answer text |
<p>All recommendations were implemented.</p><p> </p><p><strong>1 & 9</strong></p><p>The
Veterinary Medicines Regulations (VMR) provide four distribution categories, based
on the perceived risk of a veterinary medicine and striking the right balance between
appropriate controls and availability.</p><p>'Prescription Only Medicines - Veterinarian'
(POM-V) require prescribing by a vet for animals under their care, following clinical
assessment. POM-V covers those products containing narcotic or psychotropic substances
or requiring veterinary diagnosis/clinical assessment. Clients may request a prescription
which can be dispensed elsewhere.</p><p>'POM - Veterinarian, Pharmacist, Suitably
Qualified Person' (POM-VPS) and 'Non-Food Animal-VPS' products can be prescribed and/or
supplied by vets, pharmacists or SQPs; without clinical assessment but with point-of-sale
advice.</p><p>'Authorised Veterinary Medicine - General Sales List' category covers
products with safety profiles allowing distribution across a range of retailers.</p><p><strong>7</strong></p><p>The
distribution category is assessed during the veterinary medicine application procedure.
Factors considered in deciding the category include the need for clinical diagnosis,
point-of-sale advice, administration route, nature of the product/active substance
and safety profile. Cost is not considered as the scope is limited to the safety of
the product for both the animal and people handling the product.</p><p><strong>8 &
3</strong></p><p>The EU centralised procedure is compulsory for products containing
a new active substance, constituting significant therapeutic/scientific/technical
innovation, or where a marketing authorisation (MA) is in the interest of animal health
at EU level. These products are classified 'Prescription-Only' as their novelty represents
an increased risk. The UK had the flexibility to assign one of its distribution categories,
based on increased knowledge of the product's safety profile. Under the Northern Ireland
Protocol the EU centralised system will still apply in Northern Ireland.</p><p><strong>5</strong></p><p>The
Veterinary Products Committee (VPC) reviewed products over seven categories, recommending
the appropriate distribution category. In some cases, this required removal of indications
to support the products being more freely available via a lower distribution classification.</p><p><strong>6</strong></p><p>MA
holders can apply to change the category. This will be considered by the VPC unless
they previously advised on category changes for comparable products.</p><p><strong>4</strong></p><p>The
VMD may grant, without requiring a full dossier, an MA for an EU-authorised medicine
for import into the UK under Parallel Import provisions, provided the applicant demonstrates
it is identical to a UK-authorised medicine for food-producing species, or therapeutically
identical to a UK-authorised medicine for companion animals. The VMD requests a detailed
description of the product's intended re-labelling.</p><p><strong>10</strong></p><p>An
MA is initially valid for five years, after which it may be renewed upon re-evaluation
of the risk-benefit balance. Once renewed, the MA is valid indefinitely unless pharmacovigilance
raises concerns.</p><p><strong>11</strong></p><p>The VMD publishes standards and transparent
targets around the assessment processes - something recognised and welcomed by industry.
The VMD encourages companies to consult on their proposed MA application, particularly
for exceptional MAs, prior to submission or during the process itself. After EU Exit
the VMD introduced additional MA options - national-only or in parallel with an EU
application to better utilise company resources.</p><p><strong>2</strong></p><p>The
RCVS Code of Professional Conduct contains a chapter on fair trading requirements.
This includes provision of information on medicine prices.</p>
|
|