R U L E S on the Setting of Prices of Medicinal Products for Human Use

I. GENERAL PROVISIONS

Article 1

(1) These Rules regulate:
- Criteria, methods and procedures for pricing and determining the maximum permitted price and extraordinary permitted higher price of medicinal products for human use, financed from public funds (hereinafter: the Prices of Medicinal Products);
- Criteria, procedure and method for changing the maximum permitted price and extraordinary higher permitted price of medicinal products;
- Mandatory components of the application for determining the highest permitted price and extraordinary permitted higher prices of medicinal products;
- Marketing volume at which the Prices of Medicinal Products are determined or changed;
- Manner of publishing and forwarding the Prices of Medicinal Products;
- Period of validity of the maximum permitted price and extraordinary permitted higher price of medicinal products.

(2) The competent authority for the Prices of Medicinal Products in accordance herewith shall be the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (hereinafter: the Agency).

Article 2
In addition to the expressions defined in Article 6, of the Medicinal Products Act (Official Gazette of the RS, no 31/06 and 45/08; hereinafter referred to as: the Act), the following expressions shall also be used in these Rules:
1. The person subject to pricing of medicinal products (hereinafter: the Subject) shall be:
- Marketing authorisation holder or its representative,
- Authorisation holder for import and entry of medicinal products without authorisation and included on the list of urgently needed medicinal products pursuant to the Act;
- Holder of authorisation for parallel import of medicinal products;
- Holder of a favourable opinion from the European Medicines Agency for parallel distribution of medicinal products.
2. The maximum permitted price of a medicinal product shall be the price of the medicinal product determined in accordance herewith and may be used in wholesale marketing.
3. Extraordinary permitted maximum price of a medicinal product shall be the price of the medicinal product determined in accordance herewith and may be used in wholesale marketing, exceeding the maximum permitted price of the medicinal product.
4. Comparative price of a medicinal product shall mean information determined on the basis of:
- The Prices of Medicinal Products in comparative countries, calculated from publicly available data; or
- The Prices of Medicinal Products in other Member States of the European Union (hereinafter: the EU) and states signatories to the European Economic Area (hereinafter: EEA).
5. The producer's element of the wholesale price of a medicinal product (hereinafter: the PEP) shall mean the structural part of the maximum permitted wholesale price of a medicinal product or extraordinary permitted higher wholesale price of a medicinal product representing administratively acknowledged costs of the producer of a medicinal product calculated on the basis of the comparative price of a medicinal product.
6. The marking "CIP buyer" shall mean that the wholesale price of a medicinal product includes administratively acknowledged costs of the producer and transport and insurance of goods up to the end buyer and the share for covering the costs of wholesale trading.
7. Administratively acknowledged costs of the producer are costs of production of medicinal products acknowledged by the Agency under these Rules when determining the wholesale prices of medicinal products.

Article 3
Regardless of the expressions defined in Articles 5 and 6 of the Act, the following two expressions shall be used in these Rules:
1. Original medicinal product shall be a medicinal product obtaining the marketing authorisation in accordance with Article 23 of the Act and the Regulation (EC) no. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L no. 136 of 30. 4. 2004, p. 1; hereinafter: Regulation 726/2004/EC). Original medicinal products shall include original medicinal products manufactured on the basis of licences.
2. Generic medicinal product shall mean a medicinal product obtaining the marketing authorisation in accordance with Articles 25, 27, 29, 34 and 36 of the Act and the Regulation 726/2004/EC.

Article 4
These Rules determine wholesale Prices of Medicinal Products excluding value added tax, CIP buyer.

II. PRICING AND DETERMINING OF MAXIMUM PERMITTED AND EXTRAORDINARY PERMITTED HIGHER PRICES OF MEDICINAL PRODUCTS

Article 5
(1) Maximum permitted Prices of Medicinal Products are priced and determined on the basis of:
1. Comparison of the Prices of Medicinal Products in comparative countries; or
2. Comparison of the prices in other EU Member States and signatories of the EEA Agreement if the medicinal product is not present on the markets of comparative countries.
(2) Extraordinary permitted higher Prices of Medicinal Products are determined on the basis of the criteria, procedures and method specified herein.

