Trade names of medicinal products
Trade names of medicinal products
The name of the medicinal product can be an invented name, a generic name or a scientific name used in association with the name of the trademark, manufacturer, marketing authorisation holder or representative. The strength and the pharmaceutical dosage form of the medicinal product are connected the name of the product. Provisions concerning the trade names of medicinal products are included in Fimea Normative Guideline 3/2013 “Labelling and package leaflets for medicinal products”.
An invented name should not resemble the generic name to a misleading extent or otherwise exaggerate or mislead in a therapeutic or pharmaceutical sense, for example. An invented name must not be the same or misleadingly similar to another medicinal product with marketing authorisation in Finland. For safety reasons, when assessing the proposed name, it shall also be taken into account that the name does not resemble too closely the name of a product that has been marketed earlier.
Which suffixes are accepted for invented product names?
An invented name for a medicinal product shall primarily consist of one word. Use of a suffix in a product name should be avoided. Occasionally, it is nevertheless necessary to distinguish two products with the same name from each other, for example, products which have two different flavours. Fimea shall decide on the acceptance of suffixes on a case-by-case basis.
A suffix should not convey any promotional message or be misleading. Numbers should be avoided, as they can be mixed with the strength of the product. Table 1 lists examples of suffixes which are not generally acceptable, even though they may still appear in old product names.
Addition of a suffix to a product name may be accepted if its use can be deemed to improve patient safety. In addition, the suffix should make it easy to distinguish the product from other medicinal products on the market, or make its use clearer in such a manner that the user of the product understands it. It is recommended that the suffix VET be incorporated into the name of veterinary medicines. Table 2 lists suffixes that Fimea accepts under certain conditions.
Table 1, Examples of suffixes that Fimea does not deem generally acceptable (PDF, in Finnish)
Table 2, Suffixes that Fimea accepts (PDF, in Finnish)
Formation of a generic product name
A generic product name is formed by associating the generic name or the scientific name of the active substance with the name of the trademark, manufacturer, marketing authorisation holder or representative.
It has previously been recommended that a generic name should be formed so that the name indicates whether or not the strength of the preparation is expressed as a salt. Currently the generic name should be formed so that the salt form is not evident in the name even if the strength is given for the salt form. As there are preparations on the market with salt as part of the preparation name, the generic name with the salt will also continue to be required for any new preparations containing the same substance.
Can a medicinal product be on the market simultaneously with two different names?
A medicinal product can only be on the market under one name. If the name of a product is changed using a relevant variation application, the medicinal product with the old name must be withdrawn from pharmacies and wholesalers before the product is introduced on the market with a new name. The marketing authorisation holder must notify Fimea (notification of placing a medicinal product on the market) when the medicinal product is introduced on the market with the new name. For a justified reason, Fimea may grant permission to keep packages under the old and the new trade name simultaneously on the market for a maximum period of six months. The request for simultaneous marketing with justifications must be presented along with the name chance application.