08 June 2010,
Updated 14 August 2012
Authorised medicinal products can be named in three different ways:
- Invented name
- Generic name followed by a trademark or the name of the marketing authorisation holder
- Scientific name followed by a trademark or the name of the marketing authorisation holder
The Danish Health and Medicines Authority's practice concerning the three naming options is as follows:
1. Invented name
Section 58(3) of the Danish Medicines Act stipulates that: The name of a medicinal product must not be misleading in relation to the composition, effect or characteristics of the product and must not be suitable to cause confusing with other medicinal products.
Furthermore – due to the fact that Denmark has acceded to the WHO convention – an invented name must not be liable to cause confusion with INN names of active substances.
Denmark has also acceded to the convention of the Council of Europe concerning the European Pharmacopoeia. Therefore, names cannot be accepted if they include the Ph.Eur. name of an active substance.
In principle, any name of a medicinal product can be accepted if the above-mentioned is adhered to. However, the following must also be taken into consideration:
- As a main rule, the name must be pronounceable. Therefore, symbols cannot be accepted as part of a name.
- Numbers can only be included in names of combination products. If both strengths are stated, they should be separated by a slash. For contraceptive pills it may be relevant to state the number of tablets per cycle.
- Regarding extensions of existing marketing authorisations, the same name must be used and, if necessary, supplemented by a suffix. Conversely, an approved name can only be used for a new medicinal product if this product is applied for as an extension of the existing marketing authorisation for the medicinal product in question.
When considering the possible confusion with other medicinal products, the following aspects are considered:
- In general, there must be a difference of at least three letters.
- Pronunciation and spelling are considered. Even though two names have three or more different letters, they may still cause confusion. On the other hand, names that only differ by two letters may – in a few cases – be sufficiently different to not cause any confusion.
Regarding veterinary medicinal products, it might – in a few cases – be relevant to add the animal species as a suffix to the invented name.
2. Generic name followed by a trademark or the name of the marketing authorisation holder
As a rule, the generic name must be the Danish name listed in the Danish Drug Standards (Danske Lægemiddelstandarder – abbreviated DLS) or, if the active substance is not listed in the DLS, a Danish name derived from the INN according to the principles used in the DLS.
If it is a salt, a derivative or an ester, the generic name used should relate to the strength:
- If the strength is stated in relation to the base, the generic name of the base should be used.
- If the strength is stated in relation to the salt, the generic name of the salt should be used.
However, based on discussions with the pharmaceutical industry we have decided to derogate from the above principles under specific conditions.
In future, we will accept a declaration with spelling that deviates from the one used in the DLS, if it cannot lead to any confusion or be misleading. This applies to naming of a medicinal product in the form of a generic name followed by a trademark or the name of the marketing authorisation holder and in the labelling of outer and inner packaging. But it is on the terms that the deviations are intended to facilitate the making of packaging material common to several Nordic/EU/EEA countries. In the declaration under section 2 of the summary of product characteristics and section 6 of the package leaflet, the Danish spelling must still follow the DLS. This spelling will also be used in the Danish Health and Medicines Authority's register and in Medicine Prices.
When the strength is related to content of e.g. a salt or an ester, and if it cannot cause any confusion between strengths (and thus potential for dosage errors), the Danish Health and Medicines Authority can be more flexible when it comes to the requirement for consistent enforcement of the connection between strength indication and generic name in the name of a medicinal product. However, this is on the terms that the deviations are intended to facilitate the making of packaging material common to several Nordic/EU/EEA countries.
We aim to ensure the greatest possible patient safety, and we would therefore like to emphasise that:
For medicinal products where the generic name used (salt or base) does not reflect the strength indicated, the Danish Health and Medicines Authority requests that the package leaflet is supplied with a text stating the deviation. One example could be Benazepril "Company" film-coated tablets 5 mg containing 5 mg of the salt benazepril hydrochloride. The package leaflet should therefore be supplied with the following text: "Bemærk, at styrken afspejler indholdet af benazeprilhydrochlorid" (Please note that the strength reflects the benazepril hydrochloride content).
3. Scientific name followed by a trademark or the name of the marketing authorisation holder
In this connection, scientific name means the IUPAC name or something similar.
Re items 2. + 3. Suffixes
Naming in the form of a generic name or a scientific name followed by a trademark or the name of the marketing authorisation holder cannot generally be combined with suffixes.
Of patient safety reasons, addition of, e.g., the strength of a combination product may be accepted in a few special cases.
We only evaluate proposals for medicinal product names based on an actual application.
For further information, please contact the Danish Health and Medicines Authority's Regulatory Unit.