The recommended procedures – update 9.10.2018

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)  

Effect from 1.11.2018

 

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 - amendment regulation No 228/228 Coll., on Registration of Medicinal Products.

 

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 medicinal products whose distribution abroad is required to report the distributors to the State Institute for Drug Control) – link http://www.mzcr.cz/dokumenty/seznam-lecivych-pripavkujejichz-distribuci-do-zahranici-maji-distributori-povi_14530_883_1.html.

 

The 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 is determined by the amendment regulation No 228/228 Coll., on Registration of Medicinal Products.

 

The reporting duty shall be applicable to:

  • Registration holders who started the supply of the medicinal product to the Czech Republic and reported this fact to the Institute Pursuant to Section 33, paragraph 2 of Act on Pharmaceuticals. The medicinal products whose supply to the market in the Czech Republic have not yet been begun or whose supply to the Czech Republic has already been ended of are not concerned by this obligation. In order to fulfil this obligation, it is not decisive whether the registration holder is established in the Czech Republic or abroad.
  • It is not decisive for the fulfilment of this obligation whether the registration holder is established in the Czech Republic or abroad.

 

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

 

  • Each registration holder is assigned a unique identifier - the workplace code that should be send along with the reporting data. The identifier is assigned by the Institute.

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 structure of the report distinguishes between reporting of deliveries and reporting of medicinal products returned by the pharmacy or the distributor. In case of no movement of medicinal product was accomplished (delivery / return ) during the month in question, the declaration of non-delivering of medicinal products is submitted.

 

The following terms are set for effective providing and uniform data reporting:

 

  • The regular report shall be submitted by the 10th day of the following calendar month, inclusive. The report is sent to the Institute via a new web form, which you can find at https://pristupy.sukl.cz/index_en.html or through the communication interface https://api.sukl.cz 
  • From the 10th to the 20th day of the following calendar month, updates to a previously submitted report may be made.
  • After the 20th day of the month, the content of the report can only be changed by an extraordinary correction.
  • Data from the submitted reports are automatically stored in the Institute´s database. Prior to their storage, the form and content of the report are subjected to an elementary check. If the report is correct, data are stored. If the report contains errors, it is not stored in the database and an error description is displayed to the sender.
  • If the report was not entered because of serious and objective reasons by the 10th of the month, please send a written and reasoned request with the registration holder 's identification to oda@sukl_cz. Subsequently, Declaration of non-delivering of medicinal products will be entered by Institution’s department ODA that you will be able to change to reports by the 20th of the month and fill in the data to the report.
  • If the reporting was not entered by the 20th of the month, the procedure stated below is applied, with the difference that entered declaration of non-delivering the registration holder is able to modify by form of an extraordinary correction. This extraordinary correction is subject to approval by SÚKL.
  • If the registration holder additionally finds out that they have specified incomplete or incorrect data in the report, they are required to inform the Institute about a correction of the report at the email address oda@sukl_cz.

The reporting duty shall be applicable to the deliveries of:

  • Authorised medicinal products with an allocated SÚKL code whose deliveries by registration holder to the market have already begun and have not yet ended.
  • All SÚKL codes are entered to the report by the registration holder.

 

The reporting duty shall be applicable to the deliveries of human medicinal products to the Czech Republic with a distinction of customer type:

  • Pharmacy
  • Distributor

 

 

B. Structure of data provided by registration holder via electronic reporting

Each report has to be identified through these items:

1.       Workplace code – a unique identification code of the registration holder allocated by the Institute

2.       Reporting period – the period for which the report is being submitted

3.       Report ID – UUID – a unique identifier of the report

 

1. Reporting deliveries of medicinal products on the market in the Czech Republic

Report items:

1.       Report type – information on the type of the client to whom the medicinal products have been supplied

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

2.       Medicinal product movement type – the identifier of the delivery or return of goods

3.       SÚKL code – the codes allocated by SÚKL are recorded in compliance with the uniform Product Index published on the Institute´s website. The Institute´s Index contains medicinal products authorised through the decision of the Institute, products authorised by the decision of the European Commission through a centralised procedure. The Index on the Institute´s website is updated as of the first day of each month. No external codes different from the Institute´s codes may be used in this item.

4.       Name – the name of the medicinal product
5.       Price –

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.

6.       Quantity – the number of packages of the medicinal product per batch and price. The quantity shall be specified as the number of packages per specific client type, batch and price record. In case there are several batches of the medicinal product, and several prices for a single batch, the medicinal product shall be recorded with all of the prices several times and the codes shall be repeated.
7.       Batch – the batch of the medicinal product.

 

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.

Report items

  1. Workplace code – a unique identification code of the registration holder allocated by the Institute
  2. Reporting period – the period for which the report is being submitted
  3. Report ID – a unique identifier of the report allocated by the Institute’s repository
  4. Declaration – the following statement shall be entered: “No medicinal product was delivered on the market in the Czech Republic in the reporting period.”

 

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/index_en.html 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:

  • Enter reports of deliveries
  • Update a stored report of deliveries
  • Download a stored report of deliveries
  • Make a correction

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. An extraordinary 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:

  • Extraordinary report entry
  • Correction of all of the report items
  • Addition of or amendment to selected report items
  • Correction of a single report item
  • Download of the correction status

 

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:

https://testapi.sukl.cz/reg13/v2/hlaseni
https://api.sukl.cz/reg13/v2/hlaseni

 

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.

 

8. Authentication

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

 

9. Authorisation

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 workplace code 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.

 

11. 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_cz
  • technical questions, reporting issues                                                     itpodporahlaseni@sukl_cz
  • Queries and issues with using and creating a certificate                pristup@sukl_cz