GovWire

You need a specific manufacturing authorisation:

• to manufacture extemporaneous preparations for administration to named animals under the prescribing cascade, also known as specials

• to manufacture an autogenous vaccine

• to authorise a non-food animal stem cell centre for the collection, storage and supply of autologous stem cell treatments

• to authorise a non-food animal blood bank for the collection, storage and supply of blood products for the treatment of non-food animals

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)

go to:Authorisations to manufacture veterinary medicines.

General Requirements

If you are the holder of a specific manufacturing authorisation you must comply with the principles ofgood manufacturing practice (GMP), which are included inEudralex volume 4.

Your manufacturing activities must be carried out under the supervision of an appropriately qualified and experienced person, known as the person responsible for release (PRR).

Labelling

You must ensure that every container of product that you supply is labelled with:

(a) a precise description of the product

(b) the date on which the product was produced

(c) the name and address of the authorisation holder

(d) the address of the site named under the authorisation and its authorisation number

(e) the instructions for use

(f) the expiry date

(g) any necessary warnings

In the case of:

• an autogenous vaccine or an extemporaneous preparation for administration under the cascade, the product label must also include the name of the veterinary surgeon who ordered the product

• blood or a stem cell product, the product label must also include the identification of the donor animal and the date of collection

• blood or blood products there must be no specific therapeutic indication on the product label or any information related to the product

• an unauthorised veterinary medicine for administration under the cascade, the words This veterinary medicinal product does not hold a marketing authorisation must be included on the label.

Records

You must keep detailed records of each batch of veterinary medicine you manufacture, as required by GMP.

When you supply a product that youve manufactured, you must, as soon as is reasonably practicable, record the expiry date of the product and the following:

(a) in the case of an unauthorised veterinary medicine for administration under the cascade:

• (i) the name and address of the veterinary surgeon who ordered the product

• (ii) a precise description of the product

• (iii) the date of production

• (iv) the date of supply to the veterinary surgeon

(b) in the case of stem cells or blood product:

• (i) the identification of the source animal

• (ii) the name of the veterinary surgeon who collected the product, or under whose responsibility it was collected

• (iii) the date of collection of the product

• (iv) the date that the product was used or if the product was supplied to another veterinary surgeon, the name and address of that veterinary surgeon and the date the product was supplied

(c) in the case of an autogenous vaccine:

• (i) the name and address of the veterinary surgeon who ordered the vaccine

• (ii) the identification of the source animal

• (iii) the date of supply to the veterinary surgeon

You must keep those records for at least five years.

Adverse events

You must notify us of any adverse event in relation to a product that youve produced within 30 days of learning of the event.

Extemporaneous preparations (ManSA)

You need aManSAto manufacture and supply an unauthorised extemporaneous preparation for use as a veterinary medicine.

We will only grant a ManSA if we are satisfied that you will comply with the general requirements for holding a specific manufacturing authorisation and that:

• the product has been specifically ordered by a veterinary surgeon who is registered with the Royal College of Veterinary Surgeons (RCVS), for use in accordance with thecascade.

• 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 you, the manufacturer, and you cannot supply the product 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. We consider a medicine to be 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

We consider an authorised veterinary medicine to be available if it can be obtained 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. You should not take supply in these circumstances as justification for long term prescription and you should cease supply 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 the holder of a ManA, although extemporaneous preparations will not possess an MA.

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 extemporaneous preparations that you have manufactured and supplied for five years and make those records available to us on request.

You must comply with theguidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products.

Where possibleyou should use GMP-assured active substances, also referred to as active pharmaceutical ingredients or 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.

If you only manufacture an unauthorised extemporaneous preparation on an ad hoc basis, you:

• must demonstrate consistency of manufacture. As a minimum there should be a standard processthat 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 o

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