Veterinary Medicines Directorate
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 theMedicines 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 amanufacturing 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 aManAto:
- 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 forManAholders
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 withGMP
- 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)
GMPis 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 forGMPare defined inEudralex volume 4.
GMPrequirements for active substances as starting materials
The active substance (also known as the active pharmaceutical ingredient or API) must have been manufactured in accordance withEudralex 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 theMAto manufacture the veterinary medicine.
The suitability of an API supplier must be evaluated by theManAholder prior to use. This is usually obtained by:
- supplier audit, and
- provision of aQPstatement certificate ofGMP
Transmissible Spongiform Encephalopathy (TSE)
You must comply with the European Commissions 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)
TheQPs 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 QPs full role and responsibilities are defined inEudralex Volume 4, Chapter 2 and Annex 16.
At least oneQPmust be named on the authorisation and must be permanently and continuously at theManAholders 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 candidates eligibility on our behalf.
QPs must comply with theQPCode of Practice.
Exceptionally Appointed QPs
We may exceptionally appoint someone as aQPwho 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 QPs duties.
Production Manager
YourManAapplication must also nominate a suitably qualified Production Manager. Their role and responsibilities are defined in Eudralex Volume 4, Chapter 2.
Head of Quality Control
YourManAapplication 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 theQP. Their role and responsibilities are defined in Eudralex Volume 4, Chapter 2.
Batch certification for release
You may apply for aManAsolely to certify and release batches of products manufactured by a third party manufacturer.
TheQPnamed on aManAgranted 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 partys QP that the batch has been manufactured in compliance with the products MA and the requirements of GMP. However, ultimate responsibility for certification of the batch for release to market lies with the certifyingQP.
Veterinary medicines manufactured outside the UK must be imported via a ManA holders 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 holders QP may accept the batch testing carried out in the other country.