New category on medicinal product status in the medicinal product database on the HALMED webpages
20.10.2014
The Agency for Medicinal Products and Medical Devices (HALMED) has included in its medicinal product database on its webpages, a new category "Medicinal product is placed on the market in Croatia”. Every medicinal product in this database, in this field, depending on its status on the market may be allocated values like Yes, No, Shortage, Permanent discontinuation in the supply chain or Temporary discontinuation in the supply chain. The database may be searched by using one of these criteria.
Under Medicinal Products Act (Official Gazette, No 76/13, 90/14), marketing authorisation holders are obliged to notify HALMED about the first placing of the product on the market and are obliged to notify HALMED about any disruption in the supply chain, short term shortage or decision on temporary or permanent discontinuation in the supply chain, so that MALMED may act accordingly to monitor the Croatian supply chain and, if needed, undertake respective measures to ensure the prompt and adequate supply chain.
Marketing authorisation holders are invited to check if these fields are updated and in the case of an incorrect status or absence of status, send the appropriate information to HALMED. All changes in the status should be notified by e-mail stavljanjeupromet@halmed.hr.
Also, all marketing authorisation holders are invited to obligatorily notify HALMED about any shortage or disruption of the supply chain with their medicine as well as the normalisation of the supply chain by e-mail: nestasice@halmed.hr.
The detailed description of legal requirements related to notification of the medicinal product status in the supply chain is accessible here. We remind that legal consequences of disobeying provisions of Medicinal Products Act may result in a fine in the amount from 100.000,00 to 150.000,00 kn as set out in the same Act.
