Amendments have been introduced in Turkey for determining
prices, prices changes and reference price changes regarding human
medicinal products. The Council of Ministers' Decree for
Amending the Decree on Pricing of Medicinal Products for Human Use
("Amendment Decree") was published in
Official Gazette number 29631 on 21 February 2016, entering into
effect on the same date.
The Amendment Decree makes changes to the Decree on Pricing of
Medicinal Products for Human Use, dated 15 June 2015 and numbered
Changes introduced by the Amendment Decree include:
The price of products which have been
a reference product for 20 years and whose warehouseman's sale
price is above a certain value, cannot exceed 80% of the reference
price. Under the Amendment Decree, the relevant value increases
from TRY 6.93 to TRY 7.32.
The price list prepared by the
Turkish Medicines and Medical Devices Agency
("Agency") is used when determining
warehouseman's sale prices. The sale prices to the current
warehouseman will be used as the reference price if there is no
reference price for products that are 20 years old and whose
warehouseman's sale price is above a certain value, according
to the price list. Under the Amendment Decree, the relevant value
increases from TRY 6.93 to TRY 7.32.
Prices can be set independently from
the Decree for products which are approved as medicines and are
more than 20 years old (as per the Council of Ministers'
Decision dated 6 February 2004 and number 2004/6781) and whose
warehouseman's sale price is a certain value or less. Under the
Amendment Decree, the relevant value increases from TRY 6.93 to TRY
Prices can also be set independently from the Decree for
products that have a warehouseman's sale price that is below a
certain value. Under the Amendment Decree, the relevant values
increases from TRY 3.63 to TRY 3.84.
Approved warehouseman's sale
prices which may result from reference price or reference state
changes will not be reflected in prices until the changes exceed
If an amount in the Agency's
price list is voluntarily reduced, the updated price will apply
without being subject to the statutory 60 day wait-period in
certain circumstances. Price corrections by the Agency are
introduced as one of these circumstances.
Please see this
link for the full text of the Amendment Decree (only available
Information first published in the
MA | Gazette, a fortnightly legal update newsletter produced by
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