Pharmaceutical Legislation - Overview of the industry and its stakeholders

A product may be a veterinary medicine if it is..

• Medicinal by presentation

• Medicinal by function

If the product is veterinary medicine by presentation this means ..

Either the manufacturer claims medicinal products, or it is administered in the way a medicines would be e.g. an injection

If the product is veterinary medicine by function this means ..

Allows a chemical to be defined as a medicine if knowledge exists that it causes changes in the body regardless of what the manufacturer says about it

What is the role of legislation? 

Plays a pivotal part in ensuring public confidence and trust in medicines. Having access to medicines to protect animal welfare is also considered and specific schemes exists to ensure barrier do not exist. Controllers the access to medication with more stringent control on medicines with higher risk.

Why are all veterinary medicines subject to a variety of regulations?

To ensure they are safe to use and do what they are intended to do

During the licensing phase for all new medicines what is careful attention paid towards? 

Any side affects that might impact animal welfare - this is monitored even after approval

What are the regulations around the promotion of medicines?

Ensure that all claims are honest and backed up by the same degree of supportive evidence

What is the main role of legislation in veterinary medicine? (bullet points) 

• Safety - animals, humans and the environment 

• Welfare 

• Efficacy - that they do what they say they do 

• Honestly - cannot make claims without having data to back it up 

• Control access 

What does a Marketing authorisation (MA) - Vm no indicate? 

Indicates to users that their safety, quality and efficacy have been fully tested for use in the UK in the species in which use is recommended (+ongoing assessment) 

If a products needs a Marking Authorisation (MA) what should happen? 

Should apply to the Veterinary Medicines Directorate (VMD) 

All medicines require a license know as a Marketing authorisation. Every licensed medicines in the UK is held within a database complied by the VMD. To gain a marketing authorisation what happens? 

A large body of evidence is required covering the safety of the product in the target species, the manufacturing process/material and how quality is assured. For every claim the product makes the manufacture must supply supporting evidence. This has become increasing stringent which is why some older products have more all-encompassing claims. 

Once licensed what are compares required to do? 

To continue to monitor their products and report and safety issues. Licenses can and have been withdrawn!