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Veterinary Medicines Regulations

 

An Introduction to the Veterinary Medicines Regulations

 

The Veterinary Medicines Regulations set out rules by which veterinary medicines are regulated. Anyone involved in the development, production, marketing or distribution of veterinary medicines should be fully aware of the Regulations as it is a legal requirement for them to be followed.

 

This is a summary of some of the main requirements of the Regulations, although it is not intended to be exhaustive.

 

What is a veterinary medicinal product?

 

Most people associate veterinary medicinal products with liquid medicines taken orally, injected medicines or tablets in solid form, but it can also include skin applied preparations or specially impregnated dressings or poultices such as Animalintex.

 

Veterinary medicinal products are defined by the Veterinary Medicines Regulations as:

 

  • “Any substances or combination of substances presented as having properties for treating or preventing disease in animals”

This includes information on the product packaging and advertising. If it claims to be able to treat or prevent disease then it is a veterinary medicinal product.

  • “Any substances or combination  of substances which may be administered to animals with a view to either restoring, correcting or modifying physiological function by exerting a pharmacological, immunological or metabolic action”

This defines if a product is medicinal by function. For example, if it has an active ingredient – then it is defined as a veterinary medicinal product.


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Do veterinary medicinal products need a licence?

 

Yes! It is illegal to manufacture, wholesale or possess with a view for resale, a veterinary medicinal product without a licence. Licences are issued by the Veterinary Medicines Directorate and are called Marketing Authorisations. The Marketing Authorisation number must be printed on the product packaging.

 

Why do veterinary Medicinal products need a licence?

 

Imagine using a product on an animal which purports to have healing properties – but in fact doesn’t! Imagine using a product which has a serious detrimental impact on an animal! History has shown that the best way to be sure that a medicinal products work and are safe is to regulate their sale by requiring a licence.

 

How is a licence obtained?

 

By applying to the Secretary of State. The application must include all scientific documentation which is necessary to demonstrate the safety, quality and efficacy of the product in question. This is a very involved process which also requires the manufacturing process to be detailed as well as a pharmacovigilance system to be employed; a system to identify and report on serious adverse animal or human reaction to the product.

 

Does the manufacturing plant need a licence?

 

Yes! This is to ensure that the product is manufactured in a way which is consistent with the Marketing Authorisation. The licence is called a Manufacturing Authorisation and is a legal requirement.

The holder of a Manufacturing Authorisation must, amongst other things;

 

  • Have a current certificate of Good Manufacturing Practice assessed regularly by an external inspector.
  • Have a functioning system of Quality Assurance and Quality Control.
  • Employ a Qualified Person to ensure that each batch of product is manufactured and checked in accordance with the Regulations. 

 

This system ensures the safe and repeatable manufacture of a medicinal product.

 

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Are licences required to wholesale Veterinary Medicinal Products?


Yes! It is called a Wholesale Dealers Authorisation and bears the name of a Qualified Person nominated to act under the Guidelines of Good Distribution Practice, as well as details of the classes of product covered by the licence.


The underlying concept here is to ensure that products are stored and distributed in a professional manner and to facilitate recall of problematic product.

 

 


Who is allowed to supply Veterinary Medicinal Products on a retail basis?

 

It depends on the class of the product. If the product is classified AVM-GSL, such as Animalintex, there are no restrictions, but the other product classes require the involvement of a Veterinary Surgeon, Pharmacist or suitably Qualified Person to varying degrees.

 

What happens if I break the law?

 

The law as prescribed in the Veterinary Medicines Regulations is there for a very good reason – it protects not just the animals but also their owners, professionals who administer care and dealers in medicinal products.


The Veterinary Medicines Directorate is responsible for investigating potential illegal behaviour. They have far reaching powers including the right to search premises, take away evidence, seize product and initiate prosecutions. Action may be taken against individuals – not just the company they work for. Note that in addition to a monetary fine, the law allows for jail sentences of up to two years!

 

Conclusion

 

The control of Veterinary Medicinal Products is not merely an exercise in red tape. It is there for very good reason – the protection of animals, businesses and individuals. Is the product medicinal by description (in adverts or on the packet) or by function? If so it is captured by the Regulations and needs a Marketing Authorisation.


Robinson Healthcare Animalintex is the UK's only Licensed Medicinal Poultice Dressing and is tried and trusted by customers over many years.

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