What is a Marketing Authorisation?  (Back to top)

A veterinary medicinal product must be the subject of a valid Marketing Authorisation (MA), issued by the VMD, before it can be placed onto the market for sale and supply. The MA Holder (MAH) has to market that product in compliance with the terms of the authorisation.

A product may only be marketed in the UK if it is subject to a valid MA as issued by the VMD; MAs issued by other EU Member states are not valid in the UK; they only allow the product in question to be marketed by the MAH in that Member state.

If a product has been authorised via the centralised procedure (a European authorisation route), a single MA is granted by the European Commission and is considered valid in all EU Member states.

Not all products for which applications are submitted are granted MAs. Some applications for MAs are refused at the end of the assessment process due to insufficient and/or inadequate supportive data.

How can a product be authorised?  (Back to top)

There are four different routes to obtaining a marketing authorisation; these routes determine the procedures, processes and timelines used in progressing an application for a new MA in accordance with legislation. Once granted, the authorisation will be classified as nationally authorised, centrally authorised or mutually recognised.

Authorisation Routes

A national procedure the product will be classed as “nationally authorised”.

The Centralised procedure the product will be classed as “centrally authorised”.

The Mutual Recognition procedure the product will be classed as “mutually recognised”.

The Decentralised procedure the product will also be classed as “mutually recognised”.

Within these routes, there are several different types of MA that may be applied for, e.g. Copycat, Provisional, Extension or MAPI, which reflects the type and content of the data submitted in support of the application. Further information about these ‘MA types’ is available elsewhere in the FAQs.

Whichever route/type is used the resulting authorisation, as issued by the VMD or European Commission, permits the MAH to place the product on the UK market for sale and supply.

What does the Vm symbol mean?  (Back to top)

An authorised product will have an authorisation number, preceded by the symbol Vm, on its product literature, e.g. labels; this offers users a clear guarantee that the medicine has been assessed and approved in accordance with the instructions on the product literature. Please note products authorised via the centralised route will not have a Vm number on its product literature.

What is a nationally authorised product?  (Back to top)

A product that has been assessed and approved on a national basis only, i.e. there has been no interaction with other EU Member states.

What is a centrally authorised product?  (Back to top)

A centrally authorised product is one that has been assessed and approved on a community level involving all EU Member states, i.e. evaluated via the centralised procedure and approved by the European Commission.

What is a mutually recognised product?  (Back to top)

A mutually recognised product is one that has been assessed and approved on a European level involving at least two EU Member states, i.e. evaluated via the mutual recognition or decentralised procedure.

What is the centralised procedure?  (Back to top)

The centralised procedure is a European authorisation route resulting in a centrally authorised product.

If a product has been authorised using the centralised procedure it has been assessed on an EU wide basis and approved by the European Commission. This allows its authorisation in all EU Member states including the UK .

The European Medicines Agency (EMA) organises the process of evaluation using scientific expertise from all EU Member states. If a positive opinion is given by the EMA after a product has been evaluated, it is sent to the European Commission (EC). If the EC also has a favourable opinion, it makes a formal decision to authorise the product and it grants a single Marketing Authorisation that is valid in all EU Member states. Note, whilst the EC will usually endorse a positive opinion, it has the right to reject it.

Although the Veterinary Medicines Directorate does not issue a Marketing Authorisation for products authorised by the centralised procedure, the outcome is the same: the product is authorised for use in the .

The Summary of Product Characteristics (SPC) is agreed for the product as part of the process of evaluation. The SPC, which is agreed at the end of the centralised procedure, is in English and translated into all the EU languages.

Any subsequent proposed SPC changes must be approved and, if agreed, they apply to all Member states.

The centralised procedure is compulsory for some products and optional for others. Some products are not eligible for the centralised procedure.

More information about the EMA and the Centralised procedure is available on the EMA website: www.ema.europa.eu

Not all products for which applications are submitted are subsequently granted a Community Marketing Authorisation. Some applications are refused due to insufficient and/or inadequate supportive data.

What is the Mutual Recognition procedure?  (Back to top)

The mutual recognition procedure (MRP) is a European authorisation route resulting in a mutually recognised product.

Mutual recognition must be used when a product is already authorised in at least one EU Member state on a national basis and the MAH wishes to obtain an MA for the same product in at least one other EU Member state.

