Flashcards in Law Y2S2 Deck (189):
Where is legislation for medicines set out?
In HMR 2012
What does Part 3 of HMR deal with?
Manufacturing and wholesale dealing
What does Part 4 of HMR deal with?
Requirement for authorisation
What does Part 5 of HMR deal with?
What does Part 6 of HMR deal with?
Certification of homeopathic medicinal products
What does Part 7 of HMR deal with?
Traditional herbal registration
What does Part 9 of HMR deal with?
What does Part 10 of HMR deal with?
Exceptions to requirements for marketing authorisations etc
What are the main objectives of legislation?
- Ensure efficacy, safety and quality of the medicinal product
- withdrawal from use if any danger comes to light
Are authorised products and investigational products covered by legislation?
Define medicinal product
any substance or combination of substances which are:
1. presented as having properties that prevent or treat disease in humans
2. used by / administered to humans
Define authorised medicinal product
Product with marketing authorisation certificate of registration and traditional herbal registration
Define relevant medicinal product
A medicinal product that isn't a registrable homeopathic or traditional herbal medicinal product BUT has marketing authorisation
Define borderline substance
Shouldn't have any pharmacologically active substances or make medicinal claims.
Define medical device
Product covered by Medicinal Devices Regulation 2002 - includes sutures, dressings, contact lens care products.
What mark do medical devices have?
What are the licences and certificated available?
- Marketing authorisation
- Certificate of registration
- Traditional herbal registration
- Manufacturers licence
- Clinical trial authorisation
What do all relevant medicinal products require?
A marketing authorisation
In what circumstance was a 'product licence of right' granted?
Given to medicines that were on the market prior to Medicines Act 1968
Why is a MA required?
So that a product can be manufactured or assembles, imported or exported and sold or supplied. A medicinal product must be covered by a MA and held by the person responsible.
What must an application for a MA in the UK include?
1. Name and permanent address
2. Name of medicinal product
3. Detailed specification of product and constituents
4. Evaluation of potential environmental risks
5. Methods of manufacture and quality control
6. Data on - indications, compatibility and clinical studied
8. SPC, package and leaflet
9. Legal category
What are the types of application for a MA?
- New active substances
- Abridged substances
- Biological and biotechnological products
What must the licensing authority be satisfied with?
- product is safe and efficacious
- facilities for manufacture and quality control are adequate to ensure conformity with specification
How long are MAs initially granted for?
5 years - need to be renewed on expiry
What records should holders of MAs keep?
- adverse products
- sales / supplies
- sources of all materials
Are most medicinal products with a MA licence for used in children?
No - most have only been tested in adults and so use in children is unlicensed
What is the new category of MA for children?
Paediatric Use Marketing Authorisation (PUMP)
What age range was Bucculam licensed for?
3months - 18y/o
used to treat severe convulsions and epileptic seizures
When was Bucculam licensed for children?
7th September 2011
What are the labelling requirements for relevant medicinal products?
- Legible, comprehensible and indelible
- English or English + other languages
- Braille on outer packaging for blind or partially sighted people
What are the Schedule 24 outer & immediate packaging information requirements?
1. Name of medicinal product
2. Strength and pharmaceutical form
3. Target audience
4. If it has up to 3 active substances, a common name for each active substance
5. Statement of active substances in product given as number and words per dosage unit or according to administration form for a given volume of weight
6. Pharmaceutical form & contents by weight, volume or doses of product
7. A list of all excipients or a list of excipients known to give effect
8. Method / ROA
9. Space for prescribe dose to be indicated
10. Warning that it should be kept out of children's reach
11. Special warning applicable to the product
12. Expiry date in clear terms
13. Any special storage precautions
14. Precautions relating to disposal
15. Name and address of holder of MA
16. Number of MA
17. Batch number
18. Instructions for use if not POM
What is required for labelling blister packs?
1. Name of product
2. Strength and form
3. Who product is for
4. Name of active substances
5. Name of MA holder
6. Expiry date
7. Batch number
What are the labelling requirements for paracetamol?
