Law and Admin Flashcards
Name the 6 layers of the law and guidance hierarchy from 1 to 6
- Law e.g UK acts and Statutory instruments
- Regulatory guidance e.g Eudralex, ICH guidance
3.Consensus standards e.g standards from recognised organisations (ISO, BSI, etc.) - Interpretation e.g. inspection findings
- Professional guidance e.g PDA
- Company policies and procedures
To legally offer a medicinal product for sale relevant government(s) must issue a….?
Marketing Authorisation
How many products can be listed on a marketing authorisation?
One, an MA must be obtained for each product
Marketing authorisations are granted on the basis of evidence of?
Safety
Quality
Efficacy
What are the four powers of government so with respect to Marketing authorisations?
Governments may:
Grant
Refuse
Revoke
Vary marketing authorisations
Marketing authorisations are known in the EU as?
MA marketing authorisations
Marketing authorisations are known in the UK as?
PL Product Licence
The four types of marketing authorisations in the US are
NDA new drug application
ANDA abbreviated new drug application
NADA New Animal Drug Application
BLA Biologics License Application
What is Module one of the Marketing authorisation and why is it unique?
It contains regional administrative information and is not part of the Common Technical Document (CTD)
What is included in Module 2 of the Marketing authorisation of the CTD
Quality overall summary
Non-Clinical overview
Non-Clinical summary
Clinical overview
Clinical summary
Quality is Module …. Of the common technical document
3
Module 4 of the CTD is?
Non-clinical study reports
Module 5 of the CTD is
Clinical study reports
Manufacturers of medicinal products must hold a?
Manufacturing/Import authorisation (MIA)
Manufacturers must demonstrate what in relation to their MIA?
Proper conditions including adherence to GMP
Manufacturers must name a what on their MIA
QP
Distributors must hold a what?
Wholesale Distribution Authorisation (WDA)
Holders of a WDA must name a?
Responsible Person (RP)
Investigational Medicinal Products require a?
CTA clinical trial authorisation
What does PIC/S stand for?
Pharmaceutical inspection cooperation scheme
If using an alternative method to a Pharmacopoeial standard what must they often be described in?
Regulatory submissions
If including an alternative method to a pharmacopoeial standard what must be demonstrated?
Equivalence or improvement over the pharmacopoeial standard
For what length of time must pharmaceutical preparations comply with the relevant Pharmacopoeia?
Throughout shelf life
When can secondary reference standards be used for routine analysis
When calibrated agains pharmacopoeial standards
What does ICH stand for?
International Council for Harmonisation
What are the ICH working groups?
Quality
Safety
Efficacy
Multidisciplinary
Eudralex volume 4 contains
GMP for medicinal products for humans and veterinary use
Eudralex volume 9 contains
Pharmacovigilance for human and veterinary use
Eudralex volume 10 contains
Guidelines for clinical trials in humans
In the EU human medicines legislation is included in which legislation?
Directive 2001/83/EC
In the EU Reg. 536/2014 covers what?
Clinical trials
In the EU Regulation 2019/6 covers what?
Veterinary medicines
In the EU GMP and inspection for IMPs is covered under
Reg. EU 2107/1569
Regulation 536/2014 covers
EU clinical trials
What is the legal duty of the QP stated within Regulation 536/2014
To ensure compliance with GMP
Regulation 2017/1569 covers GMP for what?
IMPs
Article 12 of regulation 2017/1569 covers QP responsibilities. What are they?
Imported products are to be made in accordance with GMP equivalent to EU GMP for IMPs
Manufacturing is to be compliant with the CTA
Certification is recorded in a register or equivalent
What is a type 1A variation
Do and tell
What is a type 1 b variation
Tell, wait and do
What is a type 2 variation?
Tell and wait for approval
What is a type 4 variation
Urgent safety restrictions
Where would you find the UK legal duties of the QP?
SI 2012/1916 Schedule 7 Part 3
What are the conditons required to release batches from an MRA country without retesting?
A CoA with EU MA test results has to be supplied
You must perform an identity test
You must vary MA to name exporting site as the site of QC testing
QP certification is still required
Define a Class I EU recall
The defect presents a life threatening or serious risk to health
Communicated via a rapid alert system
Define a class II EU recall
The defect may cause mistreatment or harm to the patient but it is not life threatening or serious
Communicated via a rapid alert system
Define a Class III EU Recall
The defect is unlikely to cause harm to the patient and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification
Not communicated via a rapid alert system
Which Regulation number is the EU Medical Device Regulation?
2017/745
Which UK statutory instrument covers Medical device legislation?
SI 2002/618
State the number of the EU falsified medicines directive
2011/62/EU
Which schedule of SI 2012/1916 covers Qualified persons
7
ICH Q1 covers
Stability
ICH Q2 covers
Analytical Validation
ICH Q3 covers
Impurities
ICH Q4 covers
Pharmacopoeias
ICH Q5 covers
Quality of biotech products
ICH Q6 covers
Specifications
ICH Q7 covers
GMP for APIs
ICH Q8 covers
Pharmaceutical Development
ICH Q9 covers
Quality Risk Management
ICH Q10 covers
Pharmaceutical Quality System
ICH Q11 covers
Development and manufacture of APIs
ICH Q12 covers
Lifecycle management
ICH Q13 covers
Continuous manufacturing
ICH Q14 covers
Analytical product development
Give the number for the Human Medicines Regulations
2012/1916
Give the number for the Human Medicines Regulations
2012/1916
What are the legal duties of the QP according to Annex 16 of Eudralex volume 4
Ensure certification is permitted under the terms of the Manufacturer/ Import authorisation, Marketing Authorisation or Clinical Trial authorisation
Ensure any additional requirements of national law have been met
Certified in a register which is available for inspection and up to date
Where would you find the legal duties of the QP?
Eudralex Volume 4 part1 chapter 2
