Modifications of the Act XCVIII of 2006 (“Gyftv.”)
2022. January 4.The termination of the Home delivery of medicinal products
According to Section 3 point 22. of Gyftv. “home delivery” shall mean the transport of medicinal products – other than by mail order – to the address the buyer has indicated within the framework of the direct supply of medicinal products to the public. According to the Amendment of the Medicine Act from 1 January 2022 the definition of home delivery will include also mail order delivery. Home delivery of medicinal products may be carried out only by a specialist employee of a company holding an authorization for the direct supply of medicinal products to the public. From 1 January 2022 medicinal products (including prescription and OTC medicinal products) may not be dispensed via mail order houses.
New responsibility rules concerning the supply of medicinal products
According to the amendment of Section 16 Subsection (2a) of Gytv., if the holder of the marketing authorization does not engage in distribution operations in Hungary, the distributor (contracted distributor) shall ensure the continuous supply of the reimbursed medicinal products authorized for distribution in Hungary. According to the amendment of Section 16 Subsection (2b) of Gytv. the government body of pharmaceuticals may also declare a shortage of medicinal products that does not have a valid marketing authorization in Hungary.
According to the newly implemented Section 16 Subsection (2c) in case of shortage of medicinal product or in case of the risk of it, the government body of pharmaceuticals may impose an obligation on the holder of the marketing authorization to remedy the shortage by obtaining an alternative medicinal product to replace the medicinal product affected by the shortage. The holder of the marketing authorization or the contracted distributor may be appointed as jointly and severally liable for averting the shortage in medicinal products according to subsection (2d).
According to Section 16 Subsection (2e) the provisions related to contingency authorization are established, therefore in case if the shortage is declared on a medicinal product that does not have a valid marketing authorization in Hungary, or the control of the shortage may not be expected from issuing the resolution related to the shortage of medicinal product or the execution of the resolution did not lead to a result, the government body of pharmaceuticals upon request of the wholesale distributors authorises the purchase of the medicinal product which can be used instead of the medicinal product affected by the shortage in the quantities and for the period of time pursuant to the resolution.
According to Section 16 subsection (2f) the holder of the contingency authorization shall notify the government body of pharmaceuticals of the import of the medicinal product which has been imported to cover the shortage within 8 days.
According to Section 16 Subsection (2g) both the decision regarding to the obligation related to averting the shortage and the extract of the contingency authorization or the fact of the actual import shall be published on the website of the government body of pharmaceuticals.
According to Section 16 Subsection (2h) in case of exporting or selling abroad the medicinal products imported to Hungary for the purpose of distribution the wholesale distributor shall provide information to the government body of pharmaceuticals concerning the quantity of the medicinal products.