Guideline

The fundamental criterion is that the invented name must not constitute a risk to human or animal health.

1. The name may not indicate any misleading therapeutic or pharmaceutical properties.
2. The name may not be misleading in terms of the product composition.
3. It must not be possible for the name to be confused in print, handwriting or pronunciation with the name of an existing or recently deregistered medicinal product.
4. The name must not be of a marketing nature, nor be perceived as offensive or have an inappropriate meaning.
5. The name should preferably consist of a single word that can be pronounced and read without difficulty.
6. The name must not consist of a proper noun or words with a well-established meaning.
7. The name cannot be the same as the company name. The full or nearly full company name should not be included in the name of the medicinal product. Nor should a beginning of the company name constitute the beginning of the name of a medicinal product.
8. Suffixes should only be used exceptionally, for example if there is a need to distinguish between products containing the same active substance, for example if one product contains another substance as well. Suffixes in the form of numbers alone must be avoided to reduce the risk of being confused with the strength. Double suffixes will normally not be accepted.
   • Only abbreviations and suffixes that have an established and relevant meaning will normally be accepted and should then to the greatest extent be in Swedish.
   • Suffixes are sometimes used in the naming of vaccines for animals.
9. The first letter of the name should be capitalised. Capital letters and other distinctive characters, such as symbols, dashes and hyphens, should otherwise be avoided, as well as letters that do not exist in the Swedish alphabet.
10. At least two letters should distinguish a new proposed product name from an already approved or accepted product name.
11. For medicinal products containing a prodrug, i.e., a pharmacologically inactive compound that has to be converted to an active drug in the body before it can produce a pharmacologic effect, a different name from the invented name of the medicinal product containing the related active substance is required.
12. Medicinal products should not have the same name as products of other classifications, such as medical devices or foodstuffs.

Guideline

If the Swedish Medical Products Agency finds that there is a risk of confusion between the proposed name and an existing name, other distinguishing factors can be considered in the assessment. Such factors include the following:

• Pharmaceutical form
• Route of administration
• Indication and condition of supply
• Target species
• The degree of similarity between names weighed against the risk of harm to the animal or the user in the event of confusion.

Guideline

The Swedish Medical Products Agency recommends adding the suffix “Vet” for veterinary medicinal products. Proposed names for veterinary medicinal products, which are considered to be too similar to a name for a medicinal product for human use, may in some cases be accepted provided that the suffix “Vet” is added.

A special assessment is carried out in cases where the Swedish Medical Products Agency considers there to be a risk of a proposed name being confused with the name of a deregistered product. At least five years should pass from the deregistration before the same or a similar name can be used for a different product.

The name should also adhere to the WHO naming guidelines. The WHO recommends, for example, that invented names should not be derived from INNs (International Nonproprietary Names, i.e., the international generic name recommended by the WHO) and should not contain INN stems, in order to avoid confusion between different drugs and to avoid making the establishment of new INNs more difficult.

Guideline

1. Generic names of medicinal products shall consist of the substance INN, or, if no such name is available, the European Pharmacopoeia name. In both instances, the substance name shall be followed by the name, or a trademark, of the marketing authorisation holder (MAH).
2. If the MAH does not have a permanent operation in Sweden, the name or trademark of their local representative may be used instead. The trademark must be registered for sales by the MAH with the Swedish Patent and Registration Office (PRV) or the European Union Intellectual Property Office (EUIPO).
3. A trademark or a MAH name that is considered promotional, contains numbers, a letter combination that can be difficult to understand and perceived as unclear or confusing, or in other ways is considered to be misleading (see a) and b) above) is not suitable as part of the name of a medicinal product.
4. Generic naming of veterinary medicinal products can be used in cases where the medicinal product contains only one active substance. The active substance shall be indicated in either Swedish or English. If the Swedish name differs significantly from the English one, as in the case of potassium chloride (kaliumklorid), the name is to be given in Swedish.
5. The basic principle is that the salt must not be included in generic names as it makes the names unnecessarily long and complex, and the salt usually has no pharmacological effect. This applies whether the concentration refers to the salt or to the acid/base (parent compound). However, in some cases, the salt must be specified in order to avoid misunderstandings, for example if there is a different salt previously approved with a generic name where the strength is based on the salt. Consistent naming is strived for when it comes to medicinal products with generic names that contain the same substance and salt.
6. The basic principle is that an ester/ether will only be indicated in generic names if this is the form that has a pharmacological effect. Otherwise, the hydrolysed ester/ether (parent compound) is indicated.
7. Suffixes are only accepted exceptionally in generic names.
   • It is important to determine whether generic naming sufficiently distinguishes the medicinal product from other medicinal products or whether there are differences that are not reflected in generic naming.
   • Only abbreviations and suffixes that have an established and relevant meaning may (exceptionally) be accepted, and should then to the greatest extent be in Swedish.

Guideline

1. The same principles as are described above for invented names are also applied to herbal medicinal products.
2. The corresponding principles as described above for generic names are also applied to herbal medicinal products; however, the substance name consists of the name of the active plant used. The Latin, Swedish or English name of the plant is acceptable.
   In some cases, the name of the family can be acceptable as a generic name, such as Echinacea, Valeriana or Ginkgo. This is applicable in cases where different species can be considered interchangeable in terms of effect/safety or when the species referred to is commonly known. Certain species epithets can also be acceptable generic names, as in ginseng. Family name along with species epithet can also be an acceptable generic name, such as Hedera helix.
   
   The plant part or type of preparation should not be included in the name.

Guideline

Naming of medicinal products subject to parallel trade is subject to the same general naming principles as specified above in regard to invented and generic names, with the following additions.

1. The name of the medicinal product already approved in Sweden can in most cases be used by the wholesale distributor in the destination Member State. Exceptions may occur as it is not permitted to name a medicinal product that is subject to parallel trade using an INN name followed by the name of a MAH or local representative, which would be misleading in this context.
2. If medicinal products are obtained from different source Member States, INN names followed by the name of the wholesale distributor in the destination Member State may only be used for several of these medicinal products if they refer to the same medicinal product already approved in Sweden.
3. For a medicinal product subject to parallel trade, the invented name in the source Member State may be used as long as it is not already being used for a medicinal product approved in Sweden through another procedure, and does not violate the general principles described in the sections above in regard to invented and generic names.
4. If the medicinal product already approved in Sweden has a suffix in its invented name, the medicinal product subject to parallel trade must have the same suffix. In cases where the wholesale distributor in the destination Member State chooses to use an INN name when the corresponding medicinal product already approved in Sweden has an invented name with a suffix, the INN name must normally not contain a suffix.

Guideline

1. For a single agent (containing a homeopathic stock), the name of the product should preferably consist of the name of the corresponding monograph in the European Pharmacopoeia or in another homeopathic pharmacopoeia used officially within the EEA.
2. For compound agents (containing two or more stock preparations), including potency chords (containing several dilutions of the same stock preparation), invented names may be used. The invented name must not allude to any pharmacological effect or therapeutic indication. Otherwise, the same principles as described in the section above for invented names are applicable.