THE MINISTRY OF HEALTH AND SOCIAL WELFARE
3830
Pursuant to Article 88 of the Medicinal Products Act (Official Gazette 71/07 and 45/09), the
Minister of Health and Social Welfare hereby issues the
ORDINANCE
ESTABLISHING THE CRITERIA FOR WHOLESALE PRICING OF MEDICINAL
PRODUCTS AND THE METHOD FOR REPORTING WHOLESALE PRICES
Article 1
This Ordinance establishes the criteria for wholesale pricing of medicinal products and
the method for reporting wholesale prices.
The provisions of this Ordinance shall apply to medicinal products referred to in
Article 2, item 1 of the Medicinal Products Act that are included in the basic or the
supplementary reimbursement list of the Croatian Institute for Health Insurance (hereinafter:
“Institute”) in accordance with the Act on Compulsory Health Insurance.
Article 2
A wholesale price of a medicinal product is a selling wholesale price of a medicinal
product without value added tax.
A customs duty, calculated by adding the customs value to the manufacturing price, is
an integral part of a wholesale price of imported medicinal products.
The wholesale margin and other related costs of up to 8.5% are integral parts of the
wholesale price of the medicinal product. The wholesale price is calculated by adding the
customs value to the manufacturing price and by adding the resultant amount to the wholesale
margin and other related costs.
Article 3
In line with the provisions of this Ordinance, wholesale prices of medicinal products
shall be established by legal persons with the registered place of business in the Republic of
Croatia and holding marketing authorisations for drug products for the Republic of Croatia.
Article 4
The criteria for wholesale pricing of medicinal products shall be the following:
- a reference wholesale price of a medicinal product in other countries;
- the level of a reference wholesale price;
- a pharmacoeconomic study.
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Article 5
The basis for the reference wholesale price of a medicinal product, to be determined as
laid down by Article 7 of this Ordinance, shall be the wholesale price of the same medicinal
product (identical generic product and identical pharmaceutical form) in Italy, France and
Slovenia.
The sources of data about prices of medicinal products in reference countries are the
latest editions of the following publications: Informatore Farmaceutico, Vidal and Register
Zdravil Republike Slovenije, published until the date of calculation from Article 17,
paragraph 1 of this Ordinance.
If sources from paragraph 2 of this Article do not contain the data about prices of
medicinal products for one or two countries referred to in paragraph 1 of this Article, the
wholesale prices of medicinal products in Spain and the latest edition of Catalogo de
Medicamentos shall be used as data sources.
If sources from paragraph 3 of this Article do not contain the data about prices of
medicinal products from paragraph 1 of this Article, the wholesale prices of medicinal
products in the Czech Republic and the latest edition of Číselníky VPZ, published on
www.vzp.cz, shall be used as data sources.
Article 6
The reference price of a medicinal product shall be determined for each
pharmaceutical form separately. If reference countries have the same pharmaceutical form of
the same strength, but manufactured by different manufacturers and having different prices,
the average price of a medicinal product in a particular country shall be taken for calculation.
If reference countries do not have the same pharmaceutical form, a similar form (e.g.
tablet – sugar coated tablet) may be taken for comparison. However, medicinal products with
prolonged or controlled action cannot be equalised with usual forms.
In case of a different number of dosaging units per package, the package with the
closest number of dosaging units shall be taken into account. First, the reference price for the
dosaging unit of the reference medicinal product, and then the number of dosaging units in the
medicinal product of the legal person referred to in Article 3 of this Ordinance shall be
calculated.
In case of a difference in concentration of the active substance in the unit of a
pharmaceutical form or the absence of a particular medicinal product in reference countries,
the data about prices of medicinal products in countries referred to in Article 5, paragraph 3 of
this Ordinance, in order of mentioning, shall be used for calculation as stipulated by
paragraphs 1, 2 and 3 of this Article.
If three reference prices are not available, minimum two reference prices shall be
determined for calculation.
