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Wholesale of active ingredients
An active ingredient is any substance or a mixture of substances intended for use in the production of medicinal products which in the production procedure becomes an active ingredient of a medicinal product whose purpose is pharmacological, immunological or metabolic effect in order to re-establish, improve or change physiological functions or to determine a diagnosis.
A business entity engaged in the wholesale of active ingredients and is entered in the registry of wholesalers of active ingredients is a wholesaler of active ingredients. A wholesaler of active ingredients performs its activity in accordance with the guidelines and principles of good distribution practice for active ingredients.
A wholesaler of active ingredients must meet the following conditions:
- employ an adequate number of experts with adequate education, considering the scope and complexity of wholesaling active ingredients;
- have adequate premises, devices and equipment for the storage and transport of active ingredients in accordance with the guidelines and principles of good distribution practice for active ingredients;
- perform the activity in accordance with the guidelines and principles of good distribution practice for active ingredients.
Applies for SKD:
- Wholesale of pharmaceutical goods G46.460
Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.
The wholesaler of substances with its head office in the Republic of Slovenia can start performing their activity after being entered in the register of wholesalers of substances, managed by the relevant authority.
The competent authority issues a certificate at the entry in the register.
The register of active substances wholesalers contains the following data:
- name of business entity and permanent address, contact data (telephone, fax and e-mail);
- the list of substances sold by the wholesaler.
60 days before starting the activity, the substances wholesaler must notify the relevant authority on the activity by submitting a written application that contains:
- evidence on fulfilling the prescribed conditions
- and the list of substances that will be sold.
The competent authority enters the substances wholesaler in the register of substances wholesalers on the basis of a positive opinion of the expert commission for fulfilling the conditions for the manufacture of substances in 90 or 60 days from the date of the receipt of the complete application if they assess that the verification of the fulfilment of conditions is not necessary.
If the expert commission under the previous paragraph issues a negative opinion on fulfilling the conditions for the wholesale of substances, the competent authority issues a decision rejecting the entry in the register.
Wholesalers of substances or importers of substances inform the competent authority about counterfeits or suspected counterfeiting immediately they become aware of the aforementioned.
Slovenčeva ulica 22
A wholesaler of substances or an importer of substances verifies:
- if providers of substances meet the requirements of the guidelines and principles of good manufacturing and distribution practices for substances and
- operate in compliance with the regulations governing substances in the country of their head office.
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.
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.
- 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.
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.