R U L E S
on the listing of medicinal products and foods for special medical purposes
 

I. GENERAL PROVISIONS
Article 1
(Areas covered by the Rules)
These Rules shall, in accordance with the 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 no. 40, 11 February 1989, p. 8), regulate the criteria and procedures for listing of medicinal products and foods for special medical purposes (hereinafter: food) for outpatient treatment on the list of compulsory health insurance (hereinafter: compulsory insurance), namely:
– criteria for medicinal product listing,
– determining the lists of medicinal products,
– criteria for listing and determining the lists of medicinal products and foods,
– separation criteria,
– limited prescription and limited dispensing,
– applicants, application contents, application processing procedure and deadlines,
– agreement on price,
– highest recognised values and deadlines,
– records and publishing,
– fees.
 

Article 2
(terms)
(1) The terms used herein shall have the following meaning:
- Agency means the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices.
- Cost-Effectiveness Analysis is a type of pharmacoeconomic study that compares relative costs and effects of treatment (medicinal product). Costs are expressed in monetary units and effects in the treatment of appropriate clinical outcomes. Usually, the result of cost-effectiveness analysis is expressed as the incremental cost-effectiveness ratio (ICER); this is the ratio between the change in costs and the change in outcome. It is used when the cost-benefit analysis is not sufficient or when the expression of the outcome in monetary units is not enough.
- Cost-Utility Analysis is a sub-type of cost-effectiveness analysis in which the result is expressed in specifically determined and agreed forms, such as: additional years of quality-adjusted life-year (QALY) and disability-adjusted life year (DALY), including the subjective assessments of the quality of medical condition by the patient. The costs side is analysed in the same way as with the analysis of cost effectiveness.
– Cost-Benefit Analysis is the analysis that assesses the monetary value of costs and benefits of individual treatment and on the basis of the ratio between the two categories assesses the economic viability of treatment.
Cost-Minimization Analysis is the simplest of all pharmacoeconomic analyses, used when there are no differences between the outcomes (effects) of treatment and the comparison of costs is the only relevant issue. The treatment involving the lowest costs (and yielding the same effects) is selected.
– Budget Impact Analysis is the analysis that evaluates the budget impact of the introduction and use of the new method of treatment (medicinal product) in a certain healthcare system, subject to limited budget. The objective of such analysis should not be the precise estimate of financial implications of introducing a new medicinal product but rather the drafting of a framework that will enable the decision-maker to understand the connection between the new method of treatment and the budget impact.
- Biologically similar medicinal products are those medicinal preparations that contain recombinant proteins as active substance, obtained by means of modern biotechnological methods. The protein active substance must have very similar structure characteristics as the reference active substance and show comparable efficiency, safety and quality compared to the reference product available on the market in the European Union and registered according to the centralised procedure and corresponding to the EMEA/CHMP/BMWP/42832/2005 and EMEA/CHMP/4924/05.
The price paid from the compulsory insurance (hereinafter: the CI price) hereunder means the applicable wholesale price pursuant to the provisions of Article 97a of the Medicinal Products Act (Official Gazette of the Republic of Slovenia nos. 31/06 and 45/08) paid by the Health Insurance Institute of Slovenia (hereinafter: the HIIS) for medicinal products or the price paid by the HIIS for galenic products and foods pursuant to the act, the listing and the highest recognised value.
Added value of a medicinal product can be expressed with positive relative efficiency or relative therapeutic value or advantage in economic sense; accordingly, the added value of individual medicinal product is determined on the basis of the medicinal products or treatments in the healthcare system.
- Market accessibility means availability in wholesale trade.
- Exclusion from the list means relisting among non-classified medicinal products and cancellation of the reimbursement from compulsory insurance.
- Final treatment outcome means the outcome relating to the time of quality-adjusted life-year for the treated disease or the time until recurrence.
- The list of medicinal products is a common list of all medicinal products and foods dispensed on prescription, which are fully or partially covered from compulsory insurance. The common list consists of individual lists determined by law and specified herein.
- Substitute treatment outcome means a laboratory or another measurement or event on the basis of which the efficiency of treatment can be assumed, such as the value of blood pressure, cholesterol, glycogenic haemoglobin, hospitalisation, etc.
- The highest recognised value (hereinafter: the HRV) is the basis for the calculation of amount covered by compulsory insurance in the percentage depending on the act and the listing of the medicinal product; if the CI price is lower than the HRV, the insurance covers the CI price in the same percentage.
- New medicinal product means that there is no listed medicinal product with the same active ingredient.
- Limited dispensing means that the pharmacists in pharmacies are allowed to prescribe medicinal products and foods to the debit of compulsory insurance only within these limitations.
- Limited prescription means that the practitioners are allowed to prescribe medicinal products and foods to the debit of compulsory insurance only within these limitations.
- Relisting is a change in the listing from one list to another.
- Listing means inserting medicinal products or foods to one of the lists, relisting or exclusion from the list.
- According to these Rules, the relative efficiency or relative therapeutic value of medicinal product is the difference between the efficiency of two medicinal products which represent comparable alternatives for the achievement of desired outcome. Relative efficiency or relative therapeutic value of medicinal product is defined as a positive relationship between beneficial and harmful effects of a medical measure, established in usual conditions of health care, compared to the effects of one or more alternative measures that can be used for achieving the desired outcomes.
- The list of interchangeable medicinal products with HRV contains all classified medicinal products from the valid list of interchangeable medicinal products published by the Agency.
- Standard medicinal product or treatment is the basis for comparing the medicinal product in the process of listing. When no standard medicinal product or treatment is recommended for therapeutic indication, the common, i.e. the most often used medicinal product or treatment is used for comparison.
- Health insurance means compulsory and voluntary health insurance.
(2) Designations and abbreviations in these Rules shall have the following meaning:
- ATC means anatomic-therapeutic-chemical listing of medicinal products;
- C in the designation of the list means medicinal product with the highest recognised value;
- N means medicinal product excluded from the list;
- HRV means the highest recognised value;
- P75 means the positive list of medicinal products for outpatient treatment for which 75% of cost is covered from compulsory insurance;
- P100 means the positive list of medicinal products and foods for outpatient treatment which are fully covered from compulsory insurance;
- V means the intermediate list of medicinal products and foods for outpatient treatment for which 25% of cost is covered from compulsory insurance;
- * asterisk in the listing means medicinal product with limited prescription and/or dispensing.
 