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Article 7
The reference wholesale price of a medicinal product as per Articles 5 and 6 of this
Ordinance shall be calculated as follows:
– for Italy, the multiplication factor 0.685 shall be used to convert a retail into a wholesale
price;
– for France, the scale given in Annex 1, which forms an integral part of this Ordinance, shall
be used to convert a retail into a wholesale price;
– for Slovenia, the wholesale prices published in the latest edition of Register Zdravil
Republike Slovenije shall be used;
– for Spain, the multiplication factor 0.6933 shall be used to convert a retail into a wholesale
price; for medicinal products whose retail price is slightly higher than EUR 89.62, the fixed
margin shall be taken into account if the legal person from Article 3 of this Ordinance notifies
the Institute about their amount until the first working Monday in February.
– for the Czech Republic, the multiplication factor 0.84 shall be used to convert a retail into a
wholesale price.
Article 8
The reference wholesale price of a medicinal product in kuna shall be calculated in
accordance with the form given in Annex 2, which forms an integral part of this Ordinance,
by multiplying the reference price given in a currency of a particular state and determined
according to Article 7 of this Ordinance with its kuna mean exchange rate according to the
exchange rate of the Croatian National Bank valid at the date of calculation. Thus calculated
prices shall be added up, and their sum shall be divided by the number of prices (average
reference price).
Article 9
The level of the reference wholesale price of a medicinal product is the ratio,
expressed as percentage, between the wholesale price of a medicinal product as at the date of
calculation referred to in Article 17, paragraph 1 of this Ordinance, and the average reference
wholesale price of a medicinal product referred to in Article 8 of this Ordinance.
Article 10
Legal persons referred to in Article 3 of this Ordinance shall notify the Institute about
the harmonization of wholesale prices of all medicinal products referred to in Article 1,
paragraph 2 of this Ordinance within 30 days of the date of publication of the annual
calculation referred to in Article 17, paragraph 1 of this Ordinance on the web pages of the
Institute.
The prices of original medicinal products patented in the Republic of Croatia or in the
Member State of the European Union which exceed 90% of the average reference price as
with the date of calculation referred to in Article 17, paragraph 1, of this Ordinance, shall be
reduced to at least 90% of the average reference price.
The prices of original medicinal products which are not patented in the Republic of
Croatia or in the Member State of the European Union and which exceed 65% of the average
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reference price until the date of calculation referred to in Article 17, paragraph 1 of this
Ordinance, shall be reduced to at least 65% of the average reference price.
The prices of generic medicinal products which exceed 65% of the average reference
price as with the date of calculation referred to in Article 17, paragraph 1 of this Ordinance,
shall be reduced to at least 65% of the average reference price.
Legal persons referred to in Article 3 of this Ordinance may set lower prices than those
stipulated by this Article for medicinal products referred to in Article 1, paragraph 2 of this
Ordinance.
The prices of medicinal products that are lower than stipulated by paragraphs 2, 3 and
4 of this Article, as with the date of calculation referred to in Article 17, paragraph 1, of this
Ordinance, shall not be harmonised.
Article 11
The prices of medicinal products, the inclusion of which on the Institute’s basic or
supplementary reimbursement list is proposed by legal persons referred to in Article 3 of this
Ordinance, shall be calculated in line with the provisions of paragraphs 2, 3, 4, 5 and 6 of this
Article.
The wholesale price of an original medicinal product, which contains a new active
substance that have a considerable impact on the increase in the possibilities of recovery and
which is placed for the first time on the market of the Republic of Croatia, must not be higher
than the reference price, provided that no parallel medicinal product with the same or similar
therapeutic and pharmacological properties (third level of ATC) is registered on the market of
the Republic of Croatia.
If parallel medicinal products with the same or similar therapeutic and
pharmacological properties (third level of ATC) are registered on the market of the Republic
of Croatia, the wholesale price of an original medicinal product, which contains a new active
substance, shall not exceed 90% of the reference price of such products.
The price of a generic medicinal product with the same non-proprietary name shall not
exceed 70% of the price of the medicinal product referred to in paragraph 2 of this Article.
The price of a new generic medicinal product with the same non-proprietary name
shall not exceed 90% of the price of the medicinal product set out as stipulated in paragraph 4
of this Article.
The price of each new generic medicinal product with the same non-proprietary name
shall not exceed 90% of the price of the medicinal product with the same non-proprietary
name set out as stipulated in paragraph 5 of this Article.
Article 12
The wholesale price of a medicinal product, whose reference price cannot be
determined in any publication referred to in Article 5 of this Ordinance, shall be determined
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on the basis of the pharmacoeconomic study submitted, along with the application, by the
legal person referred to in Article 3 of this Ordinance to the Institute.
