Marketing authorisations for veterinary medicines

Unless otherwise stated, the data and documents required in support of these applications are set out in VolumesAnnex 6aII andto 6bEU ofRegulation the2019/6 Europeanand Noticethe toVeterinary ApplicantsMedicines andRegulations in Annex I2 toRequirements Directive- 2001/82/ECGuidance, as amended..

Generics

You may apply for a generic MA by referring to the safety and efficacy aspects of a data package submitted in support of an already authorised veterinary medicine, which is referred to as the reference product.

The reference product must be authorised in accordance with either Part 1 of Schedule 1 and Paragraphs 7, 8 and 9 of the Veterinary Medicines Regulation and must be authorised in:

• the UK for a GB-National MA
• the EU for a NI-National MA
• the EU for mutually recognised and decentralised procedures with NI as CMS

You cannot use a product authorised in accordance with Paragraph 10 of the VMRs, aan exceptional MAPI,MA or exceptionala MABiological (including Immunological) veterinary medicine as a reference product.

In addition to a full quality data package, you would need to provide an environmental risk assessment for the product and a user risk assessment. The type of user risk assessment provided depends on the degree of similarity between the generic and reference products.

You must also provide an environmental risk assessment as part of an application for a generic veterinary medicinal product where:

(a)        the marketing authorisation for the reference veterinary medicinal product was granted before 1st October 2005, and

(b)        no marketing authorisation has been granted since 1st October 2005 in respect of a veterinary medicinal product which has the same active substance and pharmaceutical form as the reference veterinary medicinal product, and which is indicated for use in the same target species when administered at the same or a higher total dose,

This does not apply, where the Secretary of State has confirmed in writing that an environmental risk assessment for the reference veterinary medicinal product in question has already been assessed.

For generics of injectable products, the submission of injection site residues data is necessary, unless a biowaiver exempts the need for residues studies.

You must demonstrate that the generic product is bioequivalent to the reference product, unless an exemption from demonstrating bioequivalence applies. The reference product must have been authorised for at least 10 years, or part of thea Global Marketing Authorisation where 10 years has lapsed from original authorisation, before the generic product can be placed on the market.

For applications for generic products, which are based on reference products authorised after October 2005,2005 but before 17 May 2024, the application can be submitted after 8 years of authorisation, but the generic product cannot be marketed until the 10-year data protection period has expired.

In some cases, the data protection period for the reference product may be extended to 13 years. For products indicated for the treatment of bees and fish the protection period of the reference product is automatically 13 years.

For products authorised after 17 May 2024, the periods of data protection are:

• 18 years in the case of products authorised for bees
• 14 years in the case of products authorised for cattle, sheep (for meat production), pigs, chickens, dogs and cats (major species) and where the product contains an active substance which is an antimicrobial which has not been an active substance in a veterinary medicinal product previously subject to a marketing authorisation in Great Britain
• 10 years in the case of a veterinary medicinal product authorised for cattle, sheep (for meat production), pigs, chickens, dogs and cats (major species);
• 14 years for a veterinary medicinal product authorised for all other species.

The Summary of Product Characteristics (SPC) of the generic product shouldmust followbe essentially similar to the SPC of the reference product.

The legal distribution category (LDC) of the generic product must be the same as that of the reference product. A change to the LDC cannot be processed as part of the MA application but you can submit a variation application to change the LDC after the MA has been issued.

Generics of biological products are not possible unless the Master Seed and/or working seed and production processes are the same.

The global marketing authorisation concept applies when a veterinary medicinal product has been granted an initial authorisation. Then, any subsequent authorisations issued to that Marketing Authorisation Holder for products containing the same active substance, for exampleexample, additional species, strengths, pharmaceutical forms, administration routes, and presentations, as well as any variations and extensions, shall be considered as belonging to the same global marketing authorisation. This means that for practical purposes the start of the data protection period is the date at which the initial authorisation is granted.

For Northern Ireland, the same marketing authorisation concept applies, see section 5.2 in Commission Notice – Guidance to Applicants - Veterinary Medicinal Products (europa.eu).