1. Products that contain paracetamol should say that they contain paracetamol
2. ' do not take more than the label says. If you don't better, go to GP'
What are the 4 types of manufacturers licence?
1. Manufacturer licence
2. Manufacturer 'specials' licence
3. Manufacturer licence for investigational medicinal product
4. Manufacturer licence exempt advanced therapy products
What does a manufacturer licence allow the holder to do?
Manufacturer and/or assemble medicinal products, including export to outside EEA countries and import licensed medicines from countries outside the EEA
Process carried out in making the product but not dissolving, diluting, etc
Process of diving, packaging and presenting
Can a product be manufactured without a marketing authorisation?
No - has to be covered by a MA held by the manufacture or by a person ordering the product from the manufacturer
What is specials licence for?
Unlicensed medicines or imported unlicensed medicinal products from outside the EEA
Are pharmacies are exempt from requiring a specials licence?
Yes - they can prepare extemporaneous products
The law allows manufacture and supply of medicinal products for patients with special clinical needs...
Can chiropodists prescribe special medicinal products?
Yes (as a supplementary prescriber)
Who can prescribe specials?
Supplementary prescribers - pharmacist, nurse, midwife, chiropodist, radiographer, optometrist, dietician
What are the conditions for specials?
1. Supply to appropriate person for use under supervision of pharmacist in a registered pharmacy, hospital or health centre
2. No advertising
3. Supervision & procedure should meet specified requirement
4. Records should be available for inspection
5. Manufacturer should hold specials licence
A prescriber can prescribe a 'special' if a licence medicinal product exists...
Wholesale supply goes directly to the patient...
What does wholesale dealing involve?
sale and supply of medicines by larger distributors to pharmacies and by pharmacies to GP surgeries for individual patients
A wholesale dealers licence allows the holder to wholesale P, PO, traditional herbal and GSL medicines...
A WDL allows the holder to import unlicensed medicinal products from countries outside the EEA
False - from inside EEA only
Who can a WDL holder distribute medicines to?
1. Holder of a licence relating to those products
2. Holder of equivalent EEA WL
3. Person who can all products by retail or supply in circumstances corresponding to retail sale
4. person who may lawfully administer those products
What conditions have to be complied with to hold a WDL?
Staff, premises, equipment & facilities must be adequate for handling, storage and distribution
Records be kept for specified time for recall
What is the minimum length of time that distribution records have to be kept for?
When are pharmacists exempt from licensing requirements?
When manufacture takes place on registered pharmacy premises and the manufacture is supervised
Medicinal products specially prepared for individuals have to have a licence...
False - exempt from licensing
Products manufactured for holders of authorisations are exempt from licensing...
When does Medicines Act 1968 allow counter prescribing?
Only if the patient is PRESENT in the pharmacy at the time of request
What is counter prescribing according to HMR 2012?
A pharmacist recommending a product made up by them
When is a licence not needed?
Customers request for self administration or for someone in their care
Assembly in the pharmacy
Stock mixtures - preparations for dispensing
What are chemist nostrums?
Pharmacies own name product - they must be prepared on registered premises and must not be advertised
Doctors and dentists are allowed to prepare and assemble products for individual patients..
Nurses and midwives need a licence to assemble for individual patients...
False - they don't need one
Do herbalists need a ML or MA?
No - the product is manufactured or assembled by a herbal practitioner
When can herbalists give out herbal remedies?
When the patient has been consulted, the herbalist used specialist judgement and on a registered premises
Does a manufacturer or MA holder need a licence to market products from licensed premises?
Group buying by retailer or practitioners needs a licences
False - only need a licence if the group is a separate company
When isn't a WDL needed?
When importing products for a specific person or for a product to be exported without alteration
Do food and cosmetics needs a licence?
They are generally exempt from licensing under HMR 2012
When do food needs licences?
If said to be beneficial for a particular disease or are labelled with dosages
When do vitamins need licences?
- Oral administration with no particulars / directions
- Daily adult dose doesn't exceed 2500 units for A, 25µg folic acid, 250 units D and 5µg cyanocobalamin
- Food with added vitamins >daily dosage
When do cosmetics need licences?
