The State Institute for Drug Control in Czech Republic (SUKL) has published the information with regard to reporting of registration holder pursuant to Section 33, paragraph 2 of Act on Pharmaceuticals. It draws 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”).
SUKL outlined (see below) 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 Czech Republic (REG-13) which are in effect from January 4th 2018.
With a view to the need of state administration to work with current, correct and complete data allowing to obtain a overall overview of availability of human medicinal products in the Czech Republic and fulfilment of the tasks defined for the State Institute for Drug Control (hereinafter referred to as the “Institute”) by the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (hereinafter referred to as the “Act on Pharmaceuticals”), for the purpose of technical assistance and unification of reporting procedures the Institute publishes the recommended procedures for the fulfilment of the Marketing Authorization holder's obligations (hereinafter referred to as the “registration holder”) stipulated in Section 33, paragraph 2 of the Act on Pharmaceuticals.
The scope of the data that the holders of registration are required to provide to the Institute via an electronic reporting is implied by Section 33, paragraph 2 of the Act on Pharmaceuticals as amended at the time of effect from 1.12.2017 in connection with implementing legal regulation*.
On the basis of the data from reporting provided by the registration holders, distributors and pharmacies, the Institute obtains information on the quantity of registered medicinal products available in the Czech Republic, which can then be used as the basis of issuing the Ministry of Health measures referred to under Section 11 (q) of the Act on Pharmaceuticals, by which are medicinal products, in the lack of which the availability and effectiveness of treatment of patients in the Czech Republic will be endangered, put on the list to under Section 77 (c) of the Act on Pharmaceuticals ( so called the list of irreplaceable medicinal products) – link http://www.mzcr.cz/dokumenty/seznam-lecivych-pripavkujejichz-distribuci-do-zahranici-maji-distributori-povi_14530_883_1.html.
A functional system for reporting is part of the obligations that the Act on Pharmaceuticals imposes on compliance and will be subject to regular review by the Institute. Failure of the registration holder to observe this obligation shall be classified as an offence referred to under Section 105, paragraph 5(c) and the Institute shall take the course of action outlined under Section 107, paragraph 1(c) of the Act on Pharmaceuticals.
A. Requirements governing the reporting of deliveries of medicinal products
Pursuant to Section 33, paragraph 2 of Act on Pharmaceuticals, the registration holder shall be obliged to:
The marketing authorization holders shall report electronically to the Institute complete and correct data concerning the volume of deliveries of medicinal products placed on the market in the Czech Republic, the data provided includes the identification of the marketing authorization holder, the identification of the medicinal product and the information on whether the medicinal product was delivered to a pharmacy or distributor, structure, manner, form and period of their provision through electronic reporting shall be determined by the implementing legal regulation. At the call of the Institute or Veterinary Institute, the marketing authorization holder shall provide the Institute or the Veterinary Institute with data on the volume of prescription of the medicinal product and data on the volume of supplies of medicinal products placed on the market in the Czech Republic, which he has at his disposal.
(*an amendment of the regulation No 228/2008 Coll.)
The reporting duty shall be applicable to:
Reporting data may be submitted solely by authenticated and authorised clients on the basis of an issued certificate.
For the reporting of the supply of medicinal products, it is first necessary to ask for access data to the IT systems of SÚKL, the application form is available here https://pristupy.sukl.cz/portal/#/form_Reg
Furthermore, it is necessary to have a generated and properly installed certificate that can be generated here https://pristupy.sukl.cz/index_en.html
The instructions for certificate generation can be found here https://pristupy.sukl.cz/documents/ei_navod_reg.pdf
Reports shall be submitted for each calendar month. Reports shall be forwarded to the Institute no later than within the 10th day of the end of each following calendar month.
The report must be always submitted, i.e. also in case no no medicinal product was supplied to the Czech Republic during the month in question.
The structure of the report distinguishes between reporting of deliveries and reporting of medicinal products returned by the pharmacy or the distributor.
The following terms are set for effective providing and uniform data reporting:
a) Reporting of deliveries of medicinal products to pharmacies /to persons authorised for their dispensing in the Czech Republic
b) Reporting of deliveries of medicinal products to distributors in the Czech Republic
Price – in the Czech currency (CZK).
a) In respect of medicinal products regulated by the determination of the maximum producer price and maximum profit margin or by the profit margin only, the producer price of the medicinal product for which the product has been actually placed on the market in the Czech Republic shall be specified. This price, actually applied by the producer, shall form the basis for the application of the profit margin and the determination of the sales price of the medicinal product pursuant to effective pricing regulations. It shall be specified ex. VAT.
b) In respect of non-regulated medicinal products, the sales price of the medicinal product ex. VAT shall be specified.Producer – in case of authorised medicinal products: the marketing authorisation holder Producer price – the price for which the medicinal product is supplied by the producer to the first person authorised to distribute or dispense the medicinal product, without profit margin and value-added tax.
Price regulation – the Price Regulation of the Ministry of Health 1/2013/FAR of 7 December 2012, on the regulation of prices of medicinal products or foods for special medical purposes, as amended.
Specified values – non-zero values shall be provided; the minimum permissible specified price shall be 0.01 CZK.
2. Declaration of non-execution of supply of medicinal product
The report shall be submitted in case the registration holder has not supplied any package of medicinal products on the market in the Czech Republic during the calendar month. It only applies to a medicinal product whose deliveries on the market in the Czech Republic have already begun and have not yet ended.
C. Communication interface
1. Reporting of deliveries of medicinal products and the data interface
The registration holder shall be authorised to use the reporting system via remote access.
The registration holder reports via communication interface, which is accessible https://api.sukl.cz/ or via a web reporting form, which is available https://pristupy.sukl.cz/index_en.html, for sending a report is required an authentication.
A web browser Google Chrome is recommended for filling the form. In the case of sending a report via API, you will find all the technical information here https://testapi.sukl.cz/docs/?url=/reg13.swagger.json
At web page https://pristupy.sukl.cz/index_en.html you can find Q&A concerning the reporting.
2. Data interface
The data interface contains data in the scope defined by law and by implementing regulation.
3. Electronic report identifier
It is advisable to specify the electronic report identifier and individual UUID report items in the UUIDv4 version.
4. Method of communication with the Institute
The registration holder´s information system communicates with the Institute’s repository of reporting via messages defined in the data interface. By sending a message, the repository may be requested to:
The Institute shall send a reply to each of the before mentioned message types.
5. Report correction
The report correction function, also referred as extraordinary correction, serves for the purposes of making extraordinary changes outside the predefined monthly timelines. A report entered in this manner shall be subject to internal approval by the employees of the Institute. The communication interface allows for the following correction options:
6. Access points to the Institute’s repository
Access points for the submission of reports of deliveries of medicinal products via the registration holder´s information system is available via the SSL certificate and are published at the addresses specified below:
7. Securing access to and transfer of data
Reporting of deliveries of medicinal products is conducted via a secured connection created over the public data network (Internet). The submission may only be done using an electronic certificate issued by the Institute.
Access to the repository functions is based upon an unequivocal identification of the accessing registration holder identified via a SSL certificate. The registration holder will obtain the SSL certificate upon completion of a request available on the Institute´s website https://pristupy.sukl.cz/portal/#/form_Reg
The authorisation of transactions of the accessing registration holder is thereafter conducted upon each call of the function to work with the report.
The authorisation verifies that the submitting registration holder calls functions and submits data under its identifier. The code from the received certificate and the code of the registration holder in the body of the submitted report are checked.
10. Transfer protocols and data formats
The transfer of reports of deliveries of medicinal products shall be conducted by the registration holder´s information system using the HTTP transfer protocol and its standard operations (GET/POST/PUT/DELETE). The data format of the report shall be JSON.