Pharmaceutical advertising regulation and medical device advertising in Croatia

1.1 Medicines 

Primary legal sources are:

•  the Medicines Act (Croatian: " Zakon o lijekovima”);
• the Bylaw on Advertising of Medicines (Croatian: “Pravilnik o načinu oglašavanja o lijekovima”); and
• the Act on Preventing Conflicts of Interest (Croatian: “Zakon o sprječavanju sukoba interesa”).

1.2 Medical devices 

Primary legal sources are:

•  the Medical Devices Act (Croatian: “ Zakon o medicinskim proizvodima”);
• the Act on the Implementation of Regulation (EU) 2017/745 on Medical Products and Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices (Croatian: “ Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima”); and
• the Act on Preventing Conflicts of Interest (Croatian: “Zakon o sprječavanju sukoba interesa”)

2.1 Medicines 

Yes, there are industry codes, such as the Code of conduct of innovative pharmaceutical companies of the Croatian Association of Innovative Pharmaceutical Initiative (“ iF !”). 

2.2 Medical devices 

No code of conduct yet. However, CROMED ‐ (Croatian: “ Udruga industrije medicinskih proizvoda”) was established in 2017, as a national association of MedTech Europe. 

3.1 Medicines

No particular licence / approval is necessary specifically for advertising, but there are statutory limitations as to what can be advertised. Croatian legislation considers advertising of a medicine as any form of information intended to encourage their prescribing, issuance, sale and consumption in written, oral, pictorial, audio, electronic, digital or other form. 

Prescription-only products medicine can be advertised only to healthcare professionals (as well as in in professional literature, at professional and scientific conferences), while advertising such medicine to the general public is forbidden. The latter prohibition does not apply to public health activities for the promotion of immunization, seroprophylaxis and chemoprophylaxis according to the program adopted by the Minister in accordance with the Law on Protection of the Population from Infectious Diseases. 

Over-the-counter medicines can be advertised both to the general public and to healthcare professionals. 

Moreover, advertising of a medicine that does not have a marketing authorization in the Republic of Croatia is forbidden, except at professional and scientific conferences and in the professional literature (provided that the procedure for granting a marketing authorization in accordance with is initiated and that only the common name of the drug is used, without specifying the manufacturer). 

In any case, it is forbidden to state in the advertisement that the medicine has curative properties if it does not have the approval for marketing as a medicine, or if it is not registered as a traditional herbal medicine. 

3.2 Medical devices 

Advertising of medical device is allowed towards both the general public and healthcare professionals only if such devise meet the legal requirements prescribed by the Medical Devices Act. The exception to this rule is envisaged for medical devices intended for exhibitions, demonstrations, fairs, etc. Such products must have a visible sign that they are not intended for placing on the market or putting into use. 

Medical devices intended exclusively for use within healthcare industry activities may be advertised solely to healthcare professionals. 

Any misleading claims about the medical devices are expressly forbidden. 

Yes. The distinction plays an important role regarding advertisements that are addressed to the general public. While advertising of over-the-counter medicines to the general public is permitted under certain conditions as listed below, advertising of prescription-only medicines to the general public is generally prohibited. 

Conditions that need to be fulfilled in order to advertise an over-the-counter medicine to the general public are: 

• The advertisement needs to contain:

1. at least information listed in Q 8(a);
2. a declaration stating: “Read the package leaflet carefully before use and ask your doctor or pharmacist for the risks and side effects” (“Prije upotrebe pažljivo pročitajte uputu o lijeku, a o rizicima i nuspojavama upitajte svog liječnika ili ljekarnika”); and
3. must not be misleading and it must be clearly visible that is an advertisement.

• The text “Paid medicine advertisement” (“Plaćeni oglas o lijeku”) should appear on the visible part of an article (i.e. print or published on the Internet) with a font size equal to or larger than the font size of other content of the article. 

5.1 Medicines

Advertising is forbidden as explained under Q 3.

Therefore, the main restrictions applicable to the advertising of over-the-counter medicines are:

• Advertising may only be carried out for medicines that have marketing authorisation approval for the territory of Croatia. However, if the procedure of a marketing authorisation has been initiated and if only a common name is used as a name of the medicine without specifying the manufacturer, then it would be allowed to advertise such medicines in the literature or at professional/scientific meetings (this restriction does not apply to scientific and professional international conferences held in the Republic of Croatia); and
• Advertising must be objective, must not contain any exaggeration of effects or guarantees of success and must be compatible with the product labelling, instructions for use (IFU) and summary of product characteristics (SmPC);
• Print articles and articles published on the Internet must contain a statement: “Paid advertisement on the medicine” (“Plaćeni oglas o lijeku”), which should appear on the visible part of the article with a font size equal to or larger than the font size of the other content in the article.

