Legal & Regulatory > Slovakia > Marketing, Manufacturing, Packaging & Labeling, Advertising

A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, 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?

MEDICINAL PRODUCTS

In the Slovak Republic, the following authorization procedures are available in order to obtain the market authorization of new drugs:

National procedure:

The national procedure applies, if the new medicinal product has not been authorized in any other EEA state and the applicant for the marketing authorization intends to market the new drug only in the Slovak Republic. The relevant authority for issuance of the authorization is the State Institute for Drug Control. The applicant must submit the European application form via the electronic system “eApplication”. The applicant must also submit the Slovak application form (original) and the completed European application form in paper form. The data in both forms must correspond with each other. Along with the required documentation (e.g., documentation about the results of the clinical trial), the applicant shall submit the samples of the finished medicinal product, the active substances and excipients (in the quantity required for 3 complete analyses).

When reviewing the application, the State Institute for Drug Control examines, among other matters, if the medicinal product, according to the submitted documentation, complies with the requirements of efficiency, safety and quality, if the requirements of the good clinical practice have been met during the clinical trial, if the manufacturer and importer from the countries outside the EEA are able to provide for the production and control, the risk-benefit balance associated with the use of the medicinal product is favourable.

Decentralized procedure:

The decentralized procedure applies, if the new medicinal product has not been authorized in any other EEA member state yet and the applicant for the marketing authorization intends to market the new drug in two or more EEA member states, including the Slovak Republic. The identical application for marketing authorization must be submitted simultaneously to the competent authorities of the concerned member states. In case of the Slovak Republic, the competent authority is the State Institute for Drug Control. The list of the EEA member states, to whom an application for the marketing authorization has been submitted, forms a part of the application. The applicant requests one of the member states concerned to prepare the assessment report about the medicinal product; such member state is then called a reference member state. If the Slovak Republic is the reference member state, the State Institute for Drug Control prepares draft of the assessment report and provides this report to the concerned member states for their comments within 120 days after the receipt of the application. The final assessment report represents then the basis for the local authorizations. If the Slovak Republic is not the reference member state, the applicant does not have to submit the samples of the finished medicinal product, the active substances and excipients to the State Institute for Drug Control.

Mutual recognition procedure:

The mutual recognition procedure is based on the recognition of an existing national marketing authorization (issued in an EEA member state) by one or more other EEA member states. The holder of the authorization informs the reference member state (if the Slovak Republic is not the reference member state) about submitting the application for the mutual recognition to the State Institute for Drug Control. The holder of the authorization also requests the reference member state to prepare the assessment report or to update the report (which was already prepared when granting the authorization) and provide it to the State Institute for Drug Control. If the Slovak Republic is the reference member state, the State Institute for Drug Control prepares the assessment report or updates it within 90 days following the receipt of the application and submits it to the concerned member states for their comments. The final assessment report represents then the basis for the local authorizations. If the Slovak Republic is not the reference member state, the applicant does not have to submit the samples of the finished medicinal product, the active substances and excipients to the State Institute for Drug Control.

Centralized procedure:

Medicinal products can also be authorized with a single application in all EEA countries by the European Commission through the centralized procedure. This authorization is then valid for all EEA member states, including the Slovak Republic, and no separate authorization of the State Institute for Drug Control for the Slovak Republic is then necessary.

With respect to the authorization process for the marketing of traditional herbal medicinal products and homeopathic medicinal products, please refer to Answer No. 1 of Chapter 4: Traditional Medicines and Over-the-Counter Products.

BIOLOGICS

The Act on Medicinal Products specifically addresses biologics only in connection with the authorization procedure in case of biologics which are similar to a reference biological medicinal product (so-called biosimilars). If such product does not meet the definition of a generic medicinal product, in particular due to differences between this product and the reference biological medicinal product in starting material used or technological differences in the production process, the results of the relevant toxicological and pharmacological test and the clinical trials related to these differences only must be submitted. It is not necessary to submit the results of toxicological and pharmacological test and the clinical trials already carried out in relation to the reference biological medicinal product to the State Institute for Drug Control. With respect to authorization process for the marketing of generics, please refer to Answer No. 2 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.)