Generic-hybrids

A hybrid MA follows the same principles as those for generic applications, but such applications are required:

• if you are not able to demonstrate bioequivalence to the reference product through bioavailability studies
• where bioequivalence can be demonstrated to the reference product, but you want to make changes to the active substance(s), the therapeutic indications, strength or pharmaceutical form, withdrawal period, or to the route of administration.

In practical terms this means that the applicant can cite a reference product but needs to provide bridging data to account for the differences between the proposed product and the reference product. However, it is not possible for an applicant to submit a hybrid application that deletes or adds an active substance to that of the reference product cited.

Example of a Generic-hybrid MA: The reference product is indicated for use in cats and dogs and is administered orally. You want your product to include cats and dogs but want an injectable product. You refer to the reference product to cover some of the safety and efficacy data requirements but produce your own data to support the change in the route of administration.

Biosimiliars

Where a biological product, which is similar to a reference biological product, but does not meet the conditions in the definition of a generic product because of differences relating to raw materials or in a manufacturing process. The results of appropriate pre-clinical tests or clinical tests relating to these conditions must be provided.

Bibliographic

A bibliographic MA is based on an application where all parts of the data dossier are addressed using published data. This type of MA may also be referred to as an MA based on well-established use. You must demonstrate the active substance has been used for at least 10 years in the target species for the indications applied for.

It is not possible to apply for a bibliographic MA for a biological (including immunological) veterinary medicine.

Fixed combination

An application for a product containing active substances already used in an authorised product, but not previously used in that combination in an authorised product. In this case, you don’t need to provide safety and efficacy data for the individual active substances.

Informed consent (copycats)

One of the most common types of MA. Copycat is an informal term used to describe an MA authorised based on informed consent.

For these applications you cross-refer to specific parts of the data package for an already authorised product, which is referred to as the parent product. A full Part I of the dossier must be submitted, along with the VMDS requirements, where these are not already included. Also, if applicable, a Letter of Access from parent holder; for Pharmaceutical products only, a copy of the Finished Product Specification (FPS) in the prosed product name, a statement regarding residual solvents and the European tables of materials of human and animal origin.

The parent product must be authorised in accordance with Part 1 of Schedule 1 or Paragraphs 7 and 8 of the Veterinary Medicines Regulation and must be authorised in:

• GB for a GB MA
• NI for a NI MA national or as part of an EU procedure

You cannot use a product authorised in accordance with Paragraphs 9 and 10 of the VMRs, a MAPI or an exceptional MA as a parent product.

Apart from the product name, the product’s authorisation number and, possibly, the MAH and pharmacovigilance systems, all the details of the proposed copycat are identical to the parent.

For a product to be authorised based on informed consent, the MAH for the parent product must give the VMD permission to refer to the data submitted in support of the parent product.

If the MAH of the parent product is different from the applicant, a formal letter of access from the parent MAH is required to be submitted as part of the application package submitted in support of the copycat. If the applicant is the MAH of the parent a formal letter of access is not required.

A parent MAH has a responsibility to notify a copycat holder when changes have been made to the parent MA. The parent MAH should provide the copycat holder with at least the categories used for the variation(s) and, ideally, the application number in order to apply for the same changes.

Extension

An extension is a type of variation to one of your existing MAs to create a new stand-alone MA (new extension) or to change an MA (variation extension).

You must state in your application which you are applying for.

A new extension will be dealt with as a new MA application using the same procedures and timescales. A new MA is granted at the end of the procedure.

Exceptional MAs

An exceptional MA may be granted where no fully authorised product is available in the UK to prevent or treat a particular condition, following submission of a reduced data package where specific data is not available,available. however,However, you must demonstrate that the benefits of the availability of the product on the market (immediate availability in the case of a provisional MA) outweigh any potential risks.

There are 2 types of exceptional MA:

• Provisional - a provisional MA (PMA)(PMA), wherethese no fully authorised product is available in the UK to prevent or treat a particular condition These are normally granted to help address an urgent situation, such as a new disease. PMAs are intended to exist in the short term whilst you generate data to support a full MA
• Limited – a limited MA (LMA)(LMA), maya product for a limited marketed intended to help fill an existing therapeutic gap but where the product is not expected to be sold in vast quantities; therefore, it is unrealistic to expect you to generate full data packages and incur those costs.