Article 3
(Subject of listing)
(1) The following are included into the lists:
- Medicinal products with marketing authorisation in the Republic of Slovenia,
- Medicinal products from the list of essential medicinal products which have not been granted marketing authorisation but a special authorisation for import and which may be dispensed on prescription in pharmacies in compliance with the regulations,
- Medicinal products with authorisation for parallel import,
- Medicinal products with an opinion from the European Medicines Agency for parallel distribution,
- Galenic products,
- Magistral preparations,
- Foods for special medical purposes with adjusted composition of nutrients for treating insured persons with congenital metabolism disorders,
- Other foods for special medical purposes.
(2) Medicinal products are classified with their proprietary names.

 

II. CRITERIA FOR MEDICINAL PRODUCT LISTING
Article 4
(Criteria)
(1) In the process of listing, medicinal products are assessed on the basis of the following criteria:
- Significance of medicinal product in terms of public health,
- Implementation of healthcare protection programme priorities,
- Therapeutic significance of the medicinal product,
- Relative therapeutic value of a medicinal product,
- Estimate of pharmacoeconomic data,
- Evaluation of ethical aspects,
- Healthcare protection programme priorities,
- Data and estimate from reference sources.
(2) The key criteria for listing are determined in Articles 5 to 11 hereof. Medicinal products with great significance for public health, high level of therapeutic significance and high relative therapeutic value and show good pharmacoeconomic data, achieve better conditions for adopting a decision on listing.
 

 

Article 5
(Significance for public health)
(1) The priorities of the area of prevention and treatment of diseases, disorders and conditions are considered significant for the assessment of significance of individual medicinal products in terms of public health and implementation of priorities of the healthcare protection programme, which are:
- determined in Article 23 of the Act,
- defined in the health care resolution and other national strategic documents,
- defined in the guidelines of the World Health Organisation.
(2) In the assessment from the previous paragraph, the significance of the areas not specified in the act and the strategic documents is also taken into account when they represent a large burden for public expenses.
(3) The impact on the HIIS' funds defined in its financial plan and the principle of prudent use of public funds are also taken into account in the listing.
(4) Furthermore, listing is also based on the reliability of the applicants to supply the market with their products. Another criterion of reliability is the interruptions in the supply of the Slovene market with medicinal products in the health insurance system and provision of medicinal products considered less significant due to fewer patients.
 

Article 6
(Therapeutic significance of the medicinal product)
(1) In terms of therapeutic significance, the medicinal product is defined as:
- Medicinal product with proven positive impact on final treatment outcomes,
- Medicinal product with proven positive impact on substitute treatment outcomes,
- Medicinal product with positive impact on the quality of life,
- Medicinal product with new pharmacological impact, which is the first in a new group but without evidence of positive impact on the final treatment outcome,
- New medicinal product from the pharmacological group with same therapeutic indication,
- Medicinal product with an indistinct or negligible therapeutic effect.
(2) When assessing the therapeutic effect of a medicinal product, the level of recommendation from the Slovene therapeutic guidelines or the guidelines of the European expert associations is also taken into account:
- Class I: the medicinal product is convincing and without any doubt efficient, which is why it must be used,
- Class IIa: evidence on efficiency of the medicinal product is inconsistent; however, evidence that it is efficient prevails, which is why its use is recommended,
- Class IIb: there is not enough evidence on the efficiency which is why the use of medicinal product is only recommended in special cases,
- Class III: there is no evidence of clinical efficiency of the medicinal product which is why the use is not recommended.
 

Article 7
(Relative therapeutic value)
In terms of relative therapeutic value, the medicinal product is defined as:
- a medicinal product with new therapeutic value in case it is used for treating or preventing a disease, condition or disorder for which no efficient treatment has existed so far,
- a medicinal product with new therapeutic value in case the following issues are involved, compared to the usual medicinal product or treatment:
- more favourable impact on the final treatment outcome,
- more favourable impact on the substitute treatment outcome,
- more favourable impact on the quality of life,
- efficient treatment of disease symptoms,
- improved safety profile of the medicinal product,
- more patient-friendly use of medicinal product,
- medicinal product with no evidence of new or added therapeutic value.
 

Article 8
(Pharmaceutical particulars)
(1) The HIIS assesses the medicinal product on the bases of:
- pharmacoeconomic study, including:
- partial evaluation with cost analysis,
- complete evaluation with cost analysis and treatment outcomes,
- budget impact analysis.
(2) The pharmacoeconomic study is carried out from the social aspect and the aspect of health insurance. The study is not obligatory from the social point of view, if there are any viability-related objections or when no significant differences can be expected between the social aspect and the aspect of health insurance. In such case, the adequate justification must be given.
(3) The budget impact analysis is carried out from the aspect of health insurance and separately from the aspect of compulsory insurance.
 