MEDICAL DEVICES

In order to place a medical device on the Slovak market, the manufacturer is obliged to register itself (if the manufacture’s place of business or registered seat is in the Slovak Republic) and the medical device with the State Institute for Drug Control (manufacturer’s registration). If the manufacture’s place of business or registered seat is outside the EEA, the manufacturer must appoint a representative, i.e. an individual with residency or place of business in EEA, or a legal person with the registered office in EEA, notify the State Institute for Drug Control about the appointment. If the representative’s residency, place of business or registered office is in the Slovak Republic, it has to carry out the manufacturer’s registration. If the representative’s residency, place of business or registered office is outside the Slovak Republic (however, within the EEA), no registration with the State Institute for Drug Control is required, only its notification as described below (the registration process should be carried out in the EEA member state where the representative has his/her residency, place of business or registered seat).

If the manufacture’s place of business or registered seat is outside the Slovak republic (however, within the EEA), it is sufficient to notify the State Institute for Drug Control in writing about the identification data of the manufacturer and the identification of the medical device (including its labelling and instructions for its use), in case of medical devices of class IIa, IIb and III. In case of medical devices of class I and in vitro diagnostic medical devices, this notification is optional.

For the purpose of the registration or the notification, the applicant submits to the State Institute for Drug Control an application form, along with the required documents (e.g., the manual for the medical device, the respective certificates). In case of the notification, the set of document required is smaller. After the manufacturer’s registration or upon receipt of the manufacturer’s notification, the State Institute for Drug Control will assign the medical device with a code, in both cases within 30 days.

The State Institute for Drug Control continuously maintains, inspects and updates the database of medical devices. If the medical device ceases to comply with the requirements for placing on the market or putting into service, the State Institute for Drug Control decides on the cancellation of the registration or removes the medical device from the medical device database and informs the manufacturer or the representative in writing. The State Institute for Drug Control enters the registration data of the manufacturer, the representative (if any) and the medical device into the European Database on Medical Devices (Eudamed).

In addition, the EU Medical Devices Regulation (2017/745) which is directly applicable in the Slovak Republic should fully apply from 26 May 2021. As a result, the respective provisions of the Act on Medicinal Products will be replaced by the regulation of the EU Medical Devices Regulation. Under the Act on Medicinal Products, the Slovak Office of Standards, Metrology and Testing is the authority responsible for notified bodies under Article 35 of the EU Medical Devices Regulation in the case of the Slovak Republic. With respect to clinical investigations which have started to be conducted prior to 26 May 2021 will continue to be conducted under the Act on Medicinal Products.

With respect to in vitro diagnostic medical devices, the EU In Vitro Diagnostic Medical Devices Regulation (2017/746) should fully apply in the Slovak Republic as of 26 May 2022. Until then, the respective provisions of the Act on Medicinal Products apply.

2. What is the authorization process for the marketing of generic versions of these products?

A generic version of a medicinal product requires also the marketing authorization issued by the State Institute for Drug Control. In case of generics, the applicant must prove that the product is bioequivalent to the reference medicinal product which has been registered in at least one EEA member state for at least eight years. In such case, the applicant does not have to submit to the State Institute for Drug Control the results of the toxicological, pharmacological and clinical testing carried out by the applicant for the generic version, as the applicant can submit the results of these testing already carried out in relation to the reference medicinal product. In addition, the applicant must provide the State Institute for Drug Control with all information and documents as required in the case of authorization procedure of a new medicinal product, except for the abovementioned.

The holder of the marketing authorization for the generic medicinal product is not allowed to place this product on the market until ten years following the marketing authorisation of the reference medicinal product.

3. What are the typical fees for marketing approval?

The fees for marketing approval are published at the webpage of the State Institute for Drug Control (click here).

4. What is the period of authorization and the renewal process?

The State Institute for Drug Control has 210 days for reviewing the application following its delivery. In the event that the application is not complete and the State Institute for Drug Control requests for its completion, the period shall be interrupted until the date of the submission of the required information, but no longer than by 180 days.

Marketing authorization of a medicinal product is valid for five years. The State Institute for Drug Control may prolong 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 the review of the risk-benefit balance of the medicinal product.

Based on reasonable grounds relating to the supervision of medicinal products (including the exposition of a nonsufficient amount of patient to the medicinal product), the State Institute for Drug Control may decide to extend the marketing authorization of a medicine for additional five years. Otherwise, it will issue a decision to extend the marketing authorization for an unlimited period of time.

