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Retail trade in medicinal products
Retail trade in medicinal products is the activity of purchasing, storing and dispensing a medicinal product or the use of a medicinal product with a health-care or veterinary service.
Retail trade in medicinal products for human use, which is accompanied by adequate expert support with advisory services, and retail trade in medicinal products for human use which are used for the treatment of animals, are performed in pharmacies and specialised shops, while retail trade in medicinal products for use in veterinary medicine is also implemented in veterinary organisations and other organisations which perform veterinary activities under the regulations on veterinary medicine, along with services provided to animals which these organisations have on record, or of they visit owners or caretakers of animals to make preventive veterinary or therapeutic interventions on animals.
Medicinal products for retail trade in specialised shops for which a medical or veterinary prescription is not required can be placed on the market, but only those products which are permitted by the competent authority by granting marketing authorisation.
Applies for SKD:
- Dispensing chemist in specialised stores G47.730
Pharmacy is a public service provided by public institutions and private entities on the basis of a concession.
Pharmacy service is implemented in pharmacies and their subsidiaries.
In addition to pharmacy service, pharmacies may also conduct the following activities:
- supply of auxiliary medicinal products, orthopaedic devices, care preparations and other preparations for health protection;
- issue of veterinary medicinal products;
- manufacture and quality verification of medicinal products and auxiliary medicinal products;
- consulting on prescribing and application of medicinal products.
No legal entity or individual is permitted to conduct legal transactions under the name of a pharmacy if they do not implement pharmacy services.
A pharmacy must have adequate personnel, premises and equipment with regard to the scope of services it provides, as well as a sufficient stock and types of medication.
Based on the criteria, set with the health-care plan of the Republic of Slovenia, a municipality or city publishes a public tender for implementing pharmacy activities and acquiring a concession.
The concession for implementing pharmacy activities is granted by the competent administrative authority of the municipality or city in agreement with the ministry responsible for health care, i.e. after an advance opinion of the Chamber of Pharmacies and the Health Insurance Institute of the Republic of Slovenia.
The decision on the concession also determines the territory where the pharmacy services can be provided.
An individual who wants to implement pharmacy activities, can acquire the concession only for one area.
The concession provider and the concessionaire conclude a concession contract regulating mutual relations in connection with the performance of pharmacy services, the conditions for the concessionaire, the start of the concession, the deadline for terminating the concession and the means that the concession provider provides for implementing pharmacy services.
The concession contract is concluded in written form.
Pharmacy verification is performed before the initiation of pharmacy services or when the conditions change, or every five years.
In the procedure of verifying the pharmacy the competent ministry establishes whether the pharmacy fulfils the prescribed conditions for performing pharmacy services and in accordance with their findings determines which professional work can be performed by the pharmacy.
The verification procedure is initiated upon the proposition of the concessionaire, lodged within 30 days prior to the start of the activity or within 30 days prior to the expiry of the decision on verification or after the implemented change.
The proposal must contain the application where the concessionaire states that the pharmacy fulfils the conditions determined with valid regulations and stipulates which professional works are implemented.
The competent ministry issues a decision based on the application.
The business hours of pharmacies are determined on the basis of local needs for the supply of medicinal products and must not be shorter than 40 hours a week.
The business hours of private pharmacies are approved by a competent local or municipal administrative authority.
All prescribed medicinal products may be issued only by a pharmacy.
The conditions to be observed by an authorised person upon the issue of the medicinal products are provided in the Rules on the classification, prescribing and dispensing of medicinal products for human use.
By means of a computer system, pharmacies must keep a suitable record displaying data on all issued medicinal products and also users of medicinal products which are subject to prescription.
In addition to records determined by other regulations, pharmacies must also keep a special record on medicinal products issued on the basis of a veterinary prescription, which must be available to the official veterinarian or another official person responsible for supervision and must include at least the following data:
- sequential number of entry in the record;
- date of issue of the medicinal product;
- accurate description of the product (name, pharmaceutical form and strength of the product);
- manufacturer’s sequential number of the product;
- quantity of the product issued as per prescription;
- identification of the animal;
- name, surname and address of the animal’s owner;
- name, surname and (licence) number of the veterinarian who prescribed the product and signature of the authorised person issuing the product, or name, surname and address of the doctor of veterinary medicine prescribing the product and signature of the authorised person issuing the product;
- label ''REPETATUR'' or "TO BE REPEATED" if multiple issuing of the product is determined with a veterinary prescription.
The veterinary prescription must be attached to the record referred to in the preceding paragraph. If the prescription bears the wording, ''REPETATUR'' or "TO BE REPEATED", the pharmacy keeps the prescription upon the last issue of the product.
If the prescription bears the wording, ''REPETATUR'' or "TO BE REPEATED" and the necessary additional issues are marked with a number and in words, the authorised person in the pharmacy issuing the medicinal product as per the veterinary prescription must additionally mark on the prescription the first and each following issue and add the date, signature and stamp of the pharmacy.