Further, several restrictions as to the content of advertising of the over-the-counter medicines to the general public, the most significant ones being (a complete list can be found in Article 10 of the Bylaw on Advertising of Medicines): 

• Forbidden use of a claim on absence of side effects/non-toxic/no risk of addiction;
• Forbidden use of a claim that a medicine may improve the patient’s health or that patient’s health may be harmed if the patient does not take the medicine;
• Advertising claim must not be addressed mainly or exclusively to children;
• Advertising claim must not contain a recommendation by scientists, HCPs or third parties who may encourage the consumption of medicines due to their high profile; and
• Advertising claim must not contain a promotion as a natural product to demonstrate efficiency and safety.

5.2 Medical devices 

It is prohibited to advertise medical devices which do not meet the requirements prescribed by the Law on Medical Devices, except for medical devices intended for exhibitions, demonstrations, fairs etc. Such products must have a visible label indicating that they are not intended for placing on the market nor for use. 

Misleading advertising of medical devices is forbidden. Advertising of medical devices must not contain information listed in Q 8(b). 

6.1 Medicines 

The main restrictions applicable to the advertising of medicines to HCPs (a complete list can be found in Articles 15 and 22 of the Bylaw on Advertising of Medicines) are:

• Forbidden use of a claim which suggest that a medicine or its active substance has any particular characteristics, quality or effect, if such claim cannot be based on evidence;
• The word “safe” must not be used when describing a medicine without the necessary explanation;
• The word “new” must not be used to describe a specific medicine of the MA holder which is available in the Republic of Croatia for a period exceeding one year from the date of placing on the market;
•  No premium or financial/material benefit may be granted, offered or promised to persons entitled to prescribe or supply medicines in the course of sales promotions. Excluded are benefits of insignificant value i.e. HRK 70.00 (VAT excluded) and have relevance for the medical or pharmaceutical practice. HCPs restrictions of HRK 70 applies to HCP employed in public health institutions. However, HCPs employed in private health institutions are subject to anticorruption and criminal law; and
• Free medical samples can only be distributed upon written request by HCP in the smallest available packaging and with the imprinted statement “Free medical sample – not for resale” (“besplatni uzorak – nije za prodaju”). Only certain quantities are permitted per doctor.

6.2 Medical devices 

Advertising is forbidden in cases as explained under Q 3.2.

When advertising medical devices to HCPs authorised to recommend, prescribe and issue medical devices, it is not permitted to provide any gifts or items or promise of a reward or a privilege, unless they do not exceed a value of HRK 70.00 (VAT excluded) and are related to the practice of the HCP.

Such gifts may not be provided in response to a request from HCP. HCPs restrictions of HRK 70.00 applies to HCP employed in public health institutions. HCPs employed in private health institutions are subject to anticorruption and criminal law.

7.1 Medicines

The following information must appear in advertisements directed only to HCPs:

• Essential information on the medicine in accordance with the information given in the SmPC and the approved package leaflet in the Republic of Croatia;
• Whether it is issued based on the prescription or over the counter;          
• Personal details of the marketing authorisation holder;
• Name of the medicine and international name of the active substance;            
• Approved indications and contraindications;
• Precautions and frequent side effects;
• Dosage and method of use and warnings; and 
• Last approved SmPC and package leaflet. 

Promotional materials addressed only for HCPs must contain a statement: “Only for HCPs” (Croatian: S“amo za zdravstvene radnike”) and must indicate the date on which they were drawn up or last amended. 

7.2 Medical devices 

The Law on Medical Devices prescribes only information which are not allowed to be used in advertisement. For further information please refer to Q8.2. 

Please note that, medical devices intended to be used solely for the purpose of performing a health care activity may be advertised exclusively to healthcare professionals. 

