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Naming of human medicinal products

  • Published: May 13, 2024
  • Last updated: May 13, 2024
  • Topics: Package leaflet, Labelling

About naming of human medicinal products.

The guideline has been produced to support the companies naming medicinal products. It is based on the guideline on the acceptability of names for human medicinal products processed through the centralised procedure used by the EMA.

The guideline concerns names submitted in new applications within a national, mutual recognition or decentralised procedure, and in variation applications regarding name changes in national and mutual recognition procedures. For centralised procedure applications, please refer to the EMA guideline.

This guideline concerning names should be read as a complement to the Swedish Medical Products Agency’s provisions (HSLF-FS 2021:96) on labelling and package leaflets for medicinal products for human use, and also as a complement to the provisions regarding the following categories of medicinal products.

Complement to other provisions

Homeopathic medicinal products

  • The Swedish Medical Products Agency’s provisions (HSLF-FS 2022:11) on homeopathic medicinal products for human use.

Parallel imported human medicinal products

  • The Swedish Medical Products Agency’s provisions (HSLF-FS 2022:8) on parallel imported human medicinal products.

Traditional herbal medicinal products

  • The Swedish Medical Products Agency’s provisions (LVFS 2006:3) on traditional herbal medicinal products for human use.

The above-mentioned provisions are available (in Swedish).

Definitions

Name, strength and pharmaceutical form must always be considered as a unit when identifying a medicinal product. The name alone can never be used to identify a medicinal product.

The name of the medicinal product is simply the product name and can either be an invented name or a generic name.

Suffix is defined in this guideline as a supplementary word or determinant word to the main name.

Background

The Swedish Medical Products Agency is to review and approve submitted names in new applications as well as name changes for already approved or registered medicinal products.

Chapter 4, Section 1 of the Medicinal Products Act (2015:315) states, among other things, that a medicinal product must have an acceptable and distinctive designation. Both invented names and generic names can be used in the naming of medicinal products.

The considerations below must be made when proposals for invented or generic names are submitted to the Swedish Medical Products Agency. The Swedish Medical Products Agency makes an overall assessment of the factors described below before making a decision on whether the suggested name is
acceptable.

Proposal for an invented name

The following principles shall be considered.

Section 1 ... the name of the medicinal product may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.

Guideline

The fundamental criterion is that the invented name must not constitute a risk to public 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 whole or almost the whole company name should not be included as a part of the name of a medicinal product. Nor should the beginning of a 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 but where 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.
    • For liposomal and pegylated liposomal medicinal products, the following is applicable for invented names:
    • According to an agreement in CHMP ”liposomal”/”pegylated liposomal” shall be added after the product name. The suffix shall be added after the invented name. The terms shall be spelled in English in the entire EU, i.e. also for medicinal products on the Swedish market.
    • 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.
  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 gases containing medicinal oxygen, medicinal air and medicinal nitrous oxide are strongly recommended not to have invented names as these gases are often used in acute/life-threatening situations and should therefore have generic names to enable quick identification.
  13. Medicinal products should not have the same name as products of other classifications, such as medical devices or foodstuffs.

If the Swedish Medical Products Agency finds that there is a risk of confusion between the suggested 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
  • Patient group
  • The degree of similarity between names weighed against the risk of harm to a patient in the event of confusion 

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.

Proposal for a generic name

The following principles shall be considered.

Section 1 ...the name of the medicinal product may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.

Section 2 If the marketing authorisation holder does not have a permanent establishment in Sweden, the name of the medicinal product, besides what is regulated in Section 1, may be a common or scientific name accompanied by a trade mark or the name of the local representative.

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). The local representative must have a permanent establishment in Sweden in order for the name of a medicinal product to consist of the name of, or the trademark of, the representative in the case of generic naming.
  3. A trademark or a MAH name that is considered promotional, contains numbers, consists of a letter combination that can be perceived as unclear or confusing, or in other ways is considered to be misleading (see section a) and b) above, for invented names) is not suitable as part of the name of a medicinal product.
  4. Generic names can be used in cases where the medicinal product contains up to three different active substances. 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. For herbal medicinal products and traditional medicinal products, see section below.
  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.
    • For liposomal and pegylated liposomal medicinal products, the following is applicable for generic names:
      According to an agreement in CHMP (ref 10) ”liposomal”/”pegylated liposomal” shall be added after the name of the substance but before the name of the MAH. The terms shall be spelled in English in the entire EU, i.e. also for medicinal products on the Swedish market. For example: substance name pegylated liposomal MAH name.
    • 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.

