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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 VMDs 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 g, 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 100mg/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 h

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