Naming of veterinary medicinal products
Criteria applied by the VMD for accepting and agreeing the invented name of veterinary medicinal products.
For applicants of veterinary medicinal product marketing authorisations when selecting a product name for a new marketing authorisation or when submitting variations to change the (invented) name of an authorised veterinary medicinal product.
Criteria
According to Schedule 1, paragraph 2 of the Veterinary Medicines Regulations 2013 (as amended), the name of a veterinary medicinal product may be either:
a) an invented name not liable to confusion with the common name of the product; or
b) a common/scientific name of the active substance accompanied by a trademark or the name of the marketing authorisation holder (MAH).
Invented name
An invented name is the trade name of the product; the common name is the international non-proprietary name (INN) of the active substance contained in the product, or if one does not exist, the name generally used.
The invented name appears on the Summary of Product Characteristics (SPC), product literature, for example the package labelling and leaflet, and is used in marketing and promotional material. On the SPC and product literature, the invented name is followed by the strength and pharmaceutical form and if necessary, to avoid confusion with other presentations, the target species.
The invented name and its usage are the responsibility of the applicant or MAH. All information sent by them in relation to invented names is considered and treated as confidential. The review of trademarks is not within the VMD’s remit and therefore the applicant should contact the appropriate authorities directly to obtain trademark registration. The role of the VMD is to ensure the acceptability of the name in accordance with the principles outlined in this guidance to support the safe use of the product.
General principles for acceptability
A proposed invented name is considered acceptable if there are no perceived public health and animal welfare concerns of a safety risk relating to the possibility of confusion or to misleading inferences.
Products of the same or similar name - possibility of confusion
No two products can have the same product name. It is acceptable for medicinal products to ‘switch’ invented names; however, this may lead to confusion, therefore decisions are taken on a case-by-case basis as described in the section titled Change in the (invented) name.
For generic or hybrid medicinal products, the same criteria apply as for any other medicinal product in respect to the invented name.
Another potential source of medication errors is the possibility of confusion between different products with similar names. Therefore, for reasons of safety, a proposed invented name should not be liable to confusion with the invented name of an existing product.
The possibility of confusion with an existing name should be considered in written form and in speech, taking into account:
- the number and position of the common letters
- the number of distinguishing letters, for example, letters not in common
- the phonetic similarity of letters
- the use of prefixes or suffixes
The following factors, which are not exhaustive, should also be considered:
- pharmaceutical form
- strength
- route of administration
- indications and therapeutic area
- target species
- method of sale or supply
Misleading inferences
An invented name should not be misleading with respect to therapeutic class, therapeutic claims, active substance composition or pharmaceutical connotations. It should not imply therapeutic efficacy for an indication which is not approved, nor imply greater efficacy than is justified.
An invented name of a discontinued product must not be used for a new product which contains a different active substance. If used for a new product with a different active substance or quantity of that substance, the invented name must be changed or, at least, include a qualifier to indicate the revised formulation. The acceptability of the name for the revised formulation is considered on a case-by-case basis.
The invented name should not convey any promotional message with respect to the therapeutic and/or pharmaceutical characteristics and/or the composition of the medicinal product.
Specific criteria to be considered
Format
The invented name should not contain ™ or ® or © symbols on the SPC or QRD. Apart from section 1 of the SPC, when otherwise referring to the veterinary medicinal product throughout the text, the words ‘veterinary medicinal product’ should be used rather than the invented name. The invented name should preferably consist of one word only. The whole product name should appear together on proposed mock-ups, and only the invented name is required on small immediate packaging.
Strength
The strength should be included with units appropriate to the dosage form. The units adopted must be standardised throughout the SPC and product literature.
The strength should be included for products containing either one or two active substances. For products containing two active substances, the strength should ideally be separated by a slash “ / ”. However, where the product strength is expressed as weight/volume, to avoid any confusion and to make it clearer, the strength can be separated by a plus “ + “ rather than a slash “ / “.
For example:
- Invented name XX mg/YY mg tablets for cats and dogs
- Invented name XX mg/ml+YY mg/ml solution for injection for cats and dogs
is preferable to:
- Invented name XX mg/ml/YY mg/ml solution for injection for cats
XX – Strength of first active substance
YY – Strength of second active substance
For products containing three active substances, the strength does not always have to be included in the product name.
It should be noted that when the active substances are mentioned later, for example, under section 2 of the SPC, they should appear in the same order in which they are referred to in the product name information.
Unit dosage forms
For unit dosage forms for pre-filled syringes, spot-on products, for example, the strength should always be expressed as mass of active substance, not as a concentration, such as µg, mg or g.
For example:
- Invented name XX g Oral Paste
For spot on products it is acceptable to include the strength of two active substances.
For example:
- Invented name XX mg/YY mg Spot-on Solution for Dogs
XX – Strength of first active substance
YY – Strength of second active substance
Collars
For collars the active substance should be expressed in mg/collar in the name of the product. Collars may be cut down to fit so there are some examples of collars where the active substance content is expressed in mg/g. However, it is now considered that this pharmaceutical form should be consistent with other unit dose products (as they are supplied as a single unit). It is important that section 2 of the SPC includes mg/g and mg per collar for both the active substance and excipients. It would also be acceptable to include mg/collar and the overall weight of the collar; this would allow the reader to calculate mg/g.
Products that require dilution or reconstitution
The diluted/reconstituted strength of the active substance should be stated.