Article 9
(Mandatory pharmacoeconomic data)
(1) Pharmacoeconomic data with pharmacoeconomic study and analysis of budget impacts are a mandatory enclosure to the application from Article 22 hereof, in the following cases:
- new medicinal product,
- new indication of classified medicinal product,
- change to the restrictions on prescription.
(2) For medicinal products not stated in the previous paragraph and those in relation to which no changes are expected to other direct or indirect costs, the comparison based on comparable doses is sufficient.
(3) If the preparation of pharmacoeconomic data for the territory of Slovenia would impact the conditions of deciding on the listing within the deadlines stipulated hereby and by the applicable act, instead of the pharmacoeconomic study referred to in the previous Article, a study carried out outside the Republic of Slovenia in the countries with comparable level of development of the health system can be attached to the application from Article 22 hereof. In the process of listing, the HIIS may demand the preparation of adequate study for the Slovene market. Notwithstanding the above, it adopts a temporary decision on the listing of a medicinal product and determines the deadline for submitting the required study. Following the receipt of the requested study, it shall again decide on the listing of the medicinal product within the deadlines stipulated by these rules and the applicable act.
(4) The maximum deadline set by the HIIS for subsequent submission of the required study from the previous paragraph is 3 years. When setting the deadline, the HIIS may take into account the duration of the period between the issue of the marketing authorisation and the submission of the listing application.
(5) All analyses hereunder must be based on the results of publicly available meta-analyses or high quality randomised studies. If required, any additional data may be derived from observation studies. If not enough real data are available, modelling methods can also be used for the analysis.
 

Article 10
(Pharmacoeconomic studies)
(1) The following pharmacoeconomic studies can be used as the basis for assessing the pharmacoeconomic data:
- cost-cutting analysis,
- cost-effectiveness analysis,
- cost-utility analysis,
- cost-benefit analysis,
(2) As a rule, the results of the pharmacoeconomic study are expressed as:
- additional cost of treatment needed for an additional year of quality-adjusted life years compared to the alternative treatment strategy,
- additional cost of treatment needed for an additional year of life without disease progression,
- additional cost of treatment needed for an additional year of life.

Article 11
(Contents of pharmacoeconomic studies)
(1) The pharmacoeconomic study must include at least the following items:
- basic data on the study:
- client ordering the study,
- contractor performing the study,
- disclosure of potential conflict of interests of the contractor performing the study,
- time validity of the study,
- key starting points of the study, including:
- the purpose of the study,
- aspect,
- target population of patients or indication,
- alternative treatment strategies,
- analysis period,
- analysis type,
- description of the model, in the case of model study,
- a clear record of therapy outcomes, clinical and humanist (quality of life),
- source of information on therapy outcomes (systematic overview of literature or meta-analysis),
- cost or outcome discount,
- study assumptions,
- sensitivity analysis,
- results with comments,
- methodology of transfer into Slovenia, in the case of foreign study,
- study summary,
(2) The budget impact analysis must include the following items:
- introductory information:
- epidemiological data (prevalence and incidence of disease, age, gender and risk factors),
- clinical data (description of pathology, progressing of disease and existing treatment possibilities),
- economic data (relevant pharmacoeconomic study),
- description of new treatment compared to the previous,
- the objective of budget impact analysis (they need to take into account the aspect of analysis required by the payer/decision maker),
- method and form of analysis:
- determining the population (by years, taking into account all known measures, such as limited prescription, stimulated demand, side effects),
- eligibility of new medicinal product in the treatment process,
- time dimension of analysis,
- model description,
- description of input data,
- sources of data, together with the strengths, weaknesses source reliability and selection criteria, studies and files,
- data collection process,
- description of the method(s) for compiling the analysis,
- results:
- presentation of budget impact of the introduction of a new medicinal product by year, based on pessimistic, optimistic and medium version,
- presentation of annual cost of the introduction of a new medicinal product (total cost and cost by item), based on pessimistic, optimistic and medium version,
- sensitivity analysis, if conducted,
- graphic presentation of the used model,
- indication of used model assumptions,
- computer model in the form of checklists.
 

 

Article 12
(Evaluation of ethical aspects)
In the evaluation of medicinal products for treatment of severe and rare diseases, the ethical aspect is also taken into account, if there are no other treatment options and in the case of medicinal products which considerably improve the long-term progress of the disease or quality of patient lives.
 

Article 13
(Data and estimates from reference sources)
(1) Decision is also based on the data and estimates from scientific publications, expert guidelines, findings or opinions of reference expert associations, data and guidelines of the World Health Organisation and other institutions and bodies competent for prices and reimbursement as well as from data and other publicly available sources.
(2) The level of evidence is the criteria that helps estimate certain diagnostic or therapeutic methods or procedures. In the listing process, the following classification of evidence is used for assessing the significance and impact of the study:
- 1a systematic overview and meta analysis of randomised controlled studies,
- 1b support with at least one randomised controlled study,
- 2a support with at least one well-planned controlled study without randomisation,
- 2b support with at least one study of another type or well-planned quasi experimental study,
- 3 support with well-planned non-experimental descriptive studies (e.g. comparative studies, correlation studies or studies of clinical cases),
- 4 support with an expert body report or their positions or clinical experience of renowned experts.
 

