ePrivacy and GPDR Cookie Consent by TermsFeed Generator

Important Information

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.  


Notification of revocation of SÚKL guideline UST-32

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.  


15th Annual ISoP Meeting – Cubism in Pharmacovigilance

SUKL informs on international pharmacovigilance conference held in Prague, Czech Republic on 27th - 30th October 2015.  


Vacant work position - Head of Marketing Authorisation Branch

We would like to draw your attention to a free position of Head of Marketing Authorisation Branch.  


Information from SÚKL

New the website contains a list of approved clinical trials.  


SÚKL information – form updates

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.    


New Guideline REG-70

Application for registration of the medicinal product (version 2).