R U L E S
on Medicinal Product Listing

 

I. GENERAL PROVISIONS
Article 1
(Areas covered by the Rules)
(1) These Rules on prescription medicinal products shall define:
– detailed procedure and criteria for the listing of medicinal products,
– detailed procedure and criteria for the exclusion of medicinal products from the list,
– conditions and procedure for determining the restrictions on prescribing or dispensing individual medicinal products,
– costs of procedure.
(2) These Rules shall also define:
– the manner, procedure and criteria for determining the maximum recognised value for each group of interchangeable medicinal products,
– the criteria, conditions and procedure for reaching an agreement on the prices of medicinal products with the Health Insurance Institute of Slovenia (hereinafter: the Institute),
– records on medicinal products.
 

Article 2
(Terms)
(1) The terms used herein shall have the following meaning:
– Budget Impact Analysis is the analysis that evaluates the budget impact of the introduction and use of the new method of treatment in a certain healthcare system, subject to limited budget. The objective of such analysis shall be the precise estimate of financial implications of introducing a new medicinal product on the costs and the drafting of a framework that will enable the understanding of the connection between the new method of treatment and the budget impact.
– Cost Analysis is a type of economic analysis that only takes into account the cost of treatment regardless of the treatment outcome.
– Cost-Effectiveness Analysis is a type of economic analysis that compares the costs and outcomes of treatment. Costs of treatment are expressed in monetary units and the outcome of treatment in appropriate clinical laboratory and other results. The result of cost-effectiveness analysis is expressed as the incremental cost-effectiveness ratio (ICER); this is the ratio between the change in the costs of treatment and the change in the outcome of treatment.
– Cost-Utility Analysis is a sub-type of cost-effectiveness analysis in which the treatment outcome is expressed in units such as quality-adjusted life-year (QALY), including the patient’s subjective assessments of the quality of medical condition. The costs of treatment are analysed in the same way as in the analysis of cost effectiveness.
– Cost-Minimization Analysis is used when there are no differences between the outcomes of treatment and the comparison of treatment costs is the only relevant issue. The treatment involving the lowest treatment costs and yielding the same treatment effects is selected.
– Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, i.e. similarity in terms of safety and efficacy. Bioequivalence is defined in the valid text of the instruction of the European Medicines Agency “Guideline on the investigation of bioequivalence” at the website: http://www.ema.europa.eu/docs/en_GB/document _ library/Scientific_guideline/2009/09/WC500003011.pdf.
– A hospital is a provider of healthcare services engaging in specialised hospital treatment or specialised outpatient activity at the secondary and tertiary levels of healthcare activity.
– The price of medicinal product is the applicable price of medicinal product determined or agreed upon in accordance with the Medicinal Products Act (Official Gazette of the Republic of Slovenia no. 31/06 and 45/08) and other provisions regulating medicinal products which serves as the basis for charging a medicinal product to health insurance or the providers of healthcare activity in accordance with the applicable provisions.
– Added value of a medicinal product can be expressed with therapeutic value or advantage in economic sense; accordingly, the added value is determined on the basis of the comparator.
– Market availability means the actual marketing of a medicinal product in the Republic of Slovenia of which the holder of marketing authorisation informs the Public Agency in writing, pursuant to the Medicinal Products Act.
– Pharmaceutically alternative medicinal products are medicinal products containing different salts, esters, ethers, isomers, mixed isomers, complexes or active substance derivatives or differing in terms of pharmaceutical form or strength.
– Two medicinal products are considered pharmaceutically equivalent if they have the same quality and quantity structure of active substances in the same pharmaceutical form and correspond to the same or comparable standards.
– A galenic product is a galenic medicinal product for human use.
– A generic medicinal product is a bioequivalent, pharmaceutical equivalent or alternative medicinal product.
– Marketing authorisation holder is a general term for a holder of authorisation for the marketing of a medicinal product or its representative in the Republic of Slovenia, a holder of authorisation for parallel entered or imported medicinal product, a holder of authorisation for entry or import of a medicinal product included in the list of essential medicinal products and a holder of positive opinion of the European Medicines Agency on the parallel distributed medicinal product.
– Exclusion from the list of medicinal products is termination of financing from the compulsory health insurance for a medicinal product that was excluded from the list of medicinal products since it is no longer subject to listing from Article 3 and criteria from Article 5 hereof or since one of the criteria from Article 15 hereof has been fulfilled.
– Provider of healthcare activity is a natural or legal person that has signed a contract with the Institute to perform the healthcare activity.
– Public Agency means the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices.
– Final treatment outcome means the outcome relating to the time of quality-adjusted life-year for the treated disease or the time until recurrence.
– List of medicinal products is a common term for positive and intermediate lists of prescription medicinal products.
– Substitute treatment outcome means the outcome of a laboratory or another measurement or event on the basis of which the efficacy 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 charging a medicinal product from a group of interchangeable medicinal products covered by compulsory insurance in full or in relevant percentage, depending on the act and the listing of the medicinal product.
– New medicinal product means that no medicinal product with the same active substance has yet been listed.
– Restricted dispensing means that a pharmacist in a pharmacy is allowed to dispense medicinal products to the debit of compulsory health insurance only within these limitations.
– Restricted prescription means that a doctor is allowed to prescribe medicinal products to the debit of compulsory health insurance only within these limitations.
– Code of listed medicinal product means a combined code which includes the code of the list and the percentage financed by the Institute from compulsory health insurance and potentially also the code of medicinal product with restricted prescription or dispensing and the code of medicinal product with determined HRV.
– Code of medicinal product from the list of hospital medicinal products is a combined code including the list code and the code of medicinal product with restricted prescription and the code of medicinal product with determined HRV.
– Similar biological medicinal product is a biological medicinal product pursuant to Article 28 of the Medicinal Products Act.
– Procedure is a common term for the process of listing, relisting, excluding from the list of medicinal products and the process of determining or changing the restriction of prescribing and dispensing conducted on the basis of these Rules.
– Relisting is a change in the listing from one list of medicinal products to another.
– Adjustment of pharmacoeconomic analysis is a methodological adjustment of an analysis made for one of the Member States of the European Economic Area to the Slovene territory with Slovene input data.
– Comparator is the basis for comparing the medicinal product in the procedure. A medicinal product with the same therapeutic indication is used for establishing relative efficacy. Other medicinal products in the pharmacological-therapeutic group are also included in the comparison, especially the selected medicinal products from the therapeutic guidelines and other most frequently used medicinal products. Potential other treatment procedures may also be included in the comprehensive treatment of medicinal product.
– Comparative form of medicinal product means different pharmaceutical forms with comparative release and the same application.
– A comparative dose is a dose of medicinal product which, based on the data from the Summary of Product Characteristics and professional literature, results in a comparative clinical effect in view of the comparator.
– Recommended dose is a maintenance dose of the medicinal product for an adult weighing 70 kg for a specific therapeutic indication.
– Listing is deciding in the listing of a medicinal product on the list of medicinal products.
– Relative efficacy or relative therapeutic value of medicinal product is the difference between the efficacy of two or more medicinal products which represent comparable alternatives for the achievement of desired outcome of treatment in the regular clinical practice.
– List of hospital medicinal products is the list in which the medicinal products used for treatment in hospitals are included.
– The list of interchangeable medicinal products with HRV is the list of the Institute which contains the highest recognised values of classified medicinal products from the list of interchangeable medicinal products published by the Public Agency.
– The Act is the Health Care and Health Insurance Act (Official Gazette of the Republic of Slovenia no. 72/06 – official consolidated text, 114/06 – ZUTPG, 91/07, 76/08 and 62/10 – ZUPJS).
– Prescription medicinal products are medicinal products included by the Institute on the list of medicinal products and prescribed by the personal or referring doctor which are dispensed in the pharmacies.
– Medicinal products for hospital treatment are medicinal products that can only be administered in hospitals because of the method of administration and safety reasons.
– Orphan medicinal product is the synonym used for a medicinal product used for treating a rare illness.
– Treatment is a healthcare services that includes the medicinal product.
– Healthcare institution is a provider of healthcare activity.
– Health insurance means compulsory and complementary health insurance.
(2) Designations and abbreviations in these Rules shall have the following meaning:
– ATC means anatomic-therapeutic-chemical listing of medicinal products;
– B means a medicinal product from the list of hospital medicinal products;
– C in the designation of the list means medicinal product with the highest recognised value (HRV);
– EAHP means extraordinary allowed higher price;
– N means medicinal product excluded from the list of medicinal products;
– MAP means maximum allowed price;
– HRV means the highest recognised value;
– P means the positive list of prescription medicinal products;
– V means the intermediate list of prescription medicinal products;
– * asterisk in the listing means medicinal product with limited prescription or dispensing.
 

