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Frequently Asked Questions

Information on this Exemption can be found in VMGN12 - Exemption scheme for small pet animals.

If your questions are not answered please contact Amanda Baker by emailing a.baker@vmd.defra.gsi.gov.uk.

Animals

Q. Can Exemption products be used to treat corals and other invertebrates that are kept in aquariums?

A. Yes, the Veterinary Medicines Regulations were amended in 2011 from aquarium fish to aquarium animals which now allow aquarium invertebrates to fall under the scheme.


Active Substances

Q. What active substances can be used in Exemption products?

A. Only actives that have been approved by the Secretary of State can be used in exemption products. A published list of these actives (66 kb) is on the VMD website.

Q. What is the procedure for adding active substances to the approved list?

A. Companies need to inform the VMD of any active substances they wish to be considered for inclusion under the exemption. Some basic information as described in the Application for inclusion of an active should be sent to VMD.

Q. How are the actives assessed?

A. As exemption products are not submitted for full marketing authorisations an assessment of the quality, safety and efficacy of the active is not undertaken. An active submitted for addition to the approved list is assessed by the VMD to ensure it complies with the relevant criteria, as set out in VMGN12. Antibiotics, anaesthetics, narcotics or psychotropic substances are not eligible as approved actives under the exemption. In addition an active should not require veterinary control, be intended to treat a condition which requires a precise diagnosis by a veterinary surgeon, or be likely to cause an effect that would interfere with subsequent diagnostic or therapeutic measures. The VMD will also consider whether there are any known safety issues associated with an active, and may require a relevant warning to be included in the literature for any product containing that active.

Q. Can an active be removed from the list?

A. Yes. An active ingredient may be suspended or revoked, or limited to a smaller number of species.

Q. Can trade names be used for actives?

A. No. The active name is required so it can be assessed


Routes of Administration

Q. Where does vaccination fit in with the Exemption scheme?

A. Vaccines do not fall within the exemption.


Labelling

Q. Many natural products when included in the diet have been shown to have an immunostimulatory effect. What are the labelling obligations if these are simply listed as an ingredient; linked to health benefits on-pack?

A. A product that complies with the Feeding Stuffs Regulations and makes no claim for medicinal effect is not considered to be a veterinary medicine. If a claim for an immunostimulatory effect is made, then the product must comply fully with the exemption.

Q. Can I use the words "VMD approved products" on my labels/leaflets?

A. No. The VMD only approves the actives for use in the products and not the individual products.


Placing on the market

Q. Who can import theses products?

A. Anyone. There are no restrictions on the importation of these products into the UK.

Q. What authorisations are required to sell these products?

A. There are no restrictions on the retail sale of these products. If you wish to wholesale them you will require a Wholesalers Dealers Authorisation.

If your product is not manufactured by yourself then you will require a WDA to sell it, unless the product is supplied directly from the manufacturer to the end user.


Manufacturing

Q. Is the level of inspection for Exemption products lower than that for an authorised product?

A. A company manufacturing exemption products will be subject to full GMP inspection. As with all GMP inspections, the inspectors will require standards to be in place which are appropriate for the products being manufactured and the complexity of their manufacture.

Q. Will there be a low-level qualification for the QP?

A. The QP will need to have a combination of educational qualifications and practical experience relevant to the products being manufactured and will be appointed by the VMD on a case by case basis. The QP will only be authorised for exemption specific products at a specific site.

Q. Can the GMP qualified person be the same qualified person as for licensed products?

A. Yes, an existing QP would also be permitted to release products marketed under the exemption providing they have knowledge and experience of the processes involved and are named on the manufacturing authorisation.

Q. Will release of batches by a named QP still be a requirement?

A. Yes, release of products to be marketed under the Exemption by a named qualified person will be required.

Q. What action will be taken if a manufacturer writes a specification for an ingredient which has limits for impurities that would be considered unsafe?

A. If this happens, we can raise this with the manufacturer. The European Pharmacopoeia is a good reference for ingredient quality.

Q. What action will be taken if a manufacturer writes a specification for an ingredient which has limits for impurities that would be considered unsafe?

A. If this happens, we can raise this with the manufacturer. The pharmacopoeia is a good reference for ingredient quality.

Q. Can products be manufactured anywhere in the EU or elsewhere?

A. Providing they have a manufacturers' authorisation or GMP Certificate issued by a competent authority from within the EU or a mutual recognition agreement partner (Australia, Canada, New Zealand, Switzerland). If this is not the case an inspection of the premises will be required in accordance with the Regulations.