III. DETERMINING THE LISTS OF MEDICINAL PRODUCTS
Article 14
(Lists of medicinal products)
(1) Medicinal products dispensed on prescription and intended for outpatient treatment are classified on positive and intermediate lists.
(2) The following medicinal products are included in the positive list:
- medicinal products with the designation P100 used for the treatment of persons, diseases and conditions from the fourth to the thirteenth indent of Item 1 of the first paragraph of Article 23 of the Act, meeting the following criteria:
- medicinal products of choice with proven long-term effect on the progress of life-threatening disease,
- medicinal products for further or supplemental treatment of diseases stated hereunder, which are highly recommended by the therapeutic guidelines, and
- acceptable increase in the cost arising from the increase in effectiveness,
- medicinal products with the designation P75 used for the treatment of life-threatening diseases not specified in the Act, meeting the following criteria:
- medicinal products of choice with proven long-term effect on the progress of disease,
- medicinal products for further or supplemental treatment of diseases stated hereunder, which are highly recommended by the therapeutic guidelines, and
- acceptable increase in cost arising from the increase in effectiveness.
(3) The following are included in the intermediate list marked V:
- medicinal products for the treatment of diseases under the first and the second paragraphs hereunder which are less recommended by the therapeutic guidelines and have a less favourable increase in cost arising from the increase in effectiveness,
- medicinal products for the treatment of diseases with lower levels of priority and
- medicinal products that improve the quality of life.
(4) Notwithstanding the provisions of paragraphs 2 and 3 hereunder, medicinal products with the designation P75 are reimbursed fully or to the highest recognised value when needed for the treatment of persons and conditions referred to in indents four to thirteen of Item 1, Paragraph 1 Article 23 of the Act and medicinal products from the intermediate list for children, students, apprentices and physically or mentally handicapped persons in accordance with the fifteenth indent of Item 1, Paragraph 1, Article 23 of the Act.
(5) In the case of medicinal product with two or more therapeutic indications, each therapeutic indication can be classified to the corresponding list.
 

IV. FOODS FOR SPECIAL MEDICAL PURPOSES
Article 15
(Criteria for listing)
In the process of listing, foods dispensed on prescription are assessed on the basis of the following criteria:
- significance of food in terms of public health,
- therapeutic significance of the food,
- adjustment of the composition of nutrients in food, specific for the disease, disorder or medical condition,
- agreed price of food between the applicant from the second paragraph of Article 19 hereof and the HIIS.
 

Article 16
(Determining the lists)
(1) Foods are listed on the basis of the following criteria:
- positive list with designation P100 for:
- foods with adjusted composition of nutrients for treating insured persons with congenital metabolism disorders,
- intermediate list with designation V for:
- foods for children with severe allergies and other severe forms of food intolerance,
- foods for nutrition of patients with acute deterioration of severe chronic disease with severe physical exhaustion or patients in whom such condition occurred due to side effects of therapeutic procedures for which such nutrition is obligatory and can considerably improve the quality of life and success of treatment.
(2) Notwithstanding the provisions of the previous paragraph, the foods from the intermediate lists for children, pupils, students, apprentices and with disorders in physical and mental development are reimbursed fully or up to the amount of the highest recognised value from compulsory insurance in accordance with the fifteenth indent of Item 1 of the first paragraph of Article 23 of the Act.
 

V. SEPARATION CRITERIA
Article 17
(separation criteria)
Notwithstanding the provisions of Articles 5 to 16 hereof, these lists cannot contain medicinal products that:
- do not disclose the same or added value in the therapeutic or economic sense compared to the medicinal products or foods in the same therapeutic group which have already been included in the positive or intermediate list,
- are used for alleviating the symptoms or treating medical conditions that are less significant from the point of view of public health, or
- are used in treating medical conditions that can be regulated or treated merely by changing the way of living.
 

VI. LIMITED PRESCRIPTION AND LIMITED DISPENSING
Article 18
(Limited prescription and limited dispensing)
(1) A listed medicinal product or food can be subject to limited prescription and/or dispensing. Limitation can refer to:
- population group, defined by age or other population characteristics,
- indication area; one or more approved indications may be selected from the summary of product characteristics; treatment duration can also be limited in the scope of indication area,
- disease severity, stage of disease,
- clinical specialty, group of doctors authorised for indicating and prescribing medicinal products that are reimbursed from compulsory insurance,
- mandatory previous approval by an expert committee which decides on the prescription of specific medicinal products obtained with biotechnological procedures and foods for special medical purposes,
- time or quantity limitation of dispensing medicinal products.
(2) The text of the limitation is published together with the listing.
(3) The HIIS shall issue more detailed instructions for prescribing and dispensing of magistral preparations reimbursed from compulsory insurance.
(4) Determination of HRV from Article 43 hereof does not exclude the limitation of prescription and dispensing.
 

VII. APPLICANTS, APPLICATIONS, APPLICATION PROCESSING PROCEDURE, DEADLINES
Article 19
(Applicants, initiators)
(1) The application for medicinal product listing may be submitted to the HIIS by the following applicants:
- Marketing authorisation holder or its representative in the Republic of Slovenia,
- Holder of marketing authorisation for parallel entered or imported medicinal product,
- Holder of the authorisation for entry or import of a medicinal product included in the list of urgent medicinal products,
- Holder of a favourable opinion from the European Medicines Agency for parallel distribution of medicinal products.
(2) The application for foods listing may be submitted to the HIIS by the manufacturer or its representative.
(3) Notwithstanding the provision of the first and the second paragraph hereunder, the HIIS may include medicinal products and foods on the lists also upon the initiative of hospitals or its own initiative.
(4) Based on the initiative from the previous paragraph, the HIIS informs the holder of marketing authorisation or the manufacturer from the first or the second paragraph hereunder and asks it to provide the necessary documentation, if necessary.
(5) If a medicinal product or food is taken over by a new authorisation holder or representative, the new application for listing is not needed.
 

Article 20
(Types of applications)
The applicant may submit to the HIIS the application for the listing of:
- new medicinal product,
- new indication of classified medicinal product,
- relisting,
- change to the limitation of prescription or dispensing:
- new combination of active ingredients contained by listed medicinal products,
- similar biological medicinal product,
- generic medicinal product,
- new form, strength or packaging of listed medicinal product,
- medicinal product from the list of essential medicinal products,
- galenic product,
- magistral preparation,
- foods for special medical purposes,
- withdrawal of medicinal or food product from the list.

Article 21
(Contents of the application, forwarding)
(1) The application for the listing of medicinal product or food must contain data on the applicant and technical and expert data on medicinal product or food. The application for the listing of medicinal product must also contain the decision on the highest allowed price or extraordinary allowed higher price issued by the Agency in accordance with the provisions regulating the prices of medicinal products.
(2) The application is sent to the HIIS in writing together with the copy on an electronic data carrier.
 

