12. miscellaneous legislation student

7/30/2019 12. Miscellaneous Legislation Student

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Miscellaneous Legislation affecting

Pharmacy

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Legislation relevant to retailers

Sale of Good Act 1979

Trade Descriptions Act 1968

Weights and Measures Act 1985

Environmental Protection Act 1990

waste disposal

Consumer Protection Act 1987

product liability

price control


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Sale of Goods/Faulty Goods

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relevant or related Legislation: Sale of Goods Act 1979; Supply of Goods and Services Act 1982;

Sale and Supply of Goods Act 1994; The Sale and Supply of Goods toConsumers Regulations 2002

wherever goods are bought they must conform tocontract this means they must be as described, fit for purpose and ofsatisfactory quality (i.e. not inherently faulty at the time of sale)

goods are of satisfactory quality if they reach thestandard that a reasonable person would regard assatisfactory, taking into account the price and anydescription.

aspects of quality include fitness for purpose, freedomfrom minor defects, appearance and finish, durabilityand safety.

it is the seller, not the manufacturer, who isresponsible if goods do not conform to contract


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if goods do not conform to contract at the time of sale, purchasers canrequest their money back "within a reasonable time

this is not defined and will depend on circumstances

for up to six years after purchase (five years from discovery in

Scotland) purchasers can demand damages (which a court would

equate to the cost of a repair or replacement).

a purchaser who is a consumer, i.e. is not buying in the course of a

business, can alternatively request a repair or replacement.

if repair and replacement are not possible or too costly, then the

consumer can seek a partial refund, if they have had some benefitfrom the good, or a full refund if the fault/s have meant they have

enjoyed no benefit


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in general, the onus is on all purchasers to prove thegoods did not conform to contract (e.g. was inherentlyfaulty) and should have reasonably lasted until this pointin time (i.e. perishable goods do not last for six years).

if a consumer chooses to request a repair or replacement,then for the first six months after purchase it will be forthe retailer to prove the goods did conform to contract(e.g. were not inherently faulty)

after six months and until the end of the six years, it is forthe consumer to prove the lack of conformity


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Sale of Goods and Services

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the Supply of Goods and Services Act 1982 requirestraders to provide services to a proper standard ofworkmanship

furthermore, if a definite completion date or a price

has not been fixed then the work must be completedwithin a reasonable time and for a reasonable charge

also, any material used or goods supplied in providingthe service must be of satisfactory quality

the law treats failure to meet these obligations asbreach of contract and consumers would be entitledto seek redress, if necessary through the civil courts


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Weights and Measures

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Metric units of measurement are now used for mosttransactions regulated by the Weights and Measures Act1985

Consumer & Competition Policy Directorate at theDepartment for Business, Enterprise and Regulatory

Reform (BERR) is responsible for the policy on thoseprovisions of the Weights and Measures Act

The National Weights and Measures Laboratory (NWML) isresponsible for the provisions of the Weights andMeasures Act relating to measuring equipment and

definitions of units of measurement Trading Standards Departments of Local Authorities are

responsible for enforcing weights and measures law


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Weights and Measures

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A reliable, well regulated system for weights and measures controls isone of the fundamental tenets of an effective regime of consumer

protection

The system must be one in which consumers can have confidence, so

that when they make a purchase they do so in the knowledge that

they are not being sold short weight or measure. Businesses, too, must

be protected from unscrupulous competitors who would seek to gain

an unfair competitive advantage by flouting the law.

