ACT AMENDING THE MEDICINAL PRODUCTS ACT (ZZdr-1A)
 

Article 1
In the third paragraph of Article 1 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia, no. 31/06) a new first indent shall be inserted in front of the first indent, which shall read as follows:
“- Council Directive 89/105/EEC 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);«.
The previous first to eighth indents shall become second to ninth indents.
 

Article 2
After the third paragraph of Article 44, new fourth and fifth paragraphs shall be added, reading:
“(4) The authority competent for medicinal products must inform, in the case of medicinal products for human use, the Health Insurance Institute of Slovenia (hereinafter: the Institute) within three business days of receiving the notice from the second paragraph hereunder as well as publish such information on its web portal.
(5) The authority competent for medicinal products must inform, in the case of medicinal products for veterinary use, the Veterinary Administration of the Republic of Slovenia within three business days of receiving the notice from the second paragraph hereunder as well as publish such information on its web portal.”
 

Article 3
After the full stop of the third paragraph of Article 73, a new second paragraph shall be added, reading: “The competent minister shall determine the system for accepting, storing and tracking medicinal products.”.
 

Article 4
In Points 1 and 2 of the first paragraph of Article 90, the text “valid price” shall be replaced by the text “maximum allowed price and exceptionally allowed higher price”.
 

Article 5
The text of Article 97 shall be amended to read:
”(1) The authority competent for medicinal products shall determine the maximum allowed price for the medicinal products for human use with marketing authorisation or authorisation for parallel import of medicinal products, as well as medicinal products without marketing authorisation but with entry or import authorisation which are included in the list stipulated by Article 15 hereof and are financed from public funds or intended for financing from public funds.
(2) The authority competent for medicinal products may, on the basis of an application for increasing the maximum allowed price, an opinion issued by the Committee and the established public interest in the area of health and economic justifications of risk that might arise from interrupted supply of the market with medicinal products, determine exceptionally allowed higher price.
(3) The measures for determining the maximum allowed price of medicinal products and the exceptionally allowed higher price of medicinal products, the method and procedure and the mandatory elements of the application for determining the maximum allowed price of medicinal products and the exceptionally allowed higher price of medicinal products, the volume of transactions and the period for which the maximum allowed price of medicinal products and the exceptionally allowed higher price of medicinal products are determined, and the method, criteria and procedure for amending the maximum allowed price of medicinal products shall be prescribed by the competent minister.
(4) The prices of veterinary medicinal products with marketing authorisation or entry or import authorisation, the level of which could impact animal health care and consequently harm the health of human beings, may in exceptional cases and at any level of the marketing of medicinal product be formed or determined according to the method specified by the competent minister for veterinary medicine.”
 

Article 6
After Article 97 a new Article 97.a shall be added, reading as follows:
»Article 97.a
(1) The marketing authorisation holders, the holders of authorisation for parallel imported medicinal products, entry or import authorisation holders and wholesalers may agree with the Institute or legal or natural persons performing medical activity financed from the public funds on the prices of medicinal products that are lower than the maximum allowed prices.
(2) The previous paragraph shall not apply to medicinal products for which exceptionally allowed higher price was determined.”
 

