Flashcards in Law and Ethics Year 1 Law And Legislation Lectures Deck (87)
What is Tort?
a wrongful act for which someone can be sued for damages in a civil law court,
Eg a dispensing error, mis-diagnosis, inappropriate prescribing
What is judicial precedent?
When a case is decided in higher courts, lower courts have to follow the decision
What is the misuse of drugs act in terms of legislation?
It is an act of parliament
You can get orders, regulations and rules within this act
What triggered the Medicines Act to be developed?
Required to regulate medicinal products following the Thalidomide tragedy
Medicines act was adopted to cover the process for manufacture, marketing, and supply of medicines in the UK
Updated: human medicines regulations 2012, regulates medicines by licensing!
When is a manufacturing Liscence not needed?
Not needed by a person who imports a medicinal product for personal use
Manufacturing Liscence doesn't apply to mixing of medicines
What products need a marketing authorisation (/product licence?)
Needed for every medicinal product before being prescribed/ sold.
What licences are needed for a medicinal product?
Clinical trial authorisation
Manufacturers authorisation (Manufacturing license = Manufacturing authoriSation)
Wholesale dealers licence
all these are issued by the MHRA
Manufacturers license needed to MAKE a medicinal product.
What's a manufacturers licence needed for?
Any medicinal product in the uk needs to be produced on a Site that holds an appropriate manufacturers licence.
Needed for production of products to be given to public
(needed to make or import a medicinal product, and to possess and medicinal product for any activity)
What's a Clinical trial authorisation needed for?
Needed for new products under development
Needed before being tested on humans
Who needs a wholesale dealers licence?
Any company/ individual wishing to wholesale dale (selling, supplying)
All medicinal products in the EU must hold a wholesale dealers licence
Needed for distribution to patients stage
What is quality, when assessing products quality?
A products physical, pharmaceutical and biological characteristics to ensure that each batch of this medicine is capable of performing reliably and consistently
An assessor will evaluate the safety, Quality and Efficacy of a product, who can they seek further advice from?
CHM or EAG
They may advise to licence or refuse
What does a marketing authorisation allow the holder to do?
Sell, supply, export the Medicinal product (MP), and obtain the money for this.
Allows them to carry out the manufacture or assembly of the MP for sale, supply and export
Also allows them to import the Medicinal product
The holder of the MA is either the manufacturer or the person who orders the product to be made
How long is a marketing authorisation valid for?
Up to 5 years initially
What class are new medicines usually?
How long have the manufacturer got to get the product on the market after granting of a marketing authorisation?
Must be on market within 3 years of the granting of the marketing authorisation
What four systems are used to register medicines in Europe?
In the UK, what body can medicines be registered to?
In the UK medicines are registered via the MHRA
This application for a licence will be for a licence only in the UK
For medicines to gain licence across the EU, who must they apply for a licence via?
One single application is made to the EMEA
One single European Authorisation is granted by EMEA
Also: national for only one country in EU, decentralised, and mutual recognition systems
What medicines will ONLY be licensed via a European Authorisation, so that they are guaranteed to be available to every EU member state?
• Gene therapies
• Medicines for HIV/AIDS, cancer, diabetes, Altzheimer’s
• Orphan drugs (medicines for rare diseases, occurring in less
than 5 in 10,000 people)
What three types of products are Marketing Authorisation applications done for?
New active substances
Biological and biotechnology products
Abridged products such as Generics, Existing drugs with new route, form or indication, Existing drugs in new combinations, and ‘well established’ drugs and products
What must every medicinal product dispensed have?
Summary of Product Characteristics (SmPC)
What is a Summary of product characteristics document?
A Legal document containing factual information about an MP based on data generated during the development of the product
What must a Summary of Product characteristics document include?
Name, strength and pharmaceutical form.
Qualitative and quantitative composition
Name of UK MA holder
Number of UK MA, etc, etc.
Any product being manufactured must have a Marketing authorisation.....
Otherwise there would be no point in manufacturing it as you wouldn't be able to sell it! The MA must be held by the manufacturer or the person ordering the manufacture of the product.
Who is a site of manufacture of Medicinal products inspected by?
Site inspected at least every two years
Products need to be manufactured to the standards detailed by the EC guide to Good manufacturing practice
What does a parallel import licence allow?
It allows medicinal products with a marketing authorisation to be bought in one European Member State and sold in a another.
The product cant be a vaccine, toxin, blood product, radioactive,or homeopathic.
Product must have a European MA, is a version of a product that hold a UK MA, and have the same therapeutic effect as the UK product. Must have a PIL in English
What does a WHOLESALE DEALERS licence EXCLUDE?
Pharmacy supplying to a healthcare professional for administration
Pharmacy supplying to a patient
Supply by one hospital to another in the same trust
Supply by a hospital pharmacy to a ward for administration to a patient
But it DOES include; sale of a medicinal product to a doctor to give to his patients, and this hasn't come from a pharmacy
What do phase 1 clinical trials involve?
Usually involve healthy people, to try and find out how the medicine works in the body.
Usually less than 100 people