Informative Notice
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Wholesale of medicinal products
Wholesale of medicinal products means the activities of purchase, storage, sale, admission, removal, import or export of medicinal products, except for dispensing medicinal products to individuals or legal entities for their personal use or use in health care or veterinary medicine.
Wholesale of medicinal products can be performed by legal entities or individuals who fulfil the prescribed conditions and have a valid permit issued by the authority competent for medicinal products (hereinafter referred to as wholesalers).
Business entities who fulfil the following conditions can obtain a permit for wholesale of medicinal products:
- having under contract an appropriate number (relative to the scale of the activity) of experts with a master’s degree in pharmacy or with a level of education which corresponds to that level in accordance with the law, and if necessary also experts in other relevant professions;
- from among the experts referred to in the previous item they should appoint a person responsible for the reception, storage, dispensing and transport of medicinal products and reviewing of documentation that enables the traceability of medicinal products. The responsible person should have a master’s degree in pharmacy or a level of education which corresponds to that level in accordance with the law;
- and the wholesaler should have adequate premises and necessary equipment relative to the type of medicinal products which being sold,
- keep appropriate documentation in a way that allows for the immediate recall of a medicinal product from the market and settlement of complaints;
- organise work in accordance with the principle of good distribution practice and
- have a quality assurance system which determines responsibilities, procedures and measures of risk management in relation to their activities.
A wholesaler of medicinal products may purchase medicinal products only from business entities which have a permit to produce medicinal products or a permit for wholesale distribution of medicinal products.
Applies for SKD:
- Other professional, scientific and technical activities n.e.c. M74.900
Conditions
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Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.
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The procedure for the issue of the licence for wholesale medicinal products is initiated when the business entity with head office in the Republic of Slovenia submits an application.
The competent authority decides on the issue of the licence for wholesale medicinal products in 90 days after the receipt of the complete application based on the expert committee's opinion for establishing the fulfilment of conditions for wholesale medicinal products.
The competent authority can issue the licence for wholesale medicinal products:
- for the full scope of wholesale medicinal products, containing the wholesale of all medicinal products that are being sold based on valid regulations to all business entities, to whom the wholesaler can sell medicinal products in accordance with the valid legislation;
- for a contact limited scope of wholesale medicinal products that contains the wholesale of medicinal products that can only be sold based on valid regulations, i.e. only to other holders of the licence for wholesale medicinal products
- or for product-limited scope of wholesale medicinal products that entails the wholesale of such medicinal products to those business entities to whom wholesalers can sell medicinal products in accordance with the valid legislation;
- to the Directorate of the Republic of Slovenia for Commodity Reserves.
The licence under the previous paragraph can be issued for a definite time or conditionally.
The procedure for the issue of the licence for wholesale medicinal products (hereinafter referred to as the licence) is initiated when the applicant submits an application in printed or electronic form to the authority responsible for medicinal products.
An application must include the following data and documents:
- short description of the applicant and activities that are intended for implementation (e.g. import, export, entry, removal, purchase, sale, storage, distribution, quality control);
- indication of groups of medicinal products with regard to the special regime and conditions of storage;
- the indication of wholesale activities with regard to selling:
- risk medicinal products;
- other medicinal products; active substances;
- systemisation and occupation of jobs in accordance with these rules;
- the contract with the responsible person and other persons under Article 7 of these rules, in the scope that proves employment;
- evidence on disposing of business premises, the description and ground plan of premises in the scale that applies to the actual dimensional ratio of premises;
- evidence on disposing of equipment and technical data on equipment;
- list of written instructions describing standard operational procedures on good distribution practice, good storage practice, good transport practice and good control laboratory practice (if quality control is implemented in own laboratory) and on the procedure of withdrawing a medicinal product from the market and on the procedure of destroying medicinal products;
- written statement of the applicant that they will handle waste medicinal products in accordance with regulations on waste medicinal products;
- in the case of import of medicinal products, a contract with a legal or natural entity that has the permit of the authority responsible for medicinal products for analytically testing medicinal products, if the quality control is not performed in own laboratory;
- evidence on the payment of procedure fees;
- evidence on the payment of the administrative tax for the application and decision issue.
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The certification of good distribution practice is issued by the pharmaceutical inspector to the inspected business entity:
- in 90 days from the inspection if the business entity performs wholesale of medicinal products in accordance with the principles and guidelines of good distribution practice for medicinal products or for substances,
- or in 15 days from the issue or modification of the licence for medicinal products wholesale or entry or modification in the registry of substances wholesalers.