5. What are the requirements, if any, for post-approval pharmacovigilance?

The registration holder must designate a person responsible for the pharmacovigilance with her/his residency in an EEA member state and a contact person for the pharmacovigilance in the Slovak Republic. The registration holder shall provide the State Institute for Drug Control and the European Medicines Agency with the details of these persons.

The registration holder is obliged, in particular:

• to keep and, upon request, make available to the State Institute for Drug Control the pharmacovigilance system master file;
• to establish, manage and operate a risk management system for each medicinal product;
• to monitor the outcome of risk minimisation measures which are contained in the risk management plan or which are laid down as conditions
  of the marketing authorization;
• to ascertain whether new risks have occurred or whether the risks have changed or whether there has been a change in the risk-benefit balance, and to monitor the pharmacovigilance data and on the basis of these findings to update the risk management system;
• to evaluate suspected adverse reactions to the medicinal product and report them to the EudraVigilance database as required by the applicable
  legal regulations.

The physicians, other healthcare providers, persons authorized to dispense medicines and health insurance companies are also required to immediately notify the State Institute for Drug Control of suspected adverse reactions to the medicinal product of which they learned after its registration. On the basis of the assessment of a report of suspected serious adverse reaction of a medicinal product, the State Institute for Drug Control may change, suspend or revoke the marketing registration of a medicinal product.

The registration holder shall also submit electronically a periodic safety update report to the European Medicines Agency, which contains:

• data on the benefit and risks of a medicinal product, including the results of all studies, with regard to their potential impact on the marketing approval of a medicinal product;
• a scientific assessment of the risk-benefit balance of a medicinal product;
• data on the number of packages of the medicinal product sold, the number of medical prescriptions available to the registration holder, including an estimate of the number of persons on which the medicinal product was dispensed.

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations are basically not valid in the Slovak Republic and authorization of local authorities is required, except for the authorization issued by the European Commission through the centralized procedure which is then valid for all EEA member states.

Marketing approval may be also received within the EEA following simplified procedures, i.e., 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). Still, a separate authorization issued by the State Institute for Drug Control is required.

7. Are parallel imports of medicines or devices allowed?

The Act on Medicinal Products regulates condition of the parallel imports of medicinal products. Parallel import of medicinal products may only be granted to the holder of the authorization for the wholesale distribution of medicinal products. Parallel import authorization may be granted only if a parallel imported medicinal product is registered in another EEA member state under the same conditions as a medicinal product registered in the Slovak Republic. The parallel imported medicinal product must not differ in quality, effectiveness and safety from the reference medicinal product. The medicinal product shall be distributed from the given EEA member state to the Slovak Republic:

• under the same name;
• with qualitatively and quantitatively identical active substances;
• with identical dosage form and appearance;
• with identical packaging sizes;
• with identical inner and outer packaging and with the same graphic design
  of both packaging;
• by the same manufacturer, excluding the manufacturer of the inner and outer packaging and of the written information for the user of the medicinal product.
• An application for a parallel import authorization shall be filed with the State Institute for Drug Control, which will decide on it within the period of 45 days. The authorization for parallel import of a medicinal product is valid for one year from the date on which the authorization decision became effective; this authorization may be extended for another year, even repeatedly, by the application filed at least three months before the expiry date of the authorization.

With respect to the medical devices, the manufacturer’s registration with or the notification of the State Institute for Drug Control are required. For more details please refer to Answer No. 1 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

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?

The restrictions on marketing practices can be found in the Act on Medicinal Products and the Act on Advertising. The Act on Medicinal Products prohibits to certain subjects (e.g., holders of authorization for manufacturing of medicinal products, holders of marketing approval, and the pharmacies) directly or through a third person, to induce, encourage, or otherwise influence the doctor entitled to prescribe medicinal products with respect to their prescription. Further, it is also prohibited (with respect to certain subjects, including the holders of authorization for manufacturing of medicinal products, holders of marketing approval, the pharmaceutical companies), directly or through a third person, to finance, sponsor, or otherwise directly or indirectly financially or materially support other than professional events or participation of healthcare professionals on other than professional events. The amount of the expenditures for marketing and promotion related monetary or non-monetary benefits provided to healthcare professionals (including the information about the respective healthcare professionals) are subject to reporting duties towards the National Centre of Healthcare Information under the conditions specified in the Act on Medicinal Products. According to the Act on Advertising, it is not allowed to visit persons authorized to prescribe medicinal products during their office hours in order to promote medicinal products and these persons are not allowed accept such visits.