Article 6
(1) The date of enforcement of the maximum permitted price of a medicinal product is determined by a decision and may not exceed 90 days of the receipt of complete application. If no decision is issued in such period, the date of enforcement of such price is the day following the expiry of the deadline.
(2) The date of enforcement of the extraordinary permitted higher price of a medicinal product is determined by a decision. If no decision is made within 90 days from receiving a complete application, or in the extended 60-day deadline, on the proposed extraordinary permitted higher wholesale price of the medicinal product, the date of entry into force of such price shall be the day following the expiry of the deadline.
(3) If the Agency foresees extension of the procedure, due to large amount of applications for determining extraordinary permitted higher prices within the 60-day deadline from the previous paragraph, it shall issue a decision prior to the expiry of the 90-day deadline from the previous paragraph.
(4) If no decision from the first or the second paragraph hereunder is issued within the deadlines specified hereunder, the medicinal product can be marketed at the price proposed in the application but no later than until the issue of a new decision on the basis of the application submitted within the deadlines from the first paragraph of Article 23 hereof.

Article 7
(1) The specified maximum permitted price shall apply until the enforcement of the new determined maximum permitted price of the medicinal product.
(2) The determined extraordinary permitted higher price may apply for up to one year. The validity of the price may be extended on the basis of a new application.

Article 8
(1) If the authorisation for marketing of the medicinal product is transferred to another Subject, the price used for the relevant medicinal product shall be that already determined and no new application shall be needed to determine the maximum permitted price or the extraordinary permitted higher price if it remains unchanged.
(2) The Subject shall report to the Agency data on transfer of the authorisation within 15 days from receiving the decision on transfer.

1. Criteria, procedures and method of pricing and determining maximum permitted prices of medicinal products

Article 9
(1) The Subjects shall submit to the Agency the application for determining the maximum permitted Prices of Medicinal Products for medicinal products determined in the first paragraph of Article 97 of the Act, intended for financing from public funds.
(2) Completed form B1 from Annex 1 hereto in the electronic form in .pdf and .xls formats is the constituent part of the application from the previous paragraph. Evidence on data stated in the application must be attached to it.

Article 10
Pricing and determining of maximum permitted Prices of Medicinal Products is based on the PEP value, which shall not exceed the maximum permitted price, and the additional share or a fixed amount intended to cover costs of wholesale (hereinafter: the Wholesale Margin), which shall not exceed the maximum permitted in line with the table in Annex 3 hereto.

Article 11
(1) The PEP value shall be calculated on the basis of the comparative price of a medicinal product.
(2) The calculation base for comparative Prices of Medicinal Products shall be the prices of medicinal products, financed from public funds, in comparative countries Austria, France and Germany (hereinafter: the Comparative Countries).
PEP value of medicinal products shall be determined on the basis of the latest printed or electronic publications or the pertaining websites specifying the comparative medicinal products and the date of data capture:
– Austria: Erstattungskodex (publication or website); calculation from retail prices of medicinal products,
– France: Vidal (electronic issue); calculation from retail prices of medicinal products,
– Germany: Lauer-Taxe (electronic issue or website) calculation from wholesale prices of medicinal products.
(3) Notwithstanding the provisions of the previous paragraph hereunder, as regards the comparative country Austria, the publication Warenverzeichnis shall be used for medicinal products not listed in the publication Erstattungskodex (calculation from retail Prices of Medicinal Products financed from public funds, excluding value added tax).
(4) Prices from publications of comparative countries hereunder shall be calculated by applying factors from Annex 2 hereto (hereinafter: Calculated Prices).
(5) Regardless of the provisions of the previous paragraph, the Subjects may use, as Comparative prices the Prices of Medicinal Products sold in Comparative Countries directly to healthcare providers, bypassing Wholesalers, the prices stated in the publication of a Comparative Country.
(6) In such case, stated in the previous paragraph, the Subjects shall submit:
- A statement on the existence of such method of selling medicinal products;
- A calculation of the price, taking into account the actual selling wholesale price and explanation for each of these countries, and
- Evidence on the actual selling wholesale price which, in case it is a payment document, may not be older than three months.

