Advertising of medicinal products

Advertising of medicinal products

Advertising of medicinal products must encourage people to use the products appropriately in accordance with the Medicines Act. The advertising of medicinal products must not be improper or induce people to use the products unnecessarily. Fimea monitors the advertising of all medicinal products.

Fimea intervenes in the illegal advertising of medicinal products on the basis of a defect or fault in such advertising. The process can be initiated by a complaint submitted to Fimea, also one submitted by a private individual. The complaint must always include the complainant’s contact information. No anonymous complaints are processed.

Fimea sends a reprimand to the pharmaceutical company concerning fraudulent marketing or a clarification request and a copy of the complaint submitted, but will not provide the complainant’s contact information. The company is given the opportunity to submit a rejoinder, on the basis of which Fimea will then decide on the need for further action. If further action is required, the company will be informed of the action in writing and can also submit a rejoinder. Both the company and the complainant will be informed of the action taken and the conclusion of the process.

The inverted black triangle and standardised explanatory sentence  

The Finnish Medicines Agency Fimea requires that all marketing materials for medicinal products subject to additional monitoring under European Commission Regulation (EC) No 726/2004 (art. 23) display the symbol (inverted black triangle) specified in European Commission Regulation (EC) No 198/2013 and the accompanying, standardised explanatory sentence. 

It is Fimea's view that the additional monitoring of medicinal products in accordance with the regulations referred to above, including the the relevant markings, represents information necessary to the correct and safe use of a medicinal product referred to in Section 91 a of the Medicines Act, and essential information on the medicinal product and its use referred to in Section 91 b of the Medicines Act. 

The presentation of the inverted black triangle must comply with the specifications given in the Annex to regulation (EC No 198/2013), and each side must be at least 5mm long.   Smaller triangles may not be used. The text of the explanatory sentence must be easy to read and proportionate to the size of the triangle, as indicated below. Both the triangle and the standardised explanatory sentence must be enlarged as required to make them proportionate to the font size used elsewhere in the material. 

The inverted triangle is always black. No other colours are permitted. 

The triangle and the accompanying standardised explanatory sentence must be separated from other text.  The triangle and the sentence may not be separated from each other, nor should any other text or other elements be placed in their immediate vicinity. It is, however, permitted to add explanatory sentences used in the summary of product characteristics (This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. )after the standardised explanatory sentence. 

The triangle is not to be part of the product logo. 

In the case of electronic materials, the minimum recommendation is to place the black triangle and the explanatory sentence on the page on which the name of the medicinal product is displayed for the first time (usually the front page) and on the page containing product 
information, if this is a separate page. It is recommended that the same principle be followed in the case of other materials in which the product information is provided on a separate page. 

The inverted black triangle and the standardised explanatory sentence are not required in any reminder advertisements for the medicinal products in question. 

Sample triangle and explanatory sentence: 

In Finnish: The inverted black triangle.  Tähän lääkkeeseen kohdistuu lisäseuranta.

in Swedish: The inverted black triangle.  Detta läkemedel är föremål för utökad övervakning.

In English: The inverted black triangle.  This medicinal product is subject to additional monitoring.

Recommendation for quality criteria for sales promotions of medicines

The work of pharmaceutical sales representatives is marketing, which is aimed at promoting the use of medicines.

A sales promotion event at its best provides up-to-date and good quality information about medicines and their use to practising doctors and pharmacists. In line with the rest of the pharmaceutical marketing, Fimea in Finland also monitors compliance with all parts of the pharmaceutical legislation at sales promotions. Fimea (former NAM) established in 2007 quality criteria for these sales promotion events based on the points in the Medicines Act and Decree important with respect to the communication of appropriate information about medicines which promotes their correct and safe use.

The quality criteria comprise a recommendation which Fimea hopes that the pharmaceutical companies will follow in their marketing. To the professional attending a sales promotion event the recommadation will give a perception of what can be expected of the information content of the presentation. Later Fimea will monitor the extent to which the criteria are followed at these events.

The advertising of medicinal products is prescribed under

Medicines Act (395/1987), 91–94 §
Medicines Decree, 25, 25a–i §
Consumer Protection Act (38/1978)

Ask more

Kristiina Pellas, Senior Pharmaceutical Inspector, tel. +358 29 5223422

E-mail addresses follow the form [email protected]