In the UK, transactions in goods by weight or measure are, in most

cases, regulated by the Weights and Measures Act 1985 and its

secondary legislation the Weights and Packaged Goods Regulations

2006


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Trade Descriptions Act

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The Trade Descriptions Act 1968 makes it an offencefor a trader to apply, by any means, false or misleadingstatements, or to knowingly or recklessly make suchstatements about goods and services

The Act carries criminal penalties and is enforced bylocal authorities' Trading Standards Officers

Labelling of, and the provision of information on, foodand drink is the responsibility of the Foods StandardsAgency


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Sunday and Christmas Day Shopping

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The Sunday Trading Act 1994 and the Christmas Day(Trading) Act 2004 regulate opening hours of large

shops* on Sundays and Christmas Day

The Sunday Trading Act also prohibits large shops

from opening on Easter Sunday

*Some categories of large shop are exempt from the

Sunday Trading Act 1994 including pharmacies


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Waste Disposal

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legislation (derived largely for European Directives) subjects thestorage, carriage, processing and disposal of waste to stringent

controls

the Environment Agency is responsible for regulating certain

types of waste - referred to as Controlled Waste

controlled waste can include household, industrialor

commercial waste and also covers clinical waste

this is waste which results from treating humans or animals

and which might cause infection or other harm. Some waste

is potentially particularly hazardous or harmful

there are more stringent controls on this type of waste.

see Hazardous Waste Regulations 2005


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Waste Disposal

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all producers and handlers of wastes, other than householders andtheir domestic rubbish produced at home, have a legal Duty of Carefor their wastes

definition of wastes subject to Duty of Care

a waste is any substance which the person in possession discards

or intends to discard this is a wide definition who has a legal Duty of Care?

anyone who produces or handles wastes, from the point ofproduction to final disposal, is subject to the waste managementDuty of Care

there are specific exceptions for:

private householders - but only for their own domestic rubbish

certain wastes subject to other systems of control escape their controluntil passed to a registered waste carrier


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Waste Disposal

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duty of care continues throughout the waste chain until its final disposal important to engage only reputable waste disposal contractors to remove

waste from pharmacies as initial producer may (in certain circumstances)

be held liable if any part of the disposal chain fails

waste disposal contractors are contracted by the PCT as part of the

pharmacy contractual framework

sent (with duty of care transfer note) to a suitable authorised authorised

waste disposal for incineration

Waste Management Licensing Regulations 1994 39(1)

provides conditional exemption for community pharmacies for secure

storage pending disposal elsewhere, of waste medicines returned from

patients

limits on size and length of time stored

requires registration by the pharmacy with local Environment Agency


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Hazardous Waste Regulations 2005

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requires pharmacies to separate hazardous wastemedicines from non-hazardous if technically and

economically feasible where not separated, then is

specified as hazardous waste and accompanied by a

hazardous waste consignment note medicines designated as hazardous are those identified

in the European Wastes Catalogue as exhibiting

hazardous properties such as cytotoxic/cytostatic;

teratogenic, etc

consider hazard codes relevant to hazardous materials;

safety data sheets, etc.


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Pharmacy waste

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Standard Operating Procedures for Controlled Drugs mustinclude disposal and destruction (see MEP)

Controlled Dugs Schedule 2 (and some Schedule 3)

patient returns

clearly mark and stored in CD cabinet until denaturedto render them irretrievable

denaturing should, if possible, be witnessed(pharmacist or pharmacy technician)

place in waste container only after denaturing

out of date stock see law lectures - witness/records,etc

Also See MEP


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Pharmacy waste

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Pharmacy Standard Operating Procedure include, forexample: medicine waste including hazardous medicines products other than medicines identifying incompatible products (e.g. flammable

products; oxidising products) protective measures for staff in segregating

medicines and products identifying risks to carriers and waste contractors

monitored dosage systems sharps retention/audit requirements for transfer notes


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Summary

Disposal of medicinal products

responsibility ofEnvironment Agency in England & Wales

special requirements when classified as hazardous waste

such as medicines with cytotoxic or cytostatic properties ;any medicine that possesses one of more of the following

hazardous properties is classified as cytotoxic and

cytostatic and is a hazardous waste: Toxic; Carcinogenic;

