Named Patient Drug Importation
Article #29 of the pharmacists’ ordinance (1986) allows the import and marketing of pharmaceutical drug preparations (D.P.) that are not registered in Israel.
There are 5 different routes of importation under this regulation, including:
– For compassionate use
– For use in a hospital
– For personal use via pharmacy
– For Use via Sick Fund / Medical Institution
Drug importation (under regulation 29) for more than 50 patients is considered an institutional import.
Only a licensed pharmacy or an importer/manufacturer license holder may import drug preparations according to article #29
It is forbidden to import a drug/ medicine that is not registered!
In order to make importation of drug/ medicine that is not registered, a special import permit must be applied for and issued in advance. There is a list of requirements to meet according to MOH SOPs and guidance.
Mind Pharma Europe has vast experience in processing Named Patient Drug Importation.
Mind Pharma Europe provides the required pharmacovigilance monitoring (QP-PV with a physician) and AE/SAE reporting.
Need to process importation? Contact us here.
In order to assure the quality of the D.P., the importer must fulfill the several requirements:
The drug must be imported directly from the manufacturer or the license holder or a certified pharmaceutical warehouse or a licensed pharmacy at the export country.
The drug was distributed and stored according to the instructions of the manufacturer, by licensed pharmaceutical dealers in a recognized country, according to Good Distribution Practice (GDP) as commonly practiced in these countries.
The batch of the imported drug is on the market in country of origin or recognized country – declaration
The shipment was accompanied with temperature loggers and appropriate documentation (Invoice, AWB, Pack list, CoAs).
Registration certificate from the export country
The drug package is labeled with a generic name in English (or in Latin, acc. to a special permit of MoH). In lifesaving or urgent treatments, it may be possible to receive the permit post factum.
The pharmacy shall periodically monitor drug adverse reactions by the Pharmacovigilance responsible pharmacist (QPPV) that are related to the drug/ medicine imported under regulation 29.
Need more information? Contact us here.
Mind Pharma, managed by Shavit Fragman provides:
Market Access/ Market insight guidance, Appointed Pharmacist , Responsible Pharmacist – Qualified Person (QP) & batch release , Qualified Person Pharmacovigilance (QP-PV) and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.