Article 3
(Subject of listing)
(1) The following medicinal products shall be listed:
– Medicinal products with marketing authorisation in the Republic of Slovenia,
– Medicinal products with authorisation for parallel entry or import,
– Medicinal products from the list of essential medicinal products which have not been granted marketing authorisation but a special authorisation for entry or import,
– Medicinal products with a positive opinion from the European Medicines Agency for parallel distribution,
– Galenic products of a pharmacy with authorisation to produce galenic products,
– Magistral preparations.
(2) A medicinal product for hospital treatment can be included in the list of hospital medicinal products under the conditions hereunder if the price of the medicinal product in the recommended dose exceeds the value of 5,000 euros per person per year, paid from the health insurance money.
 

Article 4
(List of medicinal products)
Prescription medicinal products are listed or relisted to the positive list of medicinal products with the designation P or the intermediate list of medicinal products with the designation V.
(2) Medicinal products for hospital treatment are included on the list of hospital medicinal products with the designation B.
(3) Medicinal products are listed with their proprietary names, except for magistral preparations.
 

II. CRITERIA FOR MEDICINAL PRODUCT LISTING AND RELISTING
Article 5
(Criteria)
In the process of listing and relisting, 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 on the medicinal product,
– Evaluation of ethical aspects,
– Healthcare protection programme priorities,
– Data and estimate from reference sources.
 

Article 6
(Significance for public health and healthcare protection programme priorities)
(1) The priorities of the area of prevention and treatment of persons 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,
– Determined in the resolution concerning the national healthcare plan,
– Defined in the documents of the World Health Organisation on the priority healthcare protection programmes in Europe.
(2) In the assessment from the previous paragraph, the significance of the areas not specified in the documents referred to in the previous paragraph is also taken into account when they are significant for public health.
 

