Entry in the register of importers of substances

Business entities entered in the register of importers of substances may import substances. These business entities include:

• holders of manufacturing authorisations,
• producers of substances and
• wholesalers of substances.

Registration and an appropriate status form are required in order to pursue the activity.

Legal basis

• Medicinal Products Act (ZZdr-2)

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

• Medicinal Products Act (ZZdr-2)
• Rules on detailed conditions of wholesale of medicinal products and determining of fulfilment of these conditions and procedure of gain the permission for traffic of wholesale of medicinal products