The member state that has already authorised the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to the other member state(s); known as a Concerned Member state(s) (CMS). The CMS(s) is asked to mutually recognise the MA of the RMS.

If the application is successful, the CMS(s) will then issue an MA for that product permitting the marketing of that product in their country.

Not all products for which applications are submitted are subsequently granted a MA. Some applications are refused due to insufficient and/or inadequate supportive data.

Please note if the UK acted as RMS this means the product was initially authorised in the UK on a national basis first; therefore, once the mutual recognition procedure has been successfully completed, the authorisation type of the UK MA will change from ‘National’ to ‘Mutually Recognised’.

What is the Decentralised procedure?  (Back to top)

The decentralised procedure (DCP) is a European authorisation route resulting in a mutually recognised product.

The difference between MRP and DCP is that a product must already be authorised in at least one member state on a national basis in order for MRP to be used. DCP may be used if the product is not already authorised in any EU member state and a company wishes to authorise it in several or all EU Member States, but does not want to use the centralised procedure, or the product is not eligible for the centralised procedure.

One of the proposed Member States will be asked by the company to act as Reference Member State (RMS). The RMS does the initial evaluation of the product and issues a draft assessment report. The other member states, known as CMSs, either agree with the RMS's evaluation or they ask further questions/raise objections.

If all the issues are resolved and the app lication is successful, each member state will then issue an MA for that product permitting it to be marketed in their country.

Not all products for which applications are submitted are subsequently granted a MA. Some applications are refused at the end of the assessment process due to insufficient and/or inadequate supportive data.

What is a renewal?  (Back to top)

An MA (ex. PMA) is initially valid for five years from date of first authorization; at the end of the five year period it will be subject to renewal, which is a mechanism for reviewing a product. This review takes into consideration any further information obtained about the product from the experience gained of its use since it was first authorised, e.g. pharmacovigilance data. This is to ensure that the VMD still considers the product's MA to be appropriate. Following this review the MA will be valid indefinitely, or the MAH will be asked to submit another renewal in a further five year’s time.

What is a variation?  (Back to top)

A variation is a change made to a Marketing Authorisation.

Variations are categorised as Type IA, Type IB and Type II. This classification reflects, in general, an increasing level of complexity involved in the assessment of the proposed change.

Further details of Types IA, Type IB and Type II variations can be obtained from the 'Pharmaceuticals' section of the European Commission's website:

What is an extension?  (Back to top)

An extension is similar to a variation in that it involves a change being made to an MA; however, an extension is a more major change and involves the original MA being 'extended'. If granted, an extension results in a new MA for the product.

An example of an extension would be adding a food-producing species. Product A is authorised for use in cattle; the MAH applies to extend this MA to include a new species, e.g. Sheep; therefore, the 'extension' MA would be for use in sheep. Following grant of the extension, the MAH can either keep the two MAs separate, i.e. Product A for Cattle and Product B for Sheep, or roll the extension MA back into the original MA, thus resulting in a product called, Product A for Cattle and Sheep.

Further details of extensions can be obtained from the 'Pharmaceuticals' section of the European Commission's website:

What is an Exceptional Marketing Authorisation?  (Back to top)

There are two types of Exceptional Marketing Authorisations under this VMD national only scheme:

• Provisional Marketing Authorisation

• Limited Marketing Authorisation

A Provisional Marketing Authorisation (PMA) is a specific type of MA, and is only issued when there is no suitable authorised medicine available to treat a particular disease or to treat a new disease in the UK. A new disease could either be one that has not been recorded before in the UK, or an existing disease whose pattern has changed to such an extent that existing medicines are no longer effective.

These authorisations are issued whilst a company continues to generate the full supporting data required to obtain a Marketing Authorisation.

The product is provisionally authorised under restricted and specific circumstances, without all the data which would normally be required to support it. Quality and safety are not compromised. A complete package of data on the product's efficacy is not necessary, although some efficacy data are required to demonstrate a positive effect.

Not all products for which applications are submitted are granted PMAs. Some applications for PMAs are refused at the end of the assessment process due to insufficient and/or inadequate supportive data.

PMAs are intended to exist only in the short term and are expired when the corresponding Marketing Authorisation is issued.

