Submission of temporary or permanent shortage of the medicinal product and the production cessation and supply chain disruption of the Croatian market
16.08.2013
According to the Art. 186 of the Medicines Act (Official Gazette, No 76/13), the marketing authorisation holder as well as legal and physical entities involved in distribution of medicines on the Croatian territory (wholesalers) are required within their scope of responsibilities to ensure an adequate and continued supply chain of medicines.
The marketing authorisation holder is required notify the Agency without delay about circumstances that may lead to disruption of the supply chain in Croatia or shortage of medicinal product, by using the form that should be submitted electronically at nestasice@halmed.hr.
In case when the marketing authorisation holder decides to cease to place the product on the market or to withdraw the product temporarily or permanently before the expiration of the marketing authorisation validity, or decides to apply for revocation of the marketing authorisation, or decides not to submit the application for renewal, it is required to notify the Agency, at least two months before the disruption of the supply chain, except when it comes to rapid safety alerts like recalls or similar exceptional circumstances. The Agency should be notified via form that should be submitted electronically at nestašice@halmed.hr
