Informative Notice
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Licence for medicinal products wholesale
The procedure for the issue of the licence for wholesale medicinal products 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 wholesale medicinal products in 90 days after the receipt of the complete application based on the expert committee's opinion for establishing the fulfilment of conditions for wholesale medicinal products.
The competent authority can issue the licence for wholesale medicinal products:
- for the full scope of wholesale medicinal products, containing the wholesale of all medicinal products that are being sold based on valid regulations to all business entities, to whom the wholesaler can sell medicinal products in accordance with the valid legislation;
- for a contact limited scope of wholesale medicinal products that contains the wholesale of medicinal products that can only be sold based on valid regulations, i.e. only to other holders of the licence for wholesale medicinal products
- or for product-limited scope of wholesale medicinal products that entails the wholesale of such medicinal products to those business entities to whom wholesalers can sell medicinal products in accordance with the valid legislation;
- to the Directorate of the Republic of Slovenia for Commodity Reserves.
The licence under the previous paragraph can be issued for a definite time or conditionally.
The procedure for the issue of the licence for wholesale medicinal products (hereinafter referred to as the licence) is initiated when the applicant submits an application in printed or electronic form to the authority responsible for medicinal products.
An application must include the following data and documents:
- short description of the applicant and activities that are intended for implementation (e.g. import, export, entry, removal, purchase, sale, storage, distribution, quality control);
- indication of groups of medicinal products with regard to the special regime and conditions of storage;
- the indication of wholesale activities with regard to selling:
- risk medicinal products;
- other medicinal products; active substances;
- systemisation and occupation of jobs in accordance with these rules;
- the contract with the responsible person and other persons under Article 7 of these rules, in the scope that proves employment;
- evidence on disposing of business premises, the description and ground plan of premises in the scale that applies to the actual dimensional ratio of premises;
- evidence on disposing of equipment and technical data on equipment;
- list of written instructions describing standard operational procedures on good distribution practice, good storage practice, good transport practice and good control laboratory practice (if quality control is implemented in own laboratory) and on the procedure of withdrawing a medicinal product from the market and on the procedure of destroying medicinal products;
- written statement of the applicant that they will handle waste medicinal products in accordance with regulations on waste medicinal products;
- in the case of import of medicinal products, a contract with a legal or natural entity that has the permit of the authority responsible for medicinal products for analytically testing medicinal products, if the quality control is not performed in own laboratory;
- evidence on the payment of procedure fees;
- evidence on the payment of the administrative tax for the application and decision issue.
Conditions
These terms apply to activity Wholesale of medicinal products
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Quality assurance system Wholesalers must establish, implement and update an efficient quality assurance system for all their business activities by actively involving the management and staff of internal organisational units in the quality assurance system.
Staff
Wholesalers must meet the following conditions relating to their staff:
- employ a number of contractually bound experts with a university degree in pharmacy suitable to the extent of the activities and nature of the work process and contractually bound experts of other suitable education;
- employ a person responsible for the receipt, storage, issue and transport of medicinal products and for reviewing documentation enabling the traceability of medicinal products. The responsible person must meet the prescribed conditions.
The wholesaler is obliged to enable continuous education and training for its staff, particularly the responsible person.
Premises and equipment
When implementing their activities, wholesalers must have at their disposal suitable premises and equipment as per the principles of good distribution practice and principles of good storage practices.
Documentation
Wholesalers must establish, conduct and update written procedures relating to the entire distribution process, and keep records on the provision of conditions for the distribution of medicinal products (calibration, equipment qualification, validation, cleaning and maintenance of premises etc.).
Wholesalers must keep records and documentation as per the preceding paragraph in a way that enables the immediate recall of a medicinal product and supervision of complaints. All handling of the medicinal product must be recorded to ensure the traceability of the product.
The documentation referred to in the preceding paragraph must contain at least:
- the date of each prescription or issue of the medicinal product; name of the product, pharmaceutical form, strength and presentation;
- serial number of the product and expiry date;
- quantity of the received or issued product; name and address of the manufacturer;
- quality analysis results and release date of each series of the medicinal product;
- name and address of the supplier;
- name and address of the recipient;
- name and address of the company responsible for transporting the medicinal product.
The wholesaler must store the documentation referred to in the preceding paragraph for at least one year after the expiry date or recall of the medicinal product or longer if this is required by the prescribed principles of good distribution practice.
Wholesalers of medicinal products used in veterinary medicine and medicinal products for human use in the case of exceptional use in veterinary medicine must submit quarterly reports to the Veterinary Administration of the Republic of Slovenia.
The reports referred to in the preceding paragraph must include at least:
- the quantity of medicinal products issued for each individual medicinal product;
- individual recipients, with the provision of data on the period to which the report refers and
- the name of the person responsible for conducting transactions with medicinal products.
The reports must be submitted in an electronic form whose standard is determined by the Veterinary Administration of the Republic of Slovenia.
The wholesaler must establish, verify and update written procedures as per the principles of good distribution practice.
Legal basis
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Wholesalers must appoint and transport medicinal products and enable the review of documentation that enables the traceability of medicinal products. The responsible person must have an appropriate education and work experience and be entered in the register of persons responsible for the acceptance, storage, issue and transport of medicinal products and the review of documentation.
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The application for the acquisition of a marketing authorisation for radiopharmaceuticals must include documentation on quality, safety and efficiency; in addition to other prescribed conditions in an individual module, it must also contain data from Annex 1 to the Rules on radiopharmacological products.
Legal basis
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The application for acquisition of a marketing authorisation for radiopharmaceutical precursors must include data which discuss the possible consequences of the poor efficiency of radiolabelling or in vivo stability of a radiolabelled complex, i.e. relating to the effects of a free radionuclide on a patient. Suitable data on professional risks must also be enclosed, which include exposure of the hospital staff and the environment to radiation.
The application for the acquisition of a marketing authorisation for radiopharmaceutical precursors must include documentation on quality, safety and efficiency; in addition to the conditions determined by the applicable regulations in a individual module, it must also contain data from Annex 2 to the Rules on radiopharmacological products.
Legal basis
Procedures
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Licence for medicinal products wholesale
Procedure costs
Administrative fee for the application and decision: 22.66 €
Fee for the licence to medicinal products wholesale: 1,250.00 €