If a veterinary prescription includes a medicinal product containing narcotic or psychotropic substances, the authorised person in the pharmacy issuing this medicinal product must keep the original and the first copy of the prescription in the records of the pharmacy.
When issuing medicinal products used in veterinary medicine in pharmacies, the provisions of the regulation governing classification, prescribing and dispensing of medicinal products for human use are applied mutatis mutandis when issuing these medicinal products.
Pharmacies must store records and prescribed annexes under this article for at least five years from the date of issue of the medicinal product and must submit them for review at the request of an official person responsible for supervision.
Relating to the scope of its work, the pharmacy must keep documentation which includes particularly:
- records on the traceability of pharmaceutical substances;
- records on the purchase and issue of illicit drugs;
- records on keeping complaints and recalls of medicinal products, medicinal devices and other products;
- records on conditions for storing medicinal products;
- records of medicinal products issued on renewable prescriptions;
- records on cleaning and maintaining premises;
- records on maintaining equipment;
- documentation on the calibration or validation of equipment and work processes;
- instructions or procedures for implementing expert tasks.
Pharmacies must store prescriptions for at least three years from the date of issue of the relevant medicinal product.
Irrespective of the provision under the preceding paragraph, pharmacies must keep special prescriptions and special supply orders for at least five years from the date of issue of the relevant medicinal product.
Prescriptions in electronic form are kept in electronic archives. Special prescriptions in electronic form must be kept for at least five years and others for at least three years from the date of issue of the relevant medicinal product.
Officially sealed record books on medicinal products containing narcotic or psychotropic substances must be kept for at least five years after the date of the last entry on the medicinal product.
Computer systems must allow a review of the records as per the preceding Article for at least three years. Pharmacies must keep records on the issue of medicinal products as per renewable prescriptions for at least three years after the date of the last entry.
All of the aforementioned documentation must be stored in accordance with the regulations governing the protection of archived material.
The retail sale of medicinal products used in veterinary medicine may also be conducted in veterinary organisations and other organisations which implement veterinary activities according to regulations on veterinary medicine in addition to services for animals which these organisations keep in their record, or if they perform veterinary preventive or therapeutic procedures on animals at the owner or keeper of the animal.
Specialised outlets may sell medicinal products for which a medical or veterinary prescription is not needed, i.e. only medicinal products with marketing authorisations issued by the competent authority.
A specialised outlet is also considered a department of the retail outlet which is spatially separate from other departments, so that the sale of other products does not affect medicinal products.
No other activity may be performed in a specialised outlet where retail sale of medicinal products is being implemented, or premises where the sale of medicinal products takes place must be spatially separate from premises where other activities are implemented.
Specialised outlets may purchase medicinal products only from wholesalers with suitable authorisations issued by the authority responsible for medicinal products.
Only medicinal products in their original packaging may be sold in a specialised retail outlet.
In addition to the retail sale of medicinal products, the following products may also be sold in specialised outlets:
- medicinal devices regulated in accordance with the regulations governing the field of medicinal devices;
- cosmetic products regulated in accordance with the regulations governing the field of cosmetic products;
- food supplements and foodstuffs for special dietary purposes, except nutritionally incomplete foodstuffs for special medical purposes compliant with the regulations on foodstuffs.
- Medicinal Products Act (ZZdr-2)
- Rules concerning the requirements to be met by specialized shops for retail trade in medicinal products and onthe procedure for ascertaining their compliance
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
The retail sale of medicinal products in a specialised outlet can be performed by business entities with the licence granted by the competent authority for performing the activity and who also fulfil the following conditions besides the general conditions for performing retail sale activities:
- they employ at least one qualified person that fulfils the prescribed conditions with regard to education and qualification, this qualified person must always be present during the working hours of the specialised outlet;
- they have the necessary equipment and appropriate premises where the medicinal products or the retail sale of medicinal products are physically or in any other way separate from other products or activities and are appropriately labelled;
- they keep appropriate documentation in the way that enables immediate withdrawal of the medicinal product and resolving of complaints;
- they have an appropriately labelled specialised outlet.
The procedure for the issue of the licence for retail sale of medicinal products in a specialised store 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 retail sale of medicinal products in a specialised store in 90 days after the receipt of the complete application based on the expert committee's opinion for establishing the fulfilment of conditions for medicinal products retail sale.
The licence under the previous paragraph is also issued for a definite time or conditionally, if the expert committee under the previous paragraph finds that the holder of the licence for retail sale of medicinal products in a specialised store does not fulfil the prescribed conditions.
The applicant submits the printed or electronic application with other documentation to the competent authority.
Medicinal products are sold in specialised outlets only to persons above the age of 18.
In the case of serious medical problems, the medical product adviser in a specialised outlet must refer the patient to a doctor or a master of pharmacy in a pharmacy.
