-made, the words “custom-made device” (in Czech);
- an indication that the device is a medical device. If the device is intended for clinical investigation only, the words “exclusively for clinical investigation” (in Czech);
- for devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a bodily orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information about the main constituent or constituents responsible for achieving the principal intended action;
- for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.
Information that is required on the label must be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging.
15. What additional information may be included in labeling and packaging?
With respect to drugs, the package leaflet can include symbols or pictograms designed to explain a particular piece of information on the product packaging or in the package leaflet or other information that is useful to the patient. This information must be in line with the SPC and cannot contain promotional elements.
As regards medical devices, instructions for use must be provided together with the devices; however, use instructions are not required for class I and class IIa devices if they can be used safely without any instructions. Residual risks, which are required to be communicated to users or other persons, must be included as limitations, contra-indications, precautions, or warnings in the information supplied by the manufacturer. Where appropriate, the information supplied by the manufacturer can take the form of internationally recognized symbols.
16. What items may not be included in labeling and packaging?
Any items that could lead to the product being used incorrectly may not be included in the labeling and packaging. For example, labeling and packaging cannot include advertisements or any generally misleading information.
With respect to medical devices, the labelling must not include text, names, trademarks, pictures and signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance. Namely, it is not allowed to use information that (i) ascribes functions and properties to the device that the device does not have, (ii) creates a false impression regarding treatment or diagnosis, functions or properties that the device does not have, (iii) fails to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose or (iv) suggests uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
In addition to any general rules for advertising, the following rules apply to the advertising of medicines:
- the advertising must be in conformity with the SPC; it must encourage rational use of the medicinal product and must not be misleading;
- different rules apply to advertising to the public and to healthcare professionals (doctors and pharmacists, not nurses); only drugs available without prescription may be advertised to the public;
- medicines containing narcotics or psychotropic substances may only be advertised to healthcare professionals;
- medicines without marketing authorization may not be advertised at all.
In addition to the general advertising requirements, any advertising of medicinal products intended for the public must be executed so that it is clear that it is an advertisement; the marketed medicinal product must be clearly identifiable and the advertisement must contain the particulars specified in the Act on Advertising (e.g. the name of the medicinal product, an explicit and understandable appeal to the users to carefully read the package leaflet that accompanies the medicinal product, information necessary for the proper use of the product).
Advertising of medicinal products intended for the public may not contain certain elements specified in the Act on Advertising, such as:
- giving the impression that consultation with a doctor, medical intervention or treatment is not necessary, especially by offering a diagnosis or offering treatment remotely;
- suggesting that the effects of the medicinal product are guaranteed, are not associated with side effects or are better or equivalent to the effects of another treatment or other medicine for human use;
- suggesting that the use of a medicinal product will improve the health of the person taking it;
- indicating that the failure to use a medicinal product may adversely affect the health of persons; this does not apply to vaccinations or vaccines that have been approved by the Ministry of Health;
- being targeted solely at people under 15 years of age;
- referring to the recommendations of scientists, health professionals or other persons that, by virtue of their actual or presumed social status, could support the consumption of the medicinal product;
- indicating that the medicinal product is a food or cosmetic product or other consumer product;
- suggesting that the safety or efficacy of a medicinal product is only guaranteed by its natural origin;
- using any image of changes to the human body caused by a disease or injury or the effect of the medicinal product on the human body, or parts thereof, in an inappropriate, exaggerated or misleading manner.
This list is not exhaustive.
For information about marketing practices such as gifts, sponsorships, travel, and entertainment, please refer to Answer No. 8 above.
In addition to any general rules for advertising, the following rules apply to the advertising of medical devices:
- only devices that comply with legal requirements for being placed on the market can be advertised. Devices that do not comply with these legal requirements can be presented at fairs, exhibitions and similar events provided that they are clearly marked as not compliant for being placed on the market;
- advertisement of a medical device cannot refer to any specific bodies of state administration;
- different rules apply to advertising to the public and to healthcare professionals; devices for use only by healthcare professionals and devices available only based on a prescription may not be advertised to the public, and samples cannot be provide to the public.
Any advertising of medical devices intended for the public must be done so that it is clear that the marketed product is a medical device or in vitro diagnostic medical device (as appropriate). The advertisement must contain the particulars specified in the Act on Advertising (e.g. the name of the medical device, its purpose, an explicit and understandable appeal to the users to carefully read the instructions for use and information necessary for the proper use of the product, if applicable).