8.1 Medicines 

Advertisement for over-the-counter medicines directed to the general public must include at least the following information: 

Name of the medicine and the scientific name of its active substance (this does not apply in the case of more than one pharmacologically active ingredient);

Information essential for the correct use of the medicine; and

Clearly visible indication that adverse effects may also be caused and that the instructions for use must therefore be strictly observed or the advice of a doctor or pharmacist sought; in acoustic or audio-visual media the indication must be in acoustic form.

8.2 Medical devices 

The Law on Medical Devices prescribes only information which are not allowed to be used in advertisement. Therefore, several restrictions as to the content of advertising of the medical devices, (a complete list can be found in Article 60) are:

• Advertising claim must not be addressed mainly or exclusively to children;
• Advertising claim must not encourage the abandonment of basic generally accepted therapeutic procedures;
• Advertising claim must not endanger human dignity; and
• Advertising claim must not contain a promotion as a natural product to demonstrate efficiency and safety. 

9.1 Medicines 

Advertising on medicines to the general public must not contain scientists or HCPs statements which would, based on their health care reputation, encourage to use medicine. On the other hand, scientific information (e.g. citations, tables) taken from medical journals or other scientific papers for the purpose of promotion of the medicines to the HCPs must be faithfully transmitted. 

9.2 Medical devices 

Advertising on medical devices to the general public must not contain:

1. unfamiliar scientific terms for common medical conditions;
2. scientists or HCPs statements which would, based on their health care reputation, help with the promotion of a medical device.

Condition under b. applies as well on advertising of medicines to the general public.

Yes. Information about comparing the effectiveness or safety of the proposed drugs or medical devices with that of others must not be advertised. 

• Yes, there are specific provisions for advertisement of medicines on the internet/in social media.  
• As a general rule, it is permitted to advertise medicines on the internet, in accordance with the
• Bylaw on Advertising of Medicines.
• In addition, the content of websites should be separated, according to the category of users into the section intended for the: a) general public; and for b) HCPs. Also, it must be updated regularly (i.e. for each webpage/topic unequivocally displayed the date when the content was last modified).
• Websites which are intended solely for the HCPs need to be protected by the username and the password.
• Websites which are available to use by the general public may contain the list of prescription-only medicines, only if the name of the medication and faithful reproduction of approved instructions for the drug are also listed.
• Further, when advertising over-the-counter medicine on the internet, it is mandatory to state (in the advertisement or notice): “Read the package leaflet carefully before use and ask your doctor or pharmacist for the risks and side effects” (“Prije upotrebe pažljivo pročitajte uputu o lijeku, a o rizicima i nuspojavama upitajte svog liječnika ili ljekarnika”). The warning must be an integral part of the advertisement (i.e. not a link).
• In case of television advertisement, the subject warning must be displayed independently (i.e. in a separate frame) and clearly readable.
• Advertising of the medicine must not be misleading and must be clearly visible that it is an advertisement. For print articles and articles published on the Internet in which the medicine is advertised, the text “Paid medicine advertisement” (“Plaćeni oglas o lijeku”) should appear on the visible part of the article with a font size equal to or larger than the font size in other parts of this article.
• (A complete list of provisions can be found in Article 23 of the Bylaw on Advertising of Medicines).
• When advertising medical products on the internet, the general rules apply to both general public and professional advertising. 

Control and supervision of the advertising regulations is the responsibility of the Pharmaceutical Inspection of the Ministry of Health (Farmaceutska inspekcija Ministarstva zdravstva). 

The subject inspection can request information, carry out on-site inspections and issue various orders and measures to establish a legally compliant state.

The claims may be asserted by competitors and certain organisations.

The Medicines Act prescribes monetary penalties in the amount of approx. EUR 13,333.00 to EUR 20,000,00 for responsible (legal or natural) person which advertise medicines contrary to the provisions of the mentioned act.

The Law on the Implementation of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices prescribes monetary penalties in the amount of approx. EUR 13,333.00 to EUR 93,000.00 for legal person in case of advertising a medical device, by using text, names, trademarks, images or symbols that could mislead the user or patient as to:

• purpose of the medical device and its safety by attributing to the product functions and features that it does not have;
• creating the wrong impression regarding treatment or diagnosis, functions or properties that the medical device does not have;
• failing to inform of the potential risk associated with the use of the medical device in accordance with its intended use. 

Competition law risks are mainly for payments/advantages granted to HCPs/labs, driving patient footfall and therefore earnings for the included HCPs/labs. 

Currently, there are no future developments envisaged, with respect to the advertisement of medicines/medical devices.