Informative Notice
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Imports of active substances
The importation of active ingredients may be performed by business entities entered in the registry of importers of active ingredients which hold a permit for the production of medicinal products, producers of active ingredients and wholesalers of active ingredients (Here in after referred to as: An importer of active ingredients)
An importer of active ingredients may only import active ingredients which are:
- produced in accordance with the guidelines and principles of good production practice for active ingredients applied in the European Union or
- the guidelines and principles of good production practice for active ingredients applied in a third country which are equivalent in terms of requirements to those determined by the European Union.
An importer of active ingredients which imports active ingredients intended for the production of medicinal products for human use may only import active ingredients accompanied by a written certificate from the competent authority from the third country stating that:
- that the standards of good production practice which are used at the location where the imported active ingredient is produced are at least equivalent to those determined by the European Union;
- that the production facility is regularly supervised by the competent authority and that
- the European Union Member States where the active ingredients are imported will be notified immediately in the event of non-compliance with the standards of good production practice.
It is not necessary to present the written certificate referred to in the previous paragraph if the third country in question is on the list of countries kept by the European Commission where the requirements and standards of good production practice are equivalent to those in the European Union.
Applies for SKD:
- Wholesale of pharmaceutical goods G46.460
Conditions
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The importers of substances with head offices in the Republic of Slovenia can start performing their activity after being entered in the register of importers of substances which is managed by the relevant authority.
The competent authority issues a certificate at the entry in the register under the previous paragraph.
The register of importers of substances contains the following information:
- the name of the business entity and permanent address, contact data (telephone, fax, e-mail)
- and the list of substances that are imported.
The importer must, 60 days before starting the activity, notify the relevant authority on their activity with a written application that contains:
- evidence on fulfilling the conditions and
- the list of substances that they intend to import.
The competent authority enters the importer of substances in the register of importers of substances on the basis of a positive opinion of the expert commission for fulfilling the conditions for the import 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 the fulfilment of conditions for importing substances, the competent authority rejects the entry in the register of importers of substances by issuing a decision.
Business entities entered in the register of importers of substances may import substances.
These business entities include:
- the holders of the authorisation for manufacturing medicinal products,
- the producers of substances and
- wholesalers of substances.
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Wholesalers of substances or importers of substances inform the competent authority about counterfeits or suspected counterfeiting immediately they become aware of the aforementioned.
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
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.
Legal basis
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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