Guidance on names for medicinal products

It is relevant for both medicinal products subjected to medicinal prescription and medicinal products not subjected to medical prescription. All names of medicinal products with marketing authorisation (MA) in Norway must be approved by the Norwegian Medical Products Agency.

In this guidance, the term "name" refers to either an invented name or the International Nonproprietary Name (INN) + MAH (marketing authorisation holder)/trademark. The identity of a medicinal product consists of its name, strength, pharmaceutical form and active substance. This guidance only addresses the evaluation of the name.

The guidance is based on the principles outlined in the EMA guideline for names in the Centralised procedure Guideline on the acceptability of names for human medicinal products processed through the centralised procedure.

Structure of the Name

The name of a medicinal product can either be:

• An invented name, or
• A name composed of the INN + MAH/trademark.

If an INN has not been established, the designation from the European Pharmacopoeia or the commonly used name should be used. In such cases, the name must be followed by the MAH/trademark.

Strength or pharmaceutical form are not considered to be part of the name.

Principles for Invented Names and INN + MAH/Trademark

• The name should be easy to pronounce in Norwegian.

• The name must only consist of letters. Numbers, special characters, symbols, and similar elements are generally not accepted.
• Descriptions of the medicinal product should not be added directly after the name. Instead the descriptions, such as flavor, can be indicated following the pharmaceutical form.

In case multilingual packaging is planned for the medicinal product, this will be taken into account when evaluating the proposed name(s).

An invented name may be required in certain cases. For instance, to distinguish between medicinal products with different pharmaceutical properties or to avoid other patient safety issues.

Additional Criteria for Invented Names

An invented name must not:

• Suggest misleading therapeutic or pharmaceutical properties or be misleading regarding the composition of the medicinal product.

• Convey a promotional message, such as one related to the use of the medicinal product.

• Have or evoke associations with words of established meaning.

• Be liable to cause confusion with the names of other medicinal products, either in print, handwriting, or speech.

• Have similarity with the INN name. Generally, no more than half the syllables of the INN name are accepted. However, this is assessed on a case-by-case basis, considering spelling and pronunciation.

Use of Qualifiers in Invented Names

The name should preferably consist of a single word. The use of a qualifier may be considered if necessary for patient safety reasons.

For veterinary medicinal products, it is recommended that the qualifier "vet" to be added to the name.

Single letters or numbers should generally be avoided, with some exceptions such as vaccines and parenteral nutrition.

Qualifiers that convey a promotional message are not accepted.

Additional Criteria for INN + MAH/Trademark Names

• MAH names or trademarks that convey a promotional message are not accepted.

• Trademarks are assessed on the same basis as invented names.

• The INN should include the salt form if the strength refers to the salt form and it is relevant to the medicinal product's effect.

• Norwegian, English, or Latin spelling is generally acceptable.

• For combinations of active substances in a medicinal product, these should be clearly separated by a slash (/).

• Qualifiers are generally not accepted but may exceptionally be approved for patient safety reasons.

Naming of Traditional and Well-Established Herbal Medicinal Products

Traditional and well-established herbal medicinal products should generally follow the same naming principles as other medicinal products. Exceptions may be made for traditional and well-established herbal medicinal products where the name has been used for dietary supplements in Norway for a long time. In such cases, consideration will be given to the established name. The condition to keep an established name for traditional and well-established herbal medicinal products is that the same name is not simultaneously used for dietary supplements.

Approved names may also be derived from the Latin botanical name. If the Latin name constitutes the name of the traditional and well-established herbal medicinal product, the name must be followed by the MAH/trademark.

Naming of Homeopathic Medicinal Products

Homeopathic medicinal products derived from one single homeopathic stock should be named by the scientific name of the stock (or other name used in a pharmacopoeia), i.e., the name used in the monograph of the European Pharmacopoeia or a pharmacopoeia used officially in an EU/EEA country.

If a homeopathic medicinal product is composed of two or more stocks, the product may be given an invented name. The approval of an invented name follows the same principles as for naming other medicinal products (see above).

The Norwegian Medical Products Agency can make exceptions for products that were on the market before registration requirements for homeopathic medicinal products were introduced. In such cases, consideration will be given to the fact that the product has an established name.