Mutagenic; Toxic for reproduction

advice available from local waste regulation authorities

NB a pharmacy or veterinary surgery is required to denature

controlled drugs prior to their disposal


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Duty of Care (DoC)

DoC requires that a waste holder (producer, carrier ordisposer) takes all reasonable steps to ensure there is no

unauthorised deposit, treatment, keeping or disposal of

controlled wastes, that it does not escape from their

control, and is only transferred to an authorised person also requires waste to be described in a way that permits

its safe handling and management and that any transfer of

waste is accompanied by a written description of the waste


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Product Liability


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Part I of the Act, which implements into UK law theprovisions of the Product Liability Directive (85/374/EEC),

came into force on 1 May 1988. Part II of the Consumer

Protection Act, containing consumer safety provisions,

came into force on 1 October 1987 these provisions apply throughout the UK.

Product Liability:

people injured by defective products may have the right

to sue for damages; product liability is the term given tolaws affecting those rights


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Consumer Protection Act 1987 (cont)

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in the past those injured had to prove a manufacturernegligent before they could successfully sue for damages

the Consumer Protection Act 1987 removes the need to

prove negligence - a customer can already sue a supplier,

without proof of negligence, under the sale of goods law the Act provides the same rights to anyone injured by a

defective product, whether or not the product was sold to

them

the Act does not affect any existing civil laws governingproduct liability


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a defective product is defined as one where the safety of the product is not such as

persons generally are entitled to expect

this definition provides an objective test of defectiveness

and refers neither to the particular injured person nor tothe particular producer

a product will not be considered defective solely because it

is of poor quality

a product will not be considered defective simply becausea safer version is subsequently put on the market


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An injured person can take action against: Producers:

usually the manufacturer; also included are processors but those

involved solely in packaging are not affected unless the packaging alters

the essential characteristics of the products

Importers:

meaning importers into the European Community, not just into the

United Kingdom - where goods are imported into another EC country

and subsequently sold in the United Kingdom, liability rests with the first

importer, not the United Kingdom importer.

Own-branders:

suppliers who put their own name on the product and give the

impression that they are the producers


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other suppliers, such as wholesalers and retailers, are not liableunless they fail to identify the producer, importer or own-

brander if asked to do so by a person suffering damage.

liability under the Act is joint and several, so the plaintiff may

sue both (or all, if more than two) defendants. It is not possible

to exclude liability under the Act by means of any contract term

or other provision

liability under this part of the Act applies to all consumer goods

and goods used at a place of work

enforcement of the Consumer Protection Act 1987 is theresponsibility of officers of the local weights and measures

authority - usually called Trading Standards Officers


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A producer or importer can avoid liability if he can prove any of sixdefences:

he did not supply the product

the state of scientific and technical knowledge at the time he

supplied the product was not such that a producer of products of

the same description as the product in question might be expectedto have discovered the defect if it had existed in his products while

they were under his control (the so-called development risks

defence);

the defect was caused by complying with the law

the defect was not in the product at the time it was supplied

the product was not supplied in the course of a business

the producer of a component will not be liable if he is able to show

that the defect was due either to the design of the finished product

or to defective specifications given to the component manufacturer

by the producer of the finished product.


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a plaintiff must begin his court action within 3 years of the date he wasinjured by the defective product or, if later, the date when they knew

they had a claim against the defendant - however, an injured person

cannot sue under this part of the Act if 10 years have elapsed since the

defective product was supplied by the producer

a person can sue under the Act for compensation for: death

personal injury

private property (provided the amount of loss or damage is 275 or

more)

the Act imposes no financial limit on a producers total liability.