 

Article 22
(Application for a new medicinal product, new indication, relisting or change to limitations)
Application for a new medicinal product, new indication, relisting or change to limitations of prescribing must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- an expert explanation stating the therapeutic significance and possible new or added value of medicinal product (form B in Appendix 1 hereto),
- data from the Summary of Product Characteristics (form B in Appendix 1 hereto),
- statement of up to three key studies and their summaries (form B in Appendix 1 hereto),
- data on potential inclusion of medicinal product in expert guidelines in the EU Member States and potential other countries (form B in Appendix 1 hereto),
- rate of reimbursement from public funds and potential limitations of prescription in the EU Member States and potential other countries (form B in Appendix 1 hereto),
- anticipated date of the launching of medicinal product on the market (form B in Appendix 1 hereto),
- data and assessment of reference sources (form C in Appendix 1 hereto),
3. pharmaceutical particulars,
4. data on CI price of medicinal product (form I in Appendix 2 hereto),
5. copy of the evidence on marketing authorization,
6. Summary of Product Characteristics approved by the Agency or the European Medicines Agency,
7. evidence for potential status of an orphan medicinal product,
8. copy of decision on the highest allowed price, formed in accordance with the rules on the prices of medicinal products,
9. evidence of submitting a potential application for extraordinary higher allowed price,
10. statement of sources for clinical, pharmacoepidemiological and pharmacoeconomic studies published in professional literature,
11. copies of clinical, pharmacoepidemiological and pharmacoeconomic study on which data in the application are based,
12. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the first paragraph of Article 19 hereof,
13. evidence on paid fees to the HIIS,
14. contact person, e-mail and telephone number.
 

Article 23
(Application for a new combination)
Application for new combination of listed medicinal product must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- an expert explanation stating the therapeutic and possible new or added value of medicinal product (form B in Appendix 1 hereto),
- data from the Summary of Product Characteristics (form B in Appendix 1 hereto),
- statement of up to three key studies and their summaries (form B in Appendix 1 hereto),
- rate of reimbursement from public funds and potential limitations of prescription in the EU Member States and potential other countries (form B in Appendix 1 hereto),
- anticipated date of the launching of medicinal product on the market (form B in Appendix 1 hereto),
3. pharmaceutical particulars,
4. data on CI price of medicinal product (form I in Appendix 2 hereto),
5. Summary of Product Characteristics approved by the Agency or the European Medicines Agency,
6. copy of decision on the highest allowed price, formed in accordance with the rules on the prices of medicinal products,
7. evidence of submitting a potential application for extraordinary higher allowed price,
8. statement of sources for clinical, pharmacoepidemiological and pharmacoeconomic studies published in professional literature,
9. copies of clinical, pharmacoepidemiological and pharmacoeconomic study on which data in the application are based,
10. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the first paragraph of Article 19 hereof,
11. evidence on paid fees to the HIIS,
12. contact person, e-mail and telephone number.
 

Article 24
(Application for similar biological medicinal product)
Application for similar biological medicinal product must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- an expert explanation stating the therapeutic and possible new or added value of medicinal product (form B in Appendix 1 hereto),
- data from the Summary of Product Characteristics (form B in Appendix 1 hereto),
- statement of up to three key studies and their summaries (form B in Appendix 1 hereto),
- anticipated date of the launching of medicinal product on the market (form B in Appendix 1 hereto),
- data and assessment of reference sources (form C in Appendix 1 hereto),
3. pharmaceutical particulars,
4. data on CI price of medicinal product (form I in Appendix 2 hereto),
5. copy of a decision on marketing authorization,
6. Summary of Product Characteristics approved by the Agency or the European Medicines Agency,
7. copy of decision on the highest allowed price, formed in accordance with the rules on the prices of medicinal products,
8. evidence of submitting a potential application for extraordinary higher allowed price,
9. statement of sources for clinical, pharmacoepidemiological and pharmacoeconomic studies published in professional literature,
10. copies of clinical, pharmacoepidemiological and pharmacoeconomic study on which data in the application are based,
11. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the first paragraph of Article 19 hereof,
12. evidence on paid fees to the HIIS,
13. contact person, e-mail and telephone number.
 

Article 25
(Application for a generic medicinal product and parallel import/distribution)
(1) Application for the listing of a new generic medicinal product must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- data from the Summary of Product Characteristics (form B in Appendix 1 hereto),
- anticipated date of the launching of medicinal product on the market (form B in Appendix 1 hereto),
3. pharmaceutical particulars,
4. data on CI price of medicinal product (form I in Appendix 2 hereto),
5. copy of a decision on marketing authorization,
6. Summary of Product Characteristics approved by the Agency or the European Medicines Agency,
7. copy of decision on the highest allowed price, formed in accordance with the rules on the prices of medicinal products,
8. evidence of submitting a potential application for extraordinary higher allowed price,
9. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the first paragraph of Article 19 hereof,
10. evidence on paid fees to the HIIS,
11. contact person, e-mail and telephone number.
(2) Application for a medicinal product with authorisation for parallel import or opinion of the European Medicines Agency for parallel distribution shall be prepared pursuant to the requirements from the previous paragraph, except in Item 5, where a copy of authorisation for parallel import or the opinion of European Medicines Agency for parallel distribution is required.

