R U L E S
on amendments and supplements to the Rules on determining prices of medicinal products for human use

Article 1
In the first paragraph of Article 1 of the Rules on determining prices of medicinal products for human use (Official Gazette of the RS, nos. 97/08 and 99/08 – amend.), the following text shall be added to the introductory sentence, after the word “Rules”: “Pursuant to Council Directive of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40 11.2.1989, p. 8)”.

Article 2
The text of Article 10 shall be amended to read: “Pricing and determining of maximum permitted Prices of Medicinal Products is based on the PEP value, which shall not exceed the maximum permitted PEP value, 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 value from Annex 3 hereto.”

Article 3
The third sentence of the first paragraph of Article 12 shall be amended to read: “The PEP value of a medicinal product shall not exceed 100% of the comparative price of a medicinal product.”

Article 4
In Annex 3, the expressions “margin” and “wholesale margin” shall be replaced by “wholesale share” in all cases and numbers.

Article 5
(1) The applications for determining the maximum allowed prices of original medicinal products that have not been resolved until the entry into force hereof shall be resolved in accordance with the provisions hereof on the basis of a supplemented application submitted by the applicants to the Agency on form B1 within five (5) days of the enforcement hereof.
(2) The applications for determining exceptionally allowed higher price of original medicinal products, submitted to the Agency in the period from 15 October 2007 to including 17 November 2008 shall be processed in line with the provisions hereof. The applications for determining exceptionally allowed higher prices that propose exceptionally allowed higher prices based on the PEP value of the original medicinal product not exceeding 100% of the comparative price of medicinal product in comparative countries, where the calculated price of such medicinal product is the lowest, shall be processed as applications for determining the maximum allowed price.

Article 6
These Rules shall enter into force on the next day after their publication in the Official Gazette of the Republic of Slovenia.

No. 0070-135/2008
Ljubljana, 13 January 2009
EVA 2008-2711-0195
Borut Miklavčič
Minister of Health

Annex 3

Table 1. Calculation of wholesale price of medicinal product*.

class PEP Wholesale share

1. For PEP values up to EUR 6 10%
2. For PEP values between EUR 6.01 and EUR 30 6.5%
3. For PEP values between EUR 30.01 and EUR 161 5%
4. For PEP values between EUR 161.01 and EUR 390 3.5%
5. For PEP values between EUR 390.01 and EUR 1,055.24 2%
6. For price equal to or higher than EUR 1,055.25 EUR 30.03

* For the first five classes, the wholesale share is calculated as a compound value of wholesale shares of individual parts of the PEP value in the table. For the last, class 6, the wholesale share is uniform, namely EUR 30.03 for a medicinal product the PEP value of which is equal to or higher than EUR 1,055.25.