For patient – Genesis

PROCEDURES AND RULES FOR IMPORTING MEDICINES AS PART OF DESTINATION IMPORT.

The basis for initiating the procedure of importing a drug from abroad is the decision of the treating physician, and the treatment is carried out under his responsibility. A request for medicines from abroad may be issued by a hospital or a doctor who provides treatment outside the hospital.

Attention!Each request must be approved by a consultant in a given field of medicine (national or provincial). The list of consultants is available on the website of the Ministry of Health.

NATIONAL CONSULTANTS – link – https://www.gov.pl/zdrowie/konsultanci-krajowi
PROVINCE CONSULTANTS – link – https://www.gov.pl/zdrowie/konsultanci-wojewodzcy

The consultant has 7 days from the date of receipt to confirm the request.

The patient submits the request in person or sends it to the Ministry of Health at the following address:

Ministry of Health
Miodowa
00-952 Warsaw

It is possible to send the request by fax or other means of electronic communication, e.g. e-mail. However, it must be remembered that the original documents must be submitted to the Ministry of Health within 5 days from the date of sending the fax or e-mail.

Regardless of how the patient submits the request, it must be delivered to the Ministry of Health within 60 days of its issuance. Otherwise, the document will become invalid.

Within 21 days from the date of receipt of the request, the Minister of Health makes a decision on the advisability of importing the medicine from abroad.

After obtaining the consent of the Minister of Health, the pharmacy has 60 days to submit the demand for fulfillment to the pharmaceutical wholesaler, which will then import the medicine from abroad. After exceeding this deadline, the demand becomes invalid.

TELEPHONE NUMBERS TO CALL IN MATTERS OF DESTINATION IMPORTATION

Telephone numbers to the Department of Drug Policy regarding Target Import:

+48 22 53 00 384
+48 22 53 00 224
+48 22 53 00 242
+48 22 53 00 275

Telephone numbers to the Department of Drug Policy regarding reimbursement of drugs imported as part of Target Import:

+48 22 634 93 41
+48 22 634 95 50
+48 22 634 95 51
+48 22 634 96 59

Fax number to the Department of Drug Policy regarding Target Import, in urgent matters or “life-saving” matters for hospitals:

+48 22 634 93 11

REQUIREMENTS SET FORTH BY THE DOCTOR PROVIDING TREATMENT OUTSIDE THE HOSPITAL

PART A

The application is completed by the treating physician at his or her own risk. The need to use a medicinal product not authorized for marketing must be confirmed by a provincial or national consultant for a given field of medicine, appointed by the doctor conducting the treatment.

The list of consultants is available on the website of the Ministry of Health.

PART B

To be completed by the Minister responsible for Health, assigning a consecutive serial number to the issued request. The decision is returned to the patient or a person authorized by him.

The patient can obtain a refund for the costs of therapy with a drug imported as part of the target import. For this purpose, together with the request, he/she submits an application for consent to reimbursement and a copy of health insurance confirmation. After obtaining the consent of the minister responsible for health for reimbursement, the patient pays a lump sum fee for each unit package.

The patient submits the completed application together with the prescription to a generally accessible pharmacy, which forwards the application to a pharmaceutical wholesaler.

REQUIREMENTS SET OUT BY THE HOSPITAL

PART A

The application is completed by the treating physician. The request must be accompanied by a justification of the requested quantity of the medicinal product and its use. The need to use a medicinal product not authorized for marketing must also be confirmed by a provincial or national consultant for a given field of medicine. The list of consultants is available on the website of the Ministry of Health. The request is also signed by the head of the medical entity running the hospital or a person authorized by him.

The hospital may issue a request for:

more than one patient on one request, then in the field for entering patient data, enter “according to the attached list”
for a patient who is unknown at the time of preparing the application, then enter “for ad hoc needs” in the patient data field

PART B

To be completed by the Minister responsible for Health, assigning a consecutive serial number to the issued request. The confirmed Decision is returned to the hospital. The demand must be directed to a pharmaceutical wholesaler for fulfillment via a hospital pharmacy, company pharmacy or hospital pharmacy department.

TO DOWNLOAD

FILES TO DOWNLOAD

PDF

DOC

PATTERN

DEMAND TEMPLATE for importing from abroad a medicinal product necessary to save the life or health of a patient authorized for marketing without the need to obtain a permit.

SAMPLE APPLICATION for consent to reimbursement of a medicinal product imported from abroad, necessary to save the life or health of a patient, authorized for marketing without the need to obtain a permit.

DEMAND TEMPLATE for importing from abroad a food product for special nutritional uses necessary to save life or health without the need to comply with the obligation to notify the Chief Sanitary Inspector about placing it on the market.

SAMPLE APPLICATION for consent to the refund of a food for particular nutritional uses necessary to save life or health, imported from abroad without the need to comply with the obligation to notify the Chief Sanitary Inspector about placing it on the market.

SAMPLE OF COMPLETED APPLICATION.

LEGAL BASIS

Act of September 6, 2001, Pharmaceutical Law (Dz.U. z 2008 r. Nr 45, poz. 271, z późn. zm. )

Regulation of the Minister of Health of March 21, 2012 on importing from abroad medicinal products necessary to save the patient’s life or health, authorized for trading without the need to obtain a permit (Dz.U. z 2012 r. poz. 349 )

Regulation of the Minister of Health of March 14, 2012 on importing from abroad foodstuffs for particular nutritional uses necessary to save life or health (Dz.U. z 2012 r. poz. 348)