Target medicine import allows the import from abroad of medications necessary to save the lives or health of patients, but are not permitted for sale in Poland.
In order for a medicine to be marketed in Poland, it must be registered at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. This is compliant with EU regulations which require medicines to be registered prior to being introduced to the market.
The EU law permits the target import of medicinal products unregistered in a given country only in exceptional cases justified by medical reasons.
In Poland, regulations concerning target import are set out in the Pharmaceutical Law and the Act on the reimbursement of medicines, food products of special nutrition purposes and medical devices, which entered into force in January 2012, as well as the resolution of the Minister of Health.
When is the target import possible?
Target import is used in emergencies and life-threatening situations. Medicines are imported for individual patients, e.g. when a therapy, in order to continue, requires a product which is no longer produced locally.
Medicinal products imported from abroad can be marketed without a permit in the following cases:
- their use is necessary to save the life or health of a patient,
- the medicinal product is legally sold in the country from which it is imported,
- there are no registered substitutes of a given medicine with the same active substance in Poland.
Submitting an application for a medicine
The basic requirement for importing a medicinal product under target import is the filing of an application by a hospital or physician in charge of a non-hospital therapy, validated by a consultant in a given medical field. The application form can be found at the website of the Ministry of Health.
The application signed by the consultant in the given medical field is then forwarded to the Ministry of Health. In urgent cases, the applications for target import may be sent directly to the Medicine Policy Department at the Ministry of Health to fax no. 634 93 11 or by e-mail.
On these grounds, the Minister of Health issues a permit to import the medicine and returns the validated application to the issuer. In certain justified cases, the Minister may reject the target import application.
Pending the Minister’s approval, the hospital submitting the application forwards it directly to a pharmaceutical wholesaler. If the application is issued by a physician conducting non-hospital treatment, he or she sends it via a commonly accessible pharmacy to a pharmaceutical wholesaler.
How to seek medicine reimbursement
Medicines from target import are also entitled to reimbursement.
In applying for reimbursement, a copy of the document confirming patient’s health insurance should be attached to the application submitted to the Minister of Health.
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