Article 12
(1) The PEP value of an original medicinal product shall be determined on the basis of the comparative price of a medicinal product, which is for original medicinal products the lowest Calculated Price of the same medicinal product in any of the comparative countries. If a medicinal product is marketed only in one or two of the comparative countries, the Calculated Prices in those countries shall apply. The PEP value of an original medicinal product shall not exceed 97% of the comparative price of a medicinal product.
(2) The PEP value of a generic medicinal product shall be determined on the basis of prices of generic medicinal products in comparative countries, as follows:
– If a generic medicinal product is marketed in all three Comparative Countries, the comparative price of a medicinal product shall be the average of mean values of the Calculated Prices in those countries. The mean value of the Calculated Prices in individual Comparative Country shall be the mean value of the lowest and highest Calculated Price. If only one medicinal product is marketed in a country, only that shall be taken into account. The PEP value of a medicinal product shall not exceed 82% of the comparative price of a medicinal product.
– If a generic medicinal product is marketed in two Comparative Countries, the comparative price shall be the average of mean values of the Calculated Prices of a medicinal product in those two Comparative Countries. The mean value of the Calculated Prices in individual country shall be the mean value of the lowest and highest Calculated Price. If only one medicinal product is marketed in a country, only that shall be taken into account. The PEP value shall not exceed 82% of the comparative price of a medicinal product.
– If a generic medicinal product is marketed in only one country, the PEP value of a generic medicinal product shall not exceed 70% of the comparative price of an original medicinal product referred to in previous paragraph.
(3) The PEP value of a similar biological medicinal product not complying with the definition of generic medicinal product shall be determined on the basis of the comparative price of a medicinal product, as follows:
- When the equivalent similar biological medicinal product is present in the markets of Comparative Countries, this value shall be the lowest Calculated price of the equivalent medicinal product in any of the Comparative Countries. If a medicinal product is marketed only in one or two of the Comparative Countries, the Calculated Prices in those countries shall apply. The PEP value of a similar biological medicinal product shall not exceed 100% of the comparative price of a medicinal product.
- Equivalent similar biological medicinal product is not available on the markets of Comparative Countries, this value shall be the median of producer prices in all other EU Member States or signatories to the EEA in which the medicinal product is marketed. If the number of these countries is even, the Comparative price of a medicinal product is determined as the mean value of producer prices in two Comparative Countries in the middle of the range. The PEP value of a similar biological medicinal product shall not exceed 100% of the comparative price of a medicinal product.
- When the medicinal product is not present on the markets of Comparative Countries nor the markets of other EU Member States or signatories to the EEA, the Comparative price of a medicinal product shall be determined as the comparative price of the original biological medicinal product to which the relevant biological medicinal product is similar. The PEP value of a similar biological medicinal product shall not exceed 72% of the comparative price of a medicinal product.

Article 13
(1) In the case of a different number of the medicinal product's prescription in packaging, packaging containing comparable number of units shall be used. The comparative price of the medicinal product shall then be calculated per number of prescription units for the Subject's medicinal product.
(2) The comparative price of a medicinal product is defined for every pharmaceutical form separately. If there is no comparable pharmaceutical form in compared countries, a similar pharmaceutical form may be compared (e.g. tablet – sugar-coated pill) whereby the pharmaceutical forms with controlled release of active ingredients cannot be put on equal footing with pharmaceutical forms with fast release.
(3) The comparative price of a medicinal product is defined for each strength separately. If there is no identical strength in compared countries, calculation of prices from other strengths shall apply mutatis mutandis.

Article 14
The PEP value of parallel imported or parallel distributed medicinal product shall be determined by comparing the Calculated Prices of the medicinal product to the authorisation of which the authorisation holder for parallel import of medicinal products or holder of an opinion of the European Medicines Agency on the parallel distributed medicinal product referred; the comparative price of a parallel imported or parallel distributed medicinal product shall equal the Calculated Price of the medicinal product to which the reference is made.
The PEP value shall not exceed 100% of the comparative price of a medicinal product.

Article 15
(1) If neither generic nor medicinal products exist in compared countries, the Subject shall submit an application to determine the maximum permitted price to the Agency in written and electronic form. Notwithstanding the provision of the second paragraph of Article 9 hereof, the application must contain the following components:
- Substantiated proposal for the maximum permitted wholesale price of the medicinal product;
- Data on the previously applicable wholesale price of the medicinal product or the maximum permitted price of medicinal product and its structure;
(the share covering production costs and wholesale costs), if any;
- Data on producer prices and Wholesale Prices of Medicinal Products excluding value added tax, CIP buyer, in other Member States of the EU or signatories to the EEA in which the medicinal product is marketed, to the best knowledge of the Subject, stating the source;
- Data on the financing of a medicinal product from public sources in other EU Member States or signatories to the EEA Agreement in which the medicinal product is marketed, to the best knowledge of the Subject;
- Evidence on data in the application.
(2) The PEP value is determined as the average of producer prices based on the Subject’s data in other EU Member States or signatories to the EEA Agreement in which the medicinal product is marketed, to the best knowledge of the Subject, and financed from public funds.

