The Polish Ministry of Finance on 20 October 2021 issued a specification for the National e-Invoicing System (NeIS), providing tips for software developers wishing to integrate their programs with NeIS (API). This specification is not a source of law, but is only a set of guidelines for developers. The NeIS test environment website (https://ksef-test.mf.gov.pl/) does not contain a graphical user interface for uploading or downloading invoices. It contains material intended for IT departments working on integration with NeIS. This address is also used by the published API. The logical structures used by the API, the OpenApi (formerly Swagger) documentation and editor, and the test environment public key have been made available. For the time being, no descriptive interface specification has been published, as was the case for e-Declaration or the Single Control File. It has been indicated that the test version will use self-generated signatures and seals for authorisation in NeIS, the test version does not offer authorisation via the Trusted Profile and token at this point. Invoices will be submitted using the API provided in batch or interactive mode. An Official Delivery Certificate will be available with a list of invoices sent in a batch packet or during an interactive session. The provided service will verify the correctness of the sent invoices with the working version of the XSD schema. The API introduces permissions that can be assigned to a system user. A privilege management facility is provided that will allow to view, grant and revoke privileges. The types of roles available in the process are also indicated. It is worth noting that the message states that it is planned to make the use of e-Invoice mandatory for entrepreneurs in Poland from 2023.
PLATFORMS THAT IMPLEMENT THE E-INVOICING OBLIGATION IN B2G IN THE EU – DIRECTIVE 2014/55/EU
In Europe, the milestone made towards electronic invoicing is April 18, 2019, was the deadline for EU member states to implement Directive 2014/55/EU. As of this date, government entities are required, at least in the area of public procurement, to be ready to receive structured electronic invoices from their suppliers.
Instead of a restrictive or uncomfortable dictate imposed by a European central authority, public and private organizations of all sizes are finding that Peppol provides greater security, reduced costs and fewer manual processing errors.
Poland has in place a system of guidelines for the evaluation of medical devices. The purpose of the guidelines is to indicate principles and acceptable methods for conducting the medical technology assessment process for medical devices, ensuring high quality analysis and reliability of the results.
The guidelines refer to the medical devices applied for in order to be covered by the guaranteed benefit status as defined in art. 15 par. 2 item 14 of the Polish Act on health care services financed from public funds (Journal of Laws 2020, item 1398, as amended), and which are processed in accordance with art. 25 of the Polish Act of 12 May 2011 on reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices (Journal of Laws 2020, item 357, as amended) and which meet all of the following criteria:
(a) are mass produced;
(b) are intended for use by an individual patient;
(c) are materially superior to products currently receiving public funding, the burden being on the applicant to demonstrate the claimed superiority;
(d) are therapeutic medical devices or are used for prophylaxis (they are not diagnostic medical devices).
When the medical device contains a drug product, the documentation should address the requirements described in the Health Technology Assessment Guidelines (Version 3.0) developed for drug technologies.
DEFINITION OF MEDICAL DEVICES AND MEDICAL TECHNOLOGY ASSESSMENT UNDER POLISH LAW
In January 2022 there have entered into force the provisions of the Polish law on special rules for the remuneration of persons performing tasks in the field of cyber security, which, