Guideline for the naming of medicinal products

Guideline for the naming of medicinal products

All names for new medicinal products and changes to already approved names must be assessed and approved by the Norwegian Medical Products Agency.

This guideline is applicable for medicinal products approved through the MRP, DCP and the national procedure. It’s based on the Guideline on the acceptability of names for human medicinal products processed through the centralised procedure.

The same principles apply to medicinal products subject to medical prescription and medicinal products not subject to medical prescription.

The following types of names can be used for medicinal products

1. Invented name

2. INN (International Nonproprietary Name, recommended by the WHO), or if one does not exist the European Pharmacopoeia name or the usual common name. In these cases, it shall be accompanied by the name of the marketing authorisation holder (MAH) or a trademark.

We strive for the following principles when approving both invented and INN-names

• The name should be easy to pronounce in Norwegian

• Numbers indicating the strength can only be part of the name for combination products. Specifications of strengths can be separated by slashes.

• For oral contraceptives, it may be relevant to specify the number of tablets per cycle.

• Taste or other description of the medicinal product cannot be part of the name, but may be declared as a supplement to the pharmaceutical form.

• The strength and pharmaceutical form shall not be part of the name.

To ensure the delivery situation in Norway, the Norwegian Medical Products Agency may take into account planned common packs with other Member States.

There are circumstances where the Norwegian Medical Products Agency will insist on an invented name rather than an INN name. This is due to the risk to patients from interchanging between products containing the same active substances but having different bioavailabilities, leading to potential differences in therapeutic effects and safety. In such cases, it is important that prescribers, pharmacists and patients can readily distinguish between products otherwise having the same drug content. Examples include:

• Prolonged-release products

• Some locally-acting products

• Critical care medicines with a narrow therapeutic window of safety and efficacy

• When there in general is a need to differ products with different properties

Additional criteria for invented name

The invented name of a medicinal product should not:

• Convey misleading therapeutic or pharmaceutical connotations

• Should not convey any promotional message with respect to the therapeutic and/or pharmaceutical characteristics of the medicinal product

• Have or give associations to words with an established significance

• Be misleading with respect to the composition of the product

• Be liable to cause confusion in print, handwriting or speech with the invented name of an existing medicinal product or related product

• Similarity to the INN name. We normally do not accept more than half of the syllables of the INN name. This will however be evaluated on a case-to-case basis, as both the spelling and pronunciation must be taken into consideration

As a main rule, the name must be pronounceable in Norwegian. Symbols will not be accepted as part of the name.

The name should preferably consist of only one word. Suffixes with numbers or letters should be avoided.

Suffixes and abbreviations with no established or relevant meaning are unacceptable. So are promotional suffixes and abbreviations. The use of descriptive abbreviations could be acceptable if there is a documented need to distinguish between different routes of administration for the same medicinal product.

Examples of acceptable, established suffixes are: comp, forte, comp forte, mite, depot.

When naming medicinal products for animals, it may be relevant to specify the animal species as a suffix to the invented name. The suffix “vet” should also be added.

If there is a risk of confusion in print, handwriting or speech between the proposed name and that of an existing product, other distinguishing factors are taken into account to prevent the proposed name to represent a risk to public health, such as:

• The pharmaceutical form

• The route of administration

• The indication and condition of supply

• Potential new pharmaceutical forms and/or routes of administration for the medicinal product concerned, as well for the other medicinal products with a similar invented name

Additional criteria for INN-name and equivalent

• The INN-name must be followed by the whole name of the MAH. Abbreviations are normally not accepted

• It is only the name of the MAH or a trademark that is acceptable

• MAH names or trademarks of promotional nature are not accepted

• Trademarks are assessed the same way as invented names

• To avoid long names, the salt part of the INN should not be part of the name, unless it is of significance for the effect of the medicinal product

• Normally we accept Norwegian, English or Latin spelling. English and Latin spelling is acceptable if there are just minor deviations in print or speech compared to Norwegian

• Suffixes cannot be used in connection with INN-names

Naming of herbal medicinal products (both traditional- and well established use)

The main principle is that the same guidance applies to herbal medicinal products as for the regular medicinal products as described above. However, the Norwegian Medical Products Agency can make exceptions for products where the name has been in use for a longer period as a food supplement in Norway. In these cases, it might be taken into account that the name is established.

To keep an established name, it’s a prerequisite that the same name won’t be used in parallel for a food supplement product.

There are examples of products where the name is derived from the botanical Latin name. If this is the case, the botanical Latin name must be followed by the name of the MAH, equivalent to the INN + MAH concept mentioned above.

Naming of Homeopathic Medicinal products

Homeopathic medicinal products from one single homeopathic stock solution must be named by the defined scientific name of the stock, followed by the dilution rate. If a homeopathic medicinal product is manufactured by combining two, or more stock solutions, the product may be named by the defined scientific name of the stock or be given an invented name. Evaluation of invented names follows the principles of name settings as for medicinal products in general (see above).