Licence for the sale of medicinal products via the internet
A pharmacy or specialised outlet with medicinal products must fulfil the following conditions for the sale of medicinal products via the internet:
- it must have a regulated online sale in accordance with regulations on electronic trading and safety of consumers with regard to internet sale;
- ensures safety at the creation, sending, receiving, storing or other processing of data in accordance with the law on personal data protection;
- ensures a quality system that rationally considers the principles and guidelines of good distribution practice for medicinal products with regard to traceability, transport and delivery of medicinal products to the delivery site;
- ensures professional counselling on individual medicinal products.
Pharmacies or specialised stores with medicinal products lodge an application for the licence for the sale of medicinal products via the internet at the ministry responsible for health. The application must contain the following data:
- name and head office of the pharmacy including the organisational unit, where the medicinal products will be sold via the internet or a specialised store with indicated location, where medicinal products will be sold via the internet;
- the number and date of evidence on the fulfilment of conditions for performing pharmacy activities or the number and date of licence for retail sale of medicinal products in a specialised store that will sell the medicinal products via the internet;
- evidence on the fulfilment of above mentioned conditions;
- the date of the initiation of the sale of medicinal products via the internet;
- the website or other information that are required for the recognition of website that sells medicinal products.
- Judicial remedy: Appeal
- Competent authority: Ministry of Health