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 USD 99.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

DRUGS

The following authorization procedures are available in the Czech Republic for obtaining market authorization of new drugs:

National Procedure

National procedure applies if the new drug had not been authorized in any other EEA state yet and the applicant for the marketing authorization intends to market the new drug only in the Czech Republic. The relevant authority for the issuance of the national authorization is the State Institute for Drug Control. The applicant must submit the relevant application in electronic form. The State Institute for Drug Control reviews and notifies the applicant whether the application is complete within 30 days after receipt thereof. If the application is considered to be complete, the State Institute for Drug Control decides on the marketing authorization within 150 days after the applicant receives the confirmation that the application is considered complete (for generic drugs) or within 210 days (for other drugs).

Decentralized Procedure

Decentralized procedure applies if the new drug had 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 Czech Republic). An identical application for marketing authorization must be submitted simultaneously to the competent authorities of all the concerned EEA member states. The competent authority in the Czech Republic is the State Institute for Drug Control. A list of the EEA member states, to which an application for marketing authorization has been submitted, forms a part of the application. 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 provides this report to the other concerned member states for their comments within 120 days after the receipt of the application. The final assessment report then acts as the basis for local authorizations.

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 states. The holder of the marketing authorization informs the reference member state about submitting 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 such report (should this have 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 application requesting it to act as the reference member state and submits it to the concerned member states for their comments. The final assessment report then represents the basis for local authorizations.

Centralized Procedure

Drugs can also be authorized through a single application in all EEA countries by the European Commission via the centralized procedure. Such 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 the marketing of traditional herbal medicinal products and homeopathic medicinal products please refer to Answer No. 1 of Traditional Medicines and Over-the-Counter Products.

BIOLOGICS

The Act on Drugs specifically addresses biologics only in connection with the authorization procedure for biologics which are similar to a reference bio- logical drug (the so-called biosimilars). For information thereon please refer to Answer No. 2 below.

MEDICAL DEVICES

In order to be able to place a medical device on the Czech market, the manufacturer, manufacturer’s representative, importer or distributor is obliged to register itself with the State Institute for Drug Control prior to the commencement of its activities. The person or entity is registered and obtains a registration number after a registration confirmation is issued by the State Institute for Drug Control. The registration is valid for 5 years and can then be repeatedly extended always by another 5 years.

In addition, 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 5 years and can be repeatedly extended always by another 5 years. Once notification is completed for a specific medical device, any additional distributor or importer of such device 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, and only informs the State Institute for Drug Control that it also distributes or imports the said device.

The State Institute for Drug Control continuously maintains, inspects and updates the database of medical devices. Registrations and notifications are processed via this database in electronic form. The State Institute for Drug Control also enters the registration data of the manufacturer, representative, importer and distributor as well as data concerning the medical device into the European Database on Medical Devices (Eudamed).

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

GENERICS

A generic version of a drug also requires a marketing authorization issued by the State Institute for Drug Control. In the case of generics, the applicant must prove that the product is bioequivalent to the reference drug which 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 the 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 is not allowed to place this product on the market before the lapse of ten or, under certain conditions, eleven years after the issuance of the marketing authorization of the reference drug.

BIOSIMILARS

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 the results of toxicological and pharmacological tests and the clinical trials already carried out in relation to the reference biological drug to the State Institute for Drug Control.

3. What are the typical fees for marketing approval?

The approximate fees for marketing authorizations are:

• National Registration: approx. EUR 9,000 to approx. EUR 11,000
• Mutual Recognition Procedure: approx. EUR 11,000
• Decentralized Procedure: approx. EUR 16,800

For further details on fees please see: http://www.sukl.eu/sukl/ust-29-version-19

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 5 years and can be extended by another 5 years on an ongoing basis. The extension request must be delivered to the State Institute for Drug Control no earlier than 6 months and no later than 2 months prior to the expiration of the registration.

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

The marketing authorization holder is obliged to maintain a pharmacovigilance system which complies with the pharmacovigilance system of the Czech Republic. Under such pharmacovigilance system, the marketing authorization holder (i) collects data on the risks of the drugs in respect of which it holds a marketing authorization, (ii) evaluates such 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, keep documents related to pharmacovigilance for a period of 10 years from the date of obtaining such documentation and make such documentation available, upon request, to the State Institute for Drug Control. The marketing authorization holder is also obliged to have a qualified person responsible for the pharmacovigilance agenda permanently and continuously available.