Limited Marketing Authorisations are introduced as a new scheme. (This scheme does not apply to FULL applications otherwise submitted in accordance with EMEA guidelines on data requirements relating to MUMS/Limited Markets). These authorisations are, intended to be used in the case of veterinary medicines which, by the nature of the indicated species or the nature of the condition they are preventing or treating, are not expected to be sold in vast quantities – so called limited market products.

Limited Marketing Authorisations are intended to help fill existing therapeutic gaps in the UK. As a result of the costs involved in generating complete data packages, and the anticipated low level of returns on the sales of such products, it is unrealistic to expect companies to generate complete data packages for limited market products and therefore there is no obligation to do so.

However, should a company wish to generate the necessary data and apply to convert a Limited Marketing Authorisation to a full Marketing Authorisation they may do so.

For both subtypes of Exceptional Marketing Authorisation it is necessary to demonstrate that the benefits of the product outweigh any risks taking fully into account any data that may be missing from the supporting data.

Each Exceptional Marketing Authorisation will be the subject of annual reassessment triggered and performed by the VMD. The purpose of the assessment is to confirm that the benefit:risk balance remains favourable. Where this is not the case according to circumstances the authorisation may be suspended or revoked.

See Veterinary Medicines Guidance Note 5 for more information:

What is a Marketing Authorisation for Parallel Import (MAPI)?  (Back to top)

A parallel import arises when

• a veterinary medicine is authorised in the UK and a product, that is identical or therapeutically the same, is authorised in at least one other Member State of the European Community, and

• the product is bought from wholesalers in one Member State, and imported into the UK for distribution.

An applicant may apply for an authorisation to place an imported product onto the market; this is known as a Marketing Authorisation for Parallel Import (MAPI). A product that has a MAPI will have new labelling reflecting the MAPI holder’s details and all the information included on the labelling and packaging of the authorised product.

NB. A MAPI may only be obtained via a national procedure; however, the VMD will liaise with the member state(s) from which the product is being imported to obtain specific information to aid the authorisation process.

What is Informed Consent?  (Back to top)

In order for a product to be authorised on the basis of Informed Consent, an MAH for a UK authorised veterinary medicine has either:

-   Given the VMD permission to refer to the data, or part of the data, on behalf of a different company in connection with a new app lication

Or

-    Has asked the VMD to refer to data already submitted in support of one of the MAH's existing MAs.

The VMD does not perform a scientific assessment on data that have previously been supplied to them and assessed by them.

In the UK there is a special type of informed consent application referred to as a ‘copycat’. In such cases the applicant cross-refers to the complete data package for an already authorised veterinary medicine, which is referred to as the ‘parent’ product. Apart from the product name, the Vm number and possibly the MAH, the Summary of Product Characteristics (SPCs) for the parent and copycat products are identical. Therefore, as the products and their SPCs are effectively the same, no scientific assessment is undertaken.

What is a Summary of Product Characteristics?  (Back to top)

A Summary of Product Characteristics (SPC) contains information about a product.

For example, the SPC gives:

·    the name, strength and pharmaceutical form of the product

·    the name and strength of each active substance

·    what animal species it can be administered to

·    what diseases it can be used to treat or, in the case of vaccines, what diseases it prevents

·    the shelf life

It also gives safety warnings, which may include:

·    warnings about the product's use, for both the person administering the product and for the animal(s) the product is being administered to

·    information about the safe disposal of the product and its packaging, to ensure safety to protect the environment.

In the case of food producing animals, the SPC also gives withdrawal periods, i.e. how long after the product has been administered can the meat, milk, eggs etc. from that animal be consumed.

The SPC forms part of a product’s MA and it cannot be changed by the MAH without prior approval from the VMD. Some products also have datasheets, which are different to the SPC. The VMD does not assess or approve datasheets, because they are not a requirement under legislation; however, the information in the datasheet should be the same as the information contained in the approved SPC.

Electronic versions of authorised SPCs (known as eSPCs) are available on the VMD’s website by clicking on the + next to the product name. It should be noted that it can take a while for eSPCs to be updated to reflect any changes to a SPC following a variation or renewal application procedure; however, the VMD has recently introduced new procedures to help ensure the integrity of the website by updating the eSPCs as quickly as possible.