Article 7
(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.
(2) When assessing the therapeutic effect of a medicinal product, the level of medicinal product recommendation in 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 effective, which is why it must be used,
– Class IIa: evidence on efficacy of the medicinal product is inconsistent; however, evidence that it is effective prevails, which is why its use is recommended,
– Class IIb: there is not enough evidence on the efficacy which is why the use of medicinal product is only recommended in special cases,
– Class III: there is no evidence of clinical efficacy of the medicinal product which is why the use is not recommended.
 

Article 8
(Relative therapeutic value of a medicinal product)
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 for which no effective treatment has existed so far,
– A medicinal product with new therapeutic value in case the following issues are involved, compared to the comparator:
a. more favourable impact on the final treatment outcome,
b. more favourable impact on the substitute treatment outcome,
c. effective treatment of disease symptoms,
d. improved safety profile of the medicinal product,
e. more patient-friendly use of medicinal product,
 

Article 9
(Estimate of pharmacoeconomic data on the medicinal product)
(1) The Institute assesses the medicinal product on the bases of the following pharmacoeconomic data:
– Pharmacoeconomic analysis, including:
a. complete evaluation with cost analysis and treatment outcomes, or
b. partial evaluation with cost analysis,
– The budget impact analysis, including from the point of view of guaranteed compulsory health insurance funds, as defined in the Institute’s financial plan. The budget impact analysis must be shown for the period of the first three years of financing from health insurance funds.
(2) The following pharmacoeconomic analyses can be used as the basis for assessing the pharmacoeconomic data:
– Cost-effectiveness analysis,
– Cost-utility analysis,
– Cost-cutting analysis,
– Cost analysis.
(3) As a rule, the results of the pharmacoeconomic analyses 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 10
(Aspect of pharmacoeconomic data)
(1) The pharmacoeconomic analysis is carried out from the aspect of health insurance. An analysis can also be conducted from the social aspect, particularly if significant difference is expected between the social aspect and the aspect of health insurance. In such case, both aspects must be shown separately.
(2) The budget impact analysis is carried out from the aspect of health insurance.
 

Article 11
(Content of pharmacoeconomic data)
(1) The pharmacoeconomic analysis must include the following items:
– Basic data on the analysis:
a. the party ordering the analysis,
b. the party conducting the analysis,
c. disclosure of potential conflict of interests of the contractor,
– Key starting points of the analysis, including:
a. the purpose of the analysis,
b. the aspect,
c. the therapeutic indication,
d. the target population,
e. common or standard treatment,
f. period to which the analysis refers,
– Analysis type,
– Description of the model, in the case of model analysis,
– A clear record of treatment outcomes, clinical and humanist (quality of life),
– Source of information on treatment outcomes (systematic overview of literature or meta-analysis),
– Discounting of the costs or treatment outcomes and statement of discount rate,
– Analysis assumptions,
– Sensitivity analysis,
– Results with comments,
– Methodology of transfer into Slovenia, in the case of foreign analysis,
– Summary of analysis,
– In the event of model analysis, the computer model in the electronic table with non-protected contents.
(2) The budget impact analysis must include the following items:
– Introductory information:
– Epidemiological data (prevalence and incidence of disease, age, gender and risk factors) for Slovenia, if data exist, otherwise from foreign sources,
b. clinical data (description of pathology, progressing of disease and existing treatment possibilities),
c. economic data (relevant pharmacoeconomic analyses),
– Description of new treatment compared to the standard treatment, including potential changes in the treatment implementation,
– The budget impact analysis (taking into account the aspect of health insurance),
– Method and form of analysis:
a. determining the population (by years, taking into account all known measures, such as restricted prescription, stimulated demand, adverse effects),
b. integration of new medicinal product in the treatment processes,
c. time dimension of analysis,
d. model description,
e. description of input data,
f. sources of data, together with the strengths, weaknesses source reliability and selection criteria, studies and files,
g. data collection process,
h. description of the method(s) for compiling the analysis,
– Results:
a. presentation of the impact of the introduction of a new medicinal product on health insurance expenses by year, based on pessimistic, optimistic and medium version,
b. 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,
c. sensitivity analysis, if conducted,
d. graphic presentation of model, if used,
e. indication of used assumptions of model, if used,
f. computer model in the form of checklists in an electronic table, with non-protected contents, if used.
(3) The form E from Annex 1 hereto can be used for the presentation of budget impacts referred to in the previous paragraph.
 

