Manufacture of authorised veterinary medicines and exempt products for small pet animals
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
You must apply for a manufacturing authorisation to manufacture:
- an authorised veterinary medicine
- a medicine marketed under Schedule 6 of the Veterinary Medicines Regulations (Exemptions for Small Pet Animals)
If you wish to apply for an authorisation to manufacture:
- an extemporaneous preparation for administration to an animal under the prescribing cascade (a ‘special’)
- a veterinary autogenous vaccine
- a blood product for administration to non-food animals
- an equine stem cell product
go to the guidance on: Specific Manufacturing Authorisations.
Manufacture of human and veterinary medicines
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). The MHRA publishes a register of sites authorised to manufacture both human and veterinary medicines.
Manufacture of an authorised veterinary medicine (ManA)
You must hold a manufacturing authorisation (ManA) to carry out any of the following manufacturing, assembly or importation activities in relation to 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 a veterinary medicine manufactured at another site in the UK including contract manufactured products
- importing a veterinary medicine from a non-EU or non-EEA country and subsequently releasing the medicine to the market (batch certification and release)
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
Requirements for ManA holders
You must comply (where appropriate to the manufacturing steps performed) with the following requirements relating to the manufacture, assembly and importation 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 good manufacturing practice (GMP) certificate issued by a UK 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
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ensure the finished product is labelled with:
- its registered name, strength and pharmaceutical form
- its batch number
- its expiry date
- its storage requirements
- any warnings required for safe handling of the product
- ensure each batch of product manufactured is batch (QC) tested to confirm that it meets its required specification before being certified/released to the market by the QP
- ensure a representative sample of the finished product is retained and made available to us for testing upon request
Good Manufacturing Practice (GMP)
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’s 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 is to ensure that each batch of veterinary medicine manufactured under their responsibly is manufactured and tested to check it complies with the Veterinary Medicines Regulations and meets the specification in its marketing authorisation. The QP’s full role and responsibilities are 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 continuously at the ManA holder’s disposal.
QPs must meet specific educational and vocational requirements and be a member of one of the following professional bodies: the Royal Society of Chemistry, the Royal Society of Biology, the Royal Pharmaceutical Society or registered with the Pharmaceutical Society of Northern Ireland. These professional bodies jointly undertake assessment of the candidate’s eligibility on our behalf.
QPs must comply with the QP Code of Practice.
Exceptionally Appointed QPs
We may exceptionally appoint someone as a QP who is not a member of one of the professional bodies but only for a specific site and a specific product; and provided that we are satisfied that the person has the educational qualifications and practical experience to carry out the QP’s duties.
Production Manager
Your ManA application must also nominate a suitably qualified Production Manager. Their role and responsibilities are defined in Eudralex Volume 4, Chapter 2.
Head of Quality Control
Your ManA application must also 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 role and responsibilities are defined in Eudralex Volume 4, Chapter 2.
Batch certification for release
You may apply for a ManA solely to certify and release batches of products manufactured by a third party manufacturer.
The QP named on a ManA granted solely for the purpose of batch certification for release may either take responsibility for all manufacturing stages conducted by the third party manufacturer or may take account of confirmation from the third party’s QP that the batch has been manufactured in compliance with the product’s MA and the requirements of GMP. However, ultimate responsibility for certification of the batch for release to market lies with the certifying QP.
Veterinary medicines manufactured outside the UK must be imported via a ManA holder’s site and also batch (QC) tested, QP certified and released. In the case of importation from a country with which the UK has a formal agreement which includes mutual recognition of batch (QC) testing, the importing ManA holder’s QP may accept the batch testing carried out in the other country.
Record-keeping requirements
The record requirements are defined in regulation 21 of the Veterinary Medicines Regulations. 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; and
- in the case of supply, the name and address of the recipient
- 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.
Export from 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 exclusively for export you must hold a ManA and comply with GMP.
Manufacture of medicines marketed under the Exemptions for Small Pet Animals (SAM)
Medicines manufactured under Schedule 6 of the Veterinary Medicines Regulations (Exemptions for Small Pet Animals) must comply with GMP and be manufactured by the holder of a ManA or a Small Animal Medicines manufacturing authorisation (SAM) issued under Schedule 2 of the Veterinary Medicines Regulations 2013 as it has effect in Northern Ireland and Great Britain or:
- for sites in EU, Australia, Canada, New Zealand and Switzerland, an authorisation issued by the relevant competent authority; or
- for sites in all other countries, approval from the Secretary of State
There are no restrictions on the importation of products which fully comply with this exemption.