How often does an SPC change after it is first approved?  (Back to top)

An SPC does not change at any set time, or at any regular interval. An SPC may change if:

-    the Marketing Authorisation Holder submits a variation

-    the Marketing Authorisation is renewed and changes are made to update the SPC to current standards

-    additional text is required, such as a warning statement, due to a safety concern

Why does the information on the SPC not match that on the label?  (Back to top)

The SPC and product literature should provide the same information. However, following a change to the terms of an MA, the SPC will be updated and made available on line within 60 days following approval of the change, but changes to the product labels and leaflet (if applicable) will take time and will normally be introduced for sale and supply within six months following approval of the change. This timescale may be shorter or longer depending on the change involved.

If you have concerns over differences in information presented please contact the Marketing Authorisation Holder or VMD for clarification.

Why does the SPC and/or product literature provided by the company not match the information detailed on the Product Information Database?   (Back to top)

Differences may occur for products authorised on a European basis as a consequence of the recently introduced variation regulations 1234/2008. Under these regulations, certain minor variations of type IA do not have to be notified to the VMD for up to 12 months following the implementation of the variation, so called “annual notifications”. The VMD has identified the following annual notifications which may affect the SPC and/or product literature:

If you have concerns over differences in information presented please contact the Marketing Authorisation Holder or VMD for clarification.

What is a UKPAR?  (Back to top)

An UKPAR is a United Kingdom Public Assessment Report. All products authorised after 30 October 2005 have an UKPAR in accordance with legislation, which can be found by clicking on the + next to the product name. An UKPAR is split into three parts:

1. Summary of product characteristics (SPC): Information about SPCs is provided elsewhere in the FAQs.

2. Scientific discussion: A summary of the assessment report drafted during the application procedure covering quality, safety, environmental safety and efficacy.

3. Post authorisation assessments: This sets out any changes that have been made to the MA since it was first authorised, e.g. any variations or renewals conducted on an MA.

These documents are available on the website within 120 days of the issue of the MA. However, it should be noted that some products do not have a scientific discussion. MAs issued on the basis of informed consent or parallel import do not have UKPARs due to the lack of data for the assessment of these types of applications.

What is a PuAR?  (Back to top)

A PuAR is a European Public Assessment Report. It is the responsibility of the member state acting as Reference Member State (RMS) for the procedure to draft the report. Where the product is mutually recognised the PuAR will appear on the VMD website only if the UK have acted as RMS. Where the UK have acted as CMS (concerned member state) the PuAR could be found on the website of the RMS or on www.hma.eu .

Why do some UKPARs and PuARs look different?  (Back to top)

The format of the PuAR differs slightly from some of the UKPARs because the PuAR template is an agreed EU format but the same categories of information are presented in both reports.  However, from 1^st January 2012 the VMD has harmonised the format of their UKPARs with the format of PuARs.

What is an EPAR?  (Back to top)

EPAR stands for European Public Assessment Report, similar to an UKPAR and PuAR but this report is produced by the European Medicines Agency when the product has been authorised via the centralised procedure.

Veterinary medicines authorised under the centralised authorisation system by the EU Commission are listed here but more information is available on the website of the European Medicines Agency.

http://www.ema.europa.eu/htms/vet/epar/a.htm

To go to the SPC and EPAR for a veterinary product click on the link to the EMA website. This link takes you straight to the list of Authorised Products for Veterinary Use. The SPC and EPAR for the product you are interested in can be accessed from this list. Some modules are in different languages. Click on 'EN' for English.

Why do some Public Assessment Reports contain more information than others?  (Back to top)

The information included in Public Assessment Reports is dependent on the data that was submitted in support of the Marketing Authorisations. For example an application for an informed consent will have no supporting quality, safety and efficacy data and therefore will only need to cross refer to the reference product.

From 1st January 2012, the VMD also started to include more information on clinical trials conducted in support of a Marketing Authorisation in the Public Assessment Report.

Why has the VMD decided to include more information on clinical trials in the Public Assessment reports that they produce?  (Back to top)

In 2010, the VMD conducted a survey on the public assessment reports which are available on the VMD Product Information Database. The aim of the survey was to establish the audience base and to determine whether the content and style of Public Assessment Reports (PARs) is appropriate. A common theme of the responses was that the clinical summaries included in the PARs were not sufficiently detailed and in addition 25% of responders said that they find the efficacy section of the PAR most useful. In order to address these comments, and to provide a greater transparency in the information presented in PARs, the VMD decided to increase the level of detail included for clinical trials (e.g. field trials and dose confirmation studies).