Article 12
(Mandatory pharmacoeconomic data)
(1) Pharmacoeconomic data with the cost-effectiveness analysis or cost-utility analysis and budget impact analysis, compiled or adjusted for Slovenia, are a mandatory enclosure to the application in the case of:
– new medicinal product,
– new therapeutic indication of classified medicinal product,
– relisting,
– determination or change to the restriction on prescribing or dispensing.
(2) In the case from the previous sentence, i.e. adjustment of pharmacoeconomic analysis, the original analysis in the English language or its official translation into the Slovene and the English language shall be a mandatory enclosure to the application.
(3) In the case of medicinal product from the first paragraph hereunder the foreseen total turnover of which does not exceed 300,000 euros to the debit of health insurance in all strengths and forms in the budget impact analysis for the first three years of financing, it shall be sufficient if the original analysis in the English language or its official translation into the Slovene and the English language, conducted in one of the Member States of the European Economic Area, is attached to the application instead of the pharmacoeconomic analysis from the first paragraph hereunder.
(4) If the medicinal product from the first paragraph hereunder exceeds the total amount of 300,000 euros to the debit of health insurance before or after the expiry of the three-year period, the marketing authorisation holder shall be obliged to submit the pharmacoeconomic analysis in accordance with the first paragraph hereunder within six months of receiving the request to do so. If the marketing authorisation holder fails to submit the analysis within the specified deadline, the Institute shall initiate the procedure for the exclusion of the medicinal product from the list.
(5) For a medicinal product from the first paragraph hereunder without significant differences in efficacy and safety compared to the comparator, the cost-cutting analysis or the cost analysis is submitted.
(6) For generic and similar biological medicinal products and combinations of listed medicinal products, a price comparison analysis must be submitted, based on comparative doses and comparative clinical efficacy of treatment.
(7) All required analyses for medicinal products 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 13
(Evaluation of ethical aspects)
The ethical aspect is considered as criterion mainly in the assessment of medicinal products for the treatment of severe or rare illnesses.
 

Article 14
(Data and estimates from reference sources)
In the scope of data and assessment criteria from reference sources, data from expert and scientific publications, therapeutic guidelines, findings and estimates of reference expert associations, data and guidelines of the World Health Organisation and other institutions and bodies competent for prices of medicinal products and public financing as well as data from other publicly available sources shall be taken into account.
 

Article 15
(Criteria for non-listing)
Notwithstanding the provisions of Article 5 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 in the same therapeutic group which have already been included in a list of medicinal products, or
– 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.
 

III. EXCLUSION FROM THE LIST OF MEDICINAL PRODUCTS
Article 16
(Exclusion from the list of medicinal products)
(1) A medicinal product shall be excluded from a list of medicinal products if it is no longer the subject of listing under Article 3 hereof, does not meet the criteria from Article 5 hereof or when one of the criteria from the previous article is met.
(2) Notwithstanding the previous paragraph, a medicinal product can be excluded from the list of medicinal products based on a written consent of the marketing authorisation holder, if the medicinal product is not available on the market for more than one year. The Institute shall check the availability on the market based on the data on the consumption of medicinal products and data of the marketing authorisation holder which the latter must submit to the Institute.
 

IV. RESTRICTED PRESCRIPTION AND DISPENSING
Article 17
(Restricted prescription and dispensing)
(1) The institute may define or change the restrictions on prescribing and/or dispensing a listed medicinal product in the process of listing or relisting. Restriction can refer to:
– Population group entitled to receive the medicinal product, defined by age or other population characteristics,
– Indication area for which the medicinal product may be prescribed; one or more approved therapeutic indications may be selected from the summary of product characteristics; treatment duration can also be limited in the scope of indication area,
– The disease severity for which the medicinal product may be prescribed,
– Type of specialisation of the doctor entitled to prescribe the medicinal product, i.e. clinical specialty or a group of specialised doctors entitled to prescribe medicinal products,
– Mandatory previous approval by an expert committee which decides on the prescription of specific medicinal products obtained with biotechnological procedures, and
– Time or quantity restriction of dispensing.
(2) The text of the restriction on prescribing or dispensing is published on the website of the Institute together with the listing or relisting. Medicinal product with restricted prescription or dispensing shall be marked with an asterisk next to the list code.
 

V. PROCEDURE
Article 18
(Initiation of procedure)
(1) The marketing authorisation holder may submit to the Institute the application for listing, relisting and deciding on or changing of the restriction on prescribing or dispensing.
(2) The health institution may address to the Institute an initiative for starting the procedure. The Institute shall inform the health institution in writing of the acceptance or non-acceptance of the initiative. If the initiative is accepted, the procedure is continued as in the case of application and a decision from Article 33 hereof is issued.
(3) The Institute may initiate the procedure upon its own initiative.
(4) The Institute shall inform of the initiative from the second paragraph the marketing authorisation holder to whom the initiative refers or the pharmacy producing the galenic product. The marketing authorisation holder or the pharmacy shall be obliged to submit to the Institute upon its written request the relevant documentation needed for the Institute’s decision. In the opposite case, the Institute shall decide on the basis of evidence available to it.
 

Article 19
(Types of applications and initiatives)
(1) The application or initiative for listing a medicinal product can refer to:
– New medicinal product,
– New therapeutic indication of listed medicinal product,
– New combination of listed medicinal products,
– Similar biological medicinal product,
– Generic medicinal product and parallel entry or import or parallel distribution,
– New form, strength or packaging of listed medicinal product,
– Medicinal product from the list of essential medicinal products,
– Galenic product,
– Magistral preparation.
(2) Application or initiative can also refer to:
– Relisting,
– Determination or change to the restriction on prescribing or dispensing,
– Exclusion from the list of medicinal products.
 

