Residues of Veterinary medicines in food 2016 Surveillance results.

We would like to have agreed QRD text for all veterinary medicinal products which can then be maintained throughout the product’s life.

This will make it easier to agree changes to the wording on your packaging and remove the need for full colour mock ups to always be submitted.

We will notify relevant Marketing Authorisation Holder’s (MAH) of any products that already have an approved National QRD held by us.

Submit your QRD text to s.response@vmd.defra.gsi.gov.uk, using the Submission of QRD text for nationally authorised MAs (MS Word Document, 49.5KB) form and the National QRD template.

We will not routinely require mock ups to be submitted. However, if we do not already hold electronic copies of your approved mock ups, we will request these.

We aim to issue the agreed version within 90 days of receipt. You do not have to update your mock ups to the latest QRD version.

Once your QRD text has been issued, a revised version should be submitted with all future applications that affect it. If an authorisation is due for renewal you can submit QRD text for approval as part of the renewal process.

If you wish to make changes to your QRD text or submit mock-ups for approval alongside the QRD text, you need to submit an application for a Type IB variation (C.II.6(b)) instead.

For further information email; notification@vmd.defra.gsi.gov.uk.

Vet Skill Ltd has today been authorised as a suitable body to maintain a register for suitably qualified persons (SQPs) to prescribe and supply veterinary medicines classified as POM-VPS and NFA-VPS.

An SQP is a professionally qualified person who is allowed to prescribe, supply and advise on the safe use of these categories of medicines in the UK, such as worming and flea treatments.

This authorisation means that Vet Skill Ltd has adequately demonstrated that they can fulfil all the necessary requirements of the Veterinary Medicines Regulations.

Guidance is available on the Retail of veterinary medicines.

These workshops will provide you with an update on the proposals and will be an open forum for discussion.

Contact Lorna Shelley at l.shelley@vmd.defra.gsi.gov.uk if you would like copies.

For failure to maintain the retail premise on the register of approved retailers of veterinary medicinal products, contrary to the Veterinary Medicines Regulations.

The annual fee was due in May. Despite numerous reminders and re-issues of the invoice, payment has not been received. Retail sale of POM-VPS medicines has continued at the premise.

Premise to restore to the register of retailers, or to cease the supply of veterinary medicines and to provide evidence that the sales have ceased and all POM-VPS stock removed.

These antimicrobial resistance (AMR) systems maps provide an overview of the factors influencing the development of AMR and their interactions.

The aim is to:

• increase awareness of the diverse factors that influence AMR
• aid research groups in identifying issues for investigation
• aid in policy development

Supplies of POM-VPS medicines occurring from outwith the registered premise, namely from a trailer unit. This breaches the Veterinary Medicines Regulations, Schedule 3, paragraph 14 (4) – Supply by a suitably qualified person.

Evidence showed stock within the trailer unit did not have sales documentation to show that the supply occurred at the registered premise and order sheets provided did not correspond with stock seen.

Improvements are for procedures and documentation to be put in place to demonstrate that supply only occurs at the registered premises and no POM-VPS stock to be carried in the trailer unless accompanied by a delivery note.

Changes have been made to the online system to further simplify the application process and reduce administrative burden.

• Certificates (SIC and STC) are now shorter and only detail essential information.

• WDIC (wholesale dealer import) certificates are now available to apply for online.

We will no longer accept postal or email WDIC applications from 1 November 2016.

Guidance on the Special Import Scheme.

Contact us by email; import.cert@vmd.defra.gsi.gov.uk.

New Marketing Authorisation applications

The last validation meeting to discuss applications for new Marketing Authorisations (MAs) will take place on Thursday 22 December 2016.

Applications to be considered for validation must be received on or before Monday 19 December 2016.

The validation meetings will resume w/c Tuesday 3 January 2017.

For further information please contact: r.sheehan@vmd.defra.gsi.gov.uk, or Tel: 01932 338374.

Manufacturing and Wholesale Dealers Authorisation applications (new and variation)

The last day for validation application discussions for Manufacturing Authorisations (ManAs) and Wholesale Dealers Authorisations (WDAs) applications (new and variation) will be on Friday 16 December 2016.

Applications to be considered for validation must be received on or before Wednesday 14 December 2016.

The validation discussions will resume w/c Tuesday 3 January 2017.

