The new version of DIS-13, version 5, brings content and technical changes in the reports on distributed medicinal products pursuant to Section 77 (1) f) of Act No. 378/2007 Coll., on Drugs (hereinafter referred to as the "Act on Drugs"), taking into account both the planned changes of the SÚKL communication environment and the expected changes in the scope of the report following the amendment of the Act on Drugs (Act No. 66 / 2017 Coll.) and its implementing Decree No. 229/2008 Coll., on the manufacturing and distribution of drugs.
Although SIDC ensure the availability of information about the data interface and the technical documentation for manufacturers and distributors, registers unpreparedness of certain systems distributors to provide for SIDC complete and accurate data about distributed medicines that are necessary for the performance of its duties and obligations under the Act on Drugs.
SIDC therefore decided to postpone the effectiveness of the DIS-13 version 5 "Delivery reports of distributed human medicinal products" on 1st September 2017, i.e. the first reports to be delivered by the distributors in the scope and manner as amended by this Guideline, will be for September 2017.
Until the effective date of the new version of the guideline, DIS-13 version 4, as amended by Supplement 3 from 2nd March 2016, remains in force.
The technical documentation for the production environment of the reporting application according to DIS-13 version 5 will be published together with the exposure of the production environment and the launch of the communication certificate delivery service on 20th June 2017.
SIDC is convinced that the postponement of the guideline provides manufacturers and distributors sufficient time for the preparation and testing of a new application for sending reports on distributed medicines, enabling the successful performance of their lawful duties.
For Small Distributors who do not have the technical equipment or cannot customize the software used, for sending messages according to the current version of DIS-13 is available a web-based application for reporting.
Surveillance Branch
23 June 2017
cz