Pharmaceutical advertising regulation and medical device advertising in North Macedonia

The Law on Medicines and Medical Devices, Official Gazette of Republic of North Macedonia nos. 106/07, 88/10, 36/11, 53/11, 136/11, 11/12, 147/13, 164/13, 27/14, 43/14, 88/15, 154/15, 228/15, 7/16, 53/16, 83/18, 113/18 и 245/18, which entered into force on 13 September 2007, (“Law on Medicines”) stipulates the manner of advertising medicines and medical devices (jointly referred to as “Medical Products”). Additionally, the Guidebook on the Manner of Advertising on Medicines and Medical Devices, Official Gazette of Republic of North Macedonia no. 66/2008 (“Guidebook on Advertising”), which is a bylaw passed in accordance with the Law on Medicines and entered into force 28 May 2008, comprehensively regulates the manner of Medical Products advertising.

Except the above-stated regulations, no other bylaws/codes of conduct regulate the manner of advertising Medical Products further.

3.1 The general public

The market authorisation holders and the producers are entitled to advertise over-the-counter Medical Products to the general public upon prior approval from the Agency on Medicines and Medical Devices (“Agency”). Furthermore, the Agency determines the fees for obtaining such an approval, as follows:

• Compensation for assessing the documentation submitted to the Agency in the procedure for obtaining an approval in case of advertising in print media (newspaper/magazine advertisement, poster, brochure, flyer, banner and billboard) or in the electronic media, is equal to:
  • EUR 200 for one pharmaceutical form, strength and size of package;
  • EUR 200 for each additional pharmaceutical form advertised in the same advertisement;
  • EUR 100 for each additional strength of the same pharmaceutical form advertised in the same advertisement; and
  • EUR 100 for each additional size or type of the package of the same pharmaceutical form and strength in the same advertisement.
• Compensation for assessment of the documentation for any form of advertising to the general public in the amount of EUR 200.

3.2 Healthcare professionals

The Law on Medicines does not require special approval for advertising to healthcare professionals. Namely, the advertising of Medical Products to healthcare professionals could be performed only by market authorisation holders for the sale of Medical Products in North Macedonia by publishing advertisements in professional magazines and publications as well as by directly informing the healthcare professionals who prescribe the Medical Products.

The main difference between the regulations that refer to the advertising of these two categories of medicines is the ban of advertising prescription-only medicines (“POM”) to the general public. POM may be advertised only under the following conditions:

• The purpose of the advertising should be to inform the expert public about the properties and the therapeutic effects of the Medical Product;
• The target of advertising should be limited to the following categories of healthcare professionals:
  • Healthcare workers that prescribe, sell, or issue the Medical Product.
  • Conduct or influence the procurement for a pharmacy or specialised store or other health institution.
  • Graduated pharmacists or other experts in production, wholesale trade or retail trade.
  • Experts employed in the Ministry on Health or in the Agency.

Please note that the same main restrictions are applicable for medicines and for medical devices. Therefore, when advertising Medical Products to the general public, following elements must not be present:

• Allegations that the expenses for the Medical Products will be borne by the Health Insurance Fund, except in cases of epidemics;
• Indications about the price of the Medical Products;
• Recommendations on the properties of the Medical Products which encourage the use of the Medical Products;
• Famous persons who might influence usage due to their popularity;
• Disease histories or diagnostic procedures that may lead to misdiagnosis or self-diagnosis;
• Inappropriate, disturbing or misleading indications of changes of the human body caused by the disease, injury or by some Medical Products;
• Data or conclusions on the efficiency of the Medical Products which is still a subject of clinical trial in North Macedonia or abroad;
• Data on the disease, diagnosis, or therapeutic procedures or the Medical Products used in the treatment procedure of specific people;
• Children using or intending to use the Medical Products;
• Children must not be the target of the advertisement; and
• Free samples may not be given to the general public and the name of the pharmacy that sells the Medical Products or the wholesaler of the Medical Products must not be indicated during advertising.

In addition to all of the above, the Guidebook on Advertising prohibits leaving certain impressions on the consumer (e.g. the impression that taking Medical Products is beneficial for the health, even when no signs of illness).

The Law on Medicines differentiates between three forms of Medical Products advertising to healthcare professionals:

• Promotion;
• Providing free samples;
• Sponsoring expert gatherings.

