GovWire

A specific manufacturing authorisation is required to manufacture any of the following:

• extemporaneous preparation for administration to an animal under the prescribing cascade (special)
• autogenous vaccine
• equine stem cell product
• non-food animal blood product

If you wish to apply for an authorisation to manufacture:

• an authorised veterinary medicine
• a veterinary medicine marketed under Schedule 6 of the Veterinary Medicines Regulations (Exemptions for Small Pet Animals) autogenous vaccine

go to: Authorisations to manufacture veterinary medicines.

Extemporaneous preparation (ManSA)

You need aManSAto manufacture and supply unauthorised extemporaneous preparations for use as veterinary medicines. These must be specifically ordered by a veterinary surgeon for use in accordance with thecascade.

You may only manufacture and supply an extemporaneous preparation to a veterinary surgeon if all of the following apply:

• there is a genuine order from that veterinary surgeon who must be registered in the UK with the Royal College of Veterinary Surgeons (RCVS)
• the product is formulated in accordance with the veterinary surgeons requirements
• the product is for administration to an animal under the veterinary surgeons care and their direct personal responsibility

The order and distribution of an extemporaneous preparation should be in response to a clinical need in a specific animal. This should be a direct process between the prescribing veterinary surgeon and the manufacturer and the product cannot be supplied via a third party, such as a wholesale dealer.

Everyone involved in the supply chain should be aware of the unauthorised status of the product. It should be clear from the products packaging that the product is unauthorised as it wont display a marketing authorisation (MA) number or have a trade name. Any product name may only be a precise description of that product such as the name of the active substance, strength and pharmaceutical form.

A ManSA does not normally permit you to manufacture an unauthorised extemporaneous preparation that is the pharmaceutical equivalent of an available authorised medicine. 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 is considered available if it is obtainable from normal distribution channels in a reasonable time. However, if an otherwise suitable authorised veterinary medicine becomes unavailable, you may manufacture and supply an unauthorised pharmaceutical equivalent of that product if it is ordered by a veterinary surgeon but this should only be a temporary measure. Supply in these circumstances should not be taken as justification for long term prescription or supply and should cease as soon as is possible following the authorised product becoming available again.

Requirements forManSAholders

The same requirements broadly apply to the manufacture of extemporaneous preparations by ManSA holders as they do for authorised veterinary medicines by ManA holders, although extemporaneous preparations will not possess an MA.

YourManSAmanufacturing site and its operations will be inspected for compliance with the Veterinary Medicines Regulations (VMR) and the principles ofgood manufacturing practice (GMP).

The VMR requires that manufacture, which includes assembly, is carried out under the supervision of appropriately qualified and experienced personnel, each of whom must be named on yourManSA. Those personnel are:

• the person responsible for Quality Control (QC)
• the Production Manager (PM)
• the person responsible for release (PR). The PR may also be the QC or a nominated deputy

You must take adequate precautions to ensure that the extemporaneous preparation is of the quality required for its intended purpose and that it complies with any relevant pharmacopoeial monograph standards.

You must keep written records of manufacture, assembly and supply for 5 years and make those records available to us on request.

You must comply with the Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products - European Medicines Agency (europa.eu).

Where possibleyou should use GMP-assured active pharmaceutical ingredients (APIs) to manufacture extemporaneous preparations.

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.

Requirements for testing extemporaneous preparations

You should conduct appropriate testing to ensure your product meets its in-house specification. For a one-off unauthorised extemporaneous preparation, 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
• 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

If you are producing more regularly prescribed extemporaneous preparations that may be stored for a length of time in anticipation of an order from a veterinary surgeon, 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 withGMPprinciples may also be required.

Labelling and record keeping requirements

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

• the name of the veterinary surgeon who ordered the product
• a precise description of the preparation
• the date of production
• the name of the ManSA 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 product
• a precise description of the preparation
• the date of production
• the expiry date
• the date of supply to the veterinary surgeon

Advertising extemporaneous preparations

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
• advertise the services you provide and the different types of dosage forms that are available, for example capsules, syrups
• provide placebo samples to a veterinary surgeon enquiring about your services

Further information on advertising can be found on the Advertise veterinary medicines legally guidance.

Autogenous Vaccine Authorisation (AVA)

You must hold a valid autogenous vaccine authorisation (AVA) to manufacture autogenous vaccines from pathogens or antigens obtained from an animal/s to be used for the treatment of that animal and/or other animals within the same epidemiological unit or in the same rearing chain. Your AVA will include specific details of your manufacturing site and the method of production.

We will only grant an AVA if we are satisfied that:

• the product has been inactivated. It is expected that most authorisations will relate to the manufacture of bacterial vaccines. Additional safeguards will be required in respect of most viral vaccines
• that the production process will produce a consistent, safe product
• the manufacturing site is under the supervision of a veterinary surgeon or a person who has sufficient qualifications and experience to manufacture the product safely
• a veterinary surgeon has confirmed a need and fully justified the use of the autogenous vaccine in preference to a UK authorised product

There are two different types of authorisation, an AVA-I (Individual) and an AVA-S (Standard). An AVA-I covers the production of a single batch

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