Licenscing Flashcards
What are the requirement for getting a manufacturers licence? ML
EPQ
appropriate equipment, facilities, and suitably trained staffs
All products are up to the standards by EC guide to good manufacturing practice
Quality assurance to ensure QSE or product
How often does MHRA inspect manufacturer site?
At least every 2 years
What does wholesale dealing cover? And give an example (practitioners)
Covers sale of mp to a person who buys the product for the purpose of sale to someone else
Sale of mp to a medical practitioner for use in their practice
What are the area the wholesale dealers licence primarily concerned with?
1 Identification of the distributor
2 Suitability of the premises used for storage and distribution and stick control
3 Wholesalers are inspected BEFORE WDL, and once during 5 year or the licence
4 Whilesale dealer GSL available
What 3 licences are issued by MHRA?
1) ml
2) Clinical trial authorisation
3) WDL
How long does Ma last in first run?
Valid for 5 years
-renew, unlimited, up to date data supplied
What type of Med usually require a MA? Why?
Pom
Because it’s subject to Pharmacovigilance (black triangle drug and yellow card reporting)
Every mp must have -
SPC summary of product characteristics - data sheet
Label
Pil
What’s parallel import licence (PLPI) and what licence must a importer hold?
Parallel import licence allows mp with Ma to be bought in one European member state and sold in another.
WDL (import), ml (repackaging +relabel in English)
What are the 2 senarios where a manufactures special licence is exceed?
1) when a product is specially manufactured or imported for the treatment of individual patient after ordered by a doc, dentist, nip, pip, supplementary p
2) when manufacture makes an unlicensed mp
From April 201 all herbal med are required to have licences, what are the name of the two?
1) traditional herbal registration THR
2) MA for licensed herbal medication
What licence does a homeopathic med must have?
Homeopathic certificate of registration