The pharmaceutical inspector can issue a decision annulling the certificate of good distribution practice, if the inspection shows that the holder of the licence for wholesale medicinal products or business entity entered in the register of substances wholesalers does not implement the principles and guidelines of good distribution practice for medicinal products or substances.
The validity of the certificate of good distribution practice is formally 5 years from the last inspection. It can be shortened according to the inspection findings.
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The activities of the wholesale distribution of medicinal products are determined in the Compilation of Community Procedures on Inspection and exchange of Information (hereinafter: Compilation of Community Procedures) which is published on the website of the European Commission in its respective and valid text.
Legal basis
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Wholesalers of medicinal products holding a wholesale marketing authorisation to perform activities to the full extent must ensure the availability of a permanent and suitable selection of medicinal products which may be subject to trading in a suitably short time no later than within 24 hours during the week or 72 hours at weekends and holidays from the received order as per the obligation to perform services in the public interest. If a health-care or a veterinary service provider or a pharmacy requires a supply of medicinal products in shorter times than provided above, this information is stated in the order to the wholesaler of products on the basis of proven medical need or medical documentation.
Wholesalers of medicinal products holding a wholesale marketing authorisation for limited production must ensure the availability of a permanent and suitable selection of products under the marketing authorisation which meet the requirements for the uninterrupted supply of these products as per the obligation to perform services in the public interest within 24 hours during the week or no later than 72 hours at weekends and holidays from the received order. If a health-care or a veterinary service provider or a pharmacy requires a supply of medicinal products in shorter times than provided above, this information is stated in the order to the wholesaler of products on the basis of proven medical need or medical documentation.
Legal basis
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It is prohibited to advertise medicinal products which do not have a marketing authorisation.
All advertising elements must be compliant with the summary of the main characteristics of the medicinal product.
Advertising of medicinal products must promote their effective use, whereby the product must be presented objectively and without exaggeration about its characteristics and must not be misleading.
Marketing authorisation holders must organise a service which prepares information on products being placed on market.
Detailed conditions for advertising medicinal products are determined in the Rules regulating the advertising of medicinal products and medical devices.
Legal basis
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The holder of the marketing authorisation has a professional division for advertising medicinal products with professional co-workers for advertising medicinal products to the expert public. The professional persons for advertising medicinal products advertise: to persons who prescribe or issue medicinal products; to health-care workers when advertising involves medicinal products for which the marketing authorisation of the authorisation of the health-care programmes provider shows that appropriate provision of information or training of the patient within the scope of health care or the training of health-care workers is required for the safe and appropriate administering of the medicinal product.
Advertising of medicinal products to the expert public is performed by professional co-workers in accordance with valid regulations. Professional co-workers for advertising medicinal products must have an appropriate education and be entered in the register of professional co-workers for advertising which is managed by the relevant authority.
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The holder of the marketing authorisation has a professional division for advertising medicinal products with professional co-workers for advertising medicinal products to expert public. The professional persons for advertising medicinal products advertise: to persons who prescribe or issue medicinal products; to health-care workers when advertising involves medicinal products for which the marketing authorisation of the authorisation of the health-care programmes provider shows that appropriate provision of information or training of the patient within the scope of health care or the training of health-care workers is required for the safe and appropriate administering of the medicinal product.
Advertising of medicinal products to the expert public is performed by professional co-workers in accordance with valid regulations. Professional co-workers for advertising medicinal products must have an appropriate education and be entered in the register of professional co-workers for advertising which is managed by the relevant authority.
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Business entities purchasing and selling or issuing medicinal products must use applicable prices of medicinal products.
The applicable price of a medicinal product for human use may be:
- an exceptionally higher allowed price; the highest allowed price;
- a price lower than the maximum allowed price on the basis of the agreement under the first paragraph of Article 159 of the Medicinal Products Act (ZZdr-2);
- a price as per the second paragraph of Article 159 of the Medicinal Products Act (ZZdr-2);
- the highest allowed price with a mandatory price reduction as per Article 160 of the Medicinal Products Act (ZZdr-2), or
- a price set freely according to the market in the relevant medicinal product, if not financed from public funds or not intended for financing from public funds.
The prices as per the first to fifth indents of the preceding paragraph are the highest prices of medicinal products, whereby business entities must not sell medicinal products above this price, but may sell them below this price.