The Act on Advertising regulates also prohibition of certain activities, such as supplying, offering and promising gifts, monetary and material benefits or profits to persons authorized to prescribe or dispense medicinal products. The persons authorized to prescribe or dispense medicinal products are also not allowed to require or accept such gifts, monetary and material benefits or profits. The marketing authorization holder may, upon written request, provide a sample of medicinal products only to a person authorized to prescribe medicinal products. The quantity of samples provided is limited to two pieces of the smallest package of the registered medicinal product per year. This sample must be labeled “FREE MEDICAL SAMPLE – NOT FOR SALE” and must be accompanied by the summary of product characteristics. Medicinal product that contains narcotic and psychotropic substances may not be provided as samples.

The Act on Advertising regulates also the sponsorship of promotional events and scientific congresses attended by the persons authorized to prescribe or dispense medicinal products which is also considered as a form of advertising. The hospitality being offered, directly or indirectly, at these events must always be strictly limited to the main scientific objective of the event and it must not be extended to persons other than healthcare professionals. According to the Act on Medicinal Products, a professional event is an event aimed exclusively on professional, scientific or educational purpose of healthcare professionals. Entertainment may form part of such events in the reasonable extent, whereas the entertainment cannot timely exceed 20% of the entire event (excluding time for travel and overnight accommodation).

The pharmaceutical companies in the Slovak Republic usually also adhere to the Ethical Code of the Pharmaceutical Industry in Slovakia which regulates the marketing practices of medicinal products in more detail, or the respective Codes of the European Federation of Pharmaceutical Industries and Associations (EFPIA), e.g. EFPIA HCP Code.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The requirements for manufacturing of medicinal products are primarily set out in the Act on Medicinal Products, in Decree of the Ministry of Health on the Requirements on the Good Manufacturing Practice, and in EU Good Manufacturing Practice (GMP) guidelines – Volume 4.

According to the Slovak legislation, the manufacturing of medical devices does not require any special authorization. Although, the manufacturer’s registration with or the notification of the State Institute for Drug Control are required before the manufacturer places the medical device on the Slovak market. For more details please refer to Answer No. 1 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising. As regards the manufacturing of medical devices, the Slovak Republic is bound by the EU Regulation on medical devices (2017/745). The manufacturer of medical devices must also observe the Act on Conformity Assessment Procedures of Products and related legal regulations.

The supervision authority in connection with manufacturing of medicinal products and medical devices is the State Institute for Drug Control.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

According to the Act on Medicinal Products the manufacturing requirements of medicinal products must comply with EU GMPs.

EU and US have entered into a mutual recognition agreement on GMP inspections. As of 11 July 2019, the Slovak Republic has become the final EU member to be given the powers to carry out good GMP inspections at a level equivalent to that prevailing in the US.

11. What is the inspection regime for manufacturing facilities?

Inspections of manufacturing facilities are carried out by the State Institute for Drug Control to ensure compliance with the obligations under the Act on Medicinal Products and the requirements of GMPs. The State Institute for Drug Control may carry out initial inspections, unannounced inspections or repeated inspections on its own initiative, at the request of another EEA member state, the European Commission or the European Medicines Agency, or on the initiative of other entities as specified in the Act on Medicinal Products (e.g. the holder of the manufacturing authorization, the holder of the authorization for wholesale distribution of the medicinal products).

Inspection is carried out by the inspectors of the State Institute for Drug Control who are authorized to, in particular:

• enter the facilities in which the medicinal products are handled, in case of suspicion that these are handled there without the necessary authorization;
• collect samples in the necessary amount and extent (without any consideration) for performing of an independent analysis;
• examine all records and documents, request for information and explanation relating to the subject matter of the inspection.