For further information please contact: inspections@vmd.defra.gsi.gov.uk.

On 22 September 2016 at Bournemouth Magistrates Court, Emilia Przemielewska pleaded guilty to 13 charges under the Veterinary Medicines Regulations. These were:

1. Five charges of possession of unauthorised veterinary medicinal products under the Veterinary Medicines Regulations
2. Five charges of importation of unauthorised veterinary medicinal products under the Veterinary Medicines Regulations
3. Three charges of supply of unauthorised veterinary medicinal products under the Veterinary Medicines Regulations

Ms Przemielewska was given a 3 year conditional discharge and fined £100 costs and a £15 victim surcharge.

This case related to the importation and sale of a number of unauthorised companion animal products, mainly flea treatments and wormers.

The supply of NFA-VPS products from Mr Pets is not in compliance with Schedule 3, paragraph 14 of the Veterinary Medicines Regulations – Supply by a suitably qualified person. As confirmed during premise inspection, NFA-VPS products are shipped from Holland directly to UK customers. The SQPs;

• do not hand over or despatch the product personally
• are not in a position to intervene if necessary during despatch
• do not check the product after it has been allocated for supply to a customer

Measures to be taken:

• Cease retail supply of NFA-VPS products by Mr Pets that are not in compliance of the VMR.
• Provide confirmation of actions taken and further intended action to be taken to ensure that the supply requirements for the supply of NFA-VPS medicines will be complied with by the 12th October 2016.

Guidance for vets, pharmacists and suitably qualified persons (SQPs) on prescribing or supplying veterinary medicines including the requirements for the registration and inspection of premises.

Registered Qualified Persons (RQP)

Under the Veterinary Medicines Regulations (VMR) vets, pharmacists and SQPs, collectively known as registered qualified persons (RQPs), can prescribe or supply certain categories of authorised veterinary medicines that they are qualified and registered to supply.

The distribution categories for authorised medicines are:

• Prescription Only Medicine – Veterinarian (POM-V)
• Prescription Only Medicine – Veterinarian, Pharmacist, SQP (POM-VPS)
• Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA-VPS)
• Authorised Veterinary Medicine – General Sales List (AVM-GSL)

The details and distribution categories for all medicines can be found on the VMD’s Product Information Database.

In addition to the above there is also an Exemption in the VMR that allows products to be supplied legally without a marketing authorisation.

POM-V medicines

A POM-V medicine may only be supplied if it has been prescribed by a vet following a clinical assessment of the animal(s), which must be under their care. The VMR doesn’t define ‘clinical assessment’ or ‘under their care’ and vets should use their professional judgment to interpret what this means in individual cases. However, the Royal College of Veterinary Surgeons (RCVS) has interpreted both phrases.

A client may ask for a written prescription if they want to buy the product from a supplier other than the prescribing vet. In either case, the prescribing vet must retain clinical responsibility for the treatment and the animal(s) under their care. A vet or pharmacist may supply POM-V products or products for use under the cascade (a provision in the VMR that allows a vet to prescribe medicines that would not otherwise be permitted) to non-clients but only against a written prescription from a vet.

The vet or pharmacist should use their specialist knowledge to check that the prescription matches their own understanding of the product. If they have any concerns about the prescription, they should contact the prescribing vet before supplying the medicine. Suppliers can refuse to supply against a prescription.

Products containing a new active substance will usually be categorised as POM-V.

POM-VPS medicines

A POM-VPS medicine may be prescribed by any RQP. A clinical assessment of the animal(s) does not have to be carried out when prescribing POM-VPS medicines and the animal doesn’t have to be under the RQP’s care. However, the RQP must have sufficient information about the animal and the condition to be treated to enable them to prescribe and supply the most appropriate product.

A customer may request a written prescription if they want to buy the product from a supplier other than the prescribing RQP. An RQP may supply POM-VPS medicines against a written prescription from another RQP.

Pharmacists and SQPs may supply a POM-VPS medicine for use under the cascade if prescribed by a vet against a written prescription.

NFA-VPS medicines

A NFA-VPS medicine doesn’t have to be prescribed but it may only be supplied by an RQP, provided the requirements for supply are followed.

AVM-GSL medicines

There are no legal restrictions on the retail supply of veterinary medicines classified as AVM-GSL.

