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PPM > TBL 3 - THE HUMAN MEDICINES REGULATIONS 2012 > Flashcards

TBL 3 - THE HUMAN MEDICINES REGULATIONS 2012 Flashcards

1
Q

What is overview of the human medicines regulation 2012 (3 things)?

A

HMR state that medicines can only be supplied to the public from pharmacies with the exception of those medicines that can safely be sold without the supervision of a pharmacist.

HMR covers labelling of meds, the containers they are supplied in and how they are advertised.

Every step of the supply chain is regulated, manufacture, import, distribution , sale and supply, labelling, advertising and pharmacovigilance.

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2
Q

What is part 1 general provision about?

A

Description of the role of ministers and general definitions, including ‘medicinal product’ and advertisement.

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3
Q

What is the Part 4 - requirement of authorisation provision about?

A

Requirement that medicinal products subject to a marketing authorisation, homeopathic certificate of registration, traditional herbal registration (THR) or article 126a authorisation.

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4
Q

What is Part 5 - Marketing authorisations about?

A

Makes specific provisions for generic medicinal products, biological medicinal products, products with well-established medicinal use and new combinations of active substances.
Determine whether a product needs to be subject to prescription requirements.
Requirement to take into account scientific and technical progress and contains rules relating to revocation, variation, suspension, withdrawal of authorisation.
Paediatric regulation

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5
Q

What is Part 6 - Certification of homeopathic medicinal products about?

A

Sets out info that must be supplied with an application for a certificate of registration
Sets out rules regarding revocation, withdrawals, and suspensions

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6
Q

What is the Part 7 - traditional herbal registrations about?

A

Describes the traditional herbal medicinal products to which it applies and sets out info that must be supplied with an application for a traditional herbal registration.
Sets out rules regarding revocation, variation, withdrawals and suspensions.

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7
Q

What is the Part 9 - Borderline products about?

A

Licensing authority determines provisionally product is a medicinal product and therefore subject to regulation as such.
Permits person supplying product to make written and oral representations to the contrary and for final determinations.

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8
Q

What is the Part 10 - exception to requirement for marketing authorisation about?

A

Provision of specials
These are unlicensed medicinal products that can be supplied providing that certain conditions are met.
Provision for parallel import licences and provides an exemption from marketing authorisation requirements for advance therapy medicinal products and the supply of unlicensed medicines in response to the spread of toxic substances or nuclear radiation.

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9
Q

What is Part 11 - pharmacovigilance about?

A

Imposes obligations on authorisation holders and licensing authority in relation to pharmacovigilance (the monitoring of the safety of medicines in clinical use and taking appropriate action to minimise risk)

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10
Q

What is Part 12 - dealings with medicinal products about?

A

Sale supply and adminsteration of medicinal products related to their classification as GSL, P and POM
Exemption from basic rules for hospitals , certain professionals and supply under patient group directions (PGDs)

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11
Q

What is Part 13 - packaging and leaflets about?

A

Info that must appear on packaging and in leaflets and contains specific rules for braille, radionuclides and homeopathic and herbal medicinal products.

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12
Q

What is the definition of a medicinal product - part a and b?

A

a. Any substances or combination of substances presented as having properties of preventing or treating disease in human beings or
b. Any substance or combination of substances that may be used by or administered to human beings with a view to Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action or Making a medical diagnosis

A = presentation of the product
B = action of the product on the body - function
Human blood and nay human blood components are not included within the definition.

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13
Q

Who issues marketing authorisations and what do medicines need to show evidence of to get an MA?

A

Before a medicinal product can be marketed, sold, supplied or imported HMR states it must have a marketing authorisation (MA).

Any meds and appliances marketed, sold, supplied or imported to the UK have to been approved by a regulatory body which has evidence of their safety, quality and efficacy when used as specified in the MA.
MHRA responsible for issuing MA’s in the UK.

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14
Q

What are meds approved via EMA’s known as?

A

Meds which were approved via EMA’s centralised route known as centrally authorised products (CAPs) were converted into UK MA’s on the day we left EU and are still authorised unless CAP holder opted out of this.

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15
Q

Who has taken over the role of pharmacovigilance from EU agencies?

A

MHRA taken over role which EU agencies has in respect of pharmacovigilance.

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16
Q

How long is marketing authorisation (MA) granted for?

A

MA granted for 5 years

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17
Q

What do the MHRA need to satisfied with for meds to be granted and MA?

A

MA granted if MHRA satisfied that medicine is safe, effective and of a suitable quality. Not allowed to consider price only SAFETY, EFFICAY AND QUALITY.

