First, paradoxically, a solution that will positively affect the availability of drugs in Poland will be to move away from the requirement to ensure this availability of the drug - in Polish packaging. This is because it is increasingly common that, especially for products used in rare diseases, produced in low volume, they are not marketed in all national packaging (e.g. intended for the Polish market), even if they are formally registered in Poland. In cases where there are a few patients using a particular drug in our country, or even dozens, it may be too costly to launch production of a separate batch of the drug in Polish packaging. Since November 1 of last year, the new wording of Article 4c of the Pharmaceutical Law has been in force (introduced under the provisions of DNUR - the big amendment to the Reimbursement Law), which allows for wider use than before of the possibility of marketing in Poland a drug in foreign-language packaging or with a foreign-language leaflet, with the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Currently, obtaining the approval of the President of the Office is possible not only for a drug that has an availability category of Lz / Rpz, but for any product for which there are difficulties in ensuring its availability. In practice, however, access to such a product under the terms of reimbursement may be difficult, if only due to the fact that reimbursement decisions are issued for a drug marked with a Polish GTIN, a...
Content locked
To gain access to the complete English section of the Medexpress.pl, kindly reach out to us at english@medexpress.pl.