(3) The maximum permitted price of the medicinal product shall equal the PEP value referred to in the previous paragraph hereunder topped by the maximum wholesale margin, in accordance with the table in Annex 3 which is attached hereto as a constituent part.

2. Criteria and elements for deciding on the extraordinary permitted higher wholesale price of medicinal products

Article 16
(1) The Subject may submit an application for determining the extraordinary permitted higher price of the medicinal product. The application shall be submitted to the Agency in two copies in written and electronic form. The application shall include:
- A statement of the Subject that the maximum permitted price of the medicinal product, determined in accordance with the criteria specified herein, is inadequate for supplying the Slovenian market, stating the findings that confirm this fact;
- Informative calculation of the maximum permitted wholesale price of the medicinal product based on criteria specified herein; on Form B!1 from Annex 1 in .pdf and .xls formats;
- Calculation of the proposed extraordinary permitted higher wholesale price of the medicinal product, on Form B2 from Annex 1 in .pdf and .xls formats;
- Grounds of the submitted proposal which shall also include data on actual costs additionally debited to the medicinal product and forming the base for the request for extraordinary higher price of the medicinal product;
- Data on producer prices and wholesale prices of the same medicinal product financed from public funds in other Member States of the EU or signatories to the EEA in which the medicinal product is marketed, to the best knowledge of the Subject, stating the source;
- Pharmacoeconomic data or other appropriate financial & economic substantiation including relevant data for the Republic of Slovenia;
- Assessment of the relative therapeutic value of the medicinal product or other appropriate pharmacoepidemiological data including relevant data for the Republic of Slovenia;
- Proof of paid fees.
(2) Notwithstanding the provisions of the previous paragraph, the Subjects do not have to state the data stipulated by the sixth and the seventh indent of the previous paragraph in the application to determine the extraordinary permitted higher price of medicinal products without marketing authorisation but with authorisation for import or entry and classified on the list of urgently needed medicinal products.

Article 17
(1) When deciding on extraordinary permitted higher price of a medicinal product, the Agency shall take into account:
- Opinion of the Committee for Medicinal Products (hereinafter: The Committee), which must be issued no later than 30 days prior to the expiry of the deadline for deciding on the application;
- The established public interest in the area of health;
- Economic substantiated assessment of risk arising from any disturbances in supply of the medicinal product.
(2) The Agency shall not determine extraordinary permitted higher price if one of the following criteria is met:
- The Committee's opinion is negative;
- There is no public interest;
- Risk arising from any disturbances in supply of the medicinal product is assessed to be low.

Article 18
(1) In its opinion based on data from the complete application, data on medicinal product and other data reflecting the situation in science and the expert field the Committee shall adopt a position regarding:
- The significance of the medicinal product within the national health care priorities, taking into account the urgency, significance and indispensability;
- Existence of public interest in health care in relation to the discussed medicinal product;
- Public health risk arising from potential disturbed supply of the medicinal product including the economic aspect.
(2) The Committee shall evaluate the date from the complete application submitted hereunder and prepare an opinion containing its findings in the form of awarding of points by applying the following criteria:
- Appropriateness of pharmacoeconomic data or other appropriate financial & economic substantiation from the Subject's application with regard to the global scientific level (3 – high, 2 – medium, 0 – low);
- Appropriateness of the assessment on relative therapeutic value of the medicinal product or other pharmaepidemiological data from the application with regard to the global scientific level (3 – high, 2 – medium, 0 – low);
- The balance of the proposed extraordinary permitted higher price with the prices of the discussed medicinal product in other countries of the EU/EEA, taking into account the essential characteristics of the compared markets (4 – proposal lower than the median prices of the medicinal product on compared markets, 2 – proposal within +5% of the median on compared markets, 1 – within +10% of the median on compared markets, 0 – more than +10% of the median on compared markets);
- Balance of the proposed extraordinary permitted higher price of medicinal products with prices of medicinal products for the same indications and the same therapeutic group with regard to data on value added of the medicinal product (3 – good, 0 – bad);
- Cost efficiency parameters (3 – disclosed, 2 – partly disclosed, 0 – poorly disclosed or undisclosed);
- Existence of specific factors important for inclusion of the discussed medicinal product in national health care programmes (0 - 4 with regard to their relevance, with substantiation).