 

Article 26
(Application for a new form, strength or packaging)
(1) Application for new form, strength or packaging of listed medicinal product must contain:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- an expert explanation stating the therapeutic and possible new or added value of medicinal product,
- data from the Summary of Product Characteristics (form B in Appendix 1 hereto),
- anticipated date of the launching of medicinal product on the market (form B in Appendix 1 hereto).
3. pharmaceutical particulars,
4. data on CI price of medicinal product (form I in Appendix 2 hereto),
5. copy of a decision on marketing authorization,
6. Summary of Product Characteristics approved by the Agency or the European Medicines Agency,
7. copy of decision on the highest allowed price, formed in accordance with the rules on the prices of medicinal products,
8. evidence of submitting a potential application for extraordinary higher allowed price,
9. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the first paragraph of Article 19 hereof,
10. evidence on paid fees to the HIIS,
11. contact person, e-mail and telephone number.
(2) If the application for a new form and strength of a listed medicinal product also refers to the new or changed therapeutic indication, the application is prepared pursuant to the requirements from Article 22 of these Rules.
 

 

Article 27
(Application for medicinal product from the list of essential medicinal products)
The application for listing a medicinal product on the list of essential medicinal products for human use must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- data from the Summary of Product Characteristics (form B in Appendix 1 hereto),
- anticipated date of the launching of medicinal product on the market (form B in Appendix 1 hereto),
3. copy of a decision on marketing authorization for special import/entry of medicinal product,
4. data on CI price of medicinal product (form I in Appendix 2 hereto),
5. summary of main product characteristics in the English language, approved in one of the EU/EEA Member States,
6. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the first paragraph of Article 19 hereof,
7. contact person, e-mail and telephone number.

Article 28
(Application for galenic product)
Application for the listing of galenic medicinal product must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- cost explanation (form B in Appendix 1 hereto),
- data from the instructions for use (form B in Appendix 1 hereto),
- anticipated date of the launching of medicinal product on the market (form B in Appendix 1 hereto),
3. data on CI price of medicinal product (form I in Appendix 2 hereto),
4. instructions for use,
5. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the first paragraph of Article 19 hereof,
6. contact person, e-mail and telephone number.
 

 

Article 29
(Application for magistral preparation)
Application for the listing of magistral preparation must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal product (form A in Appendix 1 hereto),
2. an expert explanation of the applicant stating the therapeutic indication and prescription (form B in Appendix 1 hereto),
3. contact person, their e-mail and telephone number.
 

Article 30
(Application for a food product)
Application for the listing of a food product must contain the following data and documents:
1. cover letter with data on the applicant, type of application and food product (form A in Appendix 1 hereto),
2. short summary of mandatory enclosures to the application, containing:
- an expert explanation stating the significance of food in terms of public health, therapeutic significance and adjustment of the composition of nutrients in food, specific for the disease, disorder or medical condition (form B in Appendix 1 hereto),
- data from the instructions (form B in Appendix 1 hereto),
- anticipated date of the launching of food product on the market (form B in Appendix 1 hereto),
3. data on CI price of food product (form I in Appendix 2 hereto),
4. instructions for use of food product,
5. statement of the applicant that they will immediately inform the HIIS, in relation to all their listed food products in an event of interrupted market supply lasting more than one month,
6. authorisation, in case the applicant is a legal or natural person applying for the listing on behalf of the applicant referred to in the second paragraph of Article 19 hereof,
7. evidence on paid fees to the HIIS,
8. contact person, e-mail and telephone number.
 

Article 31
(Application for exclusion of medicinal or food product from the list)
Application for the exclusion of a medicinal or food product from the list must contain the following data and documents:
1. cover letter with data on the applicant, type of application and medicinal or food product (form A in Appendix 1 hereto),
2. explanation of exclusion of medicinal or food product from the list,
3. the applicant’s assessment of risks for public health due to exclusion of medicinal or food product from the list,
4. authorisation, in case the applicant is a legal or natural person applying for the exclusion from the listing on behalf of the applicant referred to in the first or second paragraph of Article 19 hereof,
5. contact person, e-mail and telephone number.
 

Article 32
(Additional expert opinions)
In the listing process, the HIIS can obtain additional opinions of expert institutions or individuals.
 

Article 33
(Committee)
(1) In the process of listing, the HIIS obtains the expert opinion of a special expert committee for listing (hereinafter: the Committee). The members of the Committee are appointed by the Management Board of the HIIS.
(2) The Committee provides expert opinions for:
- listing of new medicinal products,
- determining limitations for prescribing or dispensing,
- listing of new indications of previously classified medicinal products,
- exclusion of medicinal products from the list under Article 38 hereof,
- other issues of the expert service of the HIIS in the area of listing and determining the HRV,
- incentives from the third paragraph of Article 19 hereof.
(3) The Committee is an expert body, independent of commercial pharmaceutical companies, which consists of experts in the field of medicine and pharmacy, with skills and knowledge in clinical pharmacology and other experts with systemic knowledge in the area of medicinal products. The Committee members shall perform their work independently and in compliance with the code of medical ethics.
(4) The Committee shall adopt its Rules of Procedure.
 

Article 34
(Processing of applications)
(1) The HIIS shall process complete applications for listing. If an application is not complete, the HIIS shall ask the applicant to complete the application within 15 days.
(2) Based on the submitted and obtained data and the criteria from Articles 5 to 17 hereof, the HIIS may request from the applicant or the marketing authorisation holder from the first or second paragraph of Article 19 hereof to submit additional data or analyses significant for adopting further decisions.
 

Article 35
(Decisions, deadlines)
(1) The HIIS shall, within 90 days of receiving a complete application, issue a decision on the listing of medicinal product to the positive or the intermediate list or a decision on non-listing. This deadline can be extended only in case the Agency has determined the highest allowed price prior to the expiry of 90 days. The process of determining the highest allowed price in accordance with the provisions regulating the prices of medicinal products and the process of including medicinal products on the positive or intermediate list, including the implementation of listing together may not last more than 180 days.
(2) The HIIS shall, within 180 days of receiving a complete application, issue a decision on the listing of galenic product and food to the positive or the intermediate list or a decision on non-listing.
 

