Marketing Authorisation Flashcards
True or false, all relevant medicinal products must have a marketing authorisation?
True
How long are MAs initially granted for?
5 years
What is an MA needed for?
In order for the drug to be manufactured, assembled, imported, exported, sold and supplied
What must the renewal of an MA contain?
Up to date knowledge and any necessary actions to be taken
What must the application for an MA include?
Name and address of applicant and manufacturer, name of medicinal product, detailed specification of product and its constituents, evaluation of potential environmental risks, methods of manufacture and quality control, therapeutic indications, contraindications, data on compatibility, clinical studies of safety and efficacy, pharmacovigilance system, SPC, package, leaflet and proposed legal category.
What are abridged applications for MAs used for?
Generic medicinal products
What must an abridged application for an MA include?
Bioequivalence must be demonstrated, same formulation, same qualitative and quantitative composition of active substances
True or false, an MA holder must produce a periodic safety report?
True
What must be included in the records kept by an MA holder?
All sales/supplies, reports of adverse reactions, sources of all materials, documents that would facilitate withdrawal/recall of product
True or false, the MHRA can reject names if they are confusing, misleading or unsafe?
True
In which case is a medicine likely to be used off licence?
In children
Who granted the new category of MA for children?
The EMA
What is the name of the new category of MA for children’s products?
PUMA (paediatric use marketing authorisation)
Name the first ever medicine to hold the PUMA licence and give its use
Buccolam (buccal midazolam) for severe convulsions and epileptic seizures
