regulatory requirements for medicinal products and devices Flashcards
Application for UK marketing authorisation
the a
applicant must be established in the United Kingdom.
the applicant must be - made in writing , signed by or on behalf of the applicant ; and unless the licensing authority directs otherwise , accompanied by any fee payable in connection with the application.
an application is treated as signed for the purposes of paragraph if it is signed with an electronic signature
the application any accompanying material must be in English
the application must include a statement indicating whether the product to which the application relates should be available - only on prescription, only from a pharmacy; or only on general sale
the application must include a statement indicating whether any terms of the authorisation are proposed relating to the method of sale or supply of the product and if so what terms are proposed.
Marketing authorisation - MA
marketing authorisation is essentially a licence to place a medicinal product on the market to be used by patients. all pharmaceutical companies legally require marketing authorisation for every product that they wish to sell and can obtain marketing authorisation only once an application has been submitted and approved
definition of a medicinal device
a medical device means any instrument , apparatus , appliance , software , implant, reagent , material or other article intended by the manufacturer to be used, alone or in combination , for human beings.
marking of medical devices
The UKCA mark is a product marking which can be used for medical devices placed on the uk market. UKCA Is not recognised in N.I instead they have a CE
what is the role of the health products regulatory authority
to protect and enhance public and animal health by regulating medicines , medical devices and other health products . they also monitor the safety of cosmetics
main responsibility of the European medicines agency
the protection and promotion of public and animal health , through the evaluation and supervision of medicines human and veterinary use
exceptions to requirement for marketing authorisation
hmr 167
the prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product if-
(a) the medicinal product is supplied in response to an unsolicited order
(b) the medicinal product is manufactured and assembled in accordance with the specification of a person who is a doctor dentist nurse independent prescriber pharmacist independent prescriber or supplementary prescriber
(c0 the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient and
(d) the following conditions are met
unlicensed medicine
a medicine without a current UK marketing authorisation
guidance for pharmacists on receipt of a prescription for an unlicensed medicine
check if there is a suitable licensed alternative available
contact prescriber to check indication, dose and other relevant information
advise patient regarding unlicensed status of the prescribed medicinal item and ensure their undestanding of its use
place the order with a specials supplier or prepare the item extemporaneously , if appropriate
keep appropriate records
ensure all prescriptions for unlicensed medicines are endorsed accurately according to the drug tariff and specials tariff rules
off-label medicine
medicine which has a MA but which is prescribed outside the terms of the MA. such practice is particularly common in prescribing paediatrics where difficulties in the development of age appropriate formulations means that many medicines used in children are used off label
onus of liability
use licensed alternative where possible
asses the risk/ benefit
establish local policies to ensure
a) pharmacist/prescribers are informed of potential consequences
b) doctors notify pharmacists if they prescribe off-label or unlicensed medicines
c) patient consent is obtained
d) use of medicine is researched appropriately using BNFC
what is clinical governance
clinical governance is a system through which NHS organisations are accountable for continuously improving the quality of their services and safe guarding high standards of care by creating an environment in which excellence in clinical care will flourish
policies and procedures
process for prescribing, ordering , procurement , supply and administration should be protocol driven and reviewed regularly. Risk assesement of unlicensed medicine use, suppliers and reporting of adverse events .
patient information must be adequate and appropriate to the indication and available in English .
clear audit trail and record maintained of all unlicensed medicines procured and supplied
regular review of unlicensed medicine use
purchasing for safety , ensure quality of unlicensed medicines and the integrity of the supply chain.
SOPS and records
request for use and purchase of a new unlicensed medicine including risk management via prescriber and patient Informed consent .
>approval to purchase
>agreement of the product specification
>purchasing procedure using lists of approved suppliers and supporting documentation
>receipt and storage of unlicensed formulations
>approval and release of unlicensed medicines
Risk assessment - low risk
purchased from trusted manufacturer or licensed in EU
obtained from a trusted specials manufacturer
commonly prepared extemporaneous or topical dermatological preparation
routinely prescribed in children (BNFC)
Risk assessment - medium risk
licensed preparations used outside licensed indications
UK license has never been sought
extemporaneously prepared products with limited stability information available to justify their shelf life and / or lacking in other evidence to support clinical use
Risk assessment - high risk
withdrawn from UK on safety grounds
manufacturer outside of EU
preparations with signification clinical risk
preparations which pose a risk to the staff administering them
preparations that are imported but which are unlicensed or extemporaneously prepared In their country of origin
compliance with risk assessment
perform risk assessment for all unlicensed medicines requested or supplied
keep adequate records
report suspected adverse drug reactions to the MHRA
report defective named patient medicines to the MHRA
ensure the patient receives a PIL or adequate written information in English
ensure SOPS for handling unlicensed medicines are in place
audit use of unlicensed medicine use or procedure
responsibilities of prescriber
only prescribe if alternative licensed product is unavailable
understand that prescriber is professionally accountable
ensure patient/ carer are well informed on named patient medicine, risk and adverse effects
obtain written consent
patient notes must reflect use of named-patient medicine and indication for use
report suspected adverse drug reactions to the MHRA
should continued prescribing be necessary the initiating consultant should liase with the GP to obtain agreement to continue to supply
key considerations when dispensing unlicensed medicines
source of named- patient medicine - are they reputable , reliable supplier
supply chain - is it robust
does supplier have an appropriate license
where is the medicine manufactured
medicine potential for adverse drug reactions
contra-indications, monitoring requirements
QC demonstrated by certificate of analysis
written information supplied with medicine
record of receipt and supply - continuity of supply
record keeping - pharmacist
product name and specification
manufacturer and supplier
date quantity ordered
batch number
source
person to whom product was supplied
date/quantity of supply
prescribers name