Only an authorised person can issue medicinal products. The authorised person for the issue of medicinal products that are issued based on a special prescription and special purchase order is a master of pharmacy who has passed the professional exam.
The authorised person for the issue of medicinal products that are issued based on a renewable prescription is a master of pharmacy with a passed professional exam.
The authorised person for the issue of medicinal products that are issued based on a medical prescription is a master and engineer of pharmacy with a passed professional exam.
The authorised person for the issue of OTC medicinal products only in pharmacies, is a master and engineer in pharmacy with passed professional exam and a pharmacy technician with passed professional exam working under the supervision of a master of pharmacy.
A pharmacy technician with passed professional exam is also an authorised person for the issue of OTC medicinal products in specialised stores besides the authorised stores under the previous paragraph.
Whenever a medicinal product is issued, on the basis of a prescription or not, the authorised person must advise the user or the recipient and inform them about the correct and safe use of the product.
Business entities conducting the retail sale of medicinal products must inform the competent authorities immediately about counterfeits or suspected counterfeiting.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
Commercial incentives which induce users to unnecessarily or excessively purchase or use medicinal products are prohibited in the retail sale of medicinal products.
Medicinal products not issued on the basis of a medical or veterinary prescription may be issued online with the approval of the minister.
The online issue of a medicinal product is the retail sale of the medicinal product, including suitable and expert independent support with advice on the use of the medicinal product, and transport and delivery of the medicinal product which ensure quality and the safety of application of the product.
The online issuing of medicinal products is implemented in pharmacies and specialised outlets. Medicinal products which may be sold in specialised outlets of medicinal products as per the provisions of the second paragraph of this article may be issued online by specialised outlets.
Before issuing medicinal products online, a pharmacy or a specialised outlet must obtain a marketing authorisation to do so.
The website of an online retailer of medicinal products as per the preceding paragraph must include the following data:
- the name and head office of the pharmacy and the organisational unit issuing medicinal products via the Internet, or a specialised outlet for medicinal products which issues products via the Internet;
- person responsible for online issuing of medicinal products;
- contact data of the ministry responsible for health;
- link to the website of the ministry responsible for health, providing data on the online issuing of medicinal products.
The pharmacy or a specialised outlet for medicinal products as per the preceding paragraph uses on its website a common logo determined by the European Commission on the basis of Directive 2011/62/EU and includes a safe link to the list of online retailers of medicinal products at the ministry responsible for health. The common logo is provided on every website of the pharmacy or a specialised outlet of medicinal products.
Online retail sales of medicinal products requiring a medicinal or a veterinary prescription are not permitted.
A pharmacy or specialised outlet with medicinal products must fulfil the following conditions for the sale of medicinal products via the internet:
- it must have a regulated online sale in accordance with regulations on electronic trading and safety of consumers with regard to internet sale;
- ensures safety at the creation, sending, receiving, storing or other processing of data in accordance with the law on personal data protection;
- ensures a quality system that rationally considers the principles and guidelines of good distribution practice for medicinal products with regard to traceability, transport and delivery of medicinal products to the delivery site;
- ensures professional counselling on individual medicinal products.
Pharmacies or specialised stores with medicinal products lodge an application for the licence for the sale of medicinal products via the internet at the ministry responsible for health. The application must contain the following data:
- name and head office of the pharmacy including the organisational unit, where the medicinal products will be sold via the internet or a specialised store with indicated location, where medicinal products will be sold via the internet;
- the number and date of evidence on the fulfilment of conditions for performing pharmacy activities or the number and date of licence for retail sale of medicinal products in a specialised store that will sell the medicinal products via the internet;
- evidence on the fulfilment of above mentioned conditions;
- the date of the initiation of the sale of medicinal products via the internet;
- the website or other information that are required for the recognition of website that sells medicinal products.
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.
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).
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
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.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
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 space of the store.
If another activity is pursued in the outlet, the space intended for this activity must be visibly separated from the section of 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 safe handling of goods.
- 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 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.
- Changing rooms for trying on clothes with a mirror, hanger and a seat must be part of the sales space where clothes are sold.
- A seat and mirror must be part of the sales space where footwear is sold.
- Shopping baskets or trolleys must be located in the sales space with self-service, except if this does not comply with the type or manner of selling goods.
Exterior of a retail outlet:
- The access to the entrance must be well organised and unobstructed.
- The façade of the outlet must include a sign in a visible position bearing the name of the company and place of establishment of the trader, and the potential name of the store.
- A schedule of the working hours of the outlet must be located n a visible position near the entrance.
- If retail is conducted also in a suitably arranged space next to the outlet, unobstructed movement must be ensured in this space.
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.
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.
A schedule of working hours of the outlet must be published in a visible position near the entrance to the outlet.
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.
Certification designation on the metering device.
Metrology Institute of the Republic of Slovenia
Tkalska ulica 15