The failure to comply with the requirements of GMPs during manufacturing of medicinal products is deemed an administrative offence according to the Act on Medicinal Products and can be subject to a fine imposed by the State Institute for Drug Control.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

In the Slovak Republic, the State Institute for Drug Control and its inspectors primarily responsible for inspecting manufacturing sites located in the Slovak Republic. Under the Act on Medicinal Products, in case of a repeated inspection, the inspector performing the initial inspection may be joined by two inspectors from the competent authority of other EEA member states which are not concerned parties in the respective dispute (in case that the competent authority of other EEA member state disagrees with the report on the results of the inspection performed by the State Institute for Drug Control).

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

MEDICINAL PRODUCTS

Specific requirements for storage, packaging and handling of medicinal products are regulated by the Decree of the Ministry of Health on Good Manufacturing Practice (GMP) Requirements and the Good Distribution Practice (GDP) Requirements, and also in the Decree of the Ministry of Health on Good Pharmacy Practice (GPP) Requirements.

As regards the premises for the wholesale distribution, the storage areas for medicinal products, active substances, excipients and packaging shall have an area of at least 150 m2 and medicinal products containing narcotic and psychotropic substances shall not be stored here, these shall be stored separately. A separate area shall be for receipt, unpacking and sorting of deliveries, and a separate area shall be for the preparation of deliveries to the pharmacies and their shipment. The Decree on the GMP and GDP Requirements specifies also the minimal material and technical equipment for the storage of medicines, active substances, excipients and packaging (e.g., calibrated thermometers and hygrometers in all premises intended for storage, refrigerators or refrigerator boxes with calibrated storage thermometers). These areas shall be kept clean.

Medicinal products, active substances, excipients and packaging are kept separate. No other goods may be stored in the same storage area. Medicinal products must be stored under the conditions specified by their manufacturer to avoid any heat or moisture damage. Temperature and humidity shall be regularly recorded, controlled and evaluated. If storage conditions require special conditions for the temperature and humidity of the storage department, the storage departments shall be equipped with devices indicating the failure to keep the required temperature and humidity. Medicinal products with expired expiration dates must be separated from other medicines and stored in a separate compartment; such medicinal products must be disposed of in accordance with the special legislation. Medicinal products with damaged closure or packaging and contaminated medicinal products shall be withdrawn from the storage. If they are not destroyed immediately, they must be stored in a separate area to avoid further handling.

Medicinal products, active substances, excipients and packaging are kept separate. No other goods may be stored in the same storage area. Medicinal products must be stored under the conditions specified by their manufacturer to avoid any heat or moisture damage. Temperature and humidity shall be regularly recorded, controlled and evaluated. If storage conditions require special conditions for the temperature and humidity of the storage department, the storage departments shall be equipped with devices indicating the failure to keep the required temperature and humidity. Medicinal products with expired expiration dates must be separated from other medicines and stored in a separate compartment; such medicinal products must be disposed of in accordance with the special legislation. Medicinal products with damaged closure or packaging and contaminated medicinal products shall be withdrawn from the storage. If they are not destroyed immediately, they must be stored in a separate area to avoid further handling.

Medicinal products, active substances, excipients and packaging shall be transported in a way to prevent the damage of the document with delivery information, their destruction, spillage or loss, the exposition to excessive heat, cold, light, moisture, microorganisms and parasites. If the transport of medicinal products requires the controlled temperature conditions, the transport shall be carried out only by motor vehicles that meet these conditions. Additional requirements apply to motor vehicles in which medicinal products containing narcotic and psychotropic substances can be transported (e.g., windows with grates, built-in safe).

MEDICAL DEVICES

The requirements for storage, packaging and handling of medical devices are less strict than those of medicinal products. They are primarily regulated in the Decree on GPP Requirements. Medical devices shall be stored separately from the medicinal products, active substances, excipients, dietetic food and additional assortment of the pharmacy. They must be stored under the conditions specified by their manufacturer to avoid any heat or moisture damage. It is necessary to monitor, record and evaluate the temperature and humidity in the storage areas on the daily basis.

Medical devices with expired dates of usable life or medical devices with damaged or dirty packaging must be stored separated and labelled “discarded”.