If business entities reduce the prices under the first and fifth indents of the penultimate paragraph during their validity, these prices are understood as applicable prices of medicinal products if the competent authority receives notification thereof, records these prices and publishes them on its website.
Business entities setting an applicable reduced price of a medicinal product as per the provisions of the preceding paragraph sell medicinal products which are financed from public funds or intended for financing from public funds for the period until the revocation of the price by the business entity which is recorded and published on the website of the competent authority within five business days after the revocation.
A business entity selling or issuing medicinal products sets for a medicinal product being financed from public funds the applicable price of the medicinal product which is the most cost-effective for the relevant business entity as per the second to sixth indents of the first paragraph of Article 159 of the Medicinal Products Act (ZZdr-2).
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
A central base of medicinal products as an electronic database is established for the purpose of monitoring the prices of medicinal products which is managed by the provider of compulsory health insurance. The database includes the following data on medicinal products:
- as per items 1 to 4 of Article 187 of the Medicinal Products Act (ZZdr-2);
- prices of medicinal products and start of the validity of prices of medicinal products as per the first to fifth indents of the second and fourth paragraphs of Article 163 of the ZZdr-2;
- revocation of the price as per the fifth paragraph of this Article and prices of medicinal products determined on the basis of the act regulating price control;
- the highest recognised values of medicinal products determined by the provider of compulsory health insurance;
- financing of medicinal products from public funds; presence of the medicinal product on the market.
The data referred to in the preceding paragraph are submitted to the central base of medicinal products on the basis of an electronic data exchange by:
- the competent authority – for data on medicinal products as per the first indent of the preceding paragraph, data on prices of medicinal products as per the first and second indents of the second and fourth paragraphs of this Article and for data on the presence of the medicinal product on the market as per the fifth indent of the preceding paragraph;
- entities as per the first to sixth indents of the first paragraph of Article 159 of the Medicinal Products Act (ZZdr-2) – for data on prices of medicinal products as per the third indent of the second paragraph of this Article;
- marketing authorisation holders as per the second paragraph of Article 159 of the Medicinal Products Act (ZZdr-2) – for data on prices of medicinal products as per the fourth indent of the second paragraph of Article 163 of the Medicinal Products Act (ZZdr-2);
- the provider of compulsory health insurance – for the highest recognised values of medicinal products as per the third indent and for data on financing medicinal products from public funds as per the fourth indent of the eighth paragraph of Article 163 of the Medicinal Products Act (ZZdr-2);
- the ministry responsible for health – for data on prices of medicinal products as per the fifth indent of the second paragraph of Article 163 of the Medicinal Products Act (ZZdr-2);
- the ministry responsible for the control of prices – for data on prices of medicinal products determined on the basis of the act governing the control of prices.
The bodies referred to in the preceding paragraph submit the data on the price of the medicinal product and the termination of its validity to the central base of medicinal products no later than two business days prior to the start or cessation of the validity of the price of the medicinal product.
Other data under the preceding paragraph must be submitted in eight days of their occurrence. Business entities with retail and wholesale marketing authorisations report on medicinal products used in veterinary medicine or submit a suitable certificate of notification also to the authority responsible for veterinary medicine.
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
Harmonisation verification of the provision of services by providers of medicinal products with good distribution practice and regulations
Wholesalers of medicinal products verify that providers of medicinal products (manufacturers, importers, wholesalers) implement their activities in compliance with the principles and guidelines of good distribution practices and regulations governing medicinal products in countries where they have their head offices and if they hold manufacturing authorisations and wholesale marketing authorisations.
Verification of manufacturing and wholesale marketing authorisations
A wholesaler of medicinal products may purchase products only from business entities that hold manufacturing authorisations or wholesale marketing authorisations.
Verification of authorisations of entities to whom medicinal products are sold
Wholesalers of medicinal products verify that the business entities to which they sell medicinal products have wholesale or retail marketing authorisations or authorisations to implement pharmacy activities, or that health security providers, social care institutions or the Slovenian Armed Forces have a verified system for the receipt, storage and traceability of medicinal products.
Verification of protective elements on medicinal products and notification of counterfeits or suspected counterfeiting
Wholesalers of medicinal products verify the protective elements on received or supplied products and immediately inform the competent authority, and the marketing authorisation holder if necessary, about counterfeits or suspected counterfeiting.
