Information to fulfill legal obligations of marketing authorisation holders

The State Institute for Drug Control (hereinafter referred to as the “Institute”) wishes to draw the attention to the obligations set out in Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (hereinafter referred to as the “Act on Pharmaceuticals”).

In compliance with the provision of Section 33, paragraph 2 of Act on Pharmaceuticals, in effect from 1.12.2017, marketing authorization holder (hereinafter referred to as the “registration holder”) is responsible for providing to the Institute with complete and correct data on the volume of supplies of medicinal products placed on the market in the Czech Republic on a regular basis. The structure, method, form and period of this provision via electronic reporting shall be specified by the implementing legal regulation, i.e. regulation No 228/2008 Coll., on Registration of Medicinal Products, which has not yet been amended. The Institute is aware of the fact, that the information and the recommended procedures for submitting correct and complete reporting of marketing authorization holders on the volume of supplies of human medicinal products placed on the market in the Czech Republic (REG-13) are based only on the basis it had at the end of 2017. Once the regulation has been amended, both documents will be modified to reflect content of regulation.

By publishing both documents, the Institute responds to the frequent questions regarding the fulfilment of the obligation stipulated in Section 33, paragraph 2 of Act on Pharmaceuticals, in order to facilitate the registration holders’ preparation for the fulfilment of this obligation especially in technical terms.    

For the purpose of technical assistance and unification of reporting procedures, the Institute has published the recomended procedures on its website, which contain details that are a technical and a content prerequisite for the successful provision of this reporting by the registration holder.

In order to provide the reporting on the volume of medicinal products supplied by the registration holder to the Czech Republic, it is necessary to request access data first– the application form is available here https://pristupy.sukl.cz/portal/#/form_Reg then is needed to generate and install the new certificate correctly, which you can generate in the external identity portal at https://pristupy.sukl.cz/index_en.html.

The data on the volume of medicinal products supplied by the registration holder in the Czech Republic should be provided by registration holder since 1st of December 2017 for those medicinal products whose deliveries to the Czech Republic have already begun and have not been ended. The report is provided to the Institute electronically via a web form, which is available on the Institute’s website at https://pristupy.sukl.cz/index_en.html, or through the API communications interface at https://api.sukl.cz/ , in the REG13 section.

We recommend using the Google Chrome browser while completing the form. In the case of sending an API report, you will find all the technical information at https://testapi.sukl.cz/docs/?url=/reg13_en.swagger.json

For any questions and technical issues you can use the following contacts:

• general questions or expert queries about the content of the report: oda@sukl.gov.cz
• technical questions, reporting issues: itpodporahlaseni@sukl.gov.cz
• queries and issues with using and creating a certificate: pristup@sukl.gov.cz