Article 7
In Article 98 paragraphs 1 and 2 be amended to read as follows:
(1) The marketing authorisation holders, the holders of authorisation for parallel imported medicinal products and entry or import authorisation holders must submit the application for determining the maximum allowed price for medicinal products from the first paragraph of Article 97 hereof and the application for determining exceptionally allowed higher price for medicinal products from the second paragraph of Article 97 hereof to the authority competent for medicinal products.
(2) The authority competent for medicinal products shall resolve the complete application for determining the maximum allowed price of medicinal products by issuing a decision within 90 days of receiving it.”.
After the second paragraph, new third, fourth and fifth paragraphs shall be added, reading:
“(3) The authority competent for medicinal products shall resolve the complete application for determining the exceptionally higher allowed price of medicinal products by issuing a decision within 90 days of receiving it. In the case of excessive workload related to the number of applications for the increase of the maximum allowed prices, the deadline may be extended once, by a maximum of 60 days.
(4) The authority competent for medicinal products must give in its decision specific justification of the reasons based on the criteria from the third paragraph of Article 97 hereof.
(5) If the decision is not issued within the deadlines from the third and the fifth paragraphs hereunder it shall be deemed that the application has been granted and the applicant can market the medicinal product at the price proposed in the application.
(6) Appeal shall be allowed against the decision specified in the second and third paragraphs of this Article within 30 days of receiving the decision. An appeal shall not suspend the execution of the decision. A decision on the appeal shall be adopted by the competent minister within 60 days of receiving the appeal. The applicant may contest the decision of the competent minister within 30 days of receiving the decision by filing a lawsuit within the administrative dispute at the Administrative Court of the Republic of Slovenia.”.
The current third and fourth paragraphs shall become the seventh and the eighth paragraphs, respectively.

Article 8
The text of Article 99 shall be amended to read:
“(1) The participants shall use the valid price of the medicinal product in the marketing of a medicinal product.
(2) The valid price of a medicinal product for human use hereunder can be:
- maximum allowed price of a medicinal product;
- the price of the medicinal product formed on the basis of the first paragraph of Article 97.a hereof which is not higher than the maximum allowed price of the medicinal product;
- exceptionally allowed higher price of a medicinal product.
(3) Records on the prices and beginning of validity of prices from the second indent of the previous paragraph hereunder shall be kept by the Institute.”.
 

Article 9
The second indent of the first paragraph of Article 102 shall be amended to read:
“- at least two years of adequate work experience in the area of medicinal products,”.
 

Article 10
In Article 115 the text “100,000 to 500,000 tolars” in the first paragraph shall be replaced by the text “400 to 2,000 euros”.
In the second paragraph the text “10,000 to 50,000 tolars” in shall be replaced by the text “40 to 200 euros”.
 

Article 11
In Article 116 the text “1,000,000 to 25,000,000 tolars” in the introductory sentence of the first paragraph shall be replaced by the text “4,000 to 100,000 euros” and a new Point 1 is entered before the existing Point 1, reading as follows:
»1. if acting contrary to Article 8 hereof;”.
The previous points 1, 2 and 3 shall become points 2, 3 and 4.
In the second paragraph the text “50,000 to 500,000 tolars” in shall be replaced by the text “200 to 2,000 euros”.
 

Article 12
In Article 117 the text “2,000,000 to 30,000,000 tolars” in the introductory sentence of the first paragraph shall be replaced by the text “8,000 to 120,000 euros” and new Points 17 and 18 are entered after the existing Point 16, reading as follows:
»17. if acting contrary to Article 13 hereof;
18. if acting contrary to Article 14 hereof;”.
In the second paragraph the text “100,000 to 1,000,000 tolars” in shall be replaced by the text “400 to 4,000 euros”.
 

Article 13
In Article 118 the text “1,000,000 to 10,000,000 tolars” in the first paragraph shall be replaced by the text “4,000 to 40,000 euros”.
In the second paragraph the text “50,000 to 500,000 tolars” in shall be replaced by the text “200 to 2,000 euros”.
TRANSITIONAL AND FINAL PROVISIONS
 

Article 14
(1) Until new prices of medicinal products are determined in accordance with this Act, the prices in force as at the day of the entry into force hereof shall apply.
(2)The competent minister shall issue the regulations laid down in Article 73 and the third paragraph of Article 97 of this Act at the latest within two months following the entry into force of this Act.
Article 15
This Act shall enter into force on the fifteenth day after its publication in the Official Gazette of the Republic of Slovenia.

No. 520-02/99-3/23
Ljubljana, 24 April 2008
EPA 1933-IV
The President
of the National Assembly
of the Republic of Slovenia
France Cukjati, MD