14. What information must be included in medicine and device labeling?

MEDICINAL PRODUCTS

The following must appear on the outer and immediate packaging of a medicinal product (in the Slovak language):

• the product name, the strength, the pharmaceutical form, and, if necessary, an indication as to whether it is a medicine intended for babies, children or adults; if the medicinal product contains no more than three active substances, an international non-proprietary name shall be provided and if such name does not exist, the common name;
• the list of active substances using international non-proprietary names of active substances, their quantity per dosage unit, depending on the form of administration, in weight units or volume units;
• the pharmaceutical form and the contents of the packaging in weight units, volume units or pieces;
• list of those excipients whose specification on the outer packaging is necessary for the proper use of a the medicinal product; if the medicinal product is injectable or intended for use on the skin or eye, all excipients must be state;
• the method and the route of administration way of use of the medicine;
• a special warning that the medicinal product must be stored out of reach of children;
• specific warnings, if this is necessary for the medicinal product;
• unencrypted expiry date (month and year);
• special storage precautions, if any;
• the method of disposal of unused medicinal products or waste materials from the medicinal products, and a reference to the method of collection of unused medicinal products;
• the name and surname, the address of residence of the registration holder, in the case of a natural person; or, the name or business name, registered seat and legal form of the registration holder, in the case of a legal entity;
• the number of the registration authorization;
• the batch number;
• classification of the medicinal product into the group of prescription-only medicinal products or into the group of non-prescription medicinal products;
• purpose and instructions on the use of a non-prescription medicinal product;
• the GTIN number, if the medicinal product is labeled with it;
• safety feature that enables the authentication of the medicinal product, identification of its packaging and the detection of unauthorized handling with the medicinal product.

The Act on Medicinal Products specifies the minimal particulars which must appear on immediate packaging which take the form of blister packs or on which the particulars above cannot be displayed.

As regards the package leaflet, it must be prepared in line with the summary of product characteristics and must be in the Slovak language. The Act on Medicinal Products lists the respective particulars which must appear on the package leaflet in the order as specified in the Act on Medicinal Products.

MEDICAL DEVICES

Each medical device must be accompanied by the information necessary for the safe and proper use of the medical device and for identification of the manufacturer, taking into account the education and knowledge of potential users. Each package of medical device shall be accompanied by instructions for use. Medical devices of class I and class IIa, the use of which is safe even without instructions do not need to contain instructions for use provided their use is secured also without the instruction for use.

The labelling of the medical device must include, inter alia, the following information:

• the manufacturer’s identification data;
• the information necessary for the user for the identification of the medical device and the contents of the packaging;
• the batch number or its code;
• the year and month until the medical device can be used safely (if necessary);
• indication that the medical device is intended for disposable use (if necessary);
• special storage and / or handling conditions;
• special instructions for use and warnings.

15. What additional information may be included in labeling and packaging?

The outer packaging of the medicinal products may also include pictorial markings, price of the medicinal product, details on the conditions of reimbursement of the medicinal product based on public health insurance, and details of the authenticity and identification of the medicinal product. The package leaflet may include sings or pictorial characters in order to explain certain information.

16. What items may not be included in labeling and packaging?

Labeling and packaging must not contain any additional information not anticipated by the Act on Medicinal Products, or not approved during the registration process before the State Institute for Drug Control. Please also refer to Answer No. 17 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

According to the Act on Advertising, advertising of medicinal products must meet the general requirements for advertising, e.g., it must be in accordance with competition rules and good morals, must not be hidden and must not have signs of unfair commercial practices. The advertisement may not present food and nutritional supplements as if they had the effects of a medicinal product. The Act on Advertising sets out in which cases a comparative advertisement is allowed.

The advertising of medicinal products, regardless of the targeted group (professional or non-expert public), must be consistent with the summary of product characteristics, must promote the rational use of the medicinal product by providing the objective information on the product characteristics, without exaggerating the characteristics of the medicinal product, and at the same time, the advertising shall not be misleading.

The Act on Advertising prohibits advertising of medicinal products:

• which are not registered in Slovak Republic;
• which contain narcotics, psychotropic substances and preparations;
• whose expenditure is subject to medical prescription;
• whose expenditure is not subject to medical prescription but are reimbursed on the basis of public health insurance.

The above mentioned prohibition does not apply to vaccination campaigns authorized by the Ministry of Health and to advertising intended for persons authorized to prescribe and dispense medicinal products. Further, the Act on Broadcasting and Retransmission prohibits media commercial communication regarding medicinal products subject to medical prescription or medicinal products which are reimbursed from the public health insurance, and prohibits advertising of medicinal products containing narcotic, psychotropic, and other addictive substances.

