Legislation update Flashcards by Alethea Charlton

Medicinal Product (MP)

any substance presenting as having properties of preventing disease in humans OR substance that may be administered in humans with a view to making a diagnosis or restoring modified physiological function by exerting pharmacological/immunological/metabolic action.

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Medicinal products does not include

whole blood or components there of (other than plasma prepared by industrial processes)

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Registered Pharmacy

Pharmacy registered in the register kept under the Health Act

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The Licensing Authority

The minister for health, social services and public safety AND/OR the secretary of stae

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Administer

by injection, oral introduction to the body OR by external application

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Healthcare Professional

doctor, dentist, pharmacist, pharmacy technician, nurse, midwife, optometrist, osteopath, chiropractor, other relevant registered profession (not social workers), registered dental care professional

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Commission in Human Medicines (CHM)

8 minister appointed members, advice on safety, quality and efficiency of medicinal products (pharmacovigilance) and ADR

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British Pharmacopoeia Commission (BPC)

8 minister appointed members that prepare the BP and list of names (headings to monographs in the BP)

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CHM and BPC may appoint their own

Expert Advisory Groups (EAG)

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License is required to

manufacture, import, assemble and possess for the reasons above

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Licence is not required for

a nurse/pharmacist to make-up a medicine on a small scale

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Wholesale Dealing

selling or supplying (or holding for this purpose) to a person who received MP with the intention of selling/supplying/administering/causing it to be administered to humans

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Wholesale Dealing Liscence

Granted within 90 days of application. Valid until surrendered/revoked.

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Notice for revoking a wholesale dealing licence

28 days of immediately for safety reasons

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Requirements for Wholesale Dealing Lisence

appropriate staff, premises, raw materials (fridges, CD safe), informed proposed change to ‘Qualified person’, quality assurance, records, specify to whom products can be sold

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MPs are subject to which legistaion?

Marketing Authorisation
Homeopathic Certificate of Registration
Traditional Herbal Registration
Article 126a Authorisation

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Relevant Medicinal Product

MP that is not a registered homeopathic product or traditional herbal medicine

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Application for marketing authorisation takes… and is valid for…

210 days

5 years

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Application for marketing authorisation considers:

Max daily dose, max single dose, efficacy, positive effect vs health risk

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Expiry for marketing authorisation if product is not put on market?

3 years

Classification of MPs consideres

max single dose, max daily dose, strength, pharmaceutical form, packaging, other circumstances

Why classify as POM

dangerous to health, frequently misused, requires further investigation, prenatally administered, addictive, risk of abuse, diagnostic purposes, hospital treatment, psychotropics and narcotics

GSL

can with reasonable safety be sold or supplied without the supervision of the pharmacist (dependent on pack size)

GSL max pack size for aspirin 75mg

16 (or 28 EC)

GSL max pack size for aspirin

GSL max pack size for paracetamol

16 (or 30 effervescent)

Things that will never be GSL

Eye-ointments, above threshold of vitamin A & D, antihelmetics (for worms), enemas

Homeopathic products are registerable if

oral or external use only, no therapeutic indication appears on label/leaflet, maximum 1 part in 1000 of mother tincture

Traditional Herbals are registerable if

external, oral of inhalation use, no need for medicinal monitoring

126a authorities

allows certain products with no UK MA but authorised EEA to be sold for public health reasons. eg creams with no active

Borderline substances

If licensing authority thinks that a product without MA is a MP. Provisional determination notice given to recipient. eg. Gluten free bread

Exceptions

Certain circumstances unlicensed product may be provided. Records for 5 years. eg. pathogens, radation, toxins, chemical or biological warefare OR prescriber deems license inappropriate and so used alternative, eg melatonin

Pharmacovigilence responsibilities of licencing authority

encourage reporting and facilitation of ADR including dissemination to the public. May lead to withdrawal of MP

EEA Health Professional

dentist/doctor in EEA state (other than the UK & Switzerland)

External use

application to the skin, teeth, oral mucosa, throat,, nose, ear, vagina or anal canal in circumstances where localised action only is necessary and systemic absorption is unlikely to occur.

External does not inlcude

throat spray, nasal spray, nasal inhalation, teething preparations, throat pastillies, lozenges or nasal drops

Patient Group Directive

relates to the sale of MP to the general public, signed by a prescriber and pharmacist

POMs, unless under direction of a prescriber it is illegal to...

sell, supply or administer parenterally (except to self)

Supply of GSL must be from

lockable premises, unopened packaging, made up elsewhere

Supply of P medicines must be from

registered pharmacy, supervision of a pharmacist, person lawfully conducting a pharmacy business

Emergency supply at prescirber request

No vets, no CDs except phenobarbital, Rx within 72h

Emergency supply at the request of a patient

30 days worth maximum, patient must pay

Previously pharmacists could... without a whole sale license

provide wholesale as long as it was a minor % of the business

Pharmacy needs a whole sale licence unless..

occasional, small amount, non-profit, individuals, record 2 years

Packaging must have

Braile, PIL, child resistant, paracetamol and asprin must be white tablets

Advertising that is prohibited

aimed at children, unlicensed, POMs, recommendations by scientists

Water for injection

can be supplied to inflate balloons or catheters, not just for injections

Optimisation of labelling

pharmacists can use professional judgement to change directions on an Rx if considered to be inappropriate