Informative Notice
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Licence for implementing activities of a specialised retail outlet with medicinal products
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.
Conditions
These terms apply to activity Retail trade in medicinal products
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A medicinal products consultant in a specialised store is responsible for the purchase, storage and sale of medicinal products and the administration of documentation. At sale, the consultant must inform the buyer on the method of use of the medicinal product, possible precautionary measures, adverse effects and other important information.
An individual must have appropriate education and have passed the professional exam, they must regularly attend trainings and be additionally trained by the professional authority that implements pharmacy activities.
The appropriately qualified person who fulfils the mentioned conditions must be present during the entire working hours of the specialised store.
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A specialised outlet must be marked accordingly:
- with a luminous sign or when this is not possible for objective reasons with a sign or a label with a graphic image of a sign as per the requirements of the Rules;
- with the name and head office of the legal entity or natural person;
- with the name and address of the specialised outlet, and notification of business hours.
Graphic image and description of the luminous sign
Rooms in a specialised outlet must be arranged functionally over a total surface of at least 35 m2. Rooms must be equipped in a way that enables quality work in accordance with good practices in the field of medicinal products.
Premises must be designed to prevent self-service sale of medicinal products for which the law prohibits self-service sale.
In addition to the minimum technical conditions determined in regulations on the outlet referring to its exterior, its rooms, equipment and devices installed, a specialised outlet must also have:
- a room for the receipt and unpacking of medicinal products, which must have an entrance for delivery of medicinal products separate from the entrance for clients;
- room for reviewing documentation;
- storage area for medicinal products which must ensure suitable storage of the products and must be physically separated from the area where other products are stored;
- room for medicinal products which must ensure that medicinal products unsuitable for sale for various reasons are physically separated from medicinal products for sale and other products;
- a sales area for medicinal products where medicinal products must be physically separated from other products and labelled in a way that enables consumers to quickly distinguish between medicinal products and other types of product;
- equipment ensuring suitable storage for medicinal products and monitoring of storage conditions;
- a wind-break if the entrance to the sales area is directly from the street;
- wardrobe area, where clean and unclean sections must be separate, and a floor which allows wet cleaning.
A system for monitoring microclimatic conditions must be established in the sales and storage areas of the specialised outlet.
Legal basis
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Medicinal products must be stored in accordance with the marketing authorisation and instructions of the manufacturer.
In the event of a deviation from the prescribed storage conditions, it is necessary to assess the impact of unsuitable storage conditions on the quality of the medicinal product in accordance with written procedures and to take suitable measures.
Unauthorised persons must be prevented from accessing the stock of medicinal products.
Legal basis
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A specialised outlet must keep documentation which includes particularly:
- records of medicinal products enabling their traceability, which must consist of the following data:
- name of the medicinal product, strength and pharmaceutical form if the product has several strengths and pharmaceutical forms and the content of packaging if a product has several packaging forms;
- name of the marketing authorisation holder;
- manufacturer’s serial number of the product and expiry date;
- received and issued quantity of the product;
- name and address of the supplier of the product;
- record on advertised and recalled products with data from the preceding point;
- record on storage conditions;
- record on cleaning and maintenance of premises;
- record on maintenance of equipment, including documentation on suitably calibrated instruments for monitoring conditions;
- records on education and expert training, and written instructions or procedures for implementing work in the field of retailing medicinal products.
Legal basis
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A specialised outlet must be secured in order to prevent the removal of medicinal products from its premises.
Legal basis
Procedures
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Licence for implementing activities of a specialised retail outlet with medicinal products
Attachments
- Complete and short name and address of the proposer
- Statement of the proposer of employment of qualified persons or statement that the proposer's personnel are contractually obliged to carry out work and tasks of a medicinal product adviser
- Evidence of education and professional examination of qualified persons
- Statement of the proposer of the disposal of business premises, description of the premises and floor plant sketch in the scale that must be stated
Procedure costs
Fee for the issue of a licence: 750.00 €