Article 20
(Application)
(1) The application must contain the data on the marketing authorisation holder, technical and expert data specified herein and the decision on the maximum allowed price or extraordinary allowed higher price.
(2) The application is sent to the Institute in writing in two copies on an electronic data carrier.
(3) If the marketing authorisation holder or its representative should change during the procedure, the application shall be supplemented with the data on the new marketing authorisation holder or its representative and the evidence on this change within eight days of the change.
(4) Original documents or copies thereof may be attached to the application.
 

Article 21
(Initiative)
(1) The initiative must contain data on the health institution which addresses the initiative to the Institute, the data on the medicinal product to which the initiative refers and the expert explanation of the proposal.
(2) The initiative shall be submitted to the Institute in written or electronic form.
(3) Unless stipulated otherwise by these Rules regarding individual issues related to the initiative, it shall be subject to the same provisions hereof as those applying to the application.
 

Article 22
(Application for a new medicinal product, new therapeutic indication, relisting and determination of or change to limitations of prescribing and dispensing)
(1) Application for a new medicinal product, new therapeutic indication, relisting and determination of or change to limitations of prescribing or dispensing must contain the following data and documents:
1. Cover letter (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Data from the summary of product characteristics (B.1.),
– Data on the treatment (B.2.),
– Expert justification (B.3.),
– Possible inclusion in the expert guidelines and the level of recommendation (B.4.),
– Rate of reimbursement from public funds in the EU Member States and potential other countries and potential limitations of prescription and dispensing (B.5.),
– Data on the marketing (B.6.),
– Data on the price (B.7.),
– Data on the cost of medicinal product (B.8.),
– Data on the impact on healthcare services (B.9.),
– Data on the pharmacoeconomic research (B.10.),
– Data on the budget impact analysis (B.11.),
– Potential proposal of the marketing authorisation holder (B.12.),
– Data and estimate from reference sources (B.13),
3. Documents (form C in Annex 1 hereto):
– Authorisation (C.1.),
– Decision on MAP or EAHP (C.2.),
– Evidence on potential status of an orphan medicinal product (C.3.),
– Evidence that the costs have been paid (C.4.),
– Authorisation, in case the applicant or proposer of initiative is a legal or natural person applying for the listing on behalf of the marketing authorisation holder (C.5.),
4. Additional expert documentation (form D in Annex 1 hereto):
– Summary of product characteristics approved by the Public Agency or the European Medicines Agency (D.1.),
– European Public Assessment Report (EPAR) if the medicinal product is registered according to the centralised procedure (D.2.),
– Clinical investigation referred to in the application summary (D.3.),
– Pharmacoeconomic research (D.4.),
– Budget impact analysis (D.5.).
(2) In addition to the data and documents from the previous paragraph, the application must also contain the treatment protocol, the inclusion and exclusion clinical criteria and medicinal products or treatments already used for the same therapeutic indication, and data on the efficacy of the new treatment compared with the existing treatment.
 

Article 23
(Application for a new combination of listed medicinal products)
Application for new combination of listed medicinal product must contain the following data and documents:
1. Cover letter (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Data from the summary of product characteristics (B.1.),
– Data on the treatment (B.2.),
– Expert justification (B.3.),
– Rate of reimbursement from public funds in the EU Member States and potential other countries and potential limitations of prescription and dispensing (B.5.),
– Data on the marketing (B.6.),
– Data on the price (B.7.),
– Data on the cost of medicinal product (B.8.),
– Pharmaceutical particulars (B.10.3),
– Potential proposal of the marketing authorisation holder (B.12.),
– Data and estimate from reference sources (B.13),
3. Documents (form C in Annex 1 hereto):
– Authorisation (C.1.),
– Decision on MAP or EAHP (C.2.),
– Evidence on potential status of an orphan medicinal product (C.3.),
– Evidence that the costs have been paid (C.4.),
– Authorisation, in case the applicant or proposer of initiative is a legal or natural person applying for the listing on behalf of the marketing authorisation holder (C.5.),
4. Additional expert documentation (form D in Annex 1 hereto):
– Summary of product characteristics approved by the Public Agency or the European Medicines Agency (D.1.),
– European Public Assessment Report (EPAR) if the medicinal product is registered according to the centralised procedure (D.2.),
– Clinical investigation referred to in the application summary (D.3.).
 

Article 24
(Application for similar biological medicinal product)
Application for similar biological medicinal product must contain the following data and documents:
1. Cover letter (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Data from the summary of product characteristics (B.1.),
– Expert justification (B.3.),
– Rate of reimbursement from public funds in the EU Member States and potential other countries and potential limitations of prescription and dispensing (B.5.),
– Data on the marketing (B.6.),
– Data on the price (B.7.),
– Data on the cost of medicinal product (B.8.),
– Pharmaceutical particulars (B.10.3),
– Potential proposal of the marketing authorisation holder (B.12.),
– Data and estimate from reference sources (B.13),
3. Documents (form C in Annex 1 hereto):
– Authorisation (C.1.),
– Decision on MAP or EAHP (C.2.),
– Evidence on potential status of an orphan medicinal product (C.3.),
– Evidence that the costs have been paid (C.4.),
– Authorisation, in case the applicant or proposer of initiative is a legal or natural person applying for the listing on behalf of the marketing authorisation holder (C.5.),
4. Additional expert documentation (form D in Annex 1 hereto):
– Summary of product characteristics approved by the Public Agency or the European Medicines Agency (D.1.),
– European Public Assessment Report (EPAR) if the medicinal product is registered according to the centralised procedure (D.2.),
– Clinical investigation referred to in the application summary (D.3.).
 