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
A trader must ensure the recording of business events regarding the condition of goods in accordance with the Slovenian Accounting Standards or International Financial Reporting Standards.
At the point of sale, the trader must provide the competent inspection authorities with the following information on the condition of goods:
- number and date of the entry document;
- name of the supplier;
- number and date of the supplier’s document;
- name, unit of measure and quantity of goods;
- the sales price of goods;
- information on changes to the sales price of goods.
Legal basis
Administrator of Legislation
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A trader determines the opening times of the outlet in accordance with his or her business decision and considering the needs of consumers. The outlet must operate in accordance with the published schedule of working hours.
When determining working hours, the trader must consider the number of employees in the outlet and their rights, obligations and responsibilities arising from the employment relationship as stipulated by the act which regulates employment relationships, and the collective agreement in the field of trade in Slovenia, primarily by the provisions referring to the organisation of working hours, breaks, rests and bonuses arising from working hours which are less favourable for employees.
Dealers may not determine the opening hours of stores on Sundays and other work-free days defined by law.
Exceptions are stores with sales area of up to 200 square meters at service stations, border crossings, ports for public transport, airports, railway and bus stations and hospitals.
Exceptions also include stores with a sales area of up to 200 square meters, if work on Sundays and other work-free days defined by law in their stores is performed exclusively by a person who as a sole proprietor is a commercial activity operator or by his or her procurator or a legal representative or procurator of a legal person involved in the commercial activity.
Work on Sundays and statutory work-free days together with a sole proprietor, a sole proprietor or his or her procurator or legal representative or the procurator of a legal entity involved in a commercial activity, can also be performed by a person who may perform temporary or occasional student work in accordance with the law governing employment and unemployment insurance, and by a person who may perform temporary or occasional work in accordance with the law governing the labour market.
Evidence
A schedule of working hours of the outlet must be published in a visible position near the entrance to the outlet.
Legal basis
Administrator of Legislation
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Retail is performed in an outlet which consists of:
- a sales space where goods are directly sold, and/or
- an open sales space where goods are directly sold, and/or
- a warehouse where goods and packaging are stored, which is not a compulsory area of the outlet.
If another activity is pursued in the outlet, the space intended for this activity must be visibly separated from the section of the outlet intended for retail or be determined as such in the internal plan of this space. The arrangement of the outlet’s equipment must ensure the safe movement of buyers in the outlet and the safe handling of goods.
Minimum equipment:
- The scales for weighing non-packaged goods must be located in the sales space in the section where the sale of non-packaged goods which must be weighed is carried out. The scales must be in compliance with metrological regulations, and suitable for the quantity and types of goods being sold. If goods are weighed together with the packaging (except paper, foil and bags used for delicacies), the scales must include the function of tare weight, which must facilitate the determination of only the actual weight of goods when establishing the price. If the scales do not have this function, the vendor must deduct the weight of the packaging from the total weight, and, when determining the price, take into account only the actual weight of the goods.
- Exterior of an outlet:
- The access to the entrance must be well organised and unobstructed.
- The façade of the outlet must include a sign in a visible space with the name of the company and place of establishment of the trader, and the potential name of the store.
- A schedule of the opening hours hours of the outlet must be located in a visible position near the entrance.
- If retail is also conducted in a suitably arranged space next to the outlet unobstructed movement must be ensured in this space.
Legal basis
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The scales used for measuring in the following fields:
- protection of human and animal health,
- environmental protection and general technical safety,
- goods and services traffic,
- procedures before administrative and judicial authorities
must fulfil metrology requirements confirmed with the first and regular certification during the whole period of application.
The first certification of the metering device is the examination of the new metering device and confirmation of its conformity with the approved type and/or prescribed metrology requirements for the respective type of metering device. The first certification is provided by the producer of the metering device or his authorised representative.
Regular certification of the metering device must be provided by its owner.
The extraordinary certification is mandatory for metering devices which were excluded from application due to re-modelling, fault or other technical deficiencies. The compliance of metering devices with the metrology requirements is determined by applying the extraordinary certification. The extraordinary certification is provided by the holder of the metering device.
Regular and extraordinary certifications are conducted by the Metrology Institute or the appointed legal entity or sole trader.
Evidence
Certification designation on the metering device.
Legal basis
Administrator of Legislation
Competent Authority
Metrology Institute of the Republic of Slovenia
Tkalska ulica 15
3000 Celje