Article 19
(1) In a favourable opinion, the Committee shall give, in addition to the statements specified in the previous Article, its position on the proposed extraordinary permitted higher price of medicinal products in one of the following manners:
- Extraordinary permitted higher price shall be determined as proposed when the sum of pointed findings from the first paragraph of the previous article herein equals or exceeds 18 for the medicinal products with marketing authorisation or authorisation for parallel import of medicinal products or equals or exceeds 10 for medicinal products without marketing authorisation but with entry or import authorisation which are included in the list stipulated by Article 15 of the Act;
- The extraordinary permitted higher price shall be determined as lower than proposed, in the amount presented in the equation:

DIVDC = NDC + DT/MT *
(PIVDC-NDC) * (min(median(ER) / PIVDC; (PIVDC – NDC) / max(median(ER); NDC))

where:
DIVDC – Determined extraordinary permitted higher price
PIVDC – Proposed extraordinary permitted higher price
NDC – Maximum permitted price
DT – Number of points achieved
MT – Maximum number of points
median(ER) – Median of prices in the EU Member States or signatories to the EEA Agreement in which the medicinal product is marketed, if data from only two countries are available, the mean of prices in those two countries shall be used, if data from only one country are available, data for that country shall be used, if that country is the Republic of Slovenia, the maximum permitted price shall be used;
- The extraordinary permitted higher price of a medicinal product shall be determined in the amount as determined and substantiated by the Committee.
(2) If the Committee issues a negative opinion, such opinion must be grounded, stating the definitions from the first paragraph of the previous Article and the number of achieved points from the evaluation of data from the application referred to in the second paragraph of the previous Article.

Article 20
The Agency establishes the presence of public interest in the area of health, considering the presence of medicinal product on the market in the scope of national health priorities and taking into account the data on the medicinal products, its use, costs of treatment in comparison with the costs of treatment with the medicinal products for the same indication area in the scope of the same therapeutic group of medicinal products obtained on the basis of protocols on data exchange between the Institute of Public Health of the Republic of Slovenia (hereinafter: the Institute) and the Health Insurance Institute of Slovenia (hereinafter: the HIIS). It may also obtain a second opinion on the presence of public interest in the medicinal product on the Slovene market from the regional expanded expert committee or a clinical department or three statements of specialists practicing medicine in legal or natural persons at the secondary or tertiary levels in the Republic of Slovenia, working in the area of the relevant pharmacotherapy.

Article 21
Prior to deciding on the maximum permitted price of a medicinal product and extraordinary permitted higher price of a medicinal product, the Agency may request from the HIIS the data on the effect of the proposed price on public expenditure at the level of the therapeutic group and pharmacotherapy.

III. AMENDING THE MAXIMUM PERMITTED PRICES OF MEDICINAL PRODUCTS AND EXTRAORDINARY PERMITTED HIGHER PRICES OF MEDICINAL PRODUCTS

Article 22
The maximum permitted prices of medicinal products are changed twice a year for medicinal products where:
- A change in the price of the medicinal product occurred in at least one of the comparative countries, resulting in a change in the comparative price of the medicinal product used as the basis for determining the maximum permitted price of the medicinal product;
- A change occurred in the price of medicinal products not present on markets of compared countries and with the maximum permitted price determined on the basis of prices on the markets of other EU Member States or signatories to the EEA Agreement or if the range of compared countries has changed.

Article 23
(1) The Subjects shall re-establish the maximum permitted prices of medicinal products for medicinal products referred to in the previous Article in accordance with the criteria specified herein and submit an application for change of maximum permitted prices to the Agency, from:
- 1 March to 1 April; and
- 1 September to 1 October, including.
(2) The application for change of maximum permitted prices shall contain:
- Proposed maximum permitted prices of medicinal products with calculation given on Form B1 from Annex 1, in written and electronic form;
- Calculation of maximum permitted prices of the Subject’s other medicinal products, which shall not be changed, on Form B1 from Annex 1, in written and electronic form;

