…even though the number of registered and commercialized products in Hungary is vast, situations still frequently arise when medicinal products indispensably needed for therapeutic purposes are not available in the market. Our company is dedicated to upholding the continuous supply of the Hungarian market hence we are working very closely with the National Institute of Pharmacy and Nutrition and the key public healthcare institutions in Hungary to ensure that any potentially arising shortages are handled quickly and effectively…
Despite the advanced development of the European healthcare supply system, Hungary still lags behind concerning access to the full spectrum of the most innovative products already available in other EU member states. Even though the number of registered and commercialized products in Hungary is vast, situations still frequently arise when medicinal products indispensably needed for therapeutic purposes are not available in the market. Unfortunately, this tendency over the last couple of years has substantially intensified in Hungary.
Shortages might occur because the needed products are not registered in Hungary. Product registration itself is a costly and lengthy process and marketing authorization holders frequently face hurdles within the realm of logistics or quality assurance. Commercial considerations are also key factors; manufacturers tend to introduce products and focus their sales on national markets where the patient population is higher, and the healthcare budgets provide more funds for reimbursement purposes.
Unfortunately, shortages also impact products that are registered in the country. In these situations, the underlying reasons are typically related to manufacturing and logistic difficulties on behalf of the marketing authorization holders. Factors that can also contribute to the emergence of shortages include the excessive geographical concentration of active ingredients needed for pharmaceutical manufacturing, the complexity of the global supply chain of medicinal products or the misguided allocation of national quotas by the manufacturers themselves.
Other market developments, such as recalls, unexpected surges in demand (epidemics, increase in off label use, etc.), natural disasters impacting manufacturing facilities, or the appearance of generic alternatives can further exacerbate the situation. It could also happen that the registration of a product expires and is not renewed by the marketing authorization holder. Products with active registrations can also be suspended and deleted from the drug registry before their registration expires upon request of the marketing authorization holder.
Regulations in Hungary permit the importation of products subject to a shortage situation upon approval of the regulatory agency through various administrative mechanisms. Such mechanisms allow wholesalers to import products that are not registered in Hungary or products that are registered but temporarily not available based on a strict licensing procedure initiated by medical professionals at healthcare institutions and administered by the regulatory agency.
In general, the regulatory agency approves all import applications that meet the following criteria:
- the product to be imported bears attributes with an added value compared to the registered alternatives available in Hungary regarding the specific therapeutic needs of the requesting patient;
- the product to be imported is lifesaving by nature;
- the registration procedure of the product to be imported has been already initiated and is pending approval by the national or European authorities;
- the product to be imported is indispensable for the patient’s therapeutic treatment as officially attested by the requesting healthcare institution;
PHARMAROAD KFT. is dedicated to upholding the continuous supply of the Hungarian pharmacies and healthcare institutions even with products that are generally or temporarily not available in the market. Hence, our Hospital Supply Division is working very closely with the National Institute of Pharmacy and Nutrition to ensure that any potentially arising shortages are handled quickly and effectively.
Regarding the different importing mechanisms (named patient imports, emergency imports, etc.) our Hospital Supply Division offers the following services:
- Quick elaboration of a comprehensive price offers for products to be imported as requested by healthcare institutions or pharmacies;
- Assistance to healthcare institutions or pharmacies in preparing import applications to be submitted to the national regulatory agency;
- Procurement of products as approved by the national regulatory agency from international suppliers verified according to the strictest quality assurance standards;
- Procurement of products as approved by the national regulatory agency from international suppliers that uphold the highest standards of supply chain integrity and are licensed distributors of manufacturers or market authorization holders not present in Hungary;
- Procurement of products fully meeting the requirements (serialized packs with anti-tampering devices) as prescribed in the legislation pertaining to the Falsified Medicines Directive and Delegated Regulation;
- Confirmation of authenticity of the imported products via verification in the corresponding national databases of the European Medicines Verification System;
- Release of products to saleable stock subject to the availability of all the relevant quality assurance documentation (COC, COA, Release Certificate, Temperature Logs, etc.);
- Delivery of products from stock within 48 hours upon the submission of purchase orders under the pre-approved emergency import procedures;
A summary of the administrative steps pertaining to the different importing mechanisms can be downloaded from here:
Tájékoztató betegek, orvosok és gyógyszertári partnerek számára
A summary of the regulatory background pertaining to the different importing mechanisms can be downloaded from here:
Tájékoztató az egyedi és kontingens import folyamatok jogszabályi hátteréről
A Pharmaroad Kft. az alábbi készítmények forgalmazására rendelkezik kontingens engedéllyel (Forrás: ogyei.gov.hu)
Kontingens lista – 2020.06.02