Furthermore, doctors, dentists, pharmacists and other healthcare practitioners are obliged to report to the State Institute for Drug Control any suspicion of any serious or unexpected effect related to the use of a drug, which could have serious consequences for the health of patients.

Manufacturers of medical devices and their authorized representatives are obliged to report any adverse incidents involving their medical devices. In addition, importers, distributors, healthcare providers, service persons, dispensers and sellers are obliged to report any suspected adverse incidents occurring in the course of providing healthcare services. The scope of legal obligations related to vigilance of medical devices will change significantly on 26 May 2020 when Regulation (EU) 2017/745 takes effect. Thereafter, manufacturers will be expressly required to establish and maintain a post-market surveillance and vigilance system. Reportable incidents will be defined differently for manufacturers/authorized representatives and for importers / distributors. Healthcare professionals, service persons, dispensers and sellers will not be expressly obliged to report suspected incidents.

6. Are foreign marketing authorizations recognized?

A foreign marketing authorization is recognized in the Czech Republic if it had been obtained through the European Medicines Agency under the centralized authorization procedure of the European Union. Otherwise, foreign marketing authorizations other than those mentioned in the previous sentence need to 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.

7. Are parallel imports of medicines or devices allowed?

An authorization for the parallel import of medicines may only be granted to the holder of the authorization for the wholesale distribution of medicines under the following conditions:

1. 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,
2. 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,
3. the medicine has identical therapeutic effects as the product authorized in the Czech Republic, does not constitute a risk to public health and is being used in accordance with the marketing authorization of the reference product.

For parallel imports of medical devices into the Czech Republic, the medical device in question must have the CE mark and be accompanied with information on its use in the Czech language. Provided that the importer is already registered with the State Institute for Drug Control and a notification has already been completed for the medical device, the distributor or importer of the device only has to inform the State Institute for Drug Control that it distributes or imports the device as well, without having to submit all the documents and information required when notifying a medical device. For more details 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 (up to approx. EUR 56 per year per healthcare professional) and, at the same time, relate to the specific professional’s activity. Similarly, healthcare professionals may not require or accept such benefits. Under Czech law, only doctors and pharmacists are considered healthcare professionals.

Samples of drugs can only be provided to persons authorized to prescribe them upon their written request, but only in a limited quantity, and each sample must correspond to the smallest available packaging of the product and it must be marked as “not for sale”. Samples of drugs containing narcotic and/or psychotropic substances are not allowed at all.

Sponsorship of meetings and conventions of experts, including the 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 (i.e. doctors and pharmacists).

Pharmaceutical 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 where it sets out procedures for the manufacture of active substances and excipients, for the manufacture and preparation of medicinal products and for their testing and storage.

As regards medical devices, the manufacturer needs to obtain the relevant trade license which is issued by the Trade Office and to register itself with the State Institute for Drug Control as a manufacturer. 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 regulations of the European Medicines Agency apply. The EU and the US have entered into a mutual recognition agreement on GMP inspections. The capability of the Czech Republic to carry out GMP inspections at a level equivalent to the US has been approved by the US FDA 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 the manufacturers’ premises are also required. Based on the schedule 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, dealing with complaints and removing goods 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.

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 are carried out by the employees of the State Institute for Drug Control. Generally, foreign inspectors are not allowed, but upon request by the competent authority of an EU member state, the State Institute for Drug Control may inform the authority about the contents of its inspection report.

Internal inspections can be carried out by 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 sets out the Good Manufacturing Practice (GMP) Requirements and the Good Distribution Practice (GDP) Requirements, and also in Decree No. 84/2008 Coll., on Good Pharmacy Practice (GPP) as well as 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 the Czech language and the name of the medicinal product must be also 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 below.

The storage location must have enough capacity so that different kinds of products can be stored in them in a clear manner and its structure must be such to meet conditions of good storage – 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 regular basis.

When handling drugs, any specific storage conditions (e.g. in terms of temperature or light) must also be maintained during the transport.