For example:
- Invented name XX mg/ml Powder and Solvent for Solution for Injection
The concentration once diluted/reconstituted should also be qualified in section 2 of the SPC, for example, equivalent to 100 mg/ml once reconstituted.
Products containing active substances as salt/esters
The strengths in the name of the medicinal product should be expressed as the quantity of the active moiety. Some relaxation is allowed for generic products where the strength of the reference product is expressed, such as, the salt. These cases would be assessed on an individual basis.
Pharmaceutical form
The full EDQM standard form should be used in the name of the medicinal product. When checking standard pharmaceutical forms refer to Standard Terms (edqm.eu).
On blister foils, the short term can be used, for example, tablet instead of film-coated tablet.
Suffixes
Qualification of invented names by letters, numbers or a combination of both should be avoided as they have greater potential than invented names to cause confusion. If a suffix is used, it must be readily-understandable and correctly-interpretable. The suffix should also be meaningful, convey useful information and relate to an important feature of the product. A word or a long suffix is preferable to a short one or two-letter suffix. Any new suffix which is proposed should comply with the general principles listed above. A limited number of suffixes have been accepted to date.
The suffix Forte or Extra is acceptable for products with a higher strength of active substance compared to an existing product in the same range. However, note that in line with the requirements of Veterinary Medicines Regulations 2013 (as amended), the name must be followed by the actual strength of the active substance(s).
For example:
- Invented name Extra XX% w/v Ready to Use Teat Dip and Teat Spray Solution
The suffix Plus or Extra is acceptable for products with an additional active compared with an existing product.
Where a suffix is used to describe the pharmaceutical form, such as, for modified-release products, it should not cause confusion with the Ph. Eur. standard term for the form.
Prefixes
A limited number of prefixes have been accepted, for example, the prefix Co- is acceptable for combination products.
Abbreviations
The use of qualifiers/abbreviations by letters as part of the invented name could in principle be acceptable if meaningful, such as, DC for dry cow. The abbreviation ‘LA’ to denote long acting should be avoided. However, proposed qualifiers should not consist of a single letter or number (Arabic or Roman), because they may be confused with the strength and/or posology of the medicinal product. Numbers in general should only be used to indicate the strength of the medicinal product.
Superlatives
The use of superlatives, such as, supreme, max, is not acceptable as this may influence a customer into buying a particular product when in fact there are others on the market which may be suitable. ‘Max’ can be included within the invented name, but it should not be a separate word.
Letters
The invented name should not comprise wholly of a random collection of initial letters or code numbers as they are considered inappropriate to identify a medicinal product. In certain cases, the use of a meaningful combination of letters, such as, ABC solution for injection, could be accepted however, this would be assessed on an individual basis.
Inappropriate words
The invented name should not trivialise the veterinary medicinal product.
Product ranges
It is acceptable to have a segment of an invented name that is used for more than one medicinal product to create a brand or range of products. This is also applicable for medicinal products with different pharmaceutical forms.
For example:
- Invented name Spot-On Solution and Invented name Tablets
However, the segment should not be used if its use is likely to result in safety or efficacy concerns resulting from confusion between the products sharing the same segment. Such concerns may arise if the products contain different active substances.
Other points
Invented names must be pronounceable.
It is acceptable to include a description of the visual appearance in the name of the medicinal product.
For example:
- Invented name XX mg Bone Shaped Tablets
It is acceptable to include wording to indicate that the product is flavoured, if it is, in the name of the medicinal product. In order for the word ‘palatable’ to be used, palatability must have been demonstrated in clinical studies.
For example:
- Invented name XX mg Flavoured Tablets
It is acceptable to include the wording ‘chewy’ to indicate the texture of the medicinal product if the product is soft gummy or gummy-like tablet that is intended to be chewed by the target species.
For example:
- Invented name Chewy XX mg Chewable Tablets
It is not acceptable to:
-
include wording that is subjective in the name of the medicinal product. For example: Invented name Tasty XX mg Tablets
-
include wording that could be misleading with respect to the target species. For example: Invented name contains the suffix ‘Feli’ is not acceptable to be used for medicinal products for dogs. Similarly, the suffix ‘Cani’ is not acceptable to be used for medicinal products for cats.
Change in the (invented) name
For a new marketing authorisation application, the product name is reviewed as part of the application. The (invented) name of a medicinal product may be changed after a marketing authorisation is granted, through a VNRA A.2 variation.
The applicant should email the VMD at [email protected] for pre-approval of the proposed invented name, prior to submission of the necessary VNRA application.
It is acceptable for medicinal products to ‘switch’ invented names if the formulations are identical, however all the above-mentioned criteria/requirements must be considered. If the products are not identical but similar, the name transfer could still be acceptable however safety implications must be considered, and this would be assessed on an individual basis. In this case, if the original product has been marketed it may be necessary to include wording such as ‘new formulation’, ‘new warnings’, ‘new indications’, on the final mock-ups but this does not need to be included in the QRD text.
This wording should be implemented for a period of time which covers the end of shelf life for any batches of original product on the market, or for the duration of the shelf life from the date of approval of the variation.
There is no requirement for submission of a variation to remove the text from the mock-ups once the above time period has elapsed. It should be noted that if the original product has been marketed at any point in the past, but it is confirmed that all batches have expired, a minimum time period for any of the above statements to be applied is 6 months.
References
EMA/248010/2007 - Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure available on Scientific guidelines | European Medicines Agency (EMA).
MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label.