Article 25
(Application for generic medicinal product and parallel entry or import or parallel distribution)
(1) Application for the listing of a new generic medicinal product must contain the following data and documents:
1. Cover letter (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Data from the summary of product characteristics (B.1.),
– Expert justification (B.3.),
– Data on the marketing (B.6.),
– Data on the price (B.7.),
– Data on the cost of medicinal product (B.8.),
– Pharmaceutical particulars (B.10.3),
– Potential proposal of the marketing authorisation holder (B.12.),
3. Documents (form C in Annex 1 hereto):
– Authorisation (C.1.),
– Decision on MAP or EAHP (C.2.),
– Evidence that the costs have been paid (C.4.),
– Authorisation, in case the applicant or proposer of initiative is a legal or natural person applying for the listing on behalf of the marketing authorisation holder (C.5.),
4. Additional expert documentation (form D in Annex 1 hereto):
– Summary of product characteristics approved by the Public Agency or the European Medicines Agency (D.1.),
– European Public Assessment Report (EPAR) if the medicinal product is registered according to the centralised procedure (D.2.).
(2) Application for the listing of a medicinal product with authorisation for parallel entry or 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 3, where the authorisation for parallel entry or import or the positive opinion of European Medicines Agency for parallel distribution is required.
 

Article 26
(Application for a new form, strength or packaging of a listed medicinal product)
(1) Application for new form, strength or packaging of listed medicinal product must contain:
1. Cover letter (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Data from the summary of product characteristics (B.1.),
– Expert justification (B.3.),
– Rate of reimbursement from public funds in the EU Member States and potential other countries and potential limitations of prescription and dispensing (B.5.),
– Data on the marketing (B.6.),
– Data on the price (B.7.),
– Data on the cost of medicinal product (B.8.),
3. Documents (form C in Annex 1 hereto):
– Authorisation (C.1.),
– Decision on MAP or EAHP (C.2.),
– Evidence on potential status of an orphan medicinal product (C.3.),
– Evidence that the costs have been paid (C.4.),
– Authorisation, in case the applicant or proposer of initiative is a legal or natural person applying for the listing on behalf of the marketing authorisation holder (C.5.),
4. Additional expert documentation (form D in Annex 1 hereto):
– Summary of product characteristics approved by the Public Agency or the European Medicines Agency (D.1.),
– Clinical investigation referred to in the application summary (D.3.).
(2) If the new form of the medicinal product affects the cost of treatment compared to the classified form, the application must also contain the pharmacoeconomic data from the section B.10.3.
 

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 (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Data from the summary of product characteristics (B.1.),
– Expert justification (B.3.),
– Data on the marketing (B.6.),
– Data on the price (B.7.),
3. Documents (form C in Annex 1 hereto):
– Authorisation (C.1.),
– Decision on MAP or EAHP (C.2.),
– Evidence on potential status of an orphan medicinal product (C.3.),
– Authorisation, in case the applicant or proposer of initiative is a legal or natural person applying for the listing on behalf of the marketing authorisation holder (C.5.),
4. Additional expert documentation (form D in Annex 1 hereto):
– Summary of product characteristics in the Slovenian language or the English language.
 

Article 28
(Initiative for galenic product)
Initiative for the listing of galenic medicinal product must contain the following data and documents:
1. Cover letter (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Data from the patient information leaflet (B.1.),
– Expert justification (B.3.),
– Data on the marketing (B.6.),
– Data on the price (B.7.),
– Data on the cost of medicinal product (B.8.),
– Potential proposal of a healthcare institution (B.12.),
3. Additional expert documentation (form D in Annex 1 hereto):
– Patient information leaflet.
 

Article 29
(Initiative for magistral preparation)
Initiative for the listing of magistral preparation must contain the following data and documents:
1. Cover letter (form A in Annex 1 hereto),
2. Application summary (form B in Annex 1 hereto), containing:
– Expert explanation of the healthcare institution stating the therapeutic indication and prescription (B.3.1., B.3.12.),
– Data on the price; framework calculation together with pharmacy service,
– Potential proposal of a healthcare institution (B.12.).
 

Article 30
(Processing of applications and initiatives)
(1) The Institute shall process complete applications and initiatives. An application or initiative shall be deemed complete if it contains all data and documents stipulated herein. If an application or initiative is incomplete, the Institute shall, within 15 days of receiving it, ask the marketing authorisation holder or the healthcare institution to supplement it.
(2) Based on the submitted and obtained data and in the case of the subject of listing from Article 3 and the criteria from Articles 5 to 15 hereof, the Institute may request from the marketing authorisation holder or the healthcare institution to submit additional data and analyses significant for adopting further decisions.
 

Article 31
(Committee for medicinal product listing)
(1) In the process of listing, the Institute obtains the expert opinion of a special committee for medicinal product listing (hereinafter: the Committee). The members of the Committee are appointed by the Management Board of the Institute for a four-year term of office.
(2) The Committee is an expert and independent body 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 in compliance with the code of medical ethics and the applicable regulations.
(3) The Committee shall adopt its Rules of Procedure.
 

