Medicines Licence And The FMD Flashcards
What are the types of licensing (3)
Marketing authorisation
Manufactures authorisation
Wholesale dealers license
When do you need a marketing authorisation
When any sale and promotion occurs
This applies to all medical products except those made extemporaneously e.g. ointment made in pharmacy
Who gives out marketing authorisation
MRHA (medicines and healthcare products regulatory agency)
They do this by a decentralised and mutual recognition system ( this means that a product can get an MA across Europe and have it given by one agency)
In Europe it is the European Medicines Agency (EMA) via a centralised system
What occurs when licensing a medicine
Specially trained panel of medicines assessors review the available evidence about medicines
This evidence comes from pre-clinical trials, additional info from manufactures
MRHA also inspects factory where the medicine is made to ensure uniform and consistent high standards
Why is licensing important
SAFTEY- the medicine is safe for its intended use
EFFICACY- that the medicine world as it is supposed to
QUALITY- medicine meets appropriate standard
So non of these factors are influenced by cost effectiveness or value of the medicine
What do MA cover
All main activities associated with marketing and use of product
Indication Dosages Recipients Cautions Route of administration
What does off-license mean
This is usage outside the terms of the marketing authorisation
I.e. selling or prescribing the product other than in accordance with the terms of the MA
This is permitted but there are legal risks if it goes wrong
What is a manufactures authorisation
This allows companies to manufacture or assemble human meds and import them from a non-EEA country
Companies must comply with EU good manufacture practise
Premise inspected by MRHA, these are regular inspections
When do you need a wholesale dealers license
1) sell or offer to sell any medicine by way of wholesale dealing
2) distribute, or sell any medicinal product, ready made VMP or industrial produced medicine is which has been imported but was not co-signed from a member state of the EU
Only licensed medicinal products can be sold via wholesale dealing
What are the Wholesale dealing exemptions
1) by a MA holder to sell there own products
2) by a person who only transports the medicinal product
3) those who solely transport the products outside of the EEA
What is the FMD
FALSIFIED MEDICINES DIRECTIVE Came into Europe 2013
Introduces measures to prevent the entry of falsified medicines into the legal supply chain
The directive now covers businesses that weren’t covered by medical law
Brokers now need a license
What is a falsified medicinal product
It’s identity including its packaging and labelling, its name or compositions (or any other unintentional defects) are falsely represented
It’s source including manufacture, country of origin and MA holder is false
It’s history including the records and document relating to the distributions channels used
What is the common EU logo
A common EU logo has been designed which must appear on the website if all legitimate retailers of medicines across the EU
All such sites must have the logo in place form 07/15
Clicking on the logo links the purchaser to the National competent authority (MRHA in UK)
What are some of the FMD safety features
Seal on outer pack to indicate weather there has been any tampering
Unique identifier which will enable individual packs to be identified, this can be checked via a independent database
What will the unique identifier consit of
PRODUCT CODE- the name , strength, form, pack size and pack type
SERIAL NUMBER- randomised numeric or alphanumeric sequence of upto 20 characters
NATIONAL REIMBURSEMENT NUMBER-not in uk
BATCH NUMBER
EXPIRY DATE
The EU thinks this can be done by 02/19
