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Individual and intervention import

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Individual import for named patient basis - Article 4 (1-4) of the Pharmaceutical Law, Article 29a of the Act on Safety of Food and Nutrition - consists of importing medicinal products or foodstuffs for special nutritional purposes (medical purposes) that do not have a marketing authorisation in Poland but are necessary to save a patient's life or health.
Such products can be imported under the condition that:

  • their use is necessary to save the patient's health or life;
  • they are authorised in the country from which they are imported and have a valid marketing authorisation;
  • they do not have a pharmaceutical equivalent in Poland: a medicine that contains the same active substance, form and dose,
  • they have not been the subject of proceedings in which the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products refused to authorise their marketing in Poland, to renew such authorisation or in which he revoked the authorisation for their marketing in Poland.

 

Individual import of a medicinal products

 

farmaceuta z lekamiIndividual import of a medicinal products or foodstuffs for special nutritional purposes (medical purposes) is legally based on the demand of the hospital/ healthcare entity, confirmed by a consultant specialising in a particular field of medicine and subsequently approved by the Minister of Health in the SOID system or the demand of a doctor who provides treatment outside the hospital/ healthcare entity, confirmed by a consultant specialising in a particular field of medicine and subsequently approved by the Minister of Health in the SOID system.

Intervention import (Article 4(8) and (9) of the Pharmaceutical Law) consists of importing medicinal products that are not registered in Poland but are temporarily authorised for marketing by the Minister of Health or licensed in Poland but in shortage.