Please note that the same main restrictions are applicable for medicines and for medical devices. All forms of advertising are strictly regulated, but the most comprehensively regulated restrictions apply to the promotion of Medical Products, i.e. following actions are forbidden:

• Encouraging prescription, issuance, purchase of Medical Products, or giving any recommendation for using or purchasing Medical Products by offering and rewarding money, giving gifts or any other benefit,
• Encouraging the expert public to replace one Medical Product with another Medical Product from the same therapeutic group, without clear medical indications;
• Drawing conclusions about the effects of a Medical Products subject to clinical trials in North Macedonia or abroad;
• Promoting a Medical Product during the process of changing the summary of Product characteristics (“SmPC”) and/or the patient-user guidelines;
• Using a SmPC and/or a patient-user guideline, with small letter size, or another type of printing that prevents easy reading and comprehension of the text;
• Publishing information through the media used in the process of advertising the health facilities, or specialised stores;
• Diminishing the significance of the precautions or adverse reactions to the Medical Product stated in the approved SmPC as well as in the user guide,
• Reducing the therapeutic value of another Medical Product with marketing authorisation or in any other way to raising doubts about the value of another Medical Product;
• Using employees of the Ministry on Health, the Agency or other persons that participate in Medical Products advertising;
• Using materials protected as intellectual property without prior consent of the owner,
• Using postcards or other forms of written messages which may be seen by the general public; and
• Using telephone, fax, electronic mail or other electronic media without explicit prior consent from the owner.

Please note that the same information should be included in the advertisements of medicines and medical devices to healthcare professionals. Generally, the advertising to healthcare professionals should include information on a Medical Product’s characteristics and its therapeutic effects.

Mandatory information is stipulated only for promotion of Medical Products, i.e. the marketing authorisation holder is obliged to indicate:

• The date of obtaining the marketing approval; or
• The date of the last change of the marketing approval, as well as updated, relevant or duly transmitted data with indication of the source; and
• Information on the manner of issuance of the Medical Product i.e. over the counter or prescription-only.

In addition to the above information, the advertisement to healthcare professionals may present information about the retail price of the Medical Products;

Please note that the same information should be included in the advertisements of medicines and medical devices to the general public. Therefore, when advertising to the general public, the message should at least contain:

• The name of the Medical Product;
• The method of use and data necessary for the proper use of the Medical Product,
• Visible, legible and understandable written or spoken warning to the user about carefully reading the user guide and consulting a doctor or pharmacist about the possible risk and adverse reactions (the exact of form of this warning is given in the Guidebook on Advertising).

The Guidebook on Advertising contains only a general requirement on indicating true and scientifically proven data in the advertisement. Generally, advertising of Medical Products must be made in accordance with the approved user guide, whilst in case of medicines, compliance with the SmPC is also required.

The Law on Medicines and the Guidebook on Advertising explicitly forbid the comparative advertisement of Medical Products in North Macedonia.

When advertising on the internet, the mandatory warning for carefully reading the user guide and consulting a doctor prior to usage (referred to also in question 8, point 3) must be an integral part of the start page (or home page) of the advertisement.

The compliance monitoring is conducted by the Agency via pharmaceutical inspectors. Pharmaceutical wholesalers with turnover above MKD 10,000,000 or approx. EUR 162,602 are subject to mandatory inspection conducted by two pharmaceutical inspectors, two tax inspectors and one custom official.

If the advertising is unlawful, the pharmaceutical inspectors are entitled to forbid it and to order destruction on all materials used for that purpose.

A fine in the amount of EUR 50,000 will be imposed on the legal entity, if it:

• Advertises prescription-only Medical Products to the general public;
• Prescribes false characteristics, highlights its positive effects, uses improper manner in describing its effects, compares Medical Products with other ones or uses any other manner that is misleading for the consumer,
• Advertises by addressing children;
• Distributes free samples to the general public;
• Advertises Medical Products without marketing authorisation; or
• Advertises Medical Products used only in healthcare institutions.

A fine in the amount of 30% thereof will be imposed on the responsible person within the legal entity, whilst the responsible employee will be fined a sum of EUR 5,000 up to EUR 7,500.

A fine in the amount of EUR 30,000 will be imposed on the legal entity, if it:

• Violates the statutory general rules for advertising Medical Products to healthcare professionals;
• Promotes Medical Products by exceeding the scientific-expert purposes; or
• Misinforms the general public on Medicine Product’s characteristics.

A fine in the amount of 30% thereof will be imposed on the responsible person within the legal entity, whilst the responsible employee will be fined a sum of EUR 3,000 up to EUR 4,500.

In respect of the advertising of Medical Products, there is no publicly available indication that any development is planned for the near future.