Regulation of Medicines Flashcards
Where in legislation is ‘Medicines Regulations’ set out?
- Under the HMR 2012 regulations (Secondary Legislation)
- These regulations sit under the Medicines Act 1968 (Primary Legislation)
You want to bring a new product onto the market, which licensing agencies do you have to get a license from?
- MHRA
- European Medicines Agency (EU) - once a product is licensed under this agency, it is harmonised across all EU countries and is therefore licensed in all of those countries
Under this legislation, which products are covered?
Both Authorised and Investigational Medicinal Products (ones that haven’t gone to market yet)
- Medicinal Product
- Authorised Medicinal Product
- Relevant Medicinal Product
- Borderline Product
- Medical Devices
What is a ‘medicinal product’?
Any substance/combination of substances:
- that present as having properties of preventing or treating disease in human beings OR
- that may be used by or administered to a human being with a view to restoring/correcting/modifying a physiological function by exerting a pharmacological/immunological/metabolic action OR
- that make a medical diagnosis
What is an ‘authorised medicinal product’?
a product with a form of license
- Medicines = Marketing Authorisation
- Homeopathies = Certificate of Registration
- Herbal Remedies = Traditional Herbal Registration
What is a ‘relevant medicinal product’?
a medicinal product that is NOT a
- registrable homeopathic medicinal product OR
- traditional herbal medicinal product
BUT does hold a marketing authorisation
What is a ‘borderline substance’?
a product which is not easy to distinguish from a medicine but if:
- has a pharmacological active substance
- makes medicinal claims
then it is regarded as MEDICINAL
- this can include things like cosmetics/food supplements etc.
What is a ‘medical device’?
these are covered by the Medicines Devices Regs that sit under the Medicines Act
European Conformity Mark (CE) - the equivalent to a marketing authorisation
- this means that the product complies with all of the legislation requirements of the EU directives and is safe/fit for purpose
What are the licenses/certificates available for covering all stages of the products development and marketing?
- Marketing Authorisation (inc. relevant medicinal products)
- Certificate of Registration (homeopathic)
- Traditional Herbal Registration
- Manufacturers License
- Wholesale Dealers License
- Clinical Trial Authorisation
What is a ‘clinical trial authorisation’?
allows for the following to occur, as the product does not yet have a license - but evidence needs to be submitted to the MHRA to obtain one
- Phase 1: small groups of HEALTHY volunteers
- Phase 2: a bigger group
- Phase 3: people that have the condition
After being given a license (being able to go on the market)
- Phase 4: post marketing studies - for the rarer size effects
What is ‘pharmacovigilance’?
a close surveillance of new products on the market, where rarer side effects may show up
may not have been possible to see these before going to market as the trial groups may not have been large enough
new substances on the market have a black triangle next to them in the BNF
new substances brought onto the market are always classified as POM
What is a ‘marketing authorisation’?
ALL relevant medicinal product have to have an MA under the Medicines Act 1968
Pharmaceutical Companies apply for an MA through the MHRA - which then make decisions based on efficacy and safety of the product and if the manufacturing process complies with all of the specifications
The MA has to be held by the person responsible for the composition of the product in the course of a business/profession
A product has to be covered by an MA in order to be:
- Manufactured/Assembled (may be in different sites)
- Imported/Exported
- Sold/Supplied
Types of MA applications made to the MHRA?
- New Active Substances
- Abridged Applications
- Biological and Biotechnology Products
Abridged Applications - GENERIC products being made once a patent is over on a drug. Don’t have to supply all of the same information as you would if it was a NEW substance. You just have to prove that the product is BIOEQUIVALENT to that on the market already.
Doesn’t apply to epileptic drugs - you cannot just switch brands
How long are MAs valid for?
MAs are initially granted for 5 YEARS, and then have to be renewed
Upon renewal, the next application must include any up to date knowledge and any action necessary about the product.
Up to date knowledge (the MA holder must keep the MHRA updated on:)
- proposed changes in the product or procedures
- any fresh information that affects the validity data from when it was first applied for
What records must the MA holder keep?
- Adverse Reports
- All sales and supplies
- Sources of all the materials to make the product
these documents can then facilitate the recall of any batches that may need to come back