If they have any antibiotic, >0.004% hormones, hexachlorophane and >1% resorcinol
What is an advertisement of medicines?
Anything designed to promote the prescription, supply, sale or use of that product
Give examples of forms of advertising
Door to door visits
Visits by medical sales reps
Supple of samples
Provision of inducements to prescribe / supply medicinal products by gift, offer or promise of any benefit / bonus
Sponsorship of promotional meetings
Sponsorship of sciencey people
MHRA are not allowed to look at advertisements before they are issued...
False - they are allowed. All MAs grants for new active substance have their promotional material vetted
When is vetting requested?
When a product is reclassified or for products that have breached regulations
Who handles advertising complaints?
MHRA and/or regulatory bodies, the outcome is published
Which regulatory body is in charge of general advertising complaints?
Which regulatory body is in charge of OTC advertising complaints?
Which regulatory body is in charge of POMs advertising complaints?
What does European legislation contain?
Rules on content of advertising and promotions & requirements for national monitoring
Which part of HMR contains general definitions relevant to advertising?
What is included in the definition of advertisements for medicinal products?
1. Visits by medicinal sales representatives
2. Supply of samples
3. Provision of inducements to provide / supply medicines
4. Sponsorship of meetings
What are the quality standards an advert has to comply with?
- Compliance in SPC
- Encouragement of rational use
- Not misleading
Unlicensed products can be promoted...
Claims can go beyond what is specified in SPC...
How should rational use be encouraged?
In terms of when medicine should be taken, how & the ROA and information presented should be rational and accurate
How long should records of advertising be kept?
3 years after the last one
POMs can be advertised to the general public...
False - only P and GSL but they have to comply with regulations
Vaccines can't be advertised...
Reference to other products in an advert is allowed...
False - it is prohibited
The advert should encourage reading of PIL...
Can adverts make comparative claims abasing other products?
No - they can say that it works faster than a standard, but the claim should not be misleading.
Can adverts claim that there are no side effects or claim fast action?
They shouldn't suggest that there are no side effects and should be cautious about claims on fast action (only related to a condition where speed of onset is necessary)
Does MHRA encourage volume based promotions?
No - sale and supply of large quantities on promotion undermines legislation of pack size restrictions
Are internet adverts acceptable?
Yes - as long as they comply with regulations.
Are public internet advertisements for POMs allowed?
No - such adverts should only be websites for healthcare professionals
What must short form advertisements contain?
Information compatible with product SPC, detailed info can be found on the website
What should adverts to person qualified to prescribe contain?
Information relating to SPC - wording must take into account their technical knowledge
What is promotional aid?
A form of reminder of advertisement - a non monetary gift for promotional purpose
What are the conditions for professional samples?
Supplied on exceptional basis
Limited number of samples of each product in a year
Supply in response to a written request, signed & dated
Suppliers maintain control and accountability
No larger than the smallest presentation available for sales
In line with requirements of article S4 (54) and be marked 'free medicinal sample - not for resale'
What conditions must medicine promoters comply with?
They must have adequate training and sufficient scientific knowledge to allow them to give accurate information and they should have a current SPC for each product produced
Define herbal medicine
Medicine product where the only active ingredients are herbal substances or herbal preparation
What is a herbal substance?
A plant or part of a plant, algae, fungi or lichen or an unprocessed exudate of a plant that is unprocessed
What is a herbal preparation?
Herbal substances that have been extracted, distilled, expressed, purified etc
What is a traditional herbal registration?
Registration granted by licensing authority
What are the types of herbal remedies?
1. Licensed herbal medicines
2. Registered traditional herbal medicines
3. Unlicensed herbal products
4. Non medicine - supplements or cosmetics
Which undeclared pharmaceutical ingredients do feline capsules have?
Chlorphenamine, oxetacaine, piroxicam and betametasone
In terms of herbal medicines, what does the MA 1968 recognise?
Pharmacists as suppliers of herbal remedies
2 types of herbal remedy suppliers (dealers & practitioners)
Herbalists are required to be registered with the Health and Care Professionals Council (HCPC)...