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18
Q

What are the safety requirements for meds (3 things)?

A

Any risks to the person administering the product or, if it is a machine the person operating it.

Any danger to the health of the community

The extent which the product may interfere with treatment, diagnosis or prevention of disease.

No meds are completely safe, all meds have some undesirable effects, interactions with other meds or assoicated dangers when taken in overdose. Means MHRA must consider risks of meds and balance them against the benefits - known risk/benefit ratio.

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19
Q

What are the efficacy requirements for meds?

A

Efficacy means meds ‘does what it says on the tin’ it has its claimed benefits.
MA can’t be refused cus there is already another product available with greater efficacy.

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20
Q

What are the quality requirements for meds?

A

Agency must assess whether meds can be produced with sufficient quality assurance.
- Can applicant guarantee:
- SHELF LIFE
- CONSISTENT LEVELS OF ACTIVE INGREDIENT IN EACH DOSE
- LOW DEGRADATION.

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21
Q

What are the 2 documents in the electronic medicines compendium (emc)?

A

2 documents - summary of product characteristics (SmPC)/Patient information leaflet (PIL)

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22
Q

What is an electronic medicines compendium (emc)?

A

’ the electronic medicines compendium (emc) contains up to date, easily accessible information about medicines licence for use in the UK, emc has more than 14000 documents all of which has been checked and approved by either UK or European government agencies which license medicines. These agencies are the UK’ MHRA and the EMA.’

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23
Q

What is a summary of product characteristic (SmPC)?

A

A Summary of Product Characteristic (or SmPC) is a monograph for medicines written and updated by pharmaceutical companies based on their product research and knowledge. It outlines important information about medicines such as form, clinical parameters and pharmacological properties

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24
Q

What are patient information leaflets (PILs) used for?

A

The purpose of patient information leaflets (PILs) is to inform patients about the administration, precautions and potential side effects of their prescribed medication.

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25
Q

What are decentralised systems?

A

Decentralized system whereby MA granted in an individual member of state and is only applied to that member state.

26
Q

Since 31st Dec 2020 EMA no longer have any jurisdiction so who took over the jurisdiction?

A

31st Dec 2020, EMA no longer have any jurisdiction in the UK. Any jurisdiction now the responsibility of the MHRA.

27
Q

What is the automatic conversion known as grandfathering?

A

CAP’s granted by 31st Dec 2020 automatically UK MA’s on 1 Jan 2021, unless holders opted out. Automatic conversion process known as grandfathering

28
Q

What is the criteria for MA to be valid?

A
  • Condition being treated
    • Dose of med
    • Pharmaceutical form
    • Patient groups it’s suitable for.
29
Q

When using unlicensed meds or off-label meds what is imposed on prescribers?

A

Using an unlicensed meds or meds ‘off-label’ doesn’t mean its unsafe, but imposes extra responsibilities on the prescriber and the supplying pharmacist. Only use these if it is appropriate.

30
Q

What is the definition of unlicensed meds?

A

A medicine which does not have a valid MA in the UK is referred to as an unlicensed medicine.

31
Q

What are the 5 principles used for the procurement and supply of specials?

A

1) Establish the optimal treatment for the patient.
2) Understand the patients experience and make a shared decision
3) Identify a preparation and a supplier
4) Monitor the patient and review the need for a special
5) Ensure effective governance is in place.

32
Q

What is the definition of off-label?

A

Off-label means that a medicine is being used in a different way from that described in the MA.

33
Q

MA for medicine conditions include….(4 things):

A

1) Indication for the medicine (what it is intended to treat)
2) Dosage of medicine which has been shown to be effective and acceptably safe.
3) Patient population in which medicine has been authorized (gender, age group, medical status etc)
4) Route of administration

34
Q

A prescriber might prescribe a medicinal product ‘off-label’ if:

A
  • The MA doesn’t reflect new knowledge
  • MA doesn’t include well proven uses.
35
Q

A generic medicinal product means a medicinal product…(3 things):

A

1) Has the same qualitative and quantitative composition in active substances as the reference medicinal product (RMP) that’s to say that product is being compared to
2) Has the same pharmaceutical form as the RMP and
3)Whose bioequivalence with RMP has been demonstrated in appropriate studies.

36
Q

What is a proprietary product and what are prescriber encouraged to do?

A

A proprietary product = branded product
More expensive then generic product so prescribers encouraged to prescribe these instead of the proprietary alternative.

37
Q

What are branded generics?

A

Branded generics are genetic drugs with brand names - may be cheaper than non-branded generics

38
Q

What is a borderline product?