A limited market is defined as a market for one of the following types of veterinary medicine:

• a veterinary medicine for the treatment or prevention of diseases that occur infrequently or in limited geographical areas
• a veterinary medicine for an animal species other than cattle, sheep for meat production, pigs, chickens, dogs or cats

For Northern Ireland, eligibility for classification as a Limited Marketing Authorisation should be confirmed with the European Medicines Agency.

An Exceptional MA is informally reassessed on an annual basis without the need for you to submit an application or any supporting data.

This reassessment will examine all relevant data available to the VMD to confirm that the benefit:risk balance remains favourable; if not, the MA may be suspended or expired.

The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.

If a formal renewal is required, this will be determined as part of the initial application and will be specified as a condition on the initial authorisation. The timing of the renewal and the supporting data to be supplied will also be specified. In these cases, a reassessment fee will apply.

Distribution Categories

Distribution CategoriesCategories, (sometimessometimes called Legal Categories)Categories, relate to the retail supply of the authorised product. For example, a product classified as 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.

Further information about Distribution Categories isrefer into the guidance for retailers.

The distribution category of an exceptional MA will be POM-V. It is possible to apply for a change in distribution category for PMAs from POM-V to POM-VPS if the product:

• has been on the market for at least 12 months with a high volume of sales
• only makes preventative claims
• has a good record in terms of adverse events (AE) and Suspected Lack of Efficacy (SLE)

The distribution category of a MAPI product will be the same as the distribution category of the parent product.

Product authorisation numbers

An authorised product in the UK will have an authorisation number preceded by the symbol Vm on its product literature and labels. This shows that the product has been assessed and approved for use in accordance with the instructions on the product literature.

The first 5 numbers are the MAH’s company number followed by a sequential product number. The first number of the product number element will be used as a territory identification number. These are:

• 4 – UK wide – Pre 2021 authorisations retaining a UK wide authorisation and these product numbers start with the number 4
• 3 – NI MA – For MAs authorised in NI only
• 5 – GB MA – For MAs valid in GB only

Central authorisations issued by the European Commission (EC) are valid in allNorthern EUIreland, member states, including NI, and will have an EU MA number.

Post authorisation steps

Renewals

An MA must be renewed 5 years following initial authorisation.

See Apply to renew a marketing authorisation for a veterinary medicine.

Note - Exceptional MAs are reassessed annually. A formal renewal may be required if this is specified as a condition on the initial authorisation.

Variations

To make any changes to your MA you willmust need to submit a variation application to the VMD.

SeeRefer to Apply to change a marketing authorisation for an animal medicine.

Note - Exceptional MAs are subject to the same variation procedures as other types of MA.

Referrals

We have the authority and procedures in the UK for reviewing products and requesting changes and for taking action as a result of Pharmacovigilance data, should new data/evidence come to light.

NI MAs and existing MAs valid UK wide authorised through EU procedures remain subject to EU Referral procedures.

UK Public Assessment Reports (UKPARs)

In most cases a public assessment report (PuAR) will be available on the VMD’s Product Information Database (PID) along with the SPC, label text and a post authorisation assessment (PAA). The PAA lists all applications completed on a product since initial authorisation.

Please note that for some products originally authorised under an EU procedure and converted to a Great Britain and/or Northern Ireland authorisation on the1 1st January 2021, a UK Public Assessment Report (UKPAR) may not be immediately available. We will endeavour to populate this information over time.

For exceptional MAs and copycats only the SPC and PAA will be available.

For mutually recognised products the PuAR will be available from the member state that acted as the RMS for the procedure.

For centrally authorised products, the SPC, PuAR and PAA will be available on the EMA website.

How to apply

SeeRefer to Apply for a Marketing Authorisation for Veterinary Medicine.

Contact us

Email: postmaster@vmd.gov.uk