Periodic fees from 1 April 2012 - Per licence per fee period
Type of licence
Fee £
New active substance 1
23,025
Derivatives with a different route of administration 1 or complex abridged 2
9,481
Other derivatives 1
6,400
Legal status/sale category
Fee type - see note 3
Fee £
POM
Standard fee*
2,371
Reduced rate fee
1,183
'Maintenance' fee
300
P
Standard fee
300
Reduced rate fee
300
'Maintenance' fee
300
GSL
Standard fee
300
Reduced rate fee
300
'Maintenance fee'
300
PLPI
Standard fee
300
None
Standard fee
300
Reduced rate fee
300
'Maintenance fee'
300
Type of licence
Fee £
Herbal
75
Homeopathic and Anthroposophic PLRs (per PLR)
75
Simplified Homeopathic Registration
0
National Rules Homeopathic Authorisation
75
Manufacturer's licence
457
Wholesale dealer's licence
281
Wholesale dealer's licence (reduced rate or GSL)
168
Clinical trials authorisation
342
THMPD registration
75
Notes:
Payable for first five complete fee periods following the year of grant. Includes Reduced Major Drugs with turnover greater than £200,000 - otherwise treat as POM.
Payable for first three complete fee periods following the year of grant.
Standard fee - This fee relates to Prescription Only Medicine (POM) products only and means the periodic fee payable where the value of the product sold or supplied does exceed £35,000 in the relevant fee period. Reduced fee - This fee related to POM products only and means the periodic fee payable where the value of the product sold or supplied does not exceed £35,000 in the relevant fee period. Lower fee - This fee means the periodic fee payable relating to a POM is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period and:
(a) that the medicinal product has not been manufactured or imported into the UK during the period of 12 months preceding the commencement of the relevant fee period; OR
(b) where the medicinal product had been manufactured or imported into the UK during the period referred to in (a) above that the value of that product sold or supplied did not exceed £1,000 during that period
All other legal status medicinal products
Lower fee - This fee is payable relating to pharmacy medicines, general sale list medicines or ‘none’ status medicines regardless of turnover.
Error in periodic fees
We appear to have published the incorrect fees for some periodic fees and these have now been corrected.
These fees levels were correct in the draft regulations that accompanied the consultation document MLX 363 but incorrect in the separate table. Apologies for any inconvenience caused.