The pharmacoeconomic study from paragraph 1 of this Article shall consist of the
introduction with an overview of problems and goals of the study, and it shall cover an
estimated number of patients during a three-year use (estimated number per year). The
method of the pharmacoeconomic study shall employ official statistical data and other data
from the Republic of Croatia, or the relevant literature data from other countries only if the
former are not available. The results of the study shall be expressed as a direct comparison of
costs with existing medicinal products. Discussion and conclusions of the study shall enable
the critical assessment of the given data, methods and analysis, as well as the applicability of
literature results, and indicate the health and economic consequences of the introduction of a
new medicinal product.
Article 13
Within 30 days of the date of publishing of the annual calculation on web pages of the
Institute referred to in Article 17, paragraph 1 of this Ordinance, legal persons referred to in
Article 3 of this Ordinance shall determine wholesale prices of medicinal products in line with
the criteria given herein and shall notify the Institute accordingly, using both a hard copy and
an electronic form of Form 1 provided in Annex 3, which forms an integral part of this
Ordinance.
Within 30 days of the issuance of marketing authorisation, legal persons referred to in
Article 3 of this Ordinance shall notify the Institute about the proposed wholesale price of the
finished medicinal product using both a hard copy and an electronic form of Form 2 provided
in Annex 3, which forms an integral part of this Ordinance.
Article 14
The Institute shall issue a decision on the acceptance or rejection of the proposed price
of the medicinal product from Articles 10, 11 and 12 hereof within 90 days of the date of
receipt of the application.
If the Institute establishes that the proposed price of the medicinal product notified by
the legal person referred to in Article 3 of this Ordinance does not comply with the provisions
of this Ordinance or if the legal person referred to in Article 3 of this Ordinance has not
submitted all data necessary to determine the price of the medicinal product in line with this
Ordinance to the Institute, the Institute shall impose a deadline, which shall not be shorter
than eight days, upon this legal person to harmonise the price or to supplement the
submission.
If the legal person referred to in Article 3 of this Ordinance does not notify the
Institute of the proposed price of the medicinal product or if it does not harmonise the
proposed price of the medicinal product or if it does not supplement the submission within the
extended deadline, the Institute shall determine the price in accordance with the criteria for
wholesale pricing of medicinal products stipulated by the provision of Articles 4 to 10 of this
Ordinance.
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A legal person from Article 3 of this Ordinance cannot appeal the decision of the
Institute from paragraph 1 of this Article, but it may institute administrative proceedings, in
line with the General Administrative Procedure Act.
Article 15
The Institute shall submit, using the electronic form, the data about wholesale prices of
medicinal products, the harmonisation of prices with the criteria stipulated in this Ordinance
and all changes in prices of medicinal products referred to in Article 1, paragraph 2 of this
Ordinance, to the ministry competent for health.
Article 16
Subject to prior approval by the minister competent for health, legal persons referred
to in Article 3 of this Ordinance may propose an increase in the price of medicinal products
referred to in Article 1, paragraph 2 of this Ordinance, for the products on the basic or the
supplementary reimbursement list.
Taking into account the optimal supply of medicinal products necessary for ensuring
public healthcare, the minister competent for health shall either grant or withhold the approval
from paragraph 1 of this Article within 30 days of the date of receipt of the application.
Prior approval or its withholding shall be final in the administrative procedure.
Prior approval or its withholding by the minister competent for health shall be
substantiated and contain the instruction of legal remedy.
Article 17
The first working Monday of each February shall be taken as the date of the annual
calculation of prices of medicinal products referred to in Article 8 of this Ordinance. Every
year, the Institute shall publish the annual calculation on its web pages within 90 days of the
date of annual calculation.
Legal persons from paragraph 3 of this Ordinance shall re-determine prices of
medicinal products referred to in Article 1, paragraph 2 of this Ordinance every 12 months.
Article 18
Legal persons authorised for wholesale of medicinal products shall sell those products
at the prices established pursuant to Article 14, paragraph 1 of this Ordinance.
Article 19
All procedures initiated until the date of the entry into force of this Ordinance will be
completed in accordance with the provisions of the Ordinance establishing the criteria for
wholesale pricing of medicinal products and the method for reporting wholesale prices
(Official Gazette 60/08).
