Law - Semester 2 Flashcards
Which regulations determine licensing requirements?
HMR
Which aspects of medicines does licensing affect?
Manufacture
Sale
Supply
Importation
Which bodies can provide licensing for medicines?
Medicines and Healthcare products Regulatory Agency (MHRA)
European Medicines Agency (EMA)
What are the objectives of legislation surrounding licensing?
- Efficacy, safety and quality of medicinal product
- Withdrawal of the product should any danger be discovered
What medicinal products are covered by licensing legislation?
- Authorised medicinal product
- Investigation medicinal products
Which stages does licensing legislation cover?
Initial development and research through to final marketing
What are the different types of licenses or certificates?
Marketing authorisation Certificate of registration Traditional herbal registration Manufacturer's license Wholesale dealers license Clinical trial authorisation
Describe the three stages of clinical trials
- Drug given to small groups - Evaluating safety, therapeutic range and side effects
- Drug given to a larger group - Testing efficacy and safety
- Drug given to even larger group - Increased safety, confirm efficacy, monitor side effects. Compare to other common treatments
What is a marketing authorisation and who must have one?
- Allows the sale, supply, import and export of a relevant medicinal product
- Must be held by the person in charge of the product manufacture
What must an application for a marketing authorisation contain?
- Name and address of applicant (and manufacturer)
- Name of product and specification
- Evaluation of environmental risks
- Method of manufacture and quality control
- Indications, contraindications, compatibility and clinical studies data
- Pharmacovigilance system
- Product characteristics, package and leaflet
- Proposed legal category
What type of products may require application for a marketing authorisation?
- New active substances
- Generic medicinal products
- Biological/Biotechnology products
What is important for a marketing authorisation to be granted?
- Product determined safe and effective
- Manufacturing/quality control facilities must be adequate
How long is an initial marketing authorisation valid for?
5 years
What should be continuously relayed to the licensing authority for renewal of a marketing authorisation?
Changes to products and procedures
Any new information
What records must a marketing authorisation holder have?
- Adverse reports
- Sales and supplies
- Sources of materials
- Any document that will support product withdrawal
What must a marketing authorisation holder produce regarding safety?
Periodic safety update report
When may a product name be rejected by the MHRA?
if name is misleading, could cause confusion or is generally unsafe
In what patient group are unlicensed medicines used and why?
Children - medicinal products generally only have clinical trials in adults due to ethical issues
How do clinical trials for paediatric medicines differ to adult clinical trials?
Clinical trials for every age group within paeds
What are the EU regulations to increase availability of medicines for paeds?
- Paediatric investigation plan
- Paediatric use marketing authorisation
What legislation sets out the labelling requirements for relevant medicinal products?
HMR and Misuse of Drugs Regulations
What are the requirements for labelling medicinal products?
- Easily legible and comprehensible
- Indelible
- English only or English PLUS other languages
- Braille on outer packaging and PIL for blind patients
What are the outer and immediate packaging requirements?
- Name, strength and formulation of medicinal product
- Patient group intended
- Name and amount of active substance
- Pharmaceutical form by weight/volume/no. of doses
- List of excipients that have an effect (all excipients if injectable, topical or eye prep)
- Method and route of administration
- Prescribed dose (if appropriate)
- Children statement and cautionary warnings
- Expiry date
- Storage/disposal instructions
- MA holder name and address, MA number
- Batch no
- Instruction for use
- Classification
- NO PROMOTIONAL STYLE INFO
What must a blister pack contain?
- Name, strength and formulation of RMP
- Who the product is for (if appropriate)
- Name of active substance
- Name of MA holder
- Expiry date and batch no