Guidance

Authorisations to manufacture veterinary medicines

Guidance for the pharmaceutical industry on applying for an authorisation to manufacture veterinary medicines.

For changes to this guidance as a consequence of the coronavirus (COVID-19) pandemic please refer to the VMD news and guidance on coronavirus (COVID-19) collection page

You must obtain a manufacturing authorisation (ManA) and comply with Good Manufacturing Practice (GMP) to manufacture:

  • an unauthorised veterinary medicine
  • a medicine under Schedule 6 of the current Veterinary Medicines Regulation (Exemption for Small Pet Animals)

Manufacturers of human and veterinary products

Where a site handles both human and veterinary medicines you should also refer to guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA), who also publish a register of sites authorised to manufacture both human and veterinary medicines.

Manufacturing Authorisation (ManA)

You must be a ManA holder to carry out any of the following manufacturing or assembling activities for an authorised veterinary medicine:

  • any process carried out in the course of making the medicine except for dissolving or dispersing the product in, or diluting or mixing it with some other substance used as a vehicle for the purpose of administering it

  • enclosing the medicine in a container which is labelled before it is sold or supplied (primary packing)

  • labelling the container where the medicine is already enclosed in the container in which it is to be sold or supplied (secondary packing) before the medicine is sold or supplied; this includes the over-labelling of medicines

  • batch certification of veterinary medicine manufactured at another site in the UK including contract manufactured products

  • importing veterinary medicine from a non-EU or European Economic Area (EEA) country and subsequently releasing the medicine to the market (batch certification)

You do not need a ManA to:

  • prepare, divide up, change the packaging or presentation of a veterinary medicine where this is done solely for retail supply, by or under the supervision of a veterinary surgeon or pharmacist in a registered veterinary practice premises or pharmacy (except a pharmacist may not break the immediate packaging of sterile products)

  • manufacture a veterinary medicine based on radio-active isotopes

  • manufacture a veterinary medicine for administration for research purposes in accordance with an Animal Test Certificate (ATC) or a licence issued under the Animals (Scientific Procedures) Act (A(SP)A) 1986

Duties of the ManA holder

You must comply (where appropriate to the manufacturing steps performed) with the following legal requirements relating to the manufacture and assembly of veterinary medicines:

  • manufacture the veterinary medicine in accordance with its Marketing Authorisation (MA)
  • ensure the services of a registered Qualified Person (QP) are continuously available
  • possess a current GMP certificate issued by a UK or EEA member national competent authority and ensure the veterinary medicine is produced in accordance with GMP
  • ensure Quality Assurance (QA) and Quality Control (QC) systems are in place
  • make evidence of any control testing performed in accordance with the product’s MA available to us, on request
  • ensure the finished product is labelled with:
    1. registered name, strength and pharmaceutical form
    2. batch number
    3. expiry date
    4. storage requirements
    5. any warnings required for safe handling of the product
  • ensure a representative sample of the finished product is retained and made available to us for testing upon request

Good Manufacturing Practice (GMP) Compliance

GMP is defined as the part of Quality Assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use.

The principles and guidelines for GMP are defined in Eudralex volume 4.

GMP requirements for active substances as starting materials

The active substance (also known as the Active Pharmaceutical Ingredient or API) must have been manufactured in accordance with Eudralex Volume 4, Part II. However, the following materials are exempted from the full application of Part II:

  • ectoparasiticidal active substances for veterinary use
  • substances that are used exclusively for topical application to the unbroken skin of animals and which are ectoparasiticidal, anti-bacterial or anti-fungal agents

You may only use APIs from suppliers registered on the MA to manufacture the veterinary medicine.

The suitability of an API supplier must be evaluated by the ManA holder prior to use. This is usually obtained by:

  • supplier audit, and
  • provision of a QP statement certificate of GMP

Transmissible Spongiform Encephalopathy (TSE)

You must comply with the European Commission document EMEA/410/01–Rev 2 Notes for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products.

Required Personnel

You must appoint the following personnel:

Qualified Person (QP)

The QP’s role and responsibility is defined in Eudralex Volume 4, Chapter 2 and Annex 16..

At least one QP must be named on the authorisation and must be permanently and continuous at the ManA holder’s disposal.

To place products on the GB market, QPs can be located anywhere. From January 2021, to place products on the Northern Ireland market, QPs must live in NI or the EEA.

QPs must meet specific educational and vocational requirements. They are usually expected to be members of the Royal Pharmaceutical Society, the Royal Society of Chemistry or the Royal Society of Biology. These professional bodies jointly undertake assessment of the candidate’s eligibility on our behalf. Exceptionally, we can appoint someone as a QP on a restricted named-site basis only.

QPs must comply with the QP Code of Practice. Guidance on the professional duties and responsibilities of the QP is in Eudralex Volume 4 Annex 16.

Production Manager

Your ManA application must nominate a suitably qualified Production Manager. Their responsibilities are defined in Eudralex Volume 4, Chapter 2.

Quality Control

Your ManA application must nominate a suitably qualified Head of Quality Control (QC). The Head of QC cannot be the same person as the Production Manager but they may also be the QP. Their responsibilities are defined in Eudralex Volume 4, Chapter 2.

Batch certification

We can issue a ManA solely to authorise the holder to certify and release batches of products for which they hold the MA where the medicine has been manufactured by a contract manufacturer.

The QP named on a ManA granted solely for the purpose of batch certification may either take responsibility for all manufacturing stages conducted by the contract manufacturer or may take account of the confirmation of the batch by the contract manufacturer’s QP. Ultimate responsibilty for batch certification of the batch lies with the certifying QP.

Record-keeping requirements

The record requirements are defined in the Veterinary Medicines Regulation. The records for each batch must include:

  • the name of the product
  • the quantity manufactured, assembled or supplied
  • the date of manufacture, assembly or supply
  • the batch number and expiry date
  • the name and address of the recipient, where supplied
  • all certification provided by the QP related to the batch

All records and certificates must be kept for at least 5 years from the date that the batch is placed on the market or one year after the expiry of the batch whichever is longer.

Exporting outside of the UK

Veterinary medicines manufactured in the UK should be produced to the same standards irrespective of where they will be used. If you are manufacturing medicines in the UK exclusively for export you need a ManA and must comply with GMP.

We will inspect your manufacturing site to ensure you comply with GMP.

Manufacture of products under the Exemption for Small Pet Animals (SAM)

Medicines manufactured under Schedule 6 of the Veterinary Medicines Regulations (the Exemption for Small Pet Animals) must comply with GMP and be manufactured by the holder of a manufacturing authorisation issued under:

  • Schedule 2 of the Veterinary Medicines Regulations 2013 as it has effect in Northern Ireland and Great Britain
  • a certificate issued by the competent authority (sites in EU, Australia, Canada, New Zealand and Switzerland)
  • a certificate issued by the Secretary of State (sites in all other countries)

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

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

See exemption for small pet animals guidance.

Manufacturers of extemporaneous preparations for use under the cascade (ManSA)

You need a ManSA to legally manufacture and supply unauthorised extemporaneous veterinary medicines (also known as ‘Specials’) which have been specifically prepared to the order of a veterinary surgeon for use in accordance with the cascade.

The same guidance broadly applies to ManSAs as for ManAs, although a marketing authorisation (MA) is not required.

An unauthorised medicine which is a pharmaceutical equivalent of an available authorised medicine should not be placed on the market. A medicine should be regarded as a pharmaceutical equivalent if:

  • it contains the same amount of the same active substance(s) or, for liquid dosage, forms the same concentration
  • it is in the same dosage form
  • it meets the same or comparable standards considered in the light of the clinical needs of the patient at the time of use of the medicine

An authorised veterinary medicine obtainable from normal distribution channels in a reasonable time should be considered available for use. If an otherwise suitable authorised product becomes unavailable, it may be necessary for an unauthorised pharmaceutical equivalent to be manufactured and supplied. This should a temporary measure and should not be taken as justification for long term prescription/supply.

Supply in these circumstances should cease as soon as is possible, following re-instatement of the authorised product.

You may only supply an extemporaneous product to a veterinary surgeon if all the following apply:

  • there is a genuine order from a veterinary surgeon registered in the UK
  • the product is formulated in accordance with the veterinary surgeon’s requirements
  • the product is for administration to an animal under the veterinary surgeon’s care on their direct personal responsibility

The order and distribution of extemporaneous products should be in response to a clinical need in specific animals. This should be a direct process between the prescribing vet and the manufacturer and they cannot be supplied via a third party such as a wholesale dealer.

All involved in the supply chain should be aware of the unauthorised status of the product. It should be clear from the product’s packaging that the product is unauthorised because there will be no MA number on it.

Manufacture and assembly by ManSA holders

Your ManSA manufacturing and assembly site and its operations will be inspected for compliance with the Veterinary Medicines Regulations (VMR) and the principles of GMP.

The VMR requires that manufacture or assembly is carried out under the supervision of appropriately qualified personnel, each of whom must be named on the ManSA. The personnel include:

  • a person responsible for Quality Control (QC)
  • a Production Manager
  • a person responsible for release (PRR), rather than a QP. The PRR may also be the QC or a nominated deputy

You must take adequate precautions to ensure that the product is of the quality required for its intended purpose and that it complies with any relevant pharmacopoeial monograph standards. Written records of manufacture, assembly and supply must be kept for 5 years and be made available to us on request.

You must comply with the European Commission’s Notes for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products.

Where possible GMP-assured API should be used.

You must ensure that any information you provide to us relating to the evaluation of the safety, quality or efficacy of any medicine which you import, handle, store or distribute is not false or misleading.

Advertising extemporaneous products

You may advertise the services you provide and the different types of dosage forms that are available, for example capsules, syrups.

You must not advertise or promote the specific substances that you can manufacture. However, you may provide lists of active substances and formulations with prices to a veterinary surgeon but only on request.

You may also provide placebo samples to a veterinary surgeon enquiring about your services. Further information can be found on the Advertise veterinary medicines legally guidance.

Requirements for testing extemporaneous products

You should conduct appropriate testing to ensure products meet in-house specifications. For a one-off unauthorised extemporaneous product, you must demonstrate consistency of manufacture. As a minimum there should be a standard procedure that can be validated even if the end product itself cannot be. However, there should be confirmation of homogeneity if this is appropriate to the preparation.

For a one-off unauthorised extemporaneous product, you should be able to provide justification for the specified shelf life. Such products should have a short shelf-life to reflect the fact there are no data to substantiate the validity of the stated expiry date.

However, if you are producing more regularly prescribed extemporaneous products that may be stored for a length of time waiting for orders, you should undertake real-time stability studies to justify the specified shelf-life. Depending on the nature of the products being manufactured data may be required to support the proposed shelf-life and on-going stability studies in accordance with GMP principles may also be required.

Labelling and record keeping requirements

You must ensure that extemporaneous products are labelled with the following, together with any additional information required by the terms of the ManSA:

  • the name of the veterinary surgeon who ordered the veterinary medicine
  • a precise description of the veterinary medicine
  • the date of production
  • the name of the authorisation holder and the address of the authorised site
  • the expiry date
  • any necessary warnings
  • instructions for use

You must also keep the following records for at least 5 years:

  • the name and address of the veterinary surgeon who ordered the medicine
  • a precise description of the veterinary medicine
  • the date of production
  • the expiry date
  • the date of supply to the veterinary surgeon

Wholesale supply

As the holder of a ManA, ManSA or SAM authorisation, you may store and distribute any veterinary medicine manufactured or assembled in line with your authorisation. If you buy or store any other veterinary medicine to supply to a wholesale dealer or retailer, you must hold a WDA.

If you wholesale supply a veterinary medicine that you have manufactured or assembled, you must:

  • comply with the principles of Good Distribution Practice (GDP)
  • only distribute the medicine to:
    1. a holder of a WDA relating to those products
    2. a holder of an authorisation granted by the competent authority of another country authorising the supply of those products by way of wholesale dealing
    3. a person who may legally retail supply the product or who may legally administer the product
  • ensure the appropriate and continued supply of the veterinary medicine
  • only sell, or offer for sale or supply, the veterinary medicine in accordance with an MA unless it is an exempt medicine or is distributed to another country where it can be legally used as an unlicensed veterinary medicine

Inspection of Manufacturers

Sites that are the subject of a manufacturing application are subject to a pre-approval inspection. Once a manufacturing authorisation has been granted, the site facilities and processes will be routinely inspected on an ongoing basis. The re-inspection frequency is risk- based and will depend on the level of compliance with GMP found at the last inspection.

Inspection Process

Pre-approval inspection

Before issuing a ManA, ManSA or SAM authorisation, we will have carried out a successful pre-approval inspection of your site, and any site(s) where quality control testing or other activity is contracted to a third party unless that site has already been inspected by us or the MHRA.

Scheduled inspection

We will periodically inspect your site(s) basis based on risk, although inspections will normally take place at least every 3 years.

We may inspect production facilities in countries outside of the UK that we do not have a Mutual Recognition Agreement (MRA) with.

Process: pre-approval and scheduled inspections

We will agree with you an inspection date and share the main areas that will be covered during the inspection. This will help you prepare.

After the inspection, we will send you an inspection deficiency report within 30 days. You should respond to any deficiencies cited within 30 days of receiving it.

Once we are satisfied with your response we will issue a final GMP inspection report and a GMP certificate within 90 days following the end of the inspection.

GMP certificates are only issued to ManA and SAM holders, contract QC test sites and manufacturing facilities located outside the UK that we do not have an MRA with.

Application forms, process and fees

Before completing an application for a ManA, please read the ‘Interpretation of the Union Format for Manufacturer/Importer Authorisation’ on pages 144-158 of the Compilation of Community Procedures on Inspections and Exchange of Information.

An application for a ManA, ManSA or SAM authorisation should be accompanied by a Site Master File.

To help us to efficiently process your completed application please email it to; inspections@vmd.gov.uk

Timelines

We will validate your application within 10 days of receipt provided all required information is provided. This validation time will be extended if we request further information from you.

After validation we will carry out the pre-approval inspection within 90 days.

Fees

The VMD charges a fee for:

  • processing an application for a manufacturing authorisation
  • the approval inspection of each site
  • on-going annual and inspection fees
  • processing a variation application for manufacturing authorisation
  • duplicate or multiple GMP Certificates

Fees are not refundable or transferable.

Application refusal and appeal

We may refuse to grant an authorisation or may grant an authorisation that is different than that applied for. In such cases we will notify you of the reason and how you can appeal our decision.

Powers to vary, suspend or revoke authorisations

Length of validity

An authorisation is valid indefinitely as long as the authorisation holder complies with the VMR and GMP which will be confirmed by scheduled inspections.

Variations (Changes)

You must submit a variation application to us if the details of your manufacturing authorisation change. There are 2 types of variation: administrative and scientific.

Administrative variations do not require assessment by an inspector. Examples include:

  • change of company name/trading name
  • change of owner
  • change of site address (administrative rather than site location e.g. postcode change)
  • removal of a QP, QC, Production Manager or PRR (providing that there is more than one)
  • removal of a named site
  • removal of a product type

Scientific variations require assessment by an inspector and may also require an inspection. Examples include:

  • addition of a new manufacturing activity
  • addition of categories of products handled at the site
  • addition of new site
  • change of site location
  • change or addition of QP, QC, Production Manager or PRR

Suspension and revocation

The VMD, acting on behalf of the Secretary of State, may suspend, vary or revoke a manufacturing authorisation if:

  • the holder has not complied with the VMR
  • the holder has manufactured a type of veterinary medicine which is not authorised by the manufacturing authorisation
  • the holder has produced a veterinary medicine outside the terms of its MA
  • the holder has premises or equipment which is no longer suitable
  • the registered QP is not fulfilling their duties or has left the company
  • the manufacturer fails to comply with GMP

If we consider that animal or public safety is at risk, we may suspend an authorisation with immediate effect for up to 3 months. We may also renew the suspension for further periods if required.

In all cases, the VMD will notify you of the reason for suspending or revoking your authorisation and how you can appeal the decision.

Manufacture of autogenous vaccines, equine stem cell products or non-food animal blood products

To apply for an Autogenous Vaccine Authorisation (AVA), Non-Food Animal Blood Bank Authorisation (NFABBA) or Equine Stem Cell Centre Authorisation (ESCCA) go to the Apply for product authorisations page.

Registers

Contact VMD

For application related issues contact the Inspections Administration Team by email; inspections@vmd.gov.uk or call; 01932 336911.

Published 1 June 2015
Last updated 4 January 2021 + show all updates
  1. Updated in accordance with end of Transition Period.

  2. Update to register of ManSA register

  3. Updated ManA application and variation forms

  4. Update to the Register of Sites that hold a Manufacturer’s “Specials” Authorisation

  5. Register of Sites that hold a Manufacturer’s “Specials” Authorisation Updated: 01 November 2019

  6. Updated register of Specials manufacturers

  7. Reviewed and updated to include Apply for guidance

  8. Updated Register of ManSA sites

  9. Updated Register of Specials manufacturing sites

  10. Updated Specials Register of Sites

  11. Register of Sites that hold a Manufacturer’s “Specials” Authorisation updated

  12. Updated Specials Register

  13. Updated registers

  14. First published.