Legislation update Flashcards
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.
Medicinal products does not include
whole blood or components there of (other than plasma prepared by industrial processes)
Registered Pharmacy
Pharmacy registered in the register kept under the Health Act
The Licensing Authority
The minister for health, social services and public safety AND/OR the secretary of stae
Administer
by injection, oral introduction to the body OR by external application
Healthcare Professional
doctor, dentist, pharmacist, pharmacy technician, nurse, midwife, optometrist, osteopath, chiropractor, other relevant registered profession (not social workers), registered dental care professional
Commission in Human Medicines (CHM)
8 minister appointed members, advice on safety, quality and efficiency of medicinal products (pharmacovigilance) and ADR
British Pharmacopoeia Commission (BPC)
8 minister appointed members that prepare the BP and list of names (headings to monographs in the BP)
CHM and BPC may appoint their own
Expert Advisory Groups (EAG)
License is required to
manufacture, import, assemble and possess for the reasons above
Licence is not required for
a nurse/pharmacist to make-up a medicine on a small scale
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
Wholesale Dealing Liscence
Granted within 90 days of application. Valid until surrendered/revoked.
Notice for revoking a wholesale dealing licence
28 days of immediately for safety reasons
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
MPs are subject to which legistaion?
Marketing Authorisation
Homeopathic Certificate of Registration
Traditional Herbal Registration
Article 126a Authorisation
Relevant Medicinal Product
MP that is not a registered homeopathic product or traditional herbal medicine
Application for marketing authorisation takes… and is valid for…
210 days
5 years
Application for marketing authorisation considers:
Max daily dose, max single dose, efficacy, positive effect vs health risk
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
30
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