the plaintiff must be able to show that, on the balance of probabilities,

the defect in the product caused the damage


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Pharmacists medicines - MA holder/manufacturer likely to be

primary producer

ensure adequate systems and records to ensure able to

identify producer pharmacist would have full liability for own branded

goods and for own remedies prepared by him

maintain full manufacturing records so producer of

ingredients can be identified records kept for >10 years


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Price Control

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Section 20 of the Consumer Protection Act 1987 makes it a criminaloffence for a person in the course of his business to give consumers a

misleading price indication about goods, services, accommodation

(including the sale of new homes) or facilities

it applies however you give the price indication - for example, in a TV

or press advertisement, on a website, by email or text message, in acatalogue or leaflet, on notices, price tickets or shelf-edge marking in

stores, or if you give it orally, for example on the telephone

the term "price indication" includes price comparisons as well as

indications of a single price

there is a requirement to display a price in such a way that customerssee it without having to ask, in close proximity to goods available for

sale


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Veterinary Medicines

Legislation

Classification of Medicines

Prescription

Supply Cascade

Labelling

Records keeping

MEP guide


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Legislation

The law on veterinary medicines has been uncoupledfrom the Medicines Act 1968 and there are revisions

from a European directive; these are set out in new

legislation, the Veterinary Medicines Regulations 2005

(SI No 2745) which came into force on 30 October2005


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The Veterinary Medicines

Regulations

Took effect 30 October 2005 (except for medicated feedingstuffs: 1 January 2006)

Enforced mostly by Veterinary Medicines Directorate(VMD) through the criminal courts

Implements an EU Directive and separates out from theMedicines Act all the provisions which relate to veterinarymedicine

The Regulations are revoked and replaced every year, sothe references to the Regulations should be read as

referring to the ones that are currently in force. The VMR 2011 (SI No. 2159) came into force on 1 October

2011


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Definition of

VETERINARY MEDICINAL PRODUCT

Because they transpose the requirements of EU legislation,the Veterinary Medicines Regulations use the Communitylaw definition of veterinary medicinal product

Article 1.2 of the amended Directive (2001/82/EC asamended by 2004/28/EC) defines a "veterinary medicinal

product" as: (a) any substance or combination of substances presented as

having properties for treating or preventing disease inanimals; or

(b) any substance or combination of substances which may beused in, or administered to, animals with a view either to

restoring, correcting or modifying physiological functions byexerting a pharmacological, immunological or metabolicaction, or to making a medical diagnosis

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Classification of medicines

POM-V = Prescription-only medicine veterinarian POM-VPS = Prescription-only medicine - veterinarian,

pharmacist, suitably qualified person

NFAVPS = Non-food animal - veterinarian, pharmacist, suitablyqualified person

AVM-GSL = Authorised veterinary medicine - general sales list

Other abbreviations: VMP = veterinary medicinal product

SQP = Suitably qualified person

Veterinary Medicines Directorate (VMD) Registered qualified person (RQP) - veterinary surgeon, pharmacist

or suitably qualified person according to the distribution category ofthe veterinary medicinal product concerned


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POM-V

A product will generally be included in the POM-V categorywhen it: requires a strict limitation on its use for specific safety

reasons

requires the specialised knowledge of a veterinary surgeonfor its use/application;

has a narrow safety margin requiring above average care in itsuse

is Government policy to demand professional control at a highlevel

Veterinary medicinal products containing controlled drugs

will be authorised in this distribution category Products containing Controlled Drugs in Schedule 2 or 3 of

the Misuse of Drugs Act 1968 will be clearly identified withCD and the relevant schedule detailed on their labels


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POM-V

A veterinary medicinal product, previously classifiedas a MFS, is for incorporation into animal feeding

stuffs that may only be supplied to keepers of animals

on presentation of a written medicated feeding stuff

prescription from a veterinary surgeon Such a product is therefore included in the POM-V

category.