Article 36
(Explanation)
Each decision on (non)listing of a medicinal product and foods into the positive or intermediate list or on their exclusion from the positive or intermediate list must be explained, giving grounds that are based on criteria fro Articles 5 to 17 hereof.
 

Article 37
(Appeal)
(1) An appeal may be launched against the decision within 30 days of serving. The appeal shall be lodged with the HIIS and shall not stay the execution of the decision.
(2) The HIIS shall lodge the appeal with the Ministry of Health immediately but no later than within 15 days. A decision on the appeal shall be adopted by the minister responsible for health within 60 days of receiving the appeal.
(3) The applicant may contest the decision of the competent minister within 30 days of serving the decision by filing a lawsuit within the administrative dispute at the Administrative Court of the Republic of Slovenia.
 

Article 38
(Exclusion from the list)
(1) Upon its own initiative or upon the initiative of healthcare institutions, the HIIS may introduce the procedure for exclusion of medicinal or food product from the positive or intermediate list, if it is established that such product no longer meets the criteria from Articles 5 to 17 hereof or when one of the criteria from Article 17 hereof is met. Prior to the adoption of the decision on the exclusion from the list, the HIIS shall ask the marketing authorisation holder from the first or the second paragraph of Article 19 hereof to submit the relevant facts. Decision is adopted taking into account the potential deadline for selling off the stocks, as stipulated in the decision.
(2) The HIIS may also adopt a decision on the exclusion from the list due to unavailability of medicinal product or food on the market over a period of more than one year. The HIIS checks the presence on the market by means of data on issued medicinal and food products and by means of inquiries with the holders of authorisation from the first or second paragraph of Article 19 hereof and excludes the medicinal or food product from the list on the basis of preliminary approval.
(3) The HIIS shall exclude from the list a listed medicinal product whose marketing, import, parallel import, entry or parallel distribution authorisation has expired or has been withdrawn. The provisions of Article 50 of the Medicinal Products Act are thus taken into account.
 

Article 39
(List of medicinal products for exclusion from the list)
(2) Twice a year the HIIS shall prepare a list of medicinal products excluded for the reasons from the second and third paragraph of the previous Article and propose them for adoption by the Management Board of the HIIS. The Decision of the Management Board is published on the HIIS website. The marketing authorisation holder from the first or the second paragraph of Article 19 hereof, who believed that not all conditions have been fulfilled for the exclusion of medicinal or food product, may appeal to the decision within 30 days.
 

VIII. PRICES OF MEDICINAL AND FOOD PRODUCTS PAIDFROM THE COMPULSORY INSURANCE (CI PRICES)
Article 40
(Agreement on the CI price)
(1) The agreement for change of the CI price (hereinafter: the agreement) can be proposed by the applicant from Article 19 hereof or the HIIS. The proposal shall be submitted in written or electronic form.
(2) The HIIS may agree with the applicant from the first or the second paragraph of Article 19 hereof on the CI price in the listing procedure. The agreement can refer to:
- the CI price of the medicinal or food product,
- the ratio price – volume of sale with potential reimbursement exceeded expenses, namely for:
- individual medicinal or food product or
- a package of medicinal or food products of an individual marketing authorisation holder from the first or manufacturer from the second paragraph of Article 19 hereof.
(3) The HIIS and the marketing authorisation holder from the first paragraph of Article 19 hereof may also agree on the distribution of the risks of financing for a certain medicinal product. All details and obligations are defined in such agreement.
(4) In the event of changed CI price, form I shall be a constituent part of the agreement (Agreement on the CI price) which is attached hereto as Appendix 2.
 

Article 41
(Changing of CI prices)
(1) Marketing authorisation holder from the first paragraph of Article 19 hereof may reduce the CI price at any time. It is communicated to the HIIS on form I (Agreement on the CI price) which is attached hereto as Appendix 2.
(2) Marketing authorisation holder from the first paragraph of Article 19 hereof shall be obliged to communicate the new CI price upon the change of the highest allowed price, if it is reduced below the CI price. The new CI price is sent to the HIIS within eight working days from the receipt of the decision on the highest allowed price on the II form (Notice of changed CI price) which is attached hereto as Appendix 3.
(3) Marketing authorisation holder from the first paragraph of Article 19 hereof shall be obliged to communicate the new CI price upon acquiring the approval of a higher allowed price. The new CI price is sent to the HIIS within eight working days from the receipt of the decision on the extraordinary allowed higher price on the II form (Notice of changed CI price) which is attached hereto as Appendix 3.
 

Article 42
(Enforcement of CI prices)
Marketing authorisation holder from the first paragraph of Article 19 hereof shall be obliged to inform legal entities and natural persons with authorisation to perform wholesale trading in medicinal products or authorisation to manufacture medicinal products with whom they have concluded co-operation agreements on the CI prices from Articles 40 and 41 hereof, namely:
- for medicinal products on the market, immediately after the conclusion of the agreement or no later than within eight working days prior to the implementation of changed CI price,
- for medicinal products not yet on the market within eight working days prior to the arrival on the market.
 

IX. HIGHEST RECOGNISED VALUES
Article 43
(Definition of scope)
HRV is determined for:
- medicinal products from the list of interchangeable medicinal products and for
- medicinal products on the intermediate list.
 

