GovWire

Certain medicines for small pet animals are exempt from the marketing authorisation requirements of the Veterinary Medicines Regulations (VMR) under Schedule 6.

Exempt species

Medicines for the following species are exempt provided the animals are kept exclusively as pets and are not intended to produce food for human consumption:

• aquarium animals, including fish only kept in closed water systems
• cage birds; birds kept in cages or aviaries
• homing pigeons; pigeons kept for racing or exhibition
• terrarium animals; reptiles, amphibians and arthropods kept in tanks and cages, including animals free-living in domestic gardens
• small rodents; domestic mammals of the order rodentia
• ferrets
• rabbits

Chickens, ducks and turkeys are classified as food producing animals and so medicines for these species are not, under any circumstances, covered by the exemption.

Active substances

Exempt medicines can only contain active substances which have been approved for the purposes of this exemption by the Secretary of State. Approval may not be granted if the active substance requires veterinary control, see section Medicines not included in the exemption.

List of approved active ingredients for small animals (PDF, 464 KB, 19 pages).

If you wish to market a product under the exemption which contains a substance not included on this list or for an exempt species or route of administration not currently included for a substance on the list, you should complete the application for active approval form (PDF, 89.1 KB, 4 pages).

Do not submit any studies or reports unless specifically requested. A brief justification for inclusion of the active substance will usually be sufficient.

Under the exemption, combinations of active substances may be marketed within the same product, provided each individual substance is included on the list of approved active substances.

Medicines not included in the exemption

The following medicines are not covered by this exemption:

• antibiotics
• narcotic or psychotropic substances*
• those intended for treatments or pathological processes that require a precise diagnosis by a vet or the use of which may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures

*Certain sedatives may be permitted for use with fish. Please contact the VMD for further information.

Purpose of use and route of administration

Exempt medicines are restricted to topical or oral administration routes only:

• Topical medicines are those that are applied externally to the skin and have a local or systemic action. This excludes products that are administered in the eye or ear canal, intra-nasally or via nebulisation; aerosol delivered to the airways and lungs.

• Oral medicines are defined as those that are administered in feed, in water or directly into the oral cavity.
  This excludes products that are administered by stomach or crop tubing; gavage.

Fish medicines administered via the water and not intended for direct ophthalmic use are acceptable.

Labelling requirements

Exempted products must be clearly labelled to show that they are exempt from having a Marketing Authorisation, for example using the following statement meets this requirement:

The labelling must contain the following information either on the label or, if there is insufficient space, on a package leaflet:

• name of the product
• the authorisation number of the manufacturer*
• name and strength of each active substance
• route of administration
• batch number
• expiry date
• the words, For animal treatment only
• contents by weight, volume, or the number of unit doses
• name and address of the manufacturer or distributor
• target species
• the words, Keep out of reach of children
• storage instructions
• the shelf life after the immediate packaging has been opened for the first time
• disposal advice
• full indications, including:
  • therapeutic indications
  • contra-indications
  • interaction with other medicines and other forms of interaction
• dosage instructions

*If no suitable manufacturing authorisation number is issued by the relevant National Competent Authority, the VMD can issue one.

When applying for this authorisation number you should provide evidence to demonstrate manufacture in accordance with Good Manufacturing Practice (GMP). Further guidance on manufacturing is below.

The label on the product itself must contain at least the following:

• name of the product
• name and strength of each active substance
• route of administration
• batch number
• expiry date
• the words, For animal treatment only
• any additional warnings that are required may be stipulated for the particular active substance. These can be found on the list of approved active substances

Pack sizes

Exempt products must only be sold in pack sizes suitable for a single course of treatment. The VMD considers this condition should be met by ensuring that packs contain only sufficient product to treat the following numbers of animals until symptoms are alleviated or, for preventative treatments, up to six months:

Manufacturing and supply

Exempt medicines must meet the requirements of the VMR relating to the manufacture (GMP) and wholesale dealing of veterinary medicines.

However, wholesale dealers supplying products under the exemption are not required to keep wholesale records that duplicate manufacturers records.

For further information refer to Manufacturing Authorisations for veterinary medicines and Apply for manufacturer or wholesaler of medicines licences pages.

Veterinary medicines marketed under this exemption must be manufactured by the holder of a manufacturing authorisation issued under:

• Directive EC No 2001/82 as amended (sites in UK and EU)
• a certificate issued by the competent authority (sites in Australia, Canada, New Zealand and Switzerland)
• a certificate issued by the Secretary of State (sites in all other countries)

There are no restrictions on the retail supply within the UK of products manufactured under the exemption but they may only be wholesale supplied by the holder of a Wholesale Dealer Authorisation (WDA).

For information on how to obtain a WDA go to

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