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POM-VPS

POM-VPS products can be supplied by other veterinary surgeons,

pharmacists or registered suitably qualified persons (SQPs)against a written prescription

prescription from veterinary surgeons, pharmacists or suitablyqualified persons (SQPs) *

SQPs will need to undergo approved training, be registered andcomply with a code of practice

SQPs can prescribe and supply POM-VPS and NFA-VPS but onlyfrom registered premises

For POM-VPSs the prescribing veterinary surgeon need not havethe animals under his/her care

* The customer may request a written prescription if they do notwant the prescribing RQP to supply the product. Any RQP maysupply POM-VPS medicines in accordance with a writtenprescription from another RQP


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POM-VPS

A product will generally be included in the POM-VPScategory when: it is used to reduce or prevent the effects of endemic disease in

herds, flocks or in individual animals

its use implies risks for the user, the animal, consumer safety or the

environment but users can be made aware of suitablecountermeasures through simple, oral or written, advice

a professional user can be given adequate training in its regular use

A veterinary medicinal product for incorporation into animal feedingstuffs that were able to be supplied to keepers of animals without aprescription was previously classified as MFSX. These were generally

anthelmintics. However under the amended legislation, if the productis for the treatment of food producing animals it is included within thePOM VPS category


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A clinical assessment of the animal(s) is not requiredwhen prescribing this category of veterinary

medicines

The prescribing RQP must, each time they prescribe,

be satisfied that the person administering themedicine has the competence to do so safely and that

the medicine is intended for its authorised use


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SQPs

Subject to certain conditions, Suitably QualifiedPersons (SQPs) may prescribe and supply certain

categories of veterinary medicines, mainly

parasiticides and other medicines for the routine

control of endemic disease SQPs are able to prescribe and supply POM-VPS and

NFA-VPS products for the species in which they have

training; they need to have appropriate training and

work in registered premises but will be able to operateautonomously.


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NFA - VPS

A veterinary medicinal product classified as NFA-VPS may be suppliedby a RQP

a registered veterinary surgeon

a registered pharmacist; or

a registered suitably qualified person (SQP)

A clinical assessment is not required for supply of this category ofveterinary medicine.

The RQP, however, must be satisfied, each time they supply a NFAVPSproduct, that the person administering the medicine has thecompetence to do so safely and the medicine is intended for itsauthorised use

it is part of the professional requirements of the RQP to judge howto determine that these criteria are satisfied in each case

The RQP must also provide advice related to any warnings or contra-indications relevant to it for every product


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NFA - VPS

A product will generally be included in the NFA-VPScategory when:

it is indicated for use only in non-food animals

it is used routinely to prevent or limit the effects of

endemic disease in non-food animals its use implies risks for the user, the animal, for

consumer safety or for the environment but users can be

made aware of suitable countermeasures through

simple, oral or written advice the animal keeper can be given sufficient practical

advice to permit effective/safe usage


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AVM - GSL

A veterinary medicinal product classified as an AVM-GSL may be supplied by any retailer as there are no

restrictions on its supply

A product will generally be included in the AVM-GSL

category when: its use has a wide margin of safety

it is used to alleviate or prevent the signs of disease or

support the treatment of common ailments

special advice is not required to permit safe/effectiveuse


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Prescriptions

A prescription may be verbal or in writing. Prescribingis considered to be the action of deciding, instructingand recording which treatment should beadministered to an animal

It can be carried out by any registered qualified person(RQP) that is a veterinary surgeon, pharmacist orsuitably qualified person according to the distributioncategory of the veterinary medicinal productconcerned

Generally, most written prescriptions are expected tobe provided by veterinary surgeons


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Prescriptions

As well as specifying an authorised veterinarymedicinal product, a prescription from a veterinary

surgeon may be for a product that has been

prescribed under the cascade. In these cases the

prescription may be written for a human medicine ora preparation that is to be made up to meet the

particular circumstances.

Veterinary surgeons must note on prescriptions for

human medicines that the product has beenprescribed under the cascade and this must be done

for all cascade prescriptions.


