The Target Import (Name Patient Basis) involves importing medical products from abroad which do not have a marketing authorisation in Poland and are necessary to save patient’s life or health.
Target Import (Name Patient Basis)
Target import (Name Patient Basis) involves importing medical products from abroad which do not have a marketing authorisation in Poland and are necessary to save patient’s life or health. Medical products imported from abroad are allowed to be marketed without the need to obtain an authorisation if:
The basis for importing a medical product is:
The medicine is imported by the wholesaler and the wholesaler determines the waiting time. The Minister of Health only gives permission for a medicine to be imported from abroad as a target import and has no influence on how quickly it is brought in.
From 1 January 2021, in connection with the launch of the System of Indirect Import Service (SOID), there have been changes concerning the issuance, confirmation and execution of requests for indirect import. The system makes it possible to issue orders for importing from abroad medicinal products necessary to save the life or health of a patient, referred to in Article 4(2) of the Act of 6 September 2001 – Pharmaceutical Law, as well as requests for importing foodstuffs for particular nutritional uses in accordance with art. 29a, sec. 2 of the Act of 25 August 2006 on food and nutrition safety. SOID enables the processing of submitted requests, collection by pharmacies and pharmaceutical wholesalers of information about the processed requests and communication with the minister in charge of health concerning this area.
The system is available at: https://soid.ezdrowie.gov.pl/
In order to issue the demand, the doctor should set up an account in SOID. Below there is a link to a manual containing all the data on setting up accounts and issuing demand. https://cez.gov.pl/projekty/nasze-systemy/project/system-obslugi-importu-docelowego-soid/
Ordinance of the Minister of Health of 21 March 2012 on importing from abroad medical products which are necessary to save the life or health of a patient admitted to the market without the need to obtain a licence.
Regulation of the Minister of Health of 14 March 2012 on importing from abroad foodstuffs for particular nutritional uses which are necessary to save life or health.