The VMD considers that the disclosure of additional information on the clinical trials is relevant for the veterinarian as it will give them more confidence in the products that are authorised. Evidence based medicine is now widely encouraged and veterinarians should have a certain level of information available on the studies that have been conducted so that they can make an informed choice as to treatment for the individual animal under their care. In order to determine if the benefit shown for a particular product in a study could be extrapolated to the animal that they are treating, they need to know the clinical characteristics of the animals on which the product was tested and the clinical outcomes that were observed. At the most basic, this includes details about the study design such as whether the study was randomised, controlled and blinded.

It should be noted that owners would usually give consent for their animals to be included in clinical trials and animals will be treated for their own benefit. Clinical trials are generally performed to a high standard and the VMD considers that the data generated should be published to make the public aware of the credibility of the data to support an MA.

It should also be noted that in a clinical trial all “Adverse Events” are reported, regardless of any relationship to the product being tested and so may not necessarily be suspected adverse drug reactions (SARs) to the product.

The number of animals used in a study to demonstrate efficacy are dependent on a number of factors including expected strength of association, the study design/location (s) and planned statistical analysis. Therefore the number of animals alone cannot be used as a measure of comparative efficacy between other authorised products.

What is a homeopathic remedy?  (Back to top)

A homeopathic remedy is a veterinary medicinal product prepared from homeopathic stocks in accordance with agreed guidelines. All homeopathic remedies are authorised for use in all non-food animals. The VMD is responsible for registering homeopathic remedies that were placed on the market for the first time after 1^st January 1994. A homeopathic remedy that was on the market before 1^st January 1994 may be placed on the market without being registered in accordance with the Veterinary Medicines Regulations. A list of unregistered homeopathic remedies is available on the VMD website under Product Info/Unregistered Homeopathic Remedies.

Homeopathic remedies do not have an SPC or UKPAR.

Additional background information: Homeopathic veterinary medicinal products have been subject to UK legislation since the coming into force of the Registration of Homeopathic Veterinary Medicinal Products Regulations on 31 March 1997. These regulations introduced a simplified registration scheme for homeopathic products that do not make therapeutic claims, allowing them to be marketed legally without the need for a full marketing authorisation. Homeopathic veterinary medicinal products making therapeutic claims are required to have a full marketing authorisation. The 1997 Regulations were revoked and replaced by the Veterinary Medicines Regulations 2005; however the simplified registration scheme itself remains unaltered.

Veterinary homeopathic products that were already being marketed prior to 1994 are exempt from registration and as a result, these products qualify for ‘grandfather rights’, allowing them to continue to be marketed without the need to register under the scheme. The grandfather rights apply only to individual products owned and marketed by named companies and are non-transferable between manufacturers or those marketing the products. The VMD publishes a list of products on its website which are eligible for 'grandfather rights'.

It is a requirement that the labels for all registered homeopathic remedies to contain the words "homeopathic remedy without approved therapeutic indications for veterinary use".

Further information on homeopathic remedies is available in Veterinary Medicinal Guidance Note 9 which is available on the VMD website.

What does the Vh symbol mean?  (Back to top)

A registered homeopathic remedy will have a registration number, preceded by the symbol Vh, on its product literature, e.g. labels; this shows users that the remedy has been registered by the VMD.

What does expiry of an MA mean?  (Back to top)

It means the MA ceases to be valid; therefore, the MAH will not manufacture any more products from the date the MA expired. In most cases, an MAH requests the expiry of their MA, because they no longer wish to maintain it due to commercial reasons.

Unless the MA expired due to a safety concern, the MAH may sell-off existing stock for a period of six months from date of expiry. Any product already on the market may continue to be sold and used in accordance with the instructions on the product literature.

The same principles apply to homeopathic remedies.

Please note the list of expired products contains information about products that have expired since 31^st October 2005; this Information will remain on the website for five years following expiry.