A

Licensing authority determines that an unlicensed product provisionally becomes a medicinal product and is regarded as such.

39
Q

What is an orphan drug?

A

It must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating.
Orphan drugs are medications or other medicinal products used to treat rare diseases or disorders. They are called “orphan drugs” because due to their limited market, few pharmaceutical companies pursue research into such products

40
Q

What is an early access to medicines scheme?

A

The early access to medicines scheme (EAMS ) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

41
Q

What is a parallel import?

A

The UK parallel import licensing scheme lets a medicine authorised in European Economic Area (EEA) Member State be marketed in the UK, as long as the imported product has no therapeutic difference from the cross-referenced UK product.

42
Q

What is a manufactures license?

A

A manufactures license (ML) is required if you wish to manufacture, assemble or import human medicines other from an approved country for import.

43
Q

What is a wholesale dealing?

A

Wholesale dealing refers to the sale or supply of a medicinal product to a person who is not the person who will actually use the medicinal product.

44
Q

What is pharmacovigilance?

A

Safety of all medicines is monitored throughout their marketed life

45
Q

What is the yellow card scheme?

A

Yellow card reports of suspected adverse reactions are evaluated in order to detect previously unidentified hazards or side effects.

46
Q

What kind of registration and authorisation does remedies have?

A

Herbal remedies have to have either a full MA based upon safety, quality and efficacy or a traditional herbal registration (THR)

47
Q

What are the conditions for the licencing of traditional herbal medicines (2 things)?

A

conditions, among others, include:
- that the product has been in medicinal use for a continuous period of at least 30 years (at least 15 years of which must have been in the UK or another country listed by the MHRA)
- that it has been established that the traditional use of the product is not harmful and that the pharmacological effects or efficacy of the product are plausible based on long-standing use and experience

48
Q

What is a herbal medicinal product?

A

herbal medicinal product means a medicinal product whose only active ingredients are herbal substances or herbal preparations (or both)

49
Q

What is a herbal preparation?

A

Means preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation and includes powered herbal substances, a tincture, an extract, an essential oil.

50
Q

What is a herbal substance?

A

Means part of a plant or plant, algae, fungi or lichen or unprocessed exudate of a plant, defined by the plant , either fresh or dried but otherwise unprocessed

51
Q

What is traditional herbal registration (THR)?

A

Where a product has a UK MA or THR as approved by the licensing authority in granting the authorisation or registration?

52
Q

Who came up with homeopathy?

A

Homeopathy uses a system of treatment created by Samuel Hahnemann in the 18th century with no real evidence of efficacy. Strong evidence of placebo effect with homeopathic consultations.

53
Q

What are the 2 main principles of homeopathy?

A
  • ‘like cures like’
  • Diluting a substance makes it more potent
54
Q

What is the Homeopathic remedies registered under? And what does the MHRA require evidence of?

A

Homeopathic remedies are regulated by certificates of registration granted under part 6 of the regulations.
MHRA doesn’t require applicants to prove that the remedy is effective but they do have to demonstrate product quality and safety.

55
Q

What are the 3 legal classes?

A

POM
P
GSL

56
Q

Who is responsible for setting the legal classes of meds?

A

MHRA responsible for setting the legal class of a meds and is specified in the MA for the medicine.

57
Q

Where are GSL’s sold?

A

General sale medicines:
- GSL sold in supermarkets, petrol stations and newsagents.

58
Q

What are the conditions of GSL medications?

A

GSL Conditions:
- Place where the medicine is sold must be premises capable of being closed exclude the public (rules out most market stalls, car boot sales and sales the back of a van)
- Medicine must have been packed elsewhere
The packaging must not have been opened (no split packs)

59
Q

Where pharmacy meds sold?

A

Pharmacy meds:
Meds not available on GSL can only be sold or supplied as a retail sale from pharmacy or under the supervision of a pharmacist.

60
Q

What are the 4 conditions that a POM needs to meet to be valid?

A

POM needs to meet following conditions:
Condition A:
Signed in ink by the appropriate practitioner giving it
Condition B:
Written in indelible ink or otherwise so as to be indelible. (There is an exception for health prescriptions and carbon paper but this is rarely used nowadays).
Condition C:
Must include:
· The address of the practitioner
· The appropriate date.
· An indication of the kind of practitioner giving it
· The name and address of the patient
The patient’s age if they are under 12
Condition D:
Means that a prescription for a POM is valid for 6 months from the date written on it.
This can be the date on which it was written or a later date specified by the practitioner.
NB prescriptions for certain controlled drugs are valid for only 28 days

PPM (5 decks)

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