In addition to the general advertising requirements, any advertising of medicinal products intended for the public shall be drawn so that it is clear that it is an advertising and that the marketed medicinal product can be clearly identified and 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 user’s written information that is accompanied to the medicinal product). The advertising of medicinal products intended for the public shall not contain several elements specified in the Act on Advertising which, e.g. gives the impression that medical examination or medical treatment is unnecessary, gives the impression that the effects of the medicinal product are guaranteed and are not accompanied by any adverse effects or are better than or equal to the effects of another medicinal product or other treatment, suggests that good health could be improved by using the medicinal product.

The Act on Advertising provides also certain specific advertising requirements towards the professional public in case of which the prohibition on advertising of prescription-only medicinal products does not apply. Advertising of medicinal products to the professional public must include:

• basic information on the medicinal product that complies with the summary of product characteristics;
• classification of the medicine according to the method of dispensation; • date of preparation or date of update;
• the documentation (part of the medicine promotion) must contain pre-cise and up-to-date information that is verifiable and sufficiently complete to enable the recipient to make his/her own opinion on the therapeutic value of the medicinal product;
• price offers, tables and other illustrations (taken from medical journals or other scientific works) that are used in the documentation must be reproduced faithfully and the exact source must be given.

As regards the medical devices, their advertising is not so strictly regulated in comparison with the advertising of medicinal products. Basically, the advertising of medical devices must comply with the general requirements for advertising.

With respect to restrictions on marketing practices, please also refer to Answer No. 29 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

Additionally, as regards medical devices, the EU Medical Devices Regulation (2017/745) expressly prohibits to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the medical device’s intended purpose, safety and performance by:

• ascribing functions and properties to the device which the medical device does not have;
• creating a false impression regarding treatment or diagnosis, functions or properties which the medical device does not have;
• failing to inform the user or the patient of a likely risk associated with the use of the medical device in line with its intended purpose;
• suggesting uses for the medical device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicinal products can only be dispensed in pharmacies. Medical devices can be dispensed in pharmacies and in the respective trading places for medical devices, or in optical shops (optical medical devices). Non-prescription medicinal products and medical devices (subject to limitations) can be sold also online (and delivered via post). The online sale of medicinal products can only be performed by the holder of the license to operate a public pharmacy (with respect to medicinal products or medical devices) or holder of the license to operate a trading place for medicinal devices (with respect to medical devices).

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 restrictions and requirements for electronic marketing of medicinal products and the advertising of medicinal products must comply with requirements described in Answer No. 17. of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising. Additionally, according to Act on Electronic Communications and the Act on Advertising, it is prohibited to send commercial notices via electronic means without prior customer’s consent (subject to exemptions provided in the Act on Electronic Communications).

According to the Ethical Code of the Pharmaceutical Industry in Slovakia (although the code is not obligatory, the pharmaceutical companies in the Slovak Republic usually adhere to its provisions), any information provided to the healthcare (professional) community on the internet websites, that is part of the marketing, must comply with applicable legislation and any other regulations governing the content and form of advertising and marketing of medicinal products. Such information shall be clearly marked as “information to the healthcare professionals”, whereas the information need not to be encrypted or otherwise restricted only to the healthcare professionals.

20. May medicines and devices be advertised or sold directly to consumers?

Prescription-only and reimbursable medicinal products cannot be advertised to consumers. Prescription-only medicinal products can be sold directly to the consumer subject to the presentation of the respective prescription. For further information please refer to Answers No. 17 and 18 of Chapter 3: Marketing, Manufacturing, Packaging & Labeling, Advertising.

21. How is compliance monitored?

Compliance with legal requirements of the Act on Advertising is monitored primarily by the State Institute for Drug Control with respect to the medicinal products and the Slovak Trade Inspection with respect to medical devices.

22. What are the potential penalties for noncompliance?

If the State Institute for Drug Control detects a violation of the Act on Advertising, it will prohibit circulation of such advertisement. In addition, the State Institute for Drug Control may impose a fine to the advertiser and to the marketing authorization holder of up to EUR 66,400 and to the sponsor of the advertisement a fine of up to EUR 166,000.