What does suspension of an MA mean?  (Back to top)

A marketing authorisation may be suspended for a number of reasons in accordance with the Veterinary Medicines Regulations (see part 5 of Schedule 1). A suspended product may not be placed on the market under regulation 4(1) of the regulations, but existing stock may remain on the market for sale and supply unless the supply of the product is also prohibited. Additionally, the marketing authorisation holder may be required to recall any supplies of the product that are currently on the market. Where a recall has been required, a note will be published on the VMD website under Product Info/Product Batch Recall.

The same principles apply to homeopathic remedies.

What is a controlled drug?  (Back to top)

Certain drugs are more likely to be abused than others and therefore have stricter legal controls on their supply, storage, record keeping and disposal. The Home Office has overall responsibility for controlled drugs and associated legislation which regulates both veterinary and human medicines. Any veterinary medicinal product that contains a controlled drug must meet the requirements of both the Misuse of Drugs legislation and the Veterinary Medicines Regulations.

All controlled drugs are listed in one of five Schedules in the Misuse of Drugs Regulations 2001. The substances are listed according to their therapeutic usefulness and need for legitimate access, as well as potential for misuse and harm caused by that misuse to both the individual and society.

There are approximately 30 veterinary medicines currently authorised that contain a controlled drug entered in schedule 2-5. A list of these veterinary medicines is available on the VMD website along with the schedule and if there are any additional requirements on destruction and storage. Further guidance on controlled drugs can be found in Veterinary Medicines Guidance Note 29 which is also available on the VMD website.

What is a ‘distribution category’?  (Back to top)

A Distribution Category indicates how a veterinary medicinal product can be supplied.

There are four distribution categories in the UK :

·    Prescription Only Medicine - Veterinarian (POM-V):

May only be supplied by a veterinary surgeon or a pharmacist and must be supplied in accordance with a prescription from a veterinary surgeon.

·    Prescription Only Medicine - Veterinarian, Pharmacist, Suitably Qualified Person (POM-VPS)

May only be supplied by a veterinary surgeon, pharmacist or suitably qualified person and must be in accordance with a prescription from one of those persons.

·    Non Food Animal - Veterinarian, Pharmacist, Suitably Qualified Person (NFA-VPS)

May be supplied without a prescription by a veterinary surgeon, pharmacist or suitable qualified person.

·    Authorised Veterinary Medicine - General Sales List (AVM -GSL)

There are no restrictions on the supply of AVM – GSL products.

What is a Specified Feed Additive?  (Back to top)

A specified feed additive is a prophylactic coccidiostat or histomonostat or a non antibiotic growth promoter which is intended to be added to animal feed. These feed additives are authorised by an individual Commission Regulation in accordance with Regulation 1831/2003 and can be marketed in all the Member States. They are assessed by the European Food Safety Authority and authorised in accordance with the conditions of their own Regulation following a qualified majority vote by Member States at the Commission’s Standing Committee on Animal Nutrition.

Why can’t I find this product on the market?  (Back to top)

The granting of the marketing authorisation by the VMD does not necessarily mean that the product is continually on the market in the UK ; companies are free not to market all presentations of all products and to supply to the market at their own volition.

If you find a product is not available please contact the Marketing Authorisation Holder to enquire about the situation.

Please note that some vaccines will be prohibited for use in Northern Ireland, under Article 71 of the Directive. For further information please contact;

DARD, Room 728,

Dundonald House,

Upper Newtonards Road,

Belfast, BT4 3SB.

How do I get an Authorisation for the Import of a Veterinary Medicinal Product?  (Back to top)

If a product is not licensed in the UK it may be possible to apply for a Special Treatment Certificate or Special Import Certificate (STC/SIC). These are granted to Veterinary Surgeons on an individual animal, case-by-case basis. Details together with an application form are available in Veterinary Medicines Guidance Note 7 which is also available on the VMD website.

Why does the active substance appear twice?  (Back to top)

Sometimes it appears that the active substance is listed twice as “Name (declared active), Name SecondName”. This is how the information is captured in the VMD database and reflects instances where an amount of a substance is added during manufacture but only part of it is efficacious. For example, amoxicillin trihydrate could be shown as “Amoxicillin (declared active), Amoxicillin Trihydrate” as Amoxicillin Trihydrate is added during manufacture but only the amoxicillin accounts for the efficacious action of the product.