    Names for herbal medicinal products and traditional herbal medicinal products

    The following principles shall be considered.

    1. The same principles as are described above for invented names are also applied to herbal medicinal products and traditional herbal medicinal products.
    2. The corresponding principles as described above for generic names are also applied to herbal medicinal products and traditional 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.

      Names for parallel imported human medicinal products

      The following principles shall be considered.

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

      1. In most cases, the name of the direct imported medicinal product can be used by the parallel importer. Exceptions may occur as it is not permitted to name a parallel imported medicinal product using an INN followed by the name of a MAH or local representative, which would be misleading in this context.
      2. If the parallel importer is bringing in medicinal products from different countries, the INN followed by the name of the parallel importer may be used for several of these products only if they refer to the same direct import in Sweden.
      3. For a parallel imported medicinal product, the invented name in the source country may be used if it is not already being used for a medicinal product approved in Sweden through another procedure, and if it complies with the general principles in regard to invented and generic names described in the sections above.
      4. If the direct imported medicinal product has a suffix in its invented name, the parallel imported medicinal product must have the same suffix. In cases where the parallel importer chooses to use an INN, and the corresponding direct imported medicinal product has an invented name with a suffix, the INN of the parallel imported medicinal product should normally not contain any suffix.

        Proposal for name on homeopathic medicinal products

        The following principles shall be considered.

        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.

          Review of submitted names

          New applications

          The Swedish Medical Products Agency reviews the submitted names for all new applications in national, decentralised and mutual recognition procedures.

          A submitted name will only be approved in conjunction with the medicinal product being approved or registered in Sweden.

          Name changes for already approved or registered medicinal products

          Requests for name changes for an already approved or registered medicinal product must be made in the form of a variation application.

          All names submitted in national and mutual recognition procedures will be reviewed. In cases where the procedure results in a new acceptable name, the Swedish Medical Products Agency and the applicant must agree on a time for implementation of the new name. The implementation date can be postponed for a maximum of one year after the matter is closed.

          In conjunction with the implementation, the Swedish Medical Products Agency will update its database and update and publish the product information under the new name. Packaging with the old and the new name may only be available in parallel for one month following the agreed implementation date.

          The MAH change must be completed before a name change to a generic name + new MAH can be made.

          Naming of human medicinal products

          • Published: May 13, 2024
          • Last updated: May 13, 2024
          • Topics: Package leaflet, Labelling

          About naming of human medicinal products.

          The guideline has been produced to support the companies naming medicinal products. It is based on the guideline on the acceptability of names for human medicinal products processed through the centralised procedure used by the EMA.

          The guideline concerns names submitted in new applications within a national, mutual recognition or decentralised procedure, and in variation applications regarding name changes in national and mutual recognition procedures. For centralised procedure applications, please refer to the EMA guideline.

          This guideline concerning names should be read as a complement to the Swedish Medical Products Agency’s provisions (HSLF-FS 2021:96) on labelling and package leaflets for medicinal products for human use, and also as a complement to the provisions regarding the following categories of medicinal products.

          Complement to other provisions

          Homeopathic medicinal products

          • The Swedish Medical Products Agency’s provisions (HSLF-FS 2022:11) on homeopathic medicinal products for human use.

          Parallel imported human medicinal products

          • The Swedish Medical Products Agency’s provisions (HSLF-FS 2022:8) on parallel imported human medicinal products.

          Traditional herbal medicinal products

          • The Swedish Medical Products Agency’s provisions (LVFS 2006:3) on traditional herbal medicinal products for human use.

          The above-mentioned provisions are available (in Swedish).

          Definitions

          Name, strength and pharmaceutical form must always be considered as a unit when identifying a medicinal product. The name alone can never be used to identify a medicinal product.

          The name of the medicinal product is simply the product name and can either be an invented name or a generic name.

          Suffix is defined in this guideline as a supplementary word or determinant word to the main name.

          Background

          The Swedish Medical Products Agency is to review and approve submitted names in new applications as well as name changes for already approved or registered medicinal products.

          Chapter 4, Section 1 of the Medicinal Products Act (2015:315) states, among other things, that a medicinal product must have an acceptable and distinctive designation. Both invented names and generic names can be used in the naming of medicinal products.

          The considerations below must be made when proposals for invented or generic names are submitted to the Swedish Medical Products Agency. The Swedish Medical Products Agency makes an overall assessment of the factors described below before making a decision on whether the suggested name is
          acceptable.

          Proposal for an invented name

          The following principles shall be considered.

          Section 1 ... the name of the medicinal product may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.