We may issue a SAM to a person who employs the services of a person responsible for release (PR) rather than a QP, provided we are satisfied that that person has sufficient qualifications and experience to manufacture the product safely.
For further information, see guidance for Exemptions for small pet animals.
Wholesale supply
As the holder of a ManA or SAM 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 wholesale dealer authorisation (WDA), see Veterinary medicine wholesale dealer’s authorisation
If you wholesale supply a veterinary medicine that you have manufactured or assembled, you must:
- comply with the principles of Good Distribution Practice (GDP)
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only distribute the medicine to:
- the holder of a WDA relating to those products
- the holder of an authorisation granted by the competent authority of another country authorising the supply of those products by way of wholesale dealing
- 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
Applications
- Application form for
- Application form for
- Application form for
- Application form for
Before completing an application for a ManA or SAM, 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 - ECA Academy (gmp-compliance.org).
Submit your application for a ManA or SAM, together with a Site Master File (SMF) by email to; inspections@vmd.gov.uk.
Alternatively, you may also send it via our Veterinary Medicines Digital Service.
Timelines
We will validate your application within 10 days of receiving it, provided you’ve submitted all required information. The validation time will be extended if we request further information from you.
After validation we will conduct the pre-authorisation inspection of your site within 90 days.
Application refusal and appeal
We may refuse to grant an authorisation or may grant an authorisation that is different to that you applied for. In such cases we will notify you of the reason and how you can appeal our decision.
Fees
There are fees for:
- processing an application for a new manufacturing authorisation (ManA and SAM)
- a pre-authorisation inspection of each site and subsequent risk-based inspections
- an annual fee
- processing a variation application for an existing manufacturing authorisation (ManA and SAM)
- issuing duplicate or multiple GMP Certificates
Fees applied to animal medicine authorisation applications are not refundable or transferable.
Validity of authorisations
Your authorisation will be valid continuously subject to satisfactory re-inspection of your manufacturing site.
The frequency of inspections is risk-based and derived from the compliance findings of the previous inspection.
Variation, Suspension and Revocation of an Authorisation
Voluntary variation (Change)
You must submit a variation application to us if the details of your ManA or SAM 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 for example, postcode change)
- removal of a QP, QC, Production Manager or PR (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 PR
Compulsory variation, Suspension and Revocation
We may vary, suspend or revoke your ManA or SAM if:
- you have not complied with the VMR
- you have manufactured a type of veterinary medicine which is not authorised by your manufacturing authorisation
- you have produced a veterinary medicine outside the terms of its MA
- your premises or equipment is no longer suitable
- your registered QP or PR is not fulfilling their duties or has left the company
- you have failed to comply with GMP
If we consider that animal or public safety is at risk, we may suspend your authorisation with immediate effect for up to 3 months. We may also extend the suspension for further periods if necessary.
In all cases, we will notify you of the reason for suspending, varying or revoking your authorisation and how you can appeal the decision.
Inspection of Manufacturers
Pre-authorisation inspection
Before issuing a ManA or SAM, we will normally carry out a pre-authorisation 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) based on risk and compliance, 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-authorisation 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.
Register
The register of ManA holders and SAM holders is available at:
Inspectors Declarations of Interest
We require our inspectors involved with GMP inspections to sign a Declaration of Interests (DoI) every year, to ensure that they do not have any financial or other interests that could affect their impartiality. Their DoIs are published below in the interest of transparency and to support the sharing of information with our regulatory partners.
Contact Us
You can email us at; inspections@vmd.gov.uk.
Last updated 13 December 2022 + show all updates
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Guidance on manufacturing extemporaneous preparations for administration to animals under the prescribing cascade has been moved to the guidance page ‘Specific Manufacturing Authorisations’ and the format of the retained guidance changed. The VMD Inspectors’ Declarations of Interests has been updated.
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The new ManSA register has been uploaded.
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VMD Inspectors declaration of Interests added
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Updated in accordance with end of Transition Period.
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Update to register of ManSA register
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Updated ManA application and variation forms
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Update to the Register of Sites that hold a Manufacturer’s “Specials” Authorisation
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Register of Sites that hold a Manufacturer’s “Specials” Authorisation Updated: 01 November 2019
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Updated register of Specials manufacturers
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Reviewed and updated to include Apply for guidance
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Updated Register of ManSA sites
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Updated Register of Specials manufacturing sites
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Updated Specials Register of Sites
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Register of Sites that hold a Manufacturer’s “Specials” Authorisation updated
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Updated Specials Register
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Updated registers
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First published.