The Hungarian Parliament amended certain aspects of Section 16 (5) of the Medicines Act that imposes a supply obligation on Marketing Authorisation Holders (MAHs). The amendment will come into force on 1 July.
A new definition on “patient supply need” was included in the Medicines Act. Patient supply need means “an actual need for use of a particular medicinal product by Hungarian patients”. MAHs must ensure that wholesalers are supplied with medicinal products if the wholesaler declares that the medicine is needed to satisfy patient supply need in Hungary. The Wholesale Decree contains provisions on the content of the declaration and those provisions have not been amended. The wholesalers must indicate in the declaration the name, strength, packaging and the volume of the medicinal product to be ordered as well as the expected final deadline by which it will deliver the products to healthcare service providers.
The amended Medicines Act contains certain exceptions to the supply obligation, namely if:
- the medicine has been put on the list of medicines affected by supply shortage under Section 16 (6) of the Medicines Act. Medicines are put on the list (held by the National Institute of Pharmacy and Nutrition) following notification by the MAH;
- the wholesaler had a loss in the year preceding the order of the medicine from the MAH;
- the wholesaler was subject to a final and binding decision due to illegal export of medicines in the past 5 years.
The Medicines Act provides that the medicinal products ordered under Section 16 (5) above shall not be exported from Hungary but must be supplied to Hungarian healthcare service providers. Also, the wholesalers ordering products with reference to Section 16 (5) must keep separate records on the orders and deliveries of the products.
The National Institute of Pharmacy and Nutrition continues to supervise compliance with these provisions.