Advertising of medicinal products

Common to all medicinal product advertising is that it must not be misleading or lead to misuse. Only authorised or registered medicinal products may be marketed. The Swedish Medical Products Agency (The Swedish MPA) examines the marketing of medicinal products, in line with its work to promote public and animal health.

Advertising of medicinal products for humans

A number of requirements apply to the advertising of medicinal products intended for human use.

Among others, it is forbidden to:

• market non-authorised medicinal products,
• target advertising of medicines at children,
• target advertising of prescription‍-‌only medicines at the general public (with the exception of human vaccination campaigns against infectious diseases).

Advertising must not be misleading and must comply with the summary of product characteristics. 

The advertising must contain information of particular importance either to the general public or to persons qualified to prescribe or supply medicinal products, depending on the intended recipient.

Advertising of homoeopathic medicinal products and registered traditional herbal medicinal products is also subject to supervision by the Swedish MPA.

Advertising aimed at the general public

Advertising of non‌-‌prescription medicinal products aimed at the general public must promote the proper use of the medicinal product. The consumer must not be misled into believing that the medicinal product has properties other than those for which it is authorised or registered. Moreover, advertising must not lead to people not seeking appropriate care. It must be clear that the product is a medicinal product and that the message is advertising. 

Advertisements for medicinal products aimed at the general public must at least include:

• The name of the medicinal product and the common (i.e. generic) name, if the medicinal product contains only one active ingredient.
• Information necessary to enable proper use of the medicinal product.
• An invitation to carefully read the information given in the package information leaflet. The invitation must be explicit and easily legible.

According to the Swedish MPA’s interpretation, examples of information necessary to enable proper use of the medicinal product may be information on:

• the need to make contact with the healthcare system for diagnosis prior to treatment;
• the need to make contact with the healthcare system if treatment is not effective within a certain period of time;
• restrictions on treatment for children and pregnant women;
• limitations on the duration of treatment.

The requirement that the invitation to carefully consult the information given in the package information leaflet must be explicit and easily legible has been interpreted by the Swedish MPA as meaning that:

• In written marketing, the font used in the invitation should not differ from other text in the marketing. It should be adjacent to the other text in the marketing and the product image.
• In the case of audio advertising, the invitation should be read out so that the information reaches the recipient.
• In the case of moving pictures, the invitation should be displayed long enough and in a sufficient font size to ensure that the information reaches the viewer. The invitation may be combined with reading aloud.
  The Swedish MPA’s interpretation is merely a recommendation regarding how the rules can be applied.

Advertising aimed at prescribers

Advertising of medicinal products aimed at prescribers or persons authorised to supply medicinal products must be sufficiently detailed to give an idea of the therapeutic value of the medicinal product concerned. Essential information from the summary of product characteristics and the classification of the medicinal product must be included.

Advertising of medicinal products for animals

Advertising of medicinal products for animals is subject to a number of requirements. This includes the medicinal product being authorised or registered in Sweden before it may be marketed here. The advertising must comply with the summary of product characteristics for the veterinary medicinal product being advertised. The advertising must not contain information which is misleading or could lead to misuse of the medicinal product. Furthermore, advertising must promote responsible use by presenting the veterinary medicinal product objectively and without exaggeration.

Advertising of veterinary medicinal products subject to medical prescription may only be aimed at veterinarians or persons authorised to supply such medicinal products. At the general public, it is therefore only permissible to aim adverts for non-prescription animal medicines. Samples of veterinary medicinal products must not be distributed as advertising, except for small quantities of samples, which may be distributed to veterinarians or other persons authorised to supply such medicinal products. The distribution of veterinary antimicrobial or narcotic medicinal products as samples is not permitted.

Rules on the advertising of medicinal products for animals are laid down in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (Articles 119-122) and in the Swedish MPA Regulations (HSLF‌-‌FS 2021:86) on the handling of samples of veterinary medicinal products. You can find links to the regulations at the bottom of this page, under the heading ‘Regulatory framework’.

Auditing of advertising

The Swedish MPA is responsible for monitoring the advertising of medicinal products and scrutinising the advertising of medicinal products in all media. We also receive tip-offs from businesses, healthcare professionals and private individuals. If the marketing does not comply with the rules, the company responsible can be contacted and asked to alter or stop the false advertising. If the marketing rules are not followed, the Swedish MPA may issue orders* and bans linked to a fine*.

(* Order = a decision which requires the concerned party to do something or stop doing something.

* Fine = anyone who does not comply with the order may be required to pay a sum of money.)

Tell us about illegal advertising

Your tip-offs can help other people by alerting the Swedish MPA to unlawful marketing.

Once we have received the tip‌-‌off, we will consider whether action is needed. However, because of rules on the freedom of the press and freedom of expression, we are unable to give advance notice as to whether certain marketing complies with the rules. 

Advertising in breach of the law

If the Swedish MPA becomes aware of unlawful marketing, we can initiate a supervisory case.

In most cases, we will contact the person or company responsible. They will then be given the opportunity to express their views on the marketing and how they consider it to relate to the legislation. However, there is no requirement to express an opinion on the matter.

If the Swedish MPA considers the marketing to be in breach of the law, the case may lead to a decision concerning an order or ban linked to a fine.
This could, for example, mean that the person or company responsible would be liable to pay a fine each time the marketing is repeated. Appeals against decisions by the Swedish MPA may be lodged with the Administrative Court.

Regulatory framework

Advertising of medicinal products for humans:

The rules applied by the Swedish MPA when monitoring the advertising of medicinal products for human use are laid down in Chapter 12 of the Swedish Medicinal Products Act (2015:315) and MPA Regulations (LVFS 2009:6) on the advertising of medicinal products for human use. These are based on Directive 2001‍/‌83/‌‍EC of the European Parliament and of the Council.

Medical Products Agency Regulations (LVFS 2009:6) on the advertising of medicinal products for human use

Advertising of medicinal products for animals:

The rules applied by the Swedish MPA when monitoring the advertising of medicinal products for animals are laid down in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (Articles 119 -‌122) and in MPA Regulations (HSLF‍‍-‍‍FS 2021:86) on the handling of samples of veterinary medicinal products.

Medical Products Agency Regulations (HSLF‍‍-‍‍FS 2021:86) on the handling of samples of veterinary medicinal products

General marketing rules

General marketing rules are laid down in the Swedish Marketing Act. The Swedish Consumer Agency has supervisory responsibility regarding these rules. There are also rules on advertising medicinal products and medical treatments in the Swedish Radio and Television Act.