Update of requirements for Marketing Authorisation Holders to Evaluate the Risk of the Presence of Nitrosamines
In compliance with the procedure outlined under Art. 5(3) of Regulation (EC) no. 726/2004, holders of marketing authorisations of human medicinal products containing chemically synthesised active substances and biological active substances are hereby invited to review the manufacture of their medicinal products in view of potential presence of nitrosamines. The updated conclusions dated 18.2.2021 can be found on the EMA website.
As of 04 June 2018, SÚKL guideline UST-32 EAN Code Reporting and Registration is revoked. The obligation to mark all authorised medicinal products with the European Article Number (EAN) continues to be effective; SÚKL has terminated EAN code registration as of the guideline revocation date.
SUKL informs on international pharmacovigilance conference held in Prague, Czech Republic on 27th - 30th October 2015.
We would like to draw your attention to a free position of Head of Marketing Authorisation Branch.
New the website contains a list of approved clinical trials.
The State Institute for Drug Control hereby informs about the updates to interactive forms to be conducted on May 30 2008 from 8:00 a.m. to 5:00 p.m., which will require an outage.
Application for registration of the medicinal product (version 2).