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.  

The entry of data about medicinal products authorised through the centralised procedure into the database of the State Institute for Drug Control (SÚKL) and the allocation of SÚKL codes associated therewith is carried out on an ongoing basis, as Commission implementing decisions are being published on the Commission website and as information is being published on the website of the European Medicines Agency (EMA). Data about products newly authorised by the centralised procedure and new pack sizes, including allocated SÚKL codes, are published in SÚKL´s web database.

In case of marketing authorisation transfer, change of name, and change of packaging type of a medicinal product, for centrally authorised products, the original SÚKL codes are not indexed with the letter “B” (final sale) and new SÚKL codes are not allocated; instead, the existing SÚKL codes are merely amended.

Should the marketing authorisation holder of a centrally authorised medicinal product or their authorised representative wish to obtain SÚKL codes prior to their publication in SÚKL´s web database, it is possible to submit a request for their allocation or communication thereof. The request for SÚKL code allocation has to include the implementing decision of the European Commission (where only variations to marketing authorisation are concerned, an EMA approval shall suffice), Annexes I (summary of the product characteristics), II, and III (package leaflet, labelling) in the Czech language and, in the case of a newly authorised product, extended marketing authorisation or addition of a new product variant, also an overview of medicinal product presentations. The request may be sent by e-mail to the following address: daniela.vodnanska@sukl_cz or helena.moravcova@sukl_cz.   

Thereafter, the marketing authorisation holder or their authorised representative shall be advised of the allocated SÚKL codes in the form of an identification sheet or provided with the specific SÚKL code, as requested.

 

Marketing Authorisation Branch

19. 9. 2018