Regulation of Medicines Flashcards
Where can legislation for medicines be found
Human Medicines Regulations 2012, as amended:
- System of licensing affecting manufacture, sale, supply and importation of medicinal products
- Part 3. Manufacturing and wholesale dealing
- Part 4. Requirement for authorisation
- Part 5. Marketing authorisations
- Part 6. Certification of homeopathic medicinal products
- Part 7. Traditional herbal registrations
- Part 9. Borderline products
- Part 10. Exceptions to requirements for MAs etc.
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (removes reference to EU directives)
What is the UKs licencing authority
Medicines and Healthcare products Regulatory Agency (MHRA)
no longer the european medicines agency. 2 year transition period => 31 December 2022
What brought about an increased level of medicines legislation in the 1960s?
The thalidomide tragedy
What are the main objectives of legislation
Safety, quality and efficacy of medicinal products
Withdrawal from use if any inherent danger comes to light
What is covered under the MHRAs legislation
Authorised products and investigational medicinal products (IMP) are covered by legislation
Definitions: Medicinal product Authorised medicinal product Relevant medicinal product What is a borderline product? What about medical devices?
Define meddicinal product
= any substance or combination of substances-
a) presented as having properties of preventing or treating disease in human beings; or
b) that may be used by or administered to human beings with a view to:
i. restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
ii. making a medical diagnosis
Define authorised medicinal products
If product has:
a) Marketing authorisation => medicines
b) Certificate of registration => homeopathics
c) Traditional herbal registration => herbal remedies
Define a relevant medicinal product
A medicinal product that is not—
a) a registrable homoeopathic medicinal product; or
b) a traditional herbal medicinal product; and
They are medicinal products which hold marketing authorisations
Define a borderline substance
A product which it is not easy to distinguish from a medicine, e.g. cosmetics or food supplements, herbal products
However, should any of the above contain
- a pharmacologically active substance or
- make medicinal claims
- claims to treat or prevent disease, or
- to interfere with the normal operation of a physiological function of the human body
They are regarded as medicinal
What are medical devices and what do they need to adhere to legislation
Include sutures, dressings, contact lens care products etc
Mandatory
- UKCA mark:
product marking which can be used for medical devices placed on the Great Britain (England, Wales, Scotland) market (in place of CE mark)
- CE mark:
UKCA mark not recognised in NI. CE or CE UKNI mark for NI
CE mark needed to place in EEA (and beyond)
CE/UKCA mark = manufacturer claims the product is safe and fit for its intended purpose
CE mark is regarded as equivalent to MA
Covered by the Medical Devices Regulations 2002
What stages of medicines development does the legislation cover
Involvement in any of the stages,
- from initial development/ research of an investigational medicinal product (IMP) through to
final marketing of a medicinal product,
A system of licences and certificates is used
Penalties for non compliance
WHich licences are available for medicines
Marketing Authorisation
Certificate of registration
Traditional herbal registration
Manufacturer of Medicines Licence
Wholesaler of Medicines Licence
Clinical Trial Authorisation
What are the 4 phases of clinical trials
Phase 1 - Experimental drug (treatment) in small group of people (20-80) for 1st time
To evaluate its safety, determine safe dosage range, identify S/E
Phase 2 - Experimental drug given to larger group of people actually suffering from the disease (100-300)
To see if it is effective and to further evaluate its safety
Phase 3 - Experimental drug given to large groups of people (1,000-3,000)
To confirm effectiveness, monitor S/E, compare to commonly used treatments & collect information to allow safe use
Phase 4 - Post marketing studies
For additional information, incl. risks, benefits & optimal use
Which lefislation sets out the need for marketing authorisation
Medicines Act 1968:
Products on the market prior to the licensing requirements of the Medicines Act were granted a Product Licence of Right
[Now relatively obsolete]
All relevant medicinal products must have a Marketing Authorisation
(Before 1994: Product Licence)
A relevant medicinal product must be…
… covered by a marketing authorisation
and held by the person responsible for the composition of the product
in the course of a business/profession
So that it can be:
- manufactured or assembled
- imported or exported
- sold or supplied
What are the national routes to obtain a marketing authorisation
National Routes:
- Innovative Licensing and Access Procedure (ILAP)
- National Procedure(150-day procedure) – UK, GB, NI
- Rolling review– UK, GB, NI
- ECDecision Reliance Procedure(67-day procedure)
(For 2 years from 1 January 2021, GB may adopt decisions taken by the European Commission on approval of new MAs through the centralised procedure) - MR/DCReliance Procedure(67-day procedure)
- Unfettered Access from Northern Ireland(67-day procedure) - GB
NB. National applications intended to cover marketing of a product in Northern Ireland must continue to comply with the requirements of Directive 2001/83/EC, the Community code relating to medicinal products for human use, and Regulation 726/2004 on Community Procedures and Supervision of medicinal products
What are the international routes to obtain a marketing authorisation
International routes (collaborative procedures):
- Access consortium- to market a medicine in the UK, Australia, Canada, Singapore and/or Switzerland.
- Project Orbis– programme coordinated by the US Food and Drug Administration (FDA), involving the regulatory authorities of Australia (TGA), Canada (Health Canada), the United Kingdom (MHRA), Singapore (HSA) and Brazil (ANVISA) to review and approve promising cancer treatments.
In addition to the above procedures, the following procedures can be used to obtain a marketing authorisation in Northern Ireland:
Northern Ireland may be included indecentralised or mutual recognition procedure as a Concerned Member State (CMS)
Marketing authorisationsapproved in the European Union centralised procedurewill automatically have effect in Northern Ireland
When can the MHRA reject a proposed medicine name
MHRA can reject any name => if it considers that the name: Will cause confusion Is misleading Or is otherwise unsafe
An application for UK Marketing Authorisation (MA) must include
www.legislation.gov.uk/uksi/2012/1916/schedule/8/made
lots of things…
What is the UK?
What is great britain?
UK - United Kingdom (UK) is made up of England, Scotland, Wales and Northern Ireland.
GB - Great Britain is the official collective name of of England, Scotland and Wales and their associated islands. It does not include Northern Ireland
When are marketing authorisations granted
Issued if licensing authority satisfied that
Product is safe and efficacious
Facilities for manufacture and quality control are adequate to ensure conformity with specifications
Initially granted for period of 5 years
Must be renewed on expiry
On renewal, must include up to date knowledge and any necessary action
Variations to MAs are common for new products
What must the MA holder keep the licencing authority up to date on
Proposed changes in the product or procedures
Fresh information affecting validity of data on which licence was granted
What must the MA holder keep records of
Any adverse reports
All sales/ supplies
Sources of all materials
Documents that will facilitate withdrawal or recall
=> And produce a periodic safety update report (PSUR)
What are the rules around off label medicines being used in children
The paediatric population ranges from pre-term newborns to adolescents
i.e. it is not homogeneous
Clinical trials for medicinal products are required for each age group
Ethical concerns in paediatric population
Most medicinal products with a MA have only undergone clinical testing in adults
Therefore their use in children is unlicensed or off-label
Which regulations surround the use of medicines in children
EU regulations (HMRs 2012) aim to increase the availability of specially adapted medicines for use in paediatric population
Requirement for paediatric data based on a Paediatric Investigation Plan (PIP)
New category of MA
EU: Paediatric Use Marketing Authorisation (PUMA)
