Other obligations of the wholesaler of medicinal products

Harmonisation verification of the provision of services by providers of medicinal products with good distribution practice and regulations

Wholesalers of medicinal products verify that providers of medicinal products (manufacturers, importers, wholesalers) implement their activities in compliance with the principles and guidelines of good distribution practices and regulations governing medicinal products in countries where they have their head offices and if they hold manufacturing authorisations and wholesale marketing authorisations.

Verification of manufacturing and wholesale marketing authorisations

 A wholesaler of medicinal products may purchase products only from business entities that hold manufacturing authorisations or wholesale marketing authorisations.

Verification of authorisations of entities to whom medicinal products are sold

Wholesalers of medicinal products verify that the business entities to which they sell medicinal products have wholesale or retail marketing authorisations or authorisations to implement pharmacy activities, or that health security providers, social care institutions or the Slovenian Armed Forces have a verified system for the receipt, storage and traceability of medicinal products.

Verification of protective elements on medicinal products and notification of counterfeits or suspected counterfeiting

Wholesalers of medicinal products verify the protective elements on received or supplied products and immediately inform the competent authority, and the marketing authorisation holder if necessary, about counterfeits or suspected counterfeiting.

Last updated: 08. 01. 2016