Interruptions in the Supply Chain and Shortages
Notification of temporary or permanent interruption in supply chain
In case of a temporary or permanent interruption in supply chain under Paragraph 2, Art. 55 of the Medicinal Product Act, when the marketing authorisation holder decides to:
- stop placing the product on the market
- withdraw the product from the market temporarily or permanently before the expiration of the marketing authorisation
- submit an application for withdrawal of the marketing authorisation or
- decide not to submit an application for renewal,
should notify HALMED at least two months before the interruption of supply chain (except if it is an urgent recall or other incidental circumstances), indicating the reasons for interruption in the supply chain.
The notification should be submitted by e-mail to email@example.com.
When the interruption in the supply chain is carried out due to one of the following reasons:
- the medicinal product is unacceptably harmful
- the medicinal product is insufficiently efficacious
- the benefits/risks ration is unfavourable
- qualitative and/or quantitative composition in not in conformity with the declared
- manufacturing or inspection problems have been discovered
the marketing authorisation holder is obliged, in addition to HALMED, to also notify the European Medicines Agency (EMA).
When the marketing authorisation holder decides to stop placing the product on the market, temporary or permanently withdraw the medicinal product from the market before the expiration of the current marketing authorisation, submit an application for revocation of marketing authorisation or decide not to submit a renewal application in a third country, from the reasons stated under 2, it is obliged to notify HALMED and EMA about it.
In order to harmonise the notification system in all EU Member States, the EMA has published the standard template for:
- cover letter
- table with information with medicinal products concerned.
The cover letter and the table should be submitted to HALMED by e-mail to firstname.lastname@example.org, in cases where EMA should also be notified, the notification should be submitted by mail to email@example.com.
The documentation for withdrawal of the marketing authorisation as stated in Article 47 of the Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 83/13.), should be delivered to the Registry Office or submitted via CESP.
The list of medicinal products for which HALMED has received a notification about a temporary or permanent interruption of supply chain is available here.
Shortages and disruption in the supply chain
Under Article 186 of the Medicinal Products Act, the marketing authorisation holder, as well as natural and legal persons operating as distributors on the Croatian territory, are required to ensure within their responsibility an adequate and uninterrupted medicinal product supply. The marketing authorisation holder is required to notify HALMED and the Ministry of Health, as well as the Croatian Health Insurance Institute (HZZO) for the medicinal product on the positive list, in a written form, without delay about the circumstances that may lead to interruption or shortage of the Croatian medicinal product market.
The shortage list of medicinal products notified to HALMED is available here.
In order to ensure a regular update and accurate data content of the table, marketing authorisation holders shall notify HALMED about the termination of shortage, should this information differ from the indicated in the previously submitted application form. This notification should be submitted by e-mail to firstname.lastname@example.org.