Specific requirements: vets, pharmacists, SQPs

Vets

Registration

A vet may only prescribe and supply veterinary medicines (other than those classified as AVM-GSL) if they are registered with the RCVS.

Vets may only supply medicines from premises registered with the RCVS as a Veterinary Practice Premises (VPP).

For details of registration requirements under the VMR see the RCVS website.

Supplying

A vet supplying a veterinary medicine (other than one classified as AVM-GSL) must be present when it is handed over unless they:

• authorise each transaction individually before the product is supplied
• are satisfied that the person who hands it over is competent to do so

Delegating supply

If the vet intends to delegate supply to other competent personnel, the supply must still be made from a registered VPP.

However, in exceptional circumstances, e.g. for animal welfare reasons, a vet may instruct a wholesale dealer authorisation (WDA) holder to deliver medicines directly to the client’s premises.

Mobile units

A mobile treatment unit operated by a vet doesn’t require individual registration if it’s linked to a registered VPP. However, it will be inspected with the practice. Please also see the section on registering trade stands.

A mobile unit must be registered as a VPP in its own right if the sole purpose of the unit is to retail veterinary medicines (e.g. at agricultural shows). However, small quantities of veterinary medicines may be stored and supplied from a mobile unit if the veterinary practice has one at a show or event.

Cold calling

The Veterinary Medicines Directorate (VMD) strongly discourages the unprofessional practice of unsolicited visits to farms by vets specifically to sell veterinary medicines.

Pharmacists

A registered pharmacist may only supply veterinary medicines (other than those classified as AVM-GSL) from premises:

• registered as a pharmacy with either the General Pharmaceutical Council (GPhC) or the Pharmaceutical Society of Northern Ireland (PSNI)
• registered as a VPP or approved for the storage and supply of veterinary medicines by an SQP (see Suitably Qualified Persons)

A pharmacist supplying veterinary medicines (other than one classified as AVM-GSL) must be present when it is handed over, unless the pharmacist:

• authorises each transaction individually before the product is supplied
• is satisfied that the person who hands it over is competent to do so

A pharmacist may prepare and supply an extemporaneous preparation, i.e. a medicine prepared especially for use under the cascade, against a written prescription from a vet. The product should be made using pharmacopoeia-compliant raw materials. The product should meet the requirements of the relevant general monographs of the pharmacopoeia. It may be supplied directly to the user.

Suitably Qualified Persons

SQPs may only supply veterinary medicines that they are qualified and registered to supply.

SQPs must ensure that they meet the legal requirements for prescribing and supplying POM-VPS and NFA-VPS however the product is supplied (e.g. supply in a merchant’s store, postal supply, etc).

An SQP must comply with the Code of Practice for Suitably Qualified Persons . Information on how to become an SQP is available from the Animal Medicines Training Regulatory Authority (AMTRA) and Vetskill Ltd.

An SQP supplying a veterinary medicine (other than one classified as AVM-GSL) must do one of the following:

• hand over or despatch the product personally
• ensure that, when the product is handed over or despatched, the SQP is in a position to intervene if necessary
• check the product after it has been allocated for supply to a customer and be satisfied that the person handing over or dispatching it is competent to do so

SQPs may only supply from the following premises:

• premises approved as an SQP retailer
• a pharmacy registered with the GPhC or the PSNI
• a VPP registered with the RCVS

Approved SQP Premises

Each premise an SQP supplies medicines from must be approved separately. The premises are considered to be under the control of the business in whose name the approval is granted.

To be approved and retain that approval, each premise must have a registered SQP. Approved SQP retailers must notify the VMD of any proposed change to their registered SQP.

Domestic premises may be approved as SQP retailer premises if they meet the required criteria (i.e. permanent building with a fixed address). For the purpose of approval and inspection, the part of the premises used for the retail supply of POM-VPS and NFA-VPS medicines must be made accessible to inspectors following reasonable notice.

If an SQP considers that the premises in which they’re operating no longer comply with the requirements of approval, they must immediately notify the VMD. This is necessary to ensure that the products are prescribed and supplied in accordance with the VMR and are stored correctly to maintain their safety and efficacy.

You can apply for registration of an SQP retailer premises using the application form and guidance on registering an SQP retailer premises.

Approval will only be granted following a satisfactory inspection.

