Licensing Flashcards
What is licensing ?
It is Illegal to manufacture, sell , supply, export or import… without a licence, certificate or exemption
What is a medicinal product ?
Something that prevents or treats or aids the diagnosis of disease in humans
What are the different application procedures for licensing ?
Centralised: EMA (European medicines agency)
National: (MHRA)
What happens when a licence is approved for a medicinal product?
MA allocated enabling the sale, supply, import and export of product
What do you need to demonstrate in order to get a MA for a product?
- Safety, quality and efficacy
2. Summary of product characteristics
How long is a MA valid for ?
Up to 5 years.
after renewal, valid indefinitely
If there is a problem with the product what can the MA do?
Revoke, suspend or vary a licence at any time
What are borderline products?
Products that can may or not be a medicinal product
What is advisory committee on borderline substances (ACBS)?
Products used / formulated for use in medical conditions
When is a manufacturing licence required ?
manufacturing and Assembling relevant products
ML only authorises the manufacture if :
- the licence holder also has the MA, or
2. the licence holder is making it to the order of the MA
What is wholesale dealing (wholesale dealers licence) ?
Sale of medicinal product to a person who buys it to:
- sell and supply to someone else
- Administer/ cause to be administered to someone else
What is product licence (parallel import) ?
Use medicines from european contries and import them into the uk.
Must have the UK
version of the products
