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.
- 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
- Judicial remedy: Appeal
- Competent authority: Ministry of Health