Article 44
(Procedure for medicinal product)
(1) The basis for the choice of medicinal products for determining HRV is the applicable list of interchangeable medicinal products. All listed medicinal products and medicinal products to be listed, which were proposed for listing to the Management Board of the HIIS until the adoption of HRV and are present on the Slovene market on the day of adoption of HRV, apart from those being recalled from the market in the next period of validity of the highest recognised values are selected from this list. Day of formation is the date on which the expert service of the HIIS prepares a HRV proposal and which is defined in the time schedule from Article 46 of these Rules.
(2) Groups of medicinal products are determined which are defined by the ATC designation of medicinal product, comparable form, strength and, if appropriate, comparable packaging.
(3) A comparable dose is determined for each group (e.g. tablet, ml, puff). Based on the CI prices applicable on the day of formation of HRV proposal, the prices of all comparable doses are calculated to four decimal points.
(4) HRV groups are determined with the value of the lowest price of dose in the group.
(5) The expert service of the HIIS proposes the Management Board of the HIIS to adopt, at least every six months, a new list of HRV for the groups of interchangeable medicinal products.
(6) The list of interchangeable medicinal products with HRV consists of all listed products on the currently valid list of interchangeable medicinal products with specified HRV. In addition to list designation, these medicinal products are also marked with C.
(7) HRV for individual medicinal products in a group is determined by multiplying the number of doses in the medicinal product with the HRV of the group, rounding it to two decimal points, namely upwards if the third decimal point is 5 or more, and downwards if it is less.
 

Article 45
(Data on marketing authorisation holder)
(1) In accordance with the time schedule from the next Article, the marketing authorisation holders from the first paragraph of Article 19 hereof shall be obliged to submit the following data needed for the formation of HRV:
- data on the highest allowed price and the CI price of medicinal product on form III (Notice on the CI price for HRV), attached hereto as Appendix 4 hereof,
- data on market presence for individual medicinal products.
(2) If the marketing authorisation holder from the first paragraph of Article 19 hereof wishes to reduce the CI price, the new CI price must be sent to the HIIS in accordance with the provisions of Article 41 hereof on form II (Notice of changed CI price) which is attached hereto as Appendix 3.
(3) Notwithstanding the provision of the second indent of the first paragraph hereunder, the HIIS may request the marketing authorisation holder from the first paragraph of Article 19 hereof submit, for each medicinal product, evidence on the presence of such medicinal product in at least wholesale store supplying medicinal products to pharmacies.

Article 46
(Time schedule of activities)
The HIIS shall define all deadlines and tasks of the HIIS and the marketing authorisation holders from the first paragraph of Article 19 hereof related to the formation of HRV in the Time schedule of activities for determining the highest recognised values, published by the HIIS on its website by no later than the 15th of November for the entire next year.
 

 

Article 47
(HRV for foods)
The HRV for foods included in the intermediate list is determined as 50% of the value of the CI price.
X. RECORDS, PUBLICATIONS
 

Article 48
(Records)
(1) The HIIS shall keep records of medicinal and food products included in the positive or intermediate list and of individual groups of interchangeable medicinal and food products, which shall be published on its website.
(2) The HIIS shall keep records of agreed prices with dates of validity.
 

Article 49
(Publications)
(1) The HIIS shall publish the amendments and supplements to the list on its website with the date of validity at least 15 days prior to the enforcement.
(2) The HIIS shall publish the resolutions adopted by the Management Board of the HIIS from the fifth paragraph of Article 44 hereof on its website.
(3) The HIIS shall also publish on its website a clean copy of the list of medicinal products upon each change or supplementation of the list of medicinal products.
(4) The list of interchangeable medicinal products with HRV shall be published on the HIIS website. In the period between two determinations of HRV for groups, the list is updated:
- upon each amendment and supplement to the list of medicinal products and
- upon each new announcement of medicinal products from the list of interchangeable medicinal products.
(5) The list of food products with HRV shall be published on the HIIS website, namely:
- upon each supplement to the list of food products and
- upon each amendment to the CI price of food products.
(6) The HIIS shall notify the applicants about the listing and HRV also through its system of automatic electronic notification to which the applicants shall access through a web application published at the following address: http://www.zzzs.si/egradiva.
 

XI. FEES
Article 50
(Fees)
(1) The applicant shall pay the fee for the costs of listing procedures. The fee relates to one application for one active ingredient, regardless of the strength or packaging. The fee is paid to the HIIS’ account.
(2) Depending on the type of application, the fee shall be:
- for the classification of new medicinal product: EUR 2000,
- for the listing of new indication: EUR 1500,
- listing of new combination of previously listed medicinal products: EUR 1000,
- relisting: EUR 1000,
- change to the limitation of prescription or dispensing: EUR 1000,
- listing of new form and strengths of previously listed medicinal products: EUR 500,
- listing of new packagings of previously classified medicinal products: EUR 300,
- listing of similar biological medicinal product: EUR 500,
- listing of generic medicinal product: EUR 300,
- listing of food product: EUR 1000.
(3) There is no fee for the listing of:
- galenic products,
- magistral preparations,
- medicinal products from the list of essential medicinal products.
 

XII. TRANSITIONAL PROVISIONS
Article 51
(Time schedule of activities)
The Time schedule for the year 2009 from Article 46 hereof shall be published on the website of the HIIS upon the enforcement hereof.
 

Article 52
(Prices of medicinal products with HRV)
The prices of medicinal products from the list of interchangeable medicinal products with HRV, which entered into force on 9 December 2008, that were announced by the authorisation holders in the process of determining the HRV and were enforced on 9 December 2008, shall become the CI prices taking into account the provisions of the third and the fourth paragraph of Article 41 hereof.
 

XIII. FINAL PROVISIONS
Article 53
(Cessation of validity)
The Decision on the Criteria for Classification of Medicinal Products to Lists (Official Gazette of the RS, no. 78/03) and the Rules on the Medicinal Product Listing Procedure (Official Gazette of the Republic of Slovenia, nos. 106/01 in 93/07) shall cease to apply on the date these Rules enter into force.
 

Article 54
(Beginning of validity)
These Rules shall be published in the Official Gazette of the Republic of Slovenia after they have been approved by the minister responsible for health and shall enter into force on the next day after publication.
 

No. 9000-8/2008-DI/4
Ljubljana, 10 December 2008
EVA 2008-2711-0132
President of the General Meeting of the
Health Insurance Institute of Slovenia
Pavlina Svetič