Pharmacy Law 3

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  • Created by: LBCW0502
  • Created on: 17-10-17 12:50
Why do we need legislation concerning medicines? (5)
Thalidomide tragedy in early 1960s, lots of new potent medicines post Second World War, working party examined need for new controls, patient safety on medicines agenda, Medicines Act 1968 (plus over 200 statutory amendments)
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What did the Medicines Act cover? (2)
Everything that relates to medicines for human use. Used to also cover veterinary medicines but those now under the 2005 Veterinary Medicines Regulations
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What particular aspects does the Medicines Act cover? (6)
Medicinal products, licensing system, safety/efficacy, quality, manufacturing, distribution (wholesaling)
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What is a medicinal product? (1)
Substance/combination presented as having properties to prevent/treat a disease
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What is a medicinal product? (2)
Substance/combination which has the view to restore/correct/modify physiological function by exerting pharmacological/immunological or metabolic action as well as making a medical diagnosis
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The Medicines Act covers which premises and which type of drugs? (1)
Registration, operation and inspection of pharmacies. Sale/supply of non-prescription medicines (GSL/P) and sale/supply of POMs
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The Medicines Act covers which premises and which type of drugs? (2)
Import/export of medicinal products, clinical trials, containers/packaging/labelling, regulation for sale/supply of homeopathic medicines and herbal medicines
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What are homeopathic medicines?
Medicines which affect water content in body (a claim that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people/body can heal itself)
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What is the publication of the British Pharmacopoeia?
It is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing
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What is the purpose of the Commission on Human Medicines?
Oversight of the 'working' of the Act and the monitoring of medicines safety
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Why did the MHRA review UK medicines legislation?
Due to Medicines Act 1968 plus over 200 statutory instruments - fragmented/complex/difficult to follow
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When did the Human Medicines Regulations come into force?
14th August 2012
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What does the Human Medicines Regulations replace?
The 1968 Medicines Act and all its amendments and encompasses EU directives
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What does the Human Medicines Regulations ensure? (5)
Legislation is fit-for-purpose in the UK today, consolidates information, removes some obsolete laws, amends some laws, introduces some new laws
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The Human Medicines Regulations set out legislation for what? (4)
Authorisation of medicinal products for human use, manufacture/import/distribute/sale/supply of medicinal products, labelling/advertising medicinal products, pharmacovigiliance
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Who does the Human Regulations apply to?
The whole of the UK - all medicines must have a marketing authorisation unless covered by a specific exemption
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Who enforces the legislation? (4)
European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), in GB the GPhC, in NI the Pharmaceutical Society of Northern Ireland (PSNI)
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What are the enforcements under MHRA? (6)
Licensing of medicines, manufacturing, wholesaler dealing, advertising and promotion, import and export, clinical trials
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What are the enforcements under GPhC and PSNI? (2)
Registration/operation/inspection of premises, all aspects of retail sale/supply (control/provision, quality/labelling/packaging)
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Are all medicinal products, activities and dealings subject to licensing?
Yes, unless exempted
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Who carries out national licensing?
MHRA
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The EMA covers licensing for which medicinal products?
Medicinal products covered by centralised procedures (e.g. high technology medicines)
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Which procedures requires licences? (4)
Product (MA), manufacture, wholesale and parallel import (PI)
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Is a licence needed for professional activities of a pharmacist or doctor?
No - these are permitted by exemptions
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What are the aspects required when granting MA from MHRA (EMA)? (3)
Quality, safety (balance of benefit v harm) and efficacy
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Is there a test for cost effectiveness?
No
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Who holds the MA licence? (3)
Manufacturer, importer or marketer
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How long is an MA granted for?
5 years
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Who needs an Manufacturer's Licence (ML)?
Anyone making a medicinal product that has an MA
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What are 'specials'?
Organisations which provide special authority for ML holders to manufacture to order/formula of a practitioner (normally a doctor) or a pharmacist
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Who does not need an ML?
Not needed by a pharmacist making a medicine to a prescriber's/customer's requirements
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What is retail sale?
Sale of medicines to the public
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What is wholesale supply?
Sale to somebody to sell or supply to someone else e.g. sale of medicines by pharmacists to other healthcare professionals
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What is the procedure for Wholesale Dealers Licence (WDL)? (5)
Requires a licence, premises, records, responsible person in charge and inspection
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Small supplies can be made between pharmacists without a licence in what cases? (3)
It takes place on an occasional basis, small quantities of medicines for individual patients, supply is not for profit
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What are Parallel Imports?
Version of proprietary (branded) medicine with a UK MA, imported from EU
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Why are Parallel Imports used?
They are a cheaper equivalent due to differential pricing of £ vs €. Imports must be permitted because of EU free movement of goods
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What are the aspects of Parallel Import when manufacturing only within the EU? (3)
By EU subsidiary, another company under licence, made in the UK, exported and then imported
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What are the aspects of the medicine and label for Parallel Imports? (2)
Medicine must be therapeutically identical to UK version (so same company under licence). Must be over-labelled in English
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What are the general labelling requirements? (4)
Legible, comprehensible, indelible and in English/or in English + other language provided all particular appear in all the languages used
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What are the labelling requirements regarding legal terms? (4)
Name and address of holder of MA, MA number, manufacturer's batch number and in case of self administration the instructions for use
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What are the labelling requirements regarding clinical terms and including precautions? (11)
Name of medicinal product, active ingredient per dosage form, pharmaceutical form, list of active ingredients, administration, 'keep out of reach of children', warnings, expiry date, storage, disposal, POM/P
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What are the requirements for OTC medicines?
Statutory warnings are no longer legally required except for paracetamol-containing products (new legislation for Human Medicines Regulations 2012)
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What are the requirements for labelling dispensed medicines? (8)
Name of patient, name/address of pharmacy, dispensing date, name of product, directions for use, precautions, 'keep out of reach of children', 'for external use only' e.g. liquids
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What are the requirements for containers? (3)
Contents protected from light, child resistant ('clic-loc lids'), bottles for preparations for external use only must be fluted
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Medicines Act regulations cover all forms of media of advertising including what?
Product detailing to healthcare professionals
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What do the codes of practice regard? (3)
Association of British Pharmaceutical Industry (ABPI) for POMs, Proprietary Association of Great Britain (PAGB) for OTCs, and general media
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What is the Summary of Product Characteristics (SPC)?
SPC
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When should the SPC be produced and available?
When medicines are liecensed and marketed
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What are the details in the SPC? (11)
Name, presentation, uses, dose/administration, contra-indications, warnings, legal category, pack sizes, pharmaceutical precautions, MA numbers and details of manufacturer
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What are the aspects regarding advertising? (3)
Always have summary of MA information/cost, accurate/current/verifiable/sufficient to allow recipient to form opinion on value, quotations/graphs/tables must be accurate with no distorted scales
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Other cards in this set

Card 2

Front

What did the Medicines Act cover? (2)

Back

Everything that relates to medicines for human use. Used to also cover veterinary medicines but those now under the 2005 Veterinary Medicines Regulations

Card 3

Front

What particular aspects does the Medicines Act cover? (6)

Back

Preview of the front of card 3

Card 4

Front

What is a medicinal product? (1)

Back

Preview of the front of card 4

Card 5

Front

What is a medicinal product? (2)

Back

Preview of the front of card 5
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