Herbal practitioners are restricted with the herbs they can deal...
False - They can deal any herbs as long as a one-to-one consultation has taken place with the patient being present in the shop
Which herbal remedies have been banned by MHRA?
Kava kava - has a risk of hepatotoxicity
Senecia species - fatal veno-occulusive disease
In which case would herbal remedies be banned by MHRA?
If use results in adverse reactions
Part 1 herbal medicinal products can be sold in any shop...
False - they are prohibited from sale unless sold in registered pharmacies (they are mainly anthelmintics and irritants)
Part 2 herbal medicinal products are restricted to sale in pharmacies...
False - their strength determines where they can be bought
What is aconite?
A poisons plant toxic to the heart - can cause serious ADRs
Can shop keepers sell Part 1, Part 2, GSL and THMRs?
Nope - can only sell food supplements and cosmetics
What are the conditions for THMs registration?
1. Can use without diagnosis, Rx or monitoring
2. Product given at a particular strength / dose
3. Administered externally, orally or by inhalation
4. Must have been in medicinal use for 30 years and in the EU for 15 years
5. Must have sufficient information about traditional use
THMs are not covered by a registration scheme...
False - they are covered by THMRS, all registered products are given a THR registration number
What are the labelling requirements for THMs?
There must be a statement to specify that they are THR and there should be a statement to direct patients to doctor if symptoms persist or if ADRs occur
Do traditional medicinal products have to prove efficacy, safety and quality?
No - they only have to prove safety and quality
Do companies that import THMPs from a non EU country need a licence?
Yes - need a wholesaler's import licence
Adverts for herbal medicines don't need to specify that they are herbal...
What is the Product Licence of Right?
Products on the market before the Medicines Act
Do homeopathics have therapeutics indications?
No - they can't have any therapeutic indications. They are restricted to oral and external use
When was the National Rules Scheme for Medicinal Products introduced?
1 September 2006
What is the prefix for homeopathic authorisation numbers?
Can pharmacists give out chemicals in retail?
No - need to establish the need for the chemical
What is the purpose of chemical classifications?
Allows you to find out how the chemicals can:
Harm the environment
What is the Globally Harmonised System?
A system uses for the classification and labelling of chemicals
What does the Europeans Regulation adopt in terms of chemicals?
Adopts UN GHS of classification and labelling of chemicals throughout the EU
What does CLP stand for in terms of chemicals?
Classification, labelling an packaging
When did CLP regulations come into effect?
Jan 2009 - they replaced CHIP in June 2015
What are the categories of danger?
What doesn't CLP apply to?
Chemicals in a finished state for use by a final user
What is the purpose of a label on a chemical?
For whoever is dealing with the product, the customer should be able to identify any hazards and should be able to give advice on any potential pre-cautions
What must be included on a label for a chemical?
Name, address & (telephone number of supplier in EEA)
Name of substance and nominal quantity
Where applicable : hazard pictograms, signal words, hazards statements, precautionary statements and supplemental information
What properties must the packaging have?
Must be able to contain the product, not be affected by the chemical and must be strong enough to withstand normal handling.
Should have child resistant fastening and warning of danger if give to general public
Can chiropodists and podiatrists use chemicals in practice?
Yes - they can use chemicals such as liquid phenol, pyrogallol, monochloroacetic acid or salicylic acid
If chiropodist chemicals are place on the market what conditions apply?
They are on the market at medicinal devices and should be CE marked
Can arsenic and strychnine be used as medicinal products?
Yes - if used as medicines they fall under the Medicines Act and are controlled by HMR 2012
When do arsenic and strychnine fall under the Poisons Act 1972?
When used as a non-medicinal poison
What are the 2 classes of regulated chemical substances?
Regulated explosive precursors
What is required to obtain regulated substances?
an EPP Home Office licence
What is needed to apply for a licence for regulated substances?
ID and adress
Certificate of good standing
How long is a regulated substance licence valid for and how much does it cost
Valid for up to 3 years
What needs to be presented when making a regulated substance purchase?
