The target import procedure enables therapy with drugs that are not authorized in Poland. However, bringing the drug from another country requires time and many formalities.
Why do we needtarget import ? Each drug available on the Polish market must have an appropriate registration certificate confirming its admission to trading in the country.
The patient has the right to apply for the reimbursement of the drug imported for him under the target import. In such a case, however, the consent granted by the president of the National He alth Fund is required.
Such medicinal products can be obtained without any problems in pharmacies - even if they are not available on a regular basis, a pharmacist can obtain them within a few days. Drug registration in Poland is handled by the Office for Registration of Medicinal Products, Medical Devices and Biocides, and it is done each time at the request of its manufacturer. It is related to the presentation of extensive documentation proving the effectiveness and safety of a given preparation.
Sometimes it turns out that a drug that a particular patient needs has not yet been registered in Poland. The most common reason for this is the unfavorable economic calculation - it is not profitable for the manufacturer to register the drug in Poland, because it would entail higher costs than the expected profits from its sale. It is also often caused by the expiry of a marketing authorization for a given drug in Poland.
When you can get the drug
The solution for patients who need such drugs is the direct import procedure. It consists in importing a specific medicinal product from abroad, which is necessary to save the patient's life or he alth. To start the target import procedure, three basic conditions must be met:
- the use of a given drug is necessary to save the patient's he alth or life
- the preparation is admitted to trading in the country from which it is imported
- the drug has no equivalent (with the same active substance, the same pharmaceutical form, dose and the same route of administration) that could be used in the pharmacotherapy of the patient.
Target import: where to start
The basis for the final import is an appropriate application, which is first filled in by a hospital or a doctorproviding treatment outside the hospital. It is a document that specifies the exact name, dose, form and period of use of the drug. The physician issuing the application takes full responsibility for the consequences of applying the imported medicinal product to the patient.
The need for a specific drug must be approved by a consultant in a given field of medicine - he or she confirms that the patient needs a given drug and there is no possibility of alternative therapy with drugs authorized in Poland. The list of consultants is available on the website of the Ministry of He alth (www.mz.gov.pl). The completed application should be sent to the Ministry of He alth within 30 days from the date of its issue, and officials have 21 days to issue a permit for its import.
Who is to pay for the imported drug
The patient has the right to apply for the reimbursement of the drug imported for him as part of the destination. In such a case, however, the consent granted by the President of the National He alth Fund is required, which is attached to the above-mentioned application. Obtaining it often extends the procedure of direct import, which is why most patients resign from it. Such patients, however, have to reckon with the fact that they will have to pay the full amount for the drug - and these can be very high. Therefore, before making a decision, it is worth asking the pharmacist about the estimated price of the imported medication.
Target import: last formalities
When the patient collects all necessary signatures and consents on the application for final import (attending physician, national consultant, Ministry of He alth and optionally the president of the National He alth Fund), he or she sends him and the prescription for the drug to the pharmacy. The pharmacist then sends these documents to the pharmaceutical wholesaler and waits for the drug. It is worth remembering that from the moment the application is signed by the minister, it is valid only for 60 days or, if the drug is covered by a refund, 30 days from its signing by the President of the National He alth Fund.
If a patient is treated in a hospital, the flow of documents occurs without his participation between the hospital, the National He alth Fund, the consultant and the Ministry of He alth.
There are many reasons for using the target drug import. One of them is the continuation of therapy with preparations that for various reasons are no longer available in a given country - e.g. by ending production. It is also often a question of individual therapy and life-threatening emergencies. The basis for obtaining consent for final import is always a situation in which the treatment methods available in the country have failed or other treatment options are exhausted. There are numerous pharmacies in Poland that specialize in the target import of drugs.
ImportantHow to fill in the form
Print of the demand for a medicinal product under direct import consists of three parts:
- A - to be filled in by a specialist conducting the therapeutic process and a national consultant in a given field of medical science (e.g. if the attending physician is a cardiologist, the consultant is a specialist in this field, often associated with the academic community);
- B - filled in by the minister of he alth (the document becomes invalid if it is not directed to a pharmaceutical wholesaler within 60 days from the date of confirmation by the minister of he alth);
- C - to be completed by the President of the National He alth Fund, but only when the applicant applies for a refund of the imported medicinal product.