Informative Notice
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Pharmacy verification
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.
Conditions
These terms apply to activity Retail trade in medicinal products
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A pharmacy must have suitable premises relating to the scope of activities it implements.
A pharmacy must be marked:
- with a lighted sign LEKARNA (PHARMACY) in green and in the form of a cross depicting a snake and a chalice;
- name and label of the public institution or concessionaire;
- notification on business hours;
- address and phone number of the nearest pharmacy providing the 24-hour supply of medicinal products.
Pharmacy premises must be arranged and equipped in a way that ensures quality work in accordance with good pharmacy practice.
A pharmacy must have at least the following premises for:
- the collection of medicinal products and medical devices;
- issue of medicinal products and medical devices;
- storage of medicinal products and medical devices;
- preparation of magistral preparations;
- cleaning of tools and packaging – scullery;
- consulting;
- implementing professional and administrative tasks, sanitary facilities and wardrobes.
A pharmacy implementing expert services and standby duties must have suitable premises and equipment for such work.
The total area of premises of a pharmacy with no more than two counters must not be less than 70 m2. The surface for the issue of medicinal products increases for every additional counter in a pharmacy with more than two counters.
The surfaces for issuing and storage must not be less than 40 m2.
A subsidiary pharmacy must have at least the following premises for:
- the collection of medicinal products;
- issue of medicinal products;
- sanitary facilities and wardrobes which may be separate from other pharmacy premises but must be located within the facility of the subsidiary pharmacy.
The total area of premises as per the preceding paragraph must not be less than 34 m2.
A subsidiary pharmacy which organises the preparation of individual pharmaceutical forms of magistral preparations must also have rooms for:
- the preparation of magistral preparations, and cleaning of tools and packaging – scullery.
Legal basis
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Expert pharmaceutical work is conducted in the pharmacy by expert pharmaceutical workers as per the law.
A pharmacy is managed by a master of pharmacy who meets the conditions set by law.
A pharmacy conducting expert work must employ expert pharmaceutical workers with suitable knowledge from relevant fields for the implementation of this work.
Suitably qualified expert workers as per the scope of the activity and types of product must be employed in the galenic laboratory, control analysis laboratory and the laboratory for the preparation of parenteral solutions.
A person responsible for the supervision of all preparation phases for production, manufacturing and storage of a medicinal product must be employed in the galenic laboratory who is a master of pharmacy with suitable knowledge in the field of the composition of medicinal products.
A person responsible for releasing individual series of products and pharmaceutical substances must be employed in a control analysis laboratory who is a master of pharmacy with suitable knowledge in the field of trials of medicinal products.
A person responsible for the supervision of all preparation phases for the production, manufacturing and storage of parenteral solutions must be employed in a laboratory for the preparation of parenteral solutions who is a master of pharmacy with suitable knowledge in the field of composition of medicinal products.
Legal basis
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A pharmacy and a subsidiary pharmacy must have at least the equipment provided on the list of minimum equipment.
Detailed conditions for the equipment of laboratories are provided in the Rules on the requirements to be met by the persons engaged in pharmacy activities.
Legal basis
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A pharmacy must supply necessary quantities and types of medicinal products and medical devices until the deadline determined between the ministry responsible for health (hereinafter: the ministry), the Slovene Chamber of Pharmacies and the Health Insurance Institute of the Republic of Slovenia. The pharmacy determines the required stock, whereby it must take into consideration the medicinal products and medical devices which the doctors in its area prescribe.
Medicinal products and medical devices must be stored in the pharmacy in accordance with the instructions of the manufacturer, applicable pharmacopoeia and as per the principles of good storage and pharmacy practices.
Medicinal products containing illicit drugs from groups II and III (except subgroups b.1.0. and c.1.0.) determined in the Decree on the classification of illicit drugs must be stored in a steel cabinet preventing access by unauthorised persons.
Only proprietary medicinal products prescribed by doctors for the needs of their patients are stored and issued from the convenient stock of medicinal products organised by the pharmacy.
Unauthorised persons must be prevented from accessing the convenient stock of medicinal products.
Supervision of the medicinal products in the convenient stock is implemented by the manager of the pharmacy, who is also responsible for the convenient stock, or an expert pharmaceutical worker authorised by the manager.
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A pharmacy must have at its disposal in written or electronic form:
- updated expert literature and sources for informing and consulting on medicinal products, manufacturing and providing the quality of medicinal products and other literature;
- regulations in the field of health care governing pharmacy services, medicinal products, medicinal devices and illicit drugs.
Legal basis