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

Article 33
(Decisions and deadlines)
(1) The Institute shall issue the decision on listing or non-listing no later than within 90 days of receiving the complete application. This deadline can be extended only in case the Public 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 putting medicinal products on the list, including the implementation of listing together may not last more than 180 days.
(2) Notwithstanding the previous paragraph, the Institute shall issue a decision on the listing of a galenic product within 180 days of receiving a complete initiative.
(3) The Institute shall issue a decision on relisting or a decision on rejecting the relisting, a decision on the exclusion from the list of medicinal products and a decision on the determination or change of limitation on prescribing or dispensing, or a decision on rejecting the determination or change of limitation on prescribing or dispensing within 180 days of receiving a complete application or initiative.
 

Article 34
(Explanation)
The decision from the previous article must be explained with the statement that this was the subject of listing from Article 3 of these Rules, indicating the reasons based on the criteria from Article 5 hereof, stating the reasons based on the criteria from Article 5 hereof, including the expert opinions on which the decision is based. If a decision on non-listing or exclusion of a medicinal product from the list is also issued because it does not meet the criteria from Article 15 of these Rules or since one of the above criteria was met, it must also be explained, stating the reasons based on the criteria from Article 15 of these Rules.
 

Article 35
(Appeal and judicial protection)
(1) The marketing authorisation holder or the pharmacy shall be entitled to lodge an appeal against a decision from Article 33 hereof. An appeal should be submitted within 30 days following the service of the decision. The minister responsible for health shall decide on the appeal. An appeal shall not prevent the implementation of such decision.
(2) The appeal shall be lodged with the Institute, which forwards it to the ministry responsible for health within 15 days of receiving it. A decision on the appeal shall be adopted by the minister responsible for health within 60 days of receiving the appeal by the Institute.
(3) The marketing authorisation holder or the pharmacy may contest the decision of the minister responsible for health within 30 days of receiving the decision by filing a lawsuit in an administrative dispute at the Administrative Court of the Republic of Slovenia.
 

VI. COSTS OF PROCEDURE
Article 36
Costs of the procedure
(1) The marketing authorisation holder shall pay the costs of procedure in accordance with these Rules. The costs of procedure must be paid upon the submission of the application into the account of the Institute.
(2) Depending on the type of application, the costs of procedure shall be as follows:
– For the listing of a new medicinal product: EUR 2000,
– For the listing of a new therapeutic indication: EUR 1500,
– For the determination or change to the restricted prescription or dispensing: EUR 1500,
– For the listing of a new combination of listed medicinal products: EUR 1000,
– For relisting: EUR 1000,
– For the listing of new forms and strengths of previously listed medicinal products: EUR 500,
– For the listing of a similar biological medicinal product: EUR 500,
– For the listing of a new packaging of listed medicinal products: EUR 300,
– For the listing of a generic medicinal product: EUR 300.
(3) The costs of procedure from the previous paragraph shall refer to one medicinal product with one working code. The costs of procedure shall be increased by EUR 25 for each additional working code.
(4) The costs of procedure shall not be paid in the case of listing a:
– Galenic product,
– Magistral preparation,
– Medicinal product from the list of essential medicinal products.
 

VII. HRV
Article 37
(Definition and determination)
(1) The Institute shall determine the HRV for the listed interchangeable medicinal products, namely at the level of the least expensive medicinal product in view of the comparable dosage unit within the group.
(2) The HRV for listed interchangeable medicinal products and/or its changes shall, as a rule, be determined once every two months by the Management Board of the Institute or the General Manager of the Institute, if authorised by the Management Board of the Institute.
 

Article 38
(Procedure)
(1) The basis determining the HRV is the list of interchangeable medicinal products, list of medicinal products and the prices of medicinal products. Data shall be taken into account, valid on the first day of the month in which the HRV is defined.
(2) A group of interchangeable medicinal products shall be defined by the active substance, the ATC code, strength and reference form of medicinal product (comparator). A group of interchangeable medicinal products shall consist of at least two medicinal products with proprietary names based on the working code.
(3) The HRV for a group of interchangeable medicinal products is determined by multiplying the lowest price of a reference dose, rounded to four decimal places, with the number of doses of an individual medicinal product, rounded to two decimal places, namely upwards if the third decimal digit is 5 or more, and downwards if it is less.
(4) The medicinal product from the list of interchangeable medicinal products with the HRV shall be assigned the designation C in addition to the list code.
 