Advertising of medical devices intended for the public may not contain certain elements specified in the Act on Advertising, such as:
- giving the impression that consultation with a doctor, medical intervention, or treatment is not necessary, especially by offering diagnosis or offering treatment remotely;
- suggesting that the effects of the medical device are guaranteed, are not associated with risks, or are better or equivalent to the effects of another treatment or other medical device;
- indicating that failure to use a particular medical device could adversely affect the health of persons;
- being targeted solely at people under 15 years of age,
- referring to the recommendations of scientists, health professionals or other persons that, by virtue of their actual or presumed social status, could support the use of the medical device;
- referring to clinical trials or other processes that are a condition for placing the medical device on the market;
- suggesting that the safety or efficacy of a medical device is only guaranteed by its natural origin.
This list is not exhaustive.
Furthermore, the labelling and advertisement of a medical device must not include text, names, trademarks, pictures, or signs that may mislead the user or the patient with regard to the device’s intended purpose, safety, and performance. Specifically, it is not allowed to use information that (i) ascribes functions and properties to the device that it does not have, (ii) creates a false impression regarding treatment or diagnosis or functions or properties that the device does not have, (iii) fails to inform the user or the patient of a likely risk associated with the use of the device when used for its intended purpose, or (iv) suggests uses for the device other than those stated, implying that they form part of the intended purpose for which the conformity assessment was carried out.
Advertising of medical devices intended for healthcare professionals may only be disseminated through communication channels intended predominantly for healthcare professionals and must contain the following:
- sufficient, verifiable and objective data allowing the healthcare professionals to form their own opinion about the clinical benefit of a particular medical device; data taken from professional publications or from professional press must be accurately reproduced and their source must be stated;
- the basic information included in the instructions for use of the medical device.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Medicinal products subject to a prescription can only be dispensed in pharmacies. Non-prescription medicinal products can also be sold online (and delivered via post or other delivery service). The online sale of certain non-prescription products may be prohibited by a decision of the State Institute for Drug Control. This is the case with respect to OTC products that can be dangerous to human health and the risk may be avoided (i) by an expert consultation with a pharmacist before the product is used or (ii) by imposing certain restrictions on the dispensing of the product.
Selected medicinal products that can be used without prior consultation with a doctor or pharmacist, such as teas, disinfectants or pain relief medications, may be sold in regular stores, such as gas stations or supermarkets.
A medical device that, even if its intended purpose is observed, could endanger human health or life if not used under a doctor’s supervision may be dispensed only through a medical prescription issued by a doctor. The groups of such devices are listed in a decree of the Ministry of Health. Medical prescriptions are also used when the patient is entitled to reimbursement from the public health insurance.
Medical devices subject to prescription may only be dispensed in pharmacies and through sales points for medical devices contracted by a health insurance, or through a dispensing optician (optical medical devices). Dispensing medical devices subject to an online prescription via consignment delivery is also possible. Medical devices classified as low risk can be sold in regular shops as well as online (and delivered via post or other delivery services).
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
There are no specific legal regulations for electronic marketing and advertising of medicines and medical devices; general advertising rules thus apply. With respect to advertising of medicines on the internet, the State Institute for Drug Control issued guideline specifying measures ensuring that prescription drugs are not advertised to the general public on the internet.
In addition, if sending advertisements via email, advertisers must comply with specific anti-spam legislation applicable to commercial electronic messages.
20. May medicines and devices be advertised or sold directly to consumers?
Yes, except for medicines and devices that require a prescription and devices that, according to the manufacturer’s instructions, are intended for use only by healthcare professionals – those may not be advertised or sold directly (without prescription) to consumers.
21. How is compliance monitored?
Compliance with medicines and medical devices advertising regulations is monitored by the State Institute for Drug Control. For monitoring purposes the State Institute for Drug Control is entitled to: (i) request a copy of an advertisement; an advertiser must keep advertisements for five years after the last release / broadcast of the advertisement, (ii) request documentation and information relating to an advertisement; an advertiser must keep this documentation and information for five years after the last release / broadcast of the advertisement, (iii) request from the processor of an advertisement any information about the advertiser or broadcaster of the advertisement, (iv) request from the broadcaster of an advertisement any information about the advertiser, the processor of such advertisement or the person that ordered the broadcast, (v) request evidence from the advertiser on the validity of the claims made in an advertisement, (vi) order the removal or termination, within a reasonable time period, of an advertisement that breaches applicable statutory requirements.
Television and radio advertising for medicinal products is supervised by the Council for Radio and Television Broadcasting.
22. What are the potential penalties for noncompliance?
If the State Institute for Drug Control learns of a violation of the Act on Advertising, it prohibits the distribution of the advertisement. In addition, the State Institute for Drug Control may impose a fine of up to approx. EUR 192,000.