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Form of a Written Prescription

No particular format is required for a written veterinaryprescription but prescribers must include the followinginformation:-

the name, address and telephone number of theperson prescribing the product

the qualifications enabling the person to prescribethe product; e.g. MRCVS or the SQP registrationnumber

the name and address of the owner or keeper

identity (including the species) of the animal or groupof animals

the premises at which the animals are kept if this isdifferent from the address of the owner or keeper

cont


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Form of a Written Prescription (cont)

the date of the prescription the signature or other authentication of the person

prescribing the product

the name and amount of the product prescribed

the dosage and administration instructions; anynecessary warnings (Note: dosage of as directed is not

acceptable)

the withdrawal period if relevant

if it is prescribed under the cascade, a statement to thateffect


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Prescriptions

An offence to prescribe more than the minimum amount ofVMP required for a treatmentpharmacist may need to check

Prescriptions valid for 6 months (or shorter if specified)

Repeatable prescription that does not specify the number ofrepeats repeat once

Controlled Drugs Schedules 2 and 3 prescription valid 28 DAYS

see MEP guide for details

address of prescriber in UK total quantity (words & figures)

pharmaceutical form strength (where appropriate)

name &address person to whom delivered

declaration (animal/herd under vets care)

instalment directions no repeats


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Prescriptions

Pharmacist dispensing a prescription must: only supply vet medicine specified

take reasonable steps to satisfy self that theprescription has been written and signed by a

person entitled to prescribe the product ensure vet medicine is supplied to person

named on

Note: 2009 Regulations introduced offence ofaltering a written prescription without

authorisation of the person who signed it


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Prescribing/supply

Pharmacist prescribing (or making a supply of ) a POM-VPSmust always:

advise on safe administration of product

advise as necessary on any warnings/contraindications, etc

on label/package leaflet

not prescribe (or in case of NFA-VPS, supply) more than

minimum amount required for treatment EXCEPT where:

Product is in a container specified in marketing

authorisation

Manufacturer does not supply in a smaller container, and Pharmacist is not authorised to break open package

NB only veterinary surgeon may break open immediate

packaging of injectable products


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Supply by Pharmacists

A registered pharmacist may only supply veterinary medicinalproducts from premises, which have been registered as apharmacy with either the GPhC or the Pharmaceutical Society ofNorthern Ireland and in the case of POM-VPS or NFA-VPSproducts premises approved for the storage and supply of theseproducts

It is an offence to supply a veterinary medicine that has passedits expiry date

Suspected Adverse Reactions

suspected adverse reactions surveillance scheme (SARSS) run

by Veterinary Medicines Directorate (VMD) suspected ADR in either animal or human (e.g. from

administration) must be reported to Veterinary MedicinesDirectorate


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Labelling Requirements

The label information on the product is specifically authorised toprovide necessary information relating to safety includingwarnings for the user and animal owner, so it must not beobscured by any additional labelling or amendments made tothe packaging.

A veterinary surgeon or pharmacist supplying a product againsta written prescription may amend the authorised label inaccordance with the prescription, for example to change thedose, but none of the other information on the outer packagingor the immediate container may be obscured

SQPs may only supply in accordance with the authorised label Note: Manufacturers labelling and leaflet info in MEP guide

R d k i f t i


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Record keeping for veterinary

transactions (receipt and supply)

All POM-V and POM-VPS medicines In writing/indelible

Kept for 5 years

date of transaction

identity of VMP

quantity received or supplied name and address of the supplier or recipient

batch number (for VMP for non-food producing animals BN needonly be recorder on either date batch was received or starts to beused)

where a written prescription- name and address of person whowrote and a copy of the

NB documentation kept for at least 5 years


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The Prescribing Cascade

The prescribing cascade provisions are set out in the Regulations they are available only to veterinary surgeons who have

responsibility for the treatment of the animals concerned andmay only be supplied by a veterinary surgeon or a pharmacist

if there is no medicine authorised in the UK for a condition

affecting a non-food producing species, the veterinarysurgeon responsible for treating the animal(s) may, inparticular to avoid unacceptable suffering, treat the animal(s)in accordance with the following sequence:

(a) a veterinary medicine authorised in the UK for use in

another animal species;(b) or for a different condition in the same animal species

(off-label use);


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The Prescribing Cascade (cont)

(c) or, if there is no such product:either

(i) a medicine authorised in the UK for human use

(ii) a veterinary medicine not licensed in the UK butlicensed in another member state for use with

any animal species for a non-food producingspecies

or, if there is no such product described in (ii) issuitable:

a medicine prepared extemporaneously, by a

veterinary surgeon, a pharmacist or a personholding an appropriate manufacturersauthorisation, as prescribed by the veterinarysurgeon responsible for treating the animal.

h b d


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Food producing animals

If there is no medicine authorised in the UK for a conditionaffecting a food producing species, the veterinary surgeonresponsible for treating the animal(s) may use the cascadeoptions as set out above except that the following additionalconditions apply: the treatment in any particular case is restricted to animals on a

single holding any medicine imported from another Member State (option c(ii))

must be authorised for use in a food-producing species in theother Member State

the pharmacologically active substances contained in the medicinemust be listed in Annex I, II or III to Regulation (EEC) No. 2377/90

the veterinary surgeon responsible for prescribing the medicinemust specify an appropriate withdrawal period

the veterinary surgeon responsible for prescribing the medicinemust keep specified records.


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A medicine prescribed in accordance with the cascademay be administered by the prescribing veterinary

surgeon or by a person acting under their direction.

Responsibility for the prescription and use of the

medicine remains with the prescribing veterinarysurgeon.

L b lli f di d i di i


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Labelling of dispensed veterinary medicines

under the cascade

See earlier lecture on labelling; See MEP Label must include at least:

name and address of pharmacy

name of prescriber

name and address of animal owner

identification of animal

date of supply

expiry date

name and description of product

dosage and administration instructions

special storage precautions

necessary warnings for use; target species; administration or disposal ofthe product

withdrawl period (if necessary)

Keep out of reach of children and For Animal Treatment Only


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Labelling at the time of supply

If the product is placed into a container, which has notbeen authorised as part of the marketing

authorisation, such as tablets being supplied in a

standard bottle with a child resistant closure, the

necessary information must still be provided in writing


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Summary of Key Points

The law allows owners to purchase medicines from a pharmacist or from aveterinary surgeon

For some medicines a prescription is needed, and veterinary surgeons canonly provide a prescription for POM-V medicines for animals under theircare, and following a clinical assessment

Those supplying medicines not on the general sale list must advise on safe

administration, warnings and contra-indications

It will be an offence to supply or possess an unauthorised veterinarymedicinal product

Records must be kept of all products supplied on prescriptions for fiveyears

When a batch is brought into use the batch number and date must berecorded

Suspected ADRs must be reported to the Veterinary Medicines Directoratevia Suspected Adverse Reaction Surveillance Scheme (SARSS)


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Veterinary medicines no longer controlled under the Medicines Act 1968Regulations updated every year

All medicines for food-producing animals are Prescription Only Medicines

Classes:

POM-V supplied by pharmacists and vets against a prescription from a

vet

POM-VPS - supplied by vets, pharmacists or suitably qualified persons

against a prescription from one of these

NFA-VPS similar to POM-VPS but for non-food producing animals no

prescription required

AVM-GSL - no restrictions on supply

Pharmacists must not sell human medicines for use in animals


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Prescribing Cascade used when no suitable veterinary medicine authorised and

available in UK to treat a particular species or indication

three levels:

use an UK authorised veterinary medicine indicated for same speciesbut for another condition or indicted for use in another species

use a UK authorised human medicine or use a veterinary medicineauthorised somewhere in EU* but not UK

specially prepared extemporaneous medicine

NB need to be aware of extra requirements if dealing with afood-producing species*Special Import Certificate requirements


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Veterinary Medicines

Any questions?

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