          Guideline

          The fundamental criterion is that the invented name must not constitute a risk to public 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 whole or almost the whole company name should not be included as a part of the name of a medicinal product. Nor should the beginning of a 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 but where 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.
            • For liposomal and pegylated liposomal medicinal products, the following is applicable for invented names:
            • According to an agreement in CHMP ”liposomal”/”pegylated liposomal” shall be added after the product name. The suffix shall be added after the invented name. The terms shall be spelled in English in the entire EU, i.e. also for medicinal products on the Swedish market.
            • 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.
          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 gases containing medicinal oxygen, medicinal air and medicinal nitrous oxide are strongly recommended not to have invented names as these gases are often used in acute/life-threatening situations and should therefore have generic names to enable quick identification.
          13. Medicinal products should not have the same name as products of other classifications, such as medical devices or foodstuffs.

          If the Swedish Medical Products Agency finds that there is a risk of confusion between the suggested 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
          • Patient group
          • The degree of similarity between names weighed against the risk of harm to a patient in the event of confusion 

          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.

          Proposal for a generic name

          The following principles shall be considered.

          Section 1 ...the name of the medicinal product may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.

          Section 2 If the marketing authorisation holder does not have a permanent establishment in Sweden, the name of the medicinal product, besides what is regulated in Section 1, may be a common or scientific name accompanied by a trade mark or the name of the local representative.

          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). The local representative must have a permanent establishment in Sweden in order for the name of a medicinal product to consist of the name of, or the trademark of, the representative in the case of generic naming.
          3. A trademark or a MAH name that is considered promotional, contains numbers, consists of a letter combination that can be perceived as unclear or confusing, or in other ways is considered to be misleading (see section a) and b) above, for invented names) is not suitable as part of the name of a medicinal product.
          4. Generic names can be used in cases where the medicinal product contains up to three different active substances. 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. For herbal medicinal products and traditional medicinal products, see section below.
          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.
            • For liposomal and pegylated liposomal medicinal products, the following is applicable for generic names:
              According to an agreement in CHMP (ref 10) ”liposomal”/”pegylated liposomal” shall be added after the name of the substance but before the name of the MAH. The terms shall be spelled in English in the entire EU, i.e. also for medicinal products on the Swedish market. For example: substance name pegylated liposomal MAH name.
            • 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.

            Names for herbal medicinal products and traditional herbal medicinal products

            The following principles shall be considered.

            1. The same principles as are described above for invented names are also applied to herbal medicinal products and traditional herbal medicinal products.
            2. The corresponding principles as described above for generic names are also applied to herbal medicinal products and traditional 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.

              Names for parallel imported human medicinal products

              The following principles shall be considered.

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

              1. In most cases, the name of the direct imported medicinal product can be used by the parallel importer. Exceptions may occur as it is not permitted to name a parallel imported medicinal product using an INN followed by the name of a MAH or local representative, which would be misleading in this context.
              2. If the parallel importer is bringing in medicinal products from different countries, the INN followed by the name of the parallel importer may be used for several of these products only if they refer to the same direct import in Sweden.
              3. For a parallel imported medicinal product, the invented name in the source country may be used if it is not already being used for a medicinal product approved in Sweden through another procedure, and if it complies with the general principles in regard to invented and generic names described in the sections above.
              4. If the direct imported medicinal product has a suffix in its invented name, the parallel imported medicinal product must have the same suffix. In cases where the parallel importer chooses to use an INN, and the corresponding direct imported medicinal product has an invented name with a suffix, the INN of the parallel imported medicinal product should normally not contain any suffix.

                Proposal for name on homeopathic medicinal products

                The following principles shall be considered.

                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.

                  Review of submitted names

                  New applications

                  The Swedish Medical Products Agency reviews the submitted names for all new applications in national, decentralised and mutual recognition procedures.

                  A submitted name will only be approved in conjunction with the medicinal product being approved or registered in Sweden.

                  Name changes for already approved or registered medicinal products

                  Requests for name changes for an already approved or registered medicinal product must be made in the form of a variation application.

                  All names submitted in national and mutual recognition procedures will be reviewed. In cases where the procedure results in a new acceptable name, the Swedish Medical Products Agency and the applicant must agree on a time for implementation of the new name. The implementation date can be postponed for a maximum of one year after the matter is closed.

                  In conjunction with the implementation, the Swedish Medical Products Agency will update its database and update and publish the product information under the new name. Packaging with the old and the new name may only be available in parallel for one month following the agreed implementation date.

                  The MAH change must be completed before a name change to a generic name + new MAH can be made.

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