Q. Will the integrity of products with a Finished Product Specification (FPS) be the responsibility of the VMD?

A. Companies must set their own FPS (criteria / standards). These will be reviewed during the inspection. Processes need to be in place on-site to deal with the disposition of batches which fail to meet the defined FPS. The issue of QP discretion has been discussed within the VMD. It has been agreed that for products under the scheme, the QP has complete discretion to release batches that depart from their defined method of manufacture, FPS, test methods etc. as long as they are satisfied that the safety and efficacy of the product will not be adversely affected by these deviations. The QP will be required to document such cases. It is likely that during inspections, the record of such deviations and the action taken following these will be reviewed by the inspector. If the batches are of low potency (i.e. not enough active ingredient in them) or are under filled then this may be a Trading Standards issue.

Q. If the product is packaged at another facility, will the packaging facility need a manufacturing authorisation?

A. Yes.

Q. What are the costs of a manufacturers licence?

A. In accordance with the Veterinary Medicines Regulation 2011 fees can be found here.


Pack Size

Q. My product is indicated to treat birds of varying sizes, how should the maximum pack size be calculated.

A. The pack size for cage birds and pigeons is to treat up to 50 birds. Calculate the pack size based on treating 50 birds at the lowest dose-rate indicated. For example if a product is indicated to treat both canaries and macaws, the pack size must not exceed that which will treat 50 of the smallest birds at the lowest dosage rate.


Pharmacovigilance

Q. Do all adverse reactions need to be reported to the VMD?

A. No. Only serious adverse reactions should be reported to the VMD. These should be sent within 15 days of learning of the reaction. Records of all adverse reactions are required to be kept by manufacturers, importers or retailers and should be made available to the VMD on request.

The definition of a serious adverse reaction is "an adverse reaction that results in death, is life threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or that results in permanent or prolonged signs in the animal treated."


Enforcement

Q. How do you intend to 'police' this scheme?

A. We primarily rely upon industry informing us of any wrongdoing and we follow up with the appropriate enforcement action. However, VMD's Inspection and Investigations Team also visit premises and if illegal medicines are discovered, inspectors have powers to issue seizure notices which permit the VMD to seize and ultimately destroy products.

Q. What action is taken on non UK websites selling similar but non complaint products?

A. The VMD does not have powers to stop the sale of products on non UK websites. However, the importation, possession and administration of any unauthorised product into in the UK is an offence under the Veterinary Medicines Regulations and we will take enforcement action accordingly.

Q. What action do you take when product labels are misleading?

A. To be compliant with the exemption manufactures are required to make sure certain wording is on the label. Any complaints regarding the wording of the product labels, e.g making claims which are false etc, are for Trading Standards.


General

Q. What is the status of products under the Exemption with regard to the prescribing cascade?

A. Products marketed under the Exemption fall under the third rung of the cascade, Schedule 4 regulation 1(2)(c). However, these products are not considered to have been prepared extemporaneously.

Q. The FSA has stated that no probiotics are licensed for use in fish. What implications does this have for the sale of fish foods containing probiotics?

A. A product that fully complies with the Exemption is classed as a veterinary medicine. The Animal Feed (England) Regulation 2010 do not apply to veterinary medicines.

Q. A well-balanced, complete diet is essential for enhancing the well being of an animal. Is such a diet now regarded as a medicine and will it be included in the Exemption?

A. A complete feed, with no pharmacologically active substances and no claims for medicinal effect made on the product literature, is not considered to be a veterinary medicine. Such products fall under the regulation of the Food Standards Agency.

Q. Many natural products when included in the diet have been shown to have an immunostimulatory effect. What are the labelling obligations if these are simply listed as an ingredients, linked to health benefits on-pack?

A. A product that complies with the Feeding Stuffs Regulations, and makes no claim for medicinal effect is not considered to be a veterinary medicine. If a claim for an immunostimulatory effect is made, then the product must comply fully with the exemption.

Q. What information must a company supply for each submission?

A. We will not be carrying out efficacy / safety checks. We will check the indications and ensure the active is an allowed ingredient, i.e. not an antibiotic, etc. We will not review stability data at the time a submission is made. It is the responsibility of the company to ensure that the product is stable. In addition, as part of the GMP requirements, one batch of each product per year is expected to be placed on a stability test programme. During inspections, the inspector may ask to see the stability data for a particular product.

Q. Can a nutritional feed, produced under the Exemption, make medicinal claims?

A. If no medicinal claims are stated and the ingredients are not medicinal, the Feeding Stuffs Regulations will apply. Medicinal claims may be made for products marketed fully in accordance with the Exemption.

Q. Does a claim that a product is an "immuno-stimulant" cause the product to be considered a medicine?

A. Yes.

Q. Can a biocide product also be marketed under the exemption?

A. Yes. A product can be both a biocide and an exemption product in the instances where a product is marketed as an all in one product. If a product is marketed in this way it must comply with both sets of Regulations. It will require to be registered as a biocide with the HSE.

The definition of a biocide is '…an active substance or a preparation containing one or more active substances, in the form in which it is supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on, any harmful organism by chemical or biological means'.




Last Updated: 7 January 2013

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