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Information on Marketing Authorisation

Most Frequent Deficiencies in Submission of Applications for Marketing Authorisation of Medicinal Products

SÚKL hereby notifies applicants for marketing authorisation that the marketing authorisation application dossier should contain data concerning only the strengths and pharmaceutical forms of medicinal products that are the subject of the respective applications and, furthermore, notifies about other frequent validation mistakes of marketing authorisation applicants.  


Information for marketing authorisation holders concerning ways of introducing blue-box information on medicinal product labelling

SÚKL hereby informs marketing authorisation holders about an update to the guidance laying down blue-box requirements for medicinal product labelling.  


Procedure for the Submission of Applications for Mutual Recognition of Marketing Authorisations with the Czech Republic Acting as the RMS

SÚKL hereby specifies the requirements governing the submission of applications for marketing authorisation mutual recognition procedures with the Czech Republic acting as the RMS (so called MRP/RUP-RMS).  


Principles of Identification of Medicinal Products for Human Use in the Czech Republic

Several types of information assigned to individual products are used for unambiguous identification of medicinal products in the Czech Republic and the European Union. In addition to the name of the product, the marketing authorisation holder and other information required on the packaging of medicinal products, several types of codes are used to identify, simplify and refine the handling of the products. Various ways of allocating code identification have been gradually developed in response to the changing needs of their users and the development of legislation.    


New Method of SÚKL Code Notification for Centrally Authorised Medicinal Products

SÚKL hereby informs about a new method of SÚKL code notification, i.e. a change in the issuance of identification sheets for centrally authorised medicinal products as of 1 October 2018.  


Specification of requirements governing the submission of marketing authorisations in the form of duplicates

SÚKL hereby specifies the requirements governing marketing authorisation of duplicates and documentation to be submitted as part of applications for marketing authorisation of duplicates effective as of 1 January 2018.