Legal Distribution
Categories
Legal Category
Authorised veterinary medicines fall within the first
four categories, which were established by the Veterinary Medicines
Regulations. These Regulations allow a transitional period until 1 November
2008 for manufacturers to update their packaging (inner, outer and leaflet,
for each pack size) and obtain approval from the VMD - as a result, users
will continue to see the old abbreviations on the labels of some products
for some time, but the new legal category applies nonetheless.
AVM-GSL Authorised veterinary medicine – general
sales list. This may be sold by anyone. (Formerly GSL)
NFA-VPS Non-food animal medicine – veterinarian,
pharmacist, Suitably Qualified Person. A medicine for companion animals
which must be supplied by a veterinarian, pharmacist or Suitably Qualified
Person. (Formerly PML companion animal products and a few P products.)
POM-VPS Prescription-only medicine – veterinarian,
pharmacist, Suitably Qualified Person. A medicine for food-producing animals
(including horses), to be supplied only on veterinary prescription, which
must be prescribed by a veterinarian, pharmacist or SQP (either orally or in
writing) and which must be supplied by one of those groups of people in
accordance with the prescription. (Formerly PML livestock products, MFSX
products and a few P products.)
POM-V Prescription only medicine – veterinarian. A
medicine, to be supplied only on veterinary prescription, which must be
prescribed (either orally or in writing) by a veterinarian to animals under
his care following a clinical assessment, and which may be supplied by a
veterinarian or pharmacist in accordance with the prescription. (Formerly
POM products and a few P products.)
CD A substance controlled by the Misuse of Drugs
Act 1971 and Regulations. The CD is followed by (Sch 1), (Sch 2), (Sch 3), (Sch
4) or (Sch 5) depending on the Schedule to The Misuse of Drugs Regulations
2001 (as amended) in which the preparation is included. Prescribers are
reminded that there are additional requirements relating to the prescribing
of Controlled Drugs. For more information see the BVA Code of Practice on
Medicines or the Home Office website at
www.drugs.gov.uk.
ZFA This non-official term is sometimes used to
indicate a zootechnical feed additive. These are authorised under EC
Regulation 1831/2003: the manufacturing, distributing, incorporating,
labelling, supply and use come within the scope of the Veterinary Medicines
Regulations.
SAES This non-official term is sometimes used to
indicate medicines marketed in accordance with the Small Animal Exemption
Scheme. These are medicines for use in certain pet species (aquarium fish,
cage birds, ferrets, homing pigeons, rabbits, small rodents, and terrarium
animals) the active ingredient of which has been declared by the Secretary
of State as not requiring veterinary control. These medicines are exempt
from the requirement for a marketing authorisation and are not therefore
required to prove safety, quality or efficacy, but must be manufactured to
the same standards as authorised medicines and are subject to
pharmacovigilance reporting.
Veterinary prescription
A "veterinary prescription" is defined by EU law as "any
prescription for a veterinary medicinal product issued by a professional
person qualified to do so in accordance with applicable national law". The
word "veterinary" takes its normal meaning "of or for animals". In the UK
there are two classes of medicines available only on veterinary
prescription, POM-V and POM-VPS, described above. Only in the case of POM-V
medicines does that veterinary prescription have to be issued by a
veterinary surgeon.
The act of prescribing is taken to be the decision made
by the prescriber as to which product should be supplied taking account of:
-
the circumstances of the animals being treated;
-
the available authorised veterinary medicinal
products;
-
the need for responsible use of medicines and the
requirement to prescribe the minimum amount of product necessary for the
treatment (subject to the minimum pack size manufactured and any
authority to break bulk in the Regulations);
-
the abilities and competence of the person who will
administer the product; and
-
any available animal health plan.
Briefing Documents
Further information
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