New requirements for marketing authorisation holders related to notification of interruption in medicinal product supply chain
13.11.2013
Since a change into the EU pharmacovigilance legislation came into force on the 28 October 2013 which is implemented into the Croatian legislation under Art. 55 of the Medicinal Products Act (Official Gazette, No 76/13), HALMED is publishing below instructions for notification of an interruption of the supply chain in accordance with recommendations of the European Medicines Agency (EMA).
Marketing authorisation holders of medicinal products authorised nationally or via MRP/DCP are obliged to notify competent authorities in the EU about any recall measure, indicating thereby the reason for undertaking those measures as follows:
- 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;
- decides not to submit application for renewal
is obliged to notify HALMED no later than 2 months before stopping the supply chain, except in the case of an urgent recall or other exceptional circumstances.
- When the interruption of the supply chain is carried out due to the one of the following reasons:
- medicinal product is unacceptably harmful
- medicinal product is insufficiently therapeutically efficient
- the risks outweigh the benefits
- qualitative and quantitative composition differs from declared
Marketing authorisation holders are obliged to notify both HALMED and the European Medicines Agency (EMA).
When marketing authorisation holder decides to interrupt placing the product on the market, withdraw the product temporary or permanently before the expiration of marketing authorisation, submit an application for revocation of marketing authorisation or decide not to apply for renewal in a third country, due to reasons stated under paragraph 2, its is obliged to notify both HALMED and EMA.
In order to harmonise the notification system in all EU Member States, the European Medicines Agency (EMA) has published a standard template for:
- cover letter
- table with data about the medicinal products concerned
The Cover Letter and Table should be sent to HALMED by e-mail ukidanje@halmed.hr, or in cases when this notification should be sent to the EMA by e-mail withdrawnproducts@ema.europa.eu.
Note
Supply chain disruptions or shortages in medicinal products, under Art. 186 of the Medicinal Products Act, should be as previously sent to HALMED by e-mail nestasice@halmed.hr, by completing the Application form for placing the product on the market and shortage.
Quality defect reports should be as previously sent to HALMED by completing the Application form for reporting quality defects.
The EMA will regularly publish a list of medicinal products whose marketing authorisation has been rejected, revoked or suspended on the EU territory, as well as medicinal product whose placing on the market has been prohibited and medicinal products who have been withdrawn from the market, indicating the reasons for undertaking those measures.
Detailed information related to these requirements is available on the EMA webpages, or here.