Article 20
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On the date of entry into force of this Ordinance, the Ordinance establishing the
criteria for wholesale pricing of medicinal products and the method for reporting wholesale
prices (Official Gazette 60/08) shall cease to have effect.
Article 21
This Ordinance shall be published in the Official Gazette and shall enter into force on 1
January 2010.
Class: 011-02/09-02/134
Reg. No.: 534-07-09-1
Zagreb, 11 December 2009
The Deputy Prime Minister and
the Minister of Health and Social Welfare
Darko Milinović, m.p.
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ANNEX 1
THE SCALE FOR THE CALCULATION OF PRICES IN FRANCE
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ANNEX 2
LEGAL PERSON:
SUBJECT: CALCULATION OF THE AVERAGE REFERENCE WHOLESALE PRICE
COUNT INFORMATION ABOUT THE
RY
MEDICINAL PRODUCT
INFORMATION ABOUT PRICES
OF THE MEDICINAL PRODUCT
CALCULATION
OF THE PRICE
IN CROATIA
Pharmaceu Price
in
tical form
Price in the
HRK
currency of that Wholesale price in registered for
in Croatia origina
HRK
particular
l
country
Mean
exchang
None rate of
propriet
AT
Retail Wholes
the
ary Propriet
C
Pharmaceu price
ale
Croatian
name
ary
cod
tical form of a price of
For Avera
National
(generic name
e
For uni ge
medici
a
Bank
name) –
nal
medici origina t price
valid at
INN
produc
nal
l
for for
that date
t for product packag m unit
ing (pc form
origina
for
s) (pcs)
l
original
packag packagi
ing
ng
3
1
4
5
6
7
8
9
10
packag
ing
11
12
2
ITALY
1 EUR
= HRK
FRANC
E
1 EUR
= HRK
SLOVE
NIA
1 EUR
= HRK
SPAIN
1 EUR
= HRK
CZECH
REPUB
LIC
1 CZK
= HRK
AVERAGE REFERENCE PRICE
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ANNEX 3
Form 1
LEGAL PERSON:
SUBJECT: NOTIFICATION ABOUT CHANGES OF WHOLESALE PRICES OF
MEDICINAL PRODUCTS
The
latest
publis
hed
Expiry whole
Class:
AT NonPhar
date of sale
Proprietary name
Marketi
C proprie
m.
marketin price
ng
cod tary
form
g
in
authoris
e name
authoris HRK
ation
ation
for
origin
al
packa
ging
1.
2.
Patent
ed
origin
al
medic
inal
produ
ct
Nonpatent
ed
origin
al
medic
inal
produ
ct
Gener
ic
medic
inal
produ
ct
3a.
3b.
3c.
Avera
ge
refere Level
nce
of Wholesale
price refere price in
in
HRK
nce
HRK price calculated
for in % according
origin accor to Art. 10
of the
al
ding
packa to Art. Ordinance
ging
9
(Anne
x2
U U
(7 × p p
8) x to to
100 90 80
% %
4.
5.
6.
7.
8.
9.
Propo
sed
whole
sale
price
in
HRK
for
origin
al
packa
ging
IND
EX
(11/
7) x
100
U
p
to
65
%
10 10 10
a. b. c.
11.
12.
11
Form 2
LEGAL PERSON:
SUBJECT: NOTIFICATION ABOUT WHOLESALE PRICING OF MEDICINAL PRODUCTS
PLACED FOR THE FIRST TIME ON THE MARKET OF THE REPUBLIC OF CROATIA
AT
C
cod
e
Class:
Expiry Averag Wholesale price
Marketin date of
e
in HRK
g
marketin referen
calculated
authorisat
g
ce price according to
Pharmaceut
Nonion authorisat in HRK Art. 11 of the
ical form
propriet
Proprietary name
ion
for
Ordinance
ary
original
name
packagi
ng
(Annex
2)
Origin Generi
al
c
medici medici
nal
nal
produc produc
t
t
1.
2.
3a.
3b.
Propos
ed
wholes
ale
price in
HRK
for
origina
l
packag
ing
IND
EX
(9/7)
x 100
9.
10.
Origin Generi
al
c
medici medici
nal
nal
produc produc
t
t
4.
5.
6.
7.
8a.
8b.
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