Specific requirements for storage, packaging and handling of medical devices are laid down in the Act on Medical Devices, Decree of the Ministry of Health No. 62/2015 Coll., and relevant guidelines of the State Institute for Drug Control. A medical device must not be exposed to adverse effects in order to avoid contamination, damage, theft, deterioration or confusion with another device. The distributor and the importer are also responsible for ensuring that proper conditions are also maintained during transport, even if the medical device is being transported by another person or entity. In addition, further requirements for the storage, handling and packaging of a medical device may be determined by the manufacturer of the device and included in the device’s manual, and must be complied with.

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

The following information 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 3 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 the Latin version;
• 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, in the case of a legal person, or the name or names, surname and place of business of the marketing authorization holder, in the case of a natural person, and, where applicable, the name of any representative appointed by it;
• 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 must be, among others, included on medical device labeling:

• instructions for use;
• name and address of the manufacturer;
• detailed information necessary for the user to be able to identify the device;
• the inscription “STERILE” if the device is sterile;
• the batch number with the symbol “LOT” or serial number, if applicable;
• date of latest safe use, if applicable;
• information that the device is for single use only, if applicable;
• inscription“individually manufactured medical device” in Czech, if applicable;
• inscription “only for clinical trials” in Czech, if applicable;
• special conditions for the storage and/or handling of the product;
• special operation instructions;
• any warnings;
• year of manufacture, if applicable;
• process of sterilization, if applicable;
• information that the medical device contains a derivate of human blood, if applicable.

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

The package leaflet may 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. These data must be in line with the SPC and must not contain promotional elements.

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

Any items that could lead to the incorrect use of the product may not be included in the labeling and packaging. For example, labeling and packaging may not include advertisements and/or any generally misleading information.

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 not having a marketing authorization and medicines containing narcotics or psychotropic substances may not be advertised at all.

In addition to the general advertising requirements, any advertising of medicinal products intended for the public shall be executed in such a manner that it is clear that it is an advertisement; the marketed medicinal product must be clearly identifiable 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 package leaflet that accompanies the medicinal product, information necessary for the proper use of the product).

The 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 diagnosis or offering treatment remotely,
• suggesting that the effects of the medicinal product for human use 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 for human use will improve the health of the person taking it,
• indicating that the failure to use a medicinal product for human use may adversely affect the health of persons; this does not apply in case of vaccination actions 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 non-medical professionals, which, by virtue of their actual or presumed social status, could support the consumption of medicinal products,
• 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,
• and others.

For information about marketing practices such as gifts, sponsorships, travel and entertainment, please refer to Answer No. 8 above.

The advertising of medical devices is not specifically regulated, therefore, only general rules on advertising apply.

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, which can be dangerous to human health and the risk may be avoided (i) by an expert consultation with a pharmacist prior to the use of the product 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 medication, may be sold in regular stores, such as gas stations or supermarkets.

Medical devices subject to prescription may only be dispensed in pharmacies and in trading places for medical devices, or at the optician’s (optical medical devices). 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 a guideline specifying measures ensuring that prescription drugs are not advertised to the general public on the internet.

In addition, if sending advertisements via e-mail, advertisers must comply with specific anti-spam legislation which applies to commercial electronic messages.

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

Yes, except for medicines that require a prescription – those may not be advertised or sold directly (without prescription) to consumers.

21. How is compliance monitored?

Compliance with medicines advertising regulations is monitored by the State Institute for Drug Control. For the purposes of monitoring, the State Institute for Drug Control is entitled to: (i) request a copy of an advertisement; an advertiser must keep an advertisement for 5 years after the last release/broadcast of such advertisement, (ii) request documentation and information relating to an advertisement; an advertiser must keep such documentation and information for 5 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 such 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 on the validity of the claims made in an advertisement from the advertiser, (vi) order the removal or termination of an advertisement, which breaches the applicable statutory requirements, within a reasonable time period.

Television and radio advertising for medicinal products is supervised by the Council for Radio and Television Broadcasting.

Compliance with advertising regulations with regard to medical devices is monitored by the trade offices.

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 such advertisement. In addition, the State Institute for Drug Control may impose a fine of up to approx. EUR 19,500.