THE Veterinary Medicines Directorate (VMD) recently held a “stakeholder” meeting to outline changes in the 2009 regulations.
“The poor chap in the white van is being asked to carry animal medicines and run the risk of prosecution if the paperwork is not right,” said John FitzGerald, the VMD’s director of operations. “Now we are going to focus on the owner of the medicines and not the man in the van.”
He was unable to say at what point “ownership” of medicines changes hands. Is it when they leave the supplier’s premises and are on the van? Or is it not until the recipient actually takes delivery? He promised to clarify this important point in due course.
On the subject of medicines for minor species, the VMD is keen to encourage companies to bring products to market and is anxious to demonstrate that it has procedures in place that should make this task more straightforward.
Following some recent examples of evidence of prescription tampering the VMD is bringing in regulations that will make this an offence.
Fees
On the thorny subject of fees, and more especially inspection fees, the VMD says it is required to follow government guidelines which mean any increases are inflation only.
In addition, the government requires inspection to be risk-based and not equally based. This means that premises will be inspected based on historical difficulties with that location and/or proprietor. Some premises, therefore, will have very regular inspections possibly only a few months apart whilst others could be inspected with a year or two apart.
Other changes to fees involve the removal of fees for applications on-line for Special Import Certificates, repeat Special Treatment Certificates and Research Import Certificates.
“This will allow a vet to order from a wholesale dealer without the need to hunt around Europe,” said Mr FitzGerald.
Controlled Drugs
The VMD has now recognised the difficulty that veterinary surgeons are placed in when it come to disposal of Controlled Drugs. It proposes to extend the range of people who can witness the disposal of these drugs as police do not have the time.
The intention is to create a Control Drugs Liaison Officer who will specialise in these drugs. There will be contact details on the VMD website and vets will be able to seek approval from designated responsible persons, other than police officers, for their disposal. For example, this could be the local Animal Medicine Inspector who may be visiting the vicinity, or another vet who is independent of the practice.
Proposal withdrawn
Following discussions with the Royal College, the VMD has withdrawn proposals under Schedule 3 which involve the supply by a veterinary surgeon from registered premises. This was aimed to address concern regarding storage and supply of controlled drugs by vets who wish to treat their own animals only and therefore do not have to register their premises.
This proposal was found to be unworkable and the VMD is to continue discussions with the RCVS in this area.
The whole subject of the sale of animal medicines via the internet clearly continues to exercise the mind of the regulators. The VMD is looking at the possibility of creating an on-line authorisation system for websites and the inclusion of a VMD logo of approval when the website meets certain key regulatory conditions. The VMD is currently in discussions with its lawyers and with the Royal Pharmaceutical Society (RPSGB).
In summary, the VMD was keen to emphasise it does not wish to make more legislation. It stressed that it wants to make existing legislation easier to understand and to offer full guidance notes and assistance at all times.