EPP licence and ID
What is an additional warning label needed on regulated substances?
"Acquisition, possession or use by the general public is restricted"
What information is needed on the poisons register?
Date of sale
Name and address of purchaser
Name and quantity of poison supplied
Purpose for which required
Signature of purchaser
What are the 2 classes of reportable substances?
How many lists does the Deregulation Act 2015 group poisons and explosive precursors into?
When are records made for regulated poisons in the register?
For sale or supply
Do poisons registers need to include the purpose for which the poison is required?
What is denatured alcohol?
Alcohol that has been made unsuitable for drinking by the addition of denaturants
What are the 3 types of denatured alcohol?
Completely denatured alcohol (CDA)
Industrial denatured alcohol (IDA)
Trade specific denatured alcohol (TSDA)
What is CDA used for?
Heating, lighting, and general domestic use
Who can CDA be supplied to?
Anyone, in any quantity and there are no conditions on its use and no records are needed
What is IDA used for?
Industrial purposes as a solvent for external medical application
What is added to IDA to make it unsuitable for drinking?
How many approved formulations are there of TSDA?
How can retail / hospital pharmacists obtain IDA (or TSDA)?
They need written authorisation from Revenue and Customs to obtain or receive
What does the authorisation of IDA state?
What can be received, what it can be used for and any other conditions
How long is a IDA authorisation valid for?
Indefinitely unless conditions change
What quantities of IDA can pharmacists obtain on receipt of authorisation?
>20 litres from a wholesale dealer
<20 litres from other authorised users
What are the conditions a an authorised user of IDA or TSDA?
Only use as specified in authorisation
Keep records of all dealings
Keep written signed orders from medical practitioners
Provide annual return if requested
Keep stock securely & security is pharmacists responsibility
Local R&C may need special storage
Record results of stock takes & actions taken
What must happen on receipt of IDA/TSDA?
1. Record in stock account amount received
2. Note receipt details on suppliers dispatch doc and on own copy
3. Sign one copy as receipt and give back and put the other copy in records
Can IDA be supplied to other users?
Only authorised users and the quantity has to be <20 litres
What are the conditions of IDA supply to other authorised users?
Keep copy of authorisation
Only supply for the purpose on the authorisation
When can IDA be given to members of the public?
Can be give for medical use and the requisition can come on written order or on Rx - no need for authorisation
What quantity of IDA can be given on written order?
Any - but all information should be kept by the pharmacist
What must be included on the label for surgical spirits?
'For external use only'
What do surgical spirits contain?
When can duty free spirits be used?
They can be used for medicinal purposes, in the manufacture of any product prescribed by a doctor to be made up by a pharmacist
Is isopropyl alcohol denatured?
No - it isn't covered by regulations and there is no requirement for authorisation to receive or supply
Can veterinary medicinal products go on the market without a MA?
No - it is illegal
Who can prescribe VMPs?
Suitably qualified persons
What is a POM-V?
What is a POM-VPS?
Vet and registered qualified person can prescribe
What is a NFA-VPS?
What is a AVM-GSL?
Authorised veterinary medicine
In which cases does a Vet not have to be present to supply a VMP?
When they have authorised each transaction individually or when they are confident that the person handing over is competent
What is an animal medicine advisor?
A person qualified to prescribe and/or supply VMPs under VMR
Which organisations train and register SQPs?
AMTRa or Vet Skills Ltd
Which categories of medicine can SQPs supply?
POM-VPS that have been prescribed or any NFA-VPS
What are CD2-3 classed as in veterinary medicine?
Can food producing animals have AVM-GSL?
No - they can only have POM-V
What is a legal requirements for vets in care of animals?
They have to carry out a clinical assessment of the animal and the animal has to be under their care
When are POM-VPS medicines used?
- Prevent / reduce effects of endemic disease
When can veterinary medicines be put on the market without a MA?
If they are for small pets - even still only certain medicines
What must a RQP prescribing a POM-V, POM-VPS or NFA-VPS ensure?
- Person administering is competent
- They have given advice on safe administration
- Provided info about contraindications
- Provided minimum amount needed