- All evidence on data, stated in the application, in written form.
(3) The following issues of the prescribed publications shall be used in the application for amending the maximum permitted prices of medicinal products:
a) in the period referred to in the first indent of the first paragraph hereunder:
– Austria: Erstattungskodex: the issue of 1 January of the current year or Warenverzeichnis: the February issue of the current year;
– France: Vidal: the issue no. 3/3 of the previous year or 1/3 of the current year; or
– Germany: Lauer-Taxe: The issue of 15 February of the current year;
b) in the period referred to in the second indent of the first paragraph hereunder:
– Austria: Erstattungskodex: the issue of 1 January of the current year with the supplement of 1 July of the current year or Warenverzeichnis: the August issue of the current year;
– France: Vidal: the issue no. 2/3 or 3/3 of the current year
– Germany: Lauer-Taxe: The issue of 15 August of the current year.
(4) The maximum permitted prices of medicinal products shall be changed in the manner specified hereunder also in the period when the marketing authorisation for a medicinal product has already expired and the medicinal product can be marketed, pursuant to the Act, until its expiry date but not longer than 18 months.
(5) The Agency may reduce the extraordinary permitted higher prices of medicinal products on the basis of the application submitted by the Subject, in which only the proposed reduced price of medicinal product is stated on Form B2 from Annex 1 and the date of enforcement of the proposed reduced price.

V. PUBLISHING AND FORWARDING PRICES

Article 24
(1) The Agency shall at least once a month publish the maximum permitted prices of medicinal products and extraordinary permitted higher prices of medicinal products which it has determined in accordance herewith on its website in the catalogue of information of public character, by specifying the following:
- Identification marking of the medicinal product;
- Name and presentation of the medicinal product;
- General name of the medicinal product;
- Classification marking of the medicinal product;
- Name of the Subject;
- Maximum permitted price of a medicinal product or extraordinary permitted price of a medicinal product;
- Date of entry into force of the price of the medicinal product;
- Medicinal product dispensing regime;
- Status of original medicinal product or generic product;
- Other relevant data.
(2) The Agency shall once a year report to the European Commission the applicable maximum permitted prices and extraordinary permitted higher prices of the medicinal products.
(3) At least once a month, the Agency shall submit to the HIIS, the ministry responsible for health (hereinafter: the Ministry) and the Institute the maximum permitted prices of medicinal products and extraordinary permitted higher prices of medicinal products together with PEP values in the electronic form.
(4) At least once a month, the HIIS shall submit to the Agency, the Ministry and the Institute the wholesale prices of medicinal products agreed on the basis of the first paragraph of Article 97a of the Act together with agreed PEP values in the electronic form and data on valid classifications of medicinal products to the lists.
(5) At least once a year, the Institute shall submit to the Agency, the Ministry and the HIIS data on the use of medicinal products and costs for them.

Article 25
The Subjects shall inform on the maximum permitted prices and extraordinary permitted higher prices of the medicinal products formed in accordance herewith the natural persons and legal entities with authorisation for wholesale trade in medicinal products or authorisation for production of medicinal products and concluded agreements on cooperation with them, immediately or not later than within eight days after determining the maximum permitted prices and extraordinary permitted higher prices of the medicinal products and at least three business days prior to their first use on the market.

VI. TRANSITIONAL AND FINAL PROVISIONS

Article 26
(1) Wholesale prices of medicinal products pursuant to Articles 5, 6 and 7 or 11 of the Rules on prices of medicinal products for human use (Official Gazette of the RS, no. 6/07) are the maximum permitted prices of medicinal products as at the date of entry into force hereof.
(2) Wholesale prices of medicinal products, determined on the basis of Article 13 of these Rules from the previous paragraph are extraordinary permitted higher prices of medicinal products as at the date of entry into force hereof. If no approval has been issued and the medicinal product is marketed at the proposed price, the validity of such prices shall expire with the issue of a decision based on the application submitted by the Subject in the period from 15 October to including 17 November 2008.
(3) For the determination of the maximum permitted price hereunder, the Subjects must file the application in accordance with Articles 10, 11, 12, 14 or 15 hereof in the period from 15 October to including 17 November 2008.
(4) The applications for determining the prices of medicinal products and the applications for the approval to exceed the criteria for the formation of the prices of medicinal products filed prior to the enforcement hereof shall be finalised on the basis of the provisions stipulated by the first paragraph hereunder. The prices of medicinal products shall be determined as the maximum permitted prices of medicinal products or extraordinary permitted higher prices of medicinal products.

Article 27
As of the date of enforcement hereof, the Rules on the prices of medicinal products for human use (Official Gazette of the Republic of Slovenia, no. 6/07) shall cease to apply, with the exception of Article 17 which applies until 10 December 2008.

Article 28
These Rules shall enter into force on the day following their publication in the Official Gazette of the Republic of Slovenia.

No. 72-25/2008
Ljubljana, 3 October, 2008
EVA 2008-2711-0096

Zofija Mazej Kukovič
Minister of Health