VIII. AGREEMENT ON THE PRICE OF MEDICINAL PRODUCT
Article 39
(Agreement on the price of medicinal product)
(1) The agreement on the price of medicinal product may refer to the following method of financing of the medicinal product:
– The agreed price of medicinal product,
– Discount or rebate,
– The price – sales volume ratio of a medicinal product,
– Reimbursement of exceeded expenses for a medicinal product,
– Risk sharing.
(2) The agreement on the price of medicinal product may refer to one or several medicinal products. The entry into agreement on the price of a medicinal product can be proposed by the Institute or a marketing authorisation holder, or a pharmacy if the subject of agreement on the price is a galenic product. The form Agreement on the price of medicinal product which is attached in Annex 2 herewith, is a constituent part of the agreement on the price of medicinal product. The agreement on the price of medicinal product must be made in writing and in the Slovene language in order to be valid. If the agreement on the price of medicinal product was made in the Slovene language and in a foreign language, the agreement on the price of medicinal product made in the Slovene language shall be used for resolving and disputes.
(3) Agreed price of medicinal product is the price of medicinal product agreed by the Institute on the basis of the first paragraph of Article 97.a of the Medicinal Products Act. It is not possible to agree on the price of medicinal product in the form of agreed price of medicinal product for a medicinal product with determined extraordinary allowed higher price at the time of its validity. The agreed price of medicinal product must be lower than the maximum allowed price applicable on the day of making the agreement on the price of medicinal product.
(4) Discounted price of medicinal product means that the marketing authorisation holder reduces the price of the medicinal product under the conditions agreed in the agreement on the price of medicinal product.
(5) Rebate shall mean financial or quantity discount for a medicinal product granted by the marketing authorisation holder after a specific period of time and under the conditions agreed in the agreement on the price of medicinal product.
(6) Agreement on the price – sales volume ratio of a medicinal product means that the price of a medicinal product is reduced with the increase of the sales volume by the share agreed in the agreement on the price of medicinal product.
(7) The agreement on the reimbursement of exceeded expenses means that the marketing authorisation holder shall reimburse the Institute, after the end of the agreed period, the agreed difference between the actual and the agreed amount for a medicinal product if such amount was exceeded.
(8) The agreement on risk sharing means the sharing of the financing of medicinal product by the marketing authorisation holder and the Institute on the basis of the achievement of clinical criteria stipulated in the agreement on the price of medicinal product.
 

Article 40
(Termination of agreed price of medicinal product)
If the maximum allowed price of medicinal product is reduced to or under the agreed price of such medicinal product, the agreement on the price of such medicinal product shall cease to be valid in the part relating to its agreed price unless the marketing authorisation holder and the Institute have previously agreed on a new agreed price of the medicinal product.
 

Article 41
(Enforcement of agreed prices of medicinal products)
Marketing authorisation holders or pharmacies, if the subject of the agreement on the price of medicinal product is galenic products, shall be obliged to inform legal entities and natural persons with authorisation to perform wholesale trading in medicinal products or with whom they have entered into co-operation agreements of the agreed prices of their medicinal product, namely:
– For medicinal products available on the market immediately after the conclusion of the agreement on the price of medicinal product or no later than within eight days prior to the enforcement of the agreed price of the medicinal product,
– For medicinal products not yet available on the market at least eight days prior to the arrival on the market.
 

IX. RECORDS ON MEDICINAL PRODUCTS
Article 42
(Records)
(1) The Institute shall keep the record of listed medicinal products and on the HRV of listed interchangeable medicinal products.
(2) The Institute shall keep records of agreed prices of medicinal products with validity dates.
 

Article 43
(Publications)
(1) The Institute shall publish the amendments to the list with validity dates on its website at least 14 days prior to the enforcement. The Institute shall also publish on its website a clean copy of the list of medicinal products.
(2) The Institute shall publish the list of interchangeable medicinal products with HRV or the amendments to it on its website on the next business day after determining the HRV. The Institute shall also publish on its website a consolidated text of the list of medicinal products with HRV.
(3) The agreed prices of medicinal products shall be published by the Institute on its website, if the marketing authorisation holder or the pharmacy allows such publication, which is marked on the form Agreement on the price of medicinal products. In the opposite case, the Institute shall only publish the agreed prices of medicinal products for the providers of healthcare activity.
(4) The Institute shall inform the marketing authorisation holders, the healthcare institutions that address the initiative to the Institute and the providers of healthcare activity on the listing, relisting, exclusion from the list of medicinal products and changes to the restricted prescription or dispensing and on the HRV via the system of the Institute’s system for automatic electronic informing, in which the marketing authorisation holders, the healthcare institutions that address the initiative to the Institute and the providers of healthcare activity can register through web application which is publicly available at the address http://www.zzzs.si/egradiva.
 

X. TRANSITIONAL AND FINAL PROVISIONS
Article 44
(Applications and initiatives received prior to the enforcement of the Rules)
The applications for listing, relisting, exclusion from the list of medicinal products and changes to the restricted prescription or dispensing which the Institute received prior to the enforcement of the Rules shall be treated under the provisions of the Rules on the listing of medicinal products and foods for special medical purposes on the list (Official Gazette of the Republic of Slovenia no. 126/08).
 

Article 45
(Applications and initiatives addressed to the ministry responsible for health)
For medicinal products for which the applications or the initiatives for separate financing have been submitted to the ministry responsible for health prior to the enforcement hereof, the marketing authorisation holders and the healthcare institutions may submit new applications or initiatives to the Institute, pursuant to the provisions hereof.
 

Article 46
(Cessation of validity)
With the enforcement of these Rules, the Rules on the listing of medicinal products and foods for special medical purposes on the list (Official Gazette of the Republic of Slovenia no. 126/08) shall cease to be valid.
 

Article 47
(Entry into force)
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. 9000-11/2010-DI/7
Ljubljana, 23 December 2010
EVA 2010-2711-0040
President of the General Meeting
of the Health Insurance Institute of Slovenia
Vladimir Tkalec

Annex 1: Contents of applications
Annex 2: Agreement on the price of medicinal product