SQP retailer distribution centres

A company’s distribution centre, to which POM-VPS or NFA-VPS veterinary medicines are delivered from a wholesale dealer for onward transfer to the company’s own approved SQP retailer premises, should itself be approved as an SQP retailer premises.

The distribution centre should have a named SQP with overall responsibility for the intake, storage and transfer of POM-VPS products but that SQP doesn’t need to authorise each and every transfer to the company’s other approved retail premises.

If the distribution centre is used to store veterinary medicines for supply to third party companies, it will need a wholesale dealers authorisation (WDA).

The Register of Approved SQP Retailers Premises is published here.

Requirements for all RQPs

Retail supply

When prescribing a medicine classified as POM-V or POM-VPS or supplying a medicine classified as NFA-VPS, the RQP:

• must be satisfied that the person who will use the medicine is competent to do so safely and intends to use it for an authorised purpose
• must advise on its safe administration and on any necessary warnings or contra-indications on the label or package leaflet
• must not prescribe (or, in the case of a NFA-VPS product, supply) more than the minimum amount required for the immediate treatment. However, it is a defence to show that:
  • the veterinary medicine prescribed or supplied was in a container specified in the marketing authorisation (MA)
  • the marketing authorisation does not permit smaller containers
  • the RQP is not a person authorised to break open the package before supply

In order to meet the above requirements RQPs must satisfy themselves by all reasonable means that the customer is competent to use the product safely; and satisfy themselves that the product is suitable for the animal concerned. The following sets out VMD’s expectation of what information is likely to be necessary to be assessed by the RQP prior to supply taking place. It should be noted that this information does not necessarily need to be recorded – the information that must be kept when a veterinary medicinal product is supplied is detailed in Record keeping requirements for veterinary medicines.

For pets/companion animals the following in respect of each animal:

1. Species
2. No of animal(s)
3. Weight (of each animal if more than one)
4. age
5. whether the animal is in general good health
6. whether the animal is pregnant or lactating
7. whether the animal is on any other medication
8. whether the customer knows how to use the product safely/effectively
9. whether the customer knows what the product is supposed to do
10. whether the customer has been provided with the warnings on the SPC

Food producing animals

As above and:

1. What is the animals intended food use (milk/meat/eggs etc)
2. Does the customer know the applicable withdrawal period
3. In the case of sheep dip products, that they are satisfied that the person (or a person acting on his behalf) holds a Certificate of Competence in the Safe Use of Sheep Dips. The supply of sheep dip must be made in accordance with the legislative requirements, including, for OP dips, the supply of protective gloves and the laminated notice contained in the Regulations
4. In the case of anthelmintic products for sheep and cattle, SQPs should follow the recommendations of Sustainable Control of Parasites in Sheep (SCOPS - http://www.scops.org.uk), and the Control of Worms Sustainably (COWS - http://www.cattleparasites.org.uk/), respectively
5. In the case of horses and other equidae, whether the animal has been declared as non-food producing in their horse passport

Disclaimers

The requirements on the RQP are non-delegable and cannot be transferred to the customer. ‘Disclaimers’ that, for example, simply inform a customer that they must answer yes or no to a list of questions will not be considered by VMD to meet this requirement.

Labelling at the time of retail supply

The label information on the product is specifically authorised to provide essential information for its safe and effective use. This includes warnings for the user and animal owner so it must not be obscured by any additional labelling or amendments made to the packaging.

A vet or pharmacist supplying a product against a written prescription may amend the authorised label to reflect the prescription (e.g to change the dose). However, none of the other information on the outer packaging or the immediate container must be obscured. SQPs may only supply a product in accordance with the authorised label, except when supplying a product under the cascade against a written prescription from a vet.

If a product is placed into a container which hasn’t been authorised as part of the MA (e.g tablets being supplied in a standard bottle with a child resistant closure) sufficient written information must still be provided to make sure the product is used safely.

There are additional labelling requirements for products supplied under the cascade.

When prescribing

Prescribing is the process of an RQP deciding, instructing and recording the treatment required for an animal. Prescriptions may be oral or in writing. Vets, pharmacists and SQPs can prescribe in accordance with the distribution categories for veterinary medicines.

A prescription product can only be supplied by an RQP working from a different business or premises from where the product was initially prescribed against a written prescription. However, a written prescription isn’t necessary when the prescribing RQP and supplying RQP are different but working on the same site, provided they interact in the transaction.

A prescription from a vet may be for an authorised veterinary medicine or for a product for use under the cascade.

If the prescription is not repeatable, it’s sensible for this to be stated on the prescription.

If the prescription has a section that states number of repeats, it’s recommended that this is crossed out by the prescriber if the prescription is not to be repeated.

Written prescriptions

No particular format is required for a written veterinary prescription. But they must include the following information:

• the name, address and telephone number of the person prescribing the product
• the qualifications enabling the person to prescribe the product. It is recommended to cite MRCVS or the SQP’s registration number
• the name and address of the owner or keeper
• identity (including the species) of the animal or group of animals
• the premises at which the animals are kept if this is different from the address of the owner or keeper
• the date of the prescription
• the signature or other authentication of the person prescribing the product
• the name and amount of the product prescribed
• the dosage and administration instructions
• any necessary warnings
• the withdrawal period (if relevant)
• a statement that it is prescribed under the cascade (if relevant)

An example of a vet’s prescription is available from the British Veterinary Association (BVA).

Prescription pads for SQPs are available from the Animal Health Distributors Association (AHDA).

Prescriptions are valid for up to 6 months from the date of signing unless the prescriber specifies a shorter period.

Prescriptions for Controlled Drugs (CDs)

There are specific requirements for prescriptions for CDs.

Prescription tampering

Anyone supplying a veterinary medicine against a written prescription must take reasonable steps to ensure the prescription is genuine. Anyone who alters a written prescription without authorisation to do so by the prescriber is committing an offence.

If an amendment (such as a typographic error) to a written prescription is necessary before a product can be supplied then the prescriber may give the supplier permission to make an amendment on their behalf, and this action should be recorded.

If orders against faxed or electronic prescriptions are accepted then the supplier may need to check that each prescription is genuine.

Prescribers may choose to use methods such as stickers or serial numbers to help with this. If the supplier doubts the validity of a prescription then they should telephone the prescriber to check its validity.

Unless the use of electronic transmission for prescriptions is an agreed and familiar practice between the prescriber and supplier or it is needed urgently to avoid an animal suffering, the supplier should make sure they have the original hard copy prescription before supplying the medicine.

How to reduce or discourage unauthorised alterations

For prescribers:

• placing a poster in the practice waiting room educating clients that it is an offence under the Veterinary Medicines Regulations (VMR) to alter a written prescription (Schedule 3 para 5(3))
• vets - use only the prescription template offered by the BVA or other reputable organisations
• SQP - use only the prescription template offered by AHDA
• RQP - use typed text rather than handwritten prescriptions
• RQP - write quantities as numbers and text
• RQP - initial and date any alterations to hard copy prescriptions
• RQP - include a sequential numbering system on prescriptions, where a unique identifier is added enabling suppliers to check with prescribers
• RQP - recommend clients obtain medicines from internet retailers who are accredited by the VMD’s Accredited Internet Retailer Scheme (AIRS).

See here for a list of accredited internet retailers.

For suppliers:

• if the client is new, telephone the vet named on the prescription
• check the name and address of the vet or practice on the RCVS website (N.B Not all veterinary premises are published on the RCVS website. If in any doubt contact the RCVS)
• check the name and address of the pharmacist on the GPhC or PSNI website
• check the List of SQPs and Register of Approved SQP Retailers Premises
• if the prescription is unclear or there are amendments check with the prescriber
• if you do dispense against faxed or emailed prescriptions ask for the original prescription

For online retailers:

• do not offer template electronic prescriptions on websites
• when a client adds a Prescription Only Medicine to their ‘basket’ or when proceeding to the checkout, include a warning that tampering with a prescription is an offence
• reporting instances of prescription misuse using this form.

Retail supply via the internet

The VMR apply to the sale of veterinary medicines on the internet in the same way as they do to ‘over the counter’ sales.

Internet retailers of veterinary medicines can apply to be accredited under the VMD’s Accredited Internet Retailer Scheme (AIRS). Retailers who meet the accreditation criteria will be able to display the VMD’s Internet Retailer logo on their website.

The GPhC operates an Internet Pharmacy Logo scheme to identify legitimate on line pharmacies so that the public can be sure they are purchasing safe and genuine medicines online.

Import and export of veterinary medicines

It is an offence to import and supply a veterinary medicine that’s not authorised for use in the UK unless it’s supplied against a prescription from a vet and with a suitable import certificate issued by the VMD. Details of the Special Import scheme.

The VMR allow the export of veterinary medicines, for more information see guidance on export certificates.

Vets and pharmacists may export medicines within the EU against prescriptions from vets in the European Economic Area (EEA) and Switzerland, provided that:

• they are satisfied the prescription for the product to be exported is valid
• the medicines will be used in the country where the prescription was written

Supply of sheep dip

A sheep dip can only be supplied to a person (or a person acting on his behalf) who holds a Certificate of Competence in the Safe Use of Sheep Dips showing that Parts 1 and 2 or units 1 and 2 of the assessment referred to in the Certificate have been satisfactorily completed, or NPTC Level 2 Award in the Safe Use of Sheep Dip.

The supplier must make a record of the Certificate number as soon as is reasonably practicable and keep it for at least three years.

When supplying a product containing an active substance that is an organophosphorus compound, the supplier must give the buyer a double sided laminated notice (unless the notice has been provided to the buyer within the previous twelve months and the supplier knows or has reasonable cause to believe that the buyer still has it).

The notice must be at least A4 size with a laminated transparent cover and must tell the user of the sheep dip:

• to read and act in accordance with the label, including instructions on measuring and diluting concentrate
• that sheep dip is absorbed through the skin
• always to wear the recommended protective clothing, including gloves, and have spare protective clothing available
• always to wash protective clothing before taking it off
• to direct any questions to the supplier or manufacturer

The notice must contain a diagram showing recommended protective clothing. In Wales the notice may be in Welsh as well as in English.

The supplier must also provide two pairs of gloves which must be non-lined, PVC or nitrile, heavy duty gauntlet style. They must be 0.5mm thick and at least 300mm long or provide demonstrably superior protection to the user than gloves of these specified measurements.

Buying groups

RQPs may supply POM-VPS medicines to farmers who are members of a buying group provided they fulfil the prescribing requirements of the VMR and the record keeping requirements detailed in Record-Keeping Requirements for Veterinary Medicinal Products.

To comply with these requirements the RQP must have made contact with each member of the buying group and have knowledge of the animals to be treated.

The RQP may invoice the buying group provided the terms and conditions of the group make it clear that it is acting only as an agent of the individual member supplied with the POM-VPS medicine(s) and does not take ownership of the goods supplied at any time.

Auctions

Veterinary medicines, apart from AVM-GSL and exemption products should not be offered or supplied via auctions, including on the internet.

Out of date products

It is illegal to supply a product after the expiry date shown on the pack. Any out of date products should be disposed of in accordance with the wording on the product literature.

Some products (e.g injectables) once they’re opened must be discarded after a period of time stated on their packaging. This is due to EU and national legislative requirements to ensure the stability and safety of the product. The expiry date is usually 28 days after opening but it can be shorter or longer.

Emergency wholesale supply between authorised retailers

An authorised retailer of veterinary medicines may supply products they are qualified to supply to another authorised retailer to relieve a temporary supply shortage, without a wholesale dealer’s authorisation (WDA). This exemption from the VMR is intended to prevent shortages of available medicines causing animal welfare problems. It is not intended to exempt wholesale supply from the need for a WDA.

Only the manufacturer of a veterinary medicine or a holder of a WDA may routinely supply authorised retailers with veterinary medicines.

Trade stands

Trade stands can be registered as a VPP, SQP retailer premises or pharmacy at a trade show or exhibition for the retail supply of veterinary medicines provided that the stand is within a permanent building, such as an exhibition hall, with a specific address, and the relevant storage requirements of the medicines are met.

Supplying medicines for horses

See specific guidance on Horse Medicines and Horse Passports record keeping.

Inspection of retail premises

We inspect approved SQP retailer premises and veterinary practice premises (except those VPPs that are registered with the RCVS as Practice Standards Scheme (PSS) premises), to ensure they comply with the VMR.

Inspections are carried out on a risk basis; the higher the risk the more frequent the inspections. VPPs are inspected at least every four years. SQP retailers premises are inspected at least every four to six years depending on the medicines being supplied. The VMD will generally give retailers reasonable notice that they intend carrying out a routine inspection.

The Inspection Criteria for SQPs are set out in the SQPs’ Code of Practice. The Inspection Criteria for non-PSS VPPs are available from our Inspections Administration Team inspections@vmd.defra.gsi.gov.uk and will be sent to a practice when it’s notified of an inspection.

Inspectors are authorised under the VMR to:

• inspect the premises, organisational arrangements and procedures used in the storage and distribution of medicinal products
• interview key personnel named on the authorisation
• take samples
• examine any documentation or records relating to the manufacture, assembly, storage and distribution of veterinary medicines

Following an inspection, the inspector will give the retailer a report detailing any deficiencies (also referred to as non-compliances). For major and critical deficiencies, the inspector will request details of the measures that have been, or will be, taken to correct them.

The VMD categorises deficiencies as critical, major and other (minor).

Minor (Other) Deficiencies:

• minor and poses no potential risk to human or animal health, or the environment
• does not indicate a significant deviation from the requirements of the VMR, Codes of Practice or Guidance
• cannot be classified as either critical or major because there is insufficient information to classify it as such

Major Deficiencies:

• non-critical but has produced, or has the potential to produce, a possible risk to human or animal health or the environment
• a major deviation from the requirements of the VMR
• a failure to carry out satisfactory procedures to ensure that products are manufactured, stored or distributed in accordance with their specific requirements
• a combination of more than six other (minor) deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such
• other (minor) deficiencies that have been brought to the attention of the business on previous occasions but have not been resolved

Critical Deficiencies:

• deficiencies that have produced, or have the potential to produce, a significant risk to human or animal health, or the environment
• a significant deviation from the requirements of the VMR through serious negligence or intent

Inspections are scheduled at intervals based on the number and type of deficiencies noted during an inspection, as follows:

Key to table:

Enforcement

For the most serious deficiencies or failure to comply with the VMR, we may take formal action in accordance with our Enforcement Strategy. If we decide to suspend or revoke an approval, retailers have the right to appeal against that decision.

The VMD has been made aware of a product defect with one batch of Genta-Equine 100mg/ml solution for injection for horses Vm 33848/4000, an injectable antibiotic containing Gentamicin, marketed by Franklin Pharmaceuticals Ltd and distributed by Dechra Veterinary Products.

Serious adverse events resulting in anaphylactic reactions in horses have been reported following use of this product batch. Investigations into the cause of these events are in progress.

The affected batch is 6054-81A with the expiry date January 2018.

The VMD advises that this batch should not be used and a batch recall to veterinary practice level is in progress.

For more details contact Andrew Parkinson, Quality Director, Dechra Veterinary Products; email: Andrew.parkinson@dechra.com.

Applications received on or before Tuesday 20th December will be logged onto our systems and dealt with as per normal timescales.

Any application received after this date will not be considered received until w/c Tuesday 3 January.

For further information contact: s.ward@vmd.defra.gsi.gov.uk.

Applications received on or before Tuesday 20th December will be logged onto our systems and dealt with as per normal timescales.

Any application received after this date will not be considered received until w/c Tuesday 3 January.

For further information contact: s.ward@vmd.defra.gsi.gov.uk.

A recent VMD pharmaceutical industry customer survey highlighted that improvements could be made to the Product Literature Standard. In response we are reviewing the layout and format as a priority with the aim of making this document as useful as possible.

We welcome your suggestions and comments by 31 October 2016 and sent to pls@vmd.defra.gsi.gov.uk.

The proposed timing for publishing the revised Product Literature Standard is December 2016.

The term antimicrobial includes: antibiotic, antiprotozoal, antiviral and antifungal medicines. Antimicrobial Resistance arises when the micro-organisms that cause infection survive exposure to a medicine that would normally kill them or stop their growth.

Resistance is a natural biological phenomenon but is increased and accelerated by various factors such as misuse of medicines, poor infection control practices and global trade and travel.

This is a particular concern with antibiotics. Many of the medical advances in recent years, for example organ transplantation and cancer chemotherapy, need antibiotics to prevent and treat the bacterial infections that can be caused by the treatment. Without effective antibiotics, even minor surgery and routine operations could become high risk procedures if serious infections can’t be treated.

A suitably qualified persons (SQP) is the legal term for animal medicine advisors who are entitled to prescribe and/or supply certain veterinary medicines under the Veterinary Medicines Regulations.

You must send your application for the approval of your retailer premises to the Veterinary Medicines Directorate (VMD).

SQPs can supply prescription only medicines prescribed by a vet, pharmacist or SQP (POM-VPS) and non food animal medicines without a prescription (NFA-VPS) from:

• premises approved by the VMD as suitable for the storage and supply by an SQP (SQP retailer premises)
• a pharmacy registered with the General Pharmaceutical Council, or with the Pharmaceutical Society of Northern Ireland
• a veterinary practice premises (VPP) registered with the Royal College of Veterinary Surgeons

Guidance

Requirements for SQP retailers are set out on the Retail of veterinary medicines page.

Application form

Apply for approval of your premises as an SQP retailer (MS Word Document, 2.35MB) .

Contact

You can contact the Inspections administration team by e-mail inspections@vmd.defra.gsi.gov.uk or by telephoning 01932 338475 or 338328.

Fees

There is an application fee for approval of SQP Retailer premises and an ongoing annual fee.

The application and annual fees are not refundable or transferable.

Timescales

The VMD aims to process application forms within 10 working days of receipt.

The VMD aims to carry out your premises inspection within a further 30 working days.

Until you receive written confirmation that your premises have been approved you may not buy, store or sell authorised medicines, other than those classified AVM-GSL.

Becoming an SQP

There are two bodies recognised for the registration of SQPs. For more informeation contact either;

Contact

Tel: 01359 245801, Fax: 01359 242569, email info@amtra.org.uk, or their website.

Contact

Tel: 01480 278580, Fax: 01480 278581, email info@vetskill.com, or their website.

Related information

SQP Code of Practice (PDF, 150KB, 19 pages)

Register of Approved SQP Retailers Premises.

Register of Approved SQPs

For failure to maintain the retail premise on the register of approved retailers of veterinary medicinal products, contrary to the Veterinary Medicines Regulations.

The annual fee was due in May. Despite numerous reminders and re-issues of the invoice, payment has not been received. Retail sale of POM-VPS medicines has continued at the premise.

Premise to restore to the register of retailers, or to cease the supply of veterinary medicines and to provide evidence that the sales have ceased and all POM-VPS stock removed.

This Notice has been complied with

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 only fish kept in closed water systems)
• cage birds (e.g 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

Active substances and ingredients

Exempted medicines can only contain active substances which have been approved for the purposes of this exemption by the Secretary of State. The list of approved active ingredients for small animals (PDF, 478KB, 37 pages) .

If you wish to market a product under the exemption which does not contain ingredients on this list you should complete the application for active approval form (MS Word Document, 59.9KB) .

Do not submit any studies or reports unless specifically requested. A short paragraph will usually be sufficient.

Certain sedatives may be permitted. You should confirm this with the VMD

Medicines not included in the exemption

The following medicines are not covered by this exemption:

• antibiotics
• narcotic or psychotropic substances
• medicines intended to be injected or infused into the body (eg. intravenously) or ophthalmic use, or for insertion into the ear canal

Purpose of use and route of administration

Exempted medicines must not be 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.

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, using the following statement meets this requirement:

The labelling must contain the following 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 authorisation number is issued by the relevant National Authority, the VMD can issue a manufacturing authorisation number.

When applying for this authorisation number you should provide evidence to demonstrate manufacture in accordance with Good Manufacturing Practice (GMP).

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 warning that may be stipulated for the particular active substance.

Pack sizes

Exempted 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

Exempted 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 manufacturer’s 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 exempted products.

There are no restrictions on the importation of products which fully comply with this exemption.

Pharmacovigilance

Any serious adverse events should be reported to the VMD within 15 days. Manufacturers, importers and retailers must keep records of all adverse events for 3 years to be shown to the VMD on request. For further information see the Veterinary pharmacovigilance page.

Preventing illegal use

When marketing an exempt medicine you must take reasonable measures to prevent its illegal use in animal species not covered by the exemption. For example, you must ensure that any advertising does not falsely describe the product or mislead as to its nature, quality, uses or effect.

Exempted products and the prescribing cascade

As exempted products are not authorised medicines they do not fall under the prescribing cascade. However, if a vet chooses to use an exempted product not in accordance with its product literature then they may do so in line with the principles of the prescribing cascade. By doing so, however, the medicine will no longer be deemed to be an exempted product.

For more information on exempt product please see the The Cascade: Prescribing unauthorised medicines page.