Submission of notification on placing medicinal product on the market
01.10.2013
Following the information about the submission of notification on placing medicinal products on the market, that was posted on HALMED’s web pages on 16 August 2013, we remind the marketing authorisation holders who did not submit the information earlier, to submit to HALMED the fulfilled table that should contain the information about the last date of the product on the market for all holder’s medicinal products having a valid marketing authorisation. The aforementioned information is necessary, so that HALMED who is responsible for monitoring the medicinal product supply in Croatia, can have an overview of medicinal products on the market. Based on the submitted information, HALMED may, in case of disruption of supply or shortage of medicine, undertake appropriate measures with the aim to ensure a regular supply chain in the Republic of Croatia. The information is also necessary for monitoring of deadlines for implementation of so-called Sunset Clause. The fulfilled table should be submitted to the following e-mail address: stavljanjeupromet@halmed.hr.
Continued additional information:
- In order to monitor a continuous presence of the medicinal product on the Croatian market, HALMED will once a year request from marketing authorisation holders the aforementioned information for the previous year. Information that was requested 1 October 2013, will be taken as the current data for the on-going year. HALMED will require these data for the year 2014 in the beginning of 2015.
- All new launches of the product on the market (for all medicines that were placed for the first time on the market after 1 July 2013), as well as permanent or temporary interruption of supply chain should be reported via Forms for reporting the placing of the product on the market, shortage or interruption of supply chain that is available on the HALMED’s web pages in the Forms section. The last version of the form was published on 1 October 2013. This information should be submitted for every dose and pharmaceutical form of the medicinal product
- In order to facilitate the monitoring of supply of the Croatian market and to ensure a regular supply with medicinal products in Croatia, if needed, the information about the status of the product on the market should be submitted to HALMED via the same form also for centrally authorised products.
- The date of the placing of the product on the market will be the day when the qualified person for batch release has released the product on the Croatian market, which confirms that that the product batch is manufactured and controlled in accordance with the current legislation and information indicated in the documentation submitted alongside the application for granting marketing authorisation. It is not required that the medicinal product is physically present on the Croatian market.
- With a view to the Art 54 (so-called Sunset Clause) and Art. 55 of the Medicinal Product Act, OG, No 76/13 (notification on placing the product on the market), the day of the placing of the product on the market is the day when one of the types or pack sizes of the pharmaceutical form and strength is released on the Croatian market.
The beginning of the three years period for implementing the Provision of the Art 54 (so-called Sunset Clause) is considered 1 July 2013 for all medicinal products authorised before this date , or the date of the marketing authorisation for all medicinal products authorised before 1 July 2013.
In case of further question, you may contact us via e-mail: stavljanjeupromet@halmed.hr
