Manufacturer's and Wholesale Dealer's licences: Changes from August 2006

The reasons for the changes are twofold:

• legislative requirements
• the UK’s implementation of a new format of Manufacturer’s Licence that will be common across the EU.

The major noticeable difference will be for holders of Manufacturer’s Licences and Wholesale Dealer’s (Import) licences where MHRA will  now issue licences in the style of the MIA.  The MIA (Manufacturer’s/Importer’s Authorisation) is the Community Format for Manufacturers Authorisation as defined by the European Medicines Agency (EMEA) and this single licence will encompass those activities previously covered by two licences (the Manufacturer’s and Wholesale Dealer’s (Import) licences).  Furthermore, holders of combined human and veterinary licences will in future be required to hold separate licences, one for human activities, one for veterinary activities; this change is required to comply with changes in veterinary legislation implemented by the Veterinary Medicines Directorate (VMD). 

It is not necessary for any licence-holder to take any action with respect to these changes.  In most instances licences that are currently held will remain valid and the intention will be to only issue licences in the new format when the existing licence is varied (although MHRA may review this position in the future if it becomes clear that the rate of introducing the new licence is too slow via this route).  However, for some licence-holders it will be necessary to issue licences in the new style as soon as MHRA are able and these will be dealt with as a matter of priority.  MHRA are aware of whom these licence-holders are and will take the necessary steps to issue the new style licences; there is no need for any licence-holder to contact MHRA on this matter.

For a few licence-holders the licence they currently hold will no longer be the correct licence for the purpose.  In these circumstances it will be necessary for them to be issued with a new licence of a different type.  Again, there is no need for any licence-holder to contact MHRA on this matter as MHRA are aware of whom these licence holders are and will take the necessary steps to issue the correct new licences.  However, to assist licence holders to understand whether they fall into this category the table below shows what, for any of the existing licence types, the new licence type(s) will be.  Also, as before, existing licences will remain valid until they are replaced by MHRA.

Existing Licence Type Held - Manufacturer's Licences	New Licence Type
	MIA (Human)	MIA (Veterinary)	MIA 'Specials' (Human)	MIA 'Specials' (Veterinary)	MIA(IMP)
	Code MIA	Code ManA	Code MS	Code ManSA	Code MIA(IMP)
Manufacturer's - human only	■
Manufacturer's - veterinary only		■
Manufacturer's - combined human and veterinary	■	■
Manufacturer's (Assembly Only) - human only	■
Manufacturer's (Assembly Only) - veterinary only		■
Manufacturer's (Assembly Only) - combined human and veterinary	■	■
Manufacturer's 'specials' - human only			■
Manufacturer's 'specials' - veterinary only				■
Manufacturer's 'specials' - combined human and veterinary			■	■
Manufacturer's (Investigational Medicnal Products)					■

Existing Licence Type Held - Wholesale Dealer's (Import) Licences	New Licence Type
	MIA (Human)	MIA (Veterinary)	MIA 'Specials' (Human)	MIA 'Specials' (Veterinary)	Wholesale Dealer's (Veterinary)
	Code MIA	Code ManA	Code MS	Code ManSA	Code WDA
Human only - licensed products imported	■
Human only - unlicensed products imported			■
Veterinary only - licensed products imported		■
Veterinary only - unlicensed products imported					■
Human and veterinary - licensed products imported	■	■
Human and veterinary - unlicensed products imported			■		■

Existing Licence Type Held - Wholesale Dealer's Licences	New Licence Type
	Wholesale Dealer's (Human)	Wholesale Dealer's (Veterinary)
	Code WL	Code WDA
Wholesale Dealer's - human only	■
Wholesale Dealer's - veterinary only		■
Wholesale Dealer's - combined human and veterinary	■	■

 

Existing Licence Type Held - Wholesale Dealer's Licences (GSL)	New Licence Type
	Wholesale Dealer's (Human)	Wholesale Dealer's (Veterinary)
	Code WDL	Code WDA
Wholesale Dealer's (GSL) - human only	■
Wholesale Dealer's (GSL) - veterinary only		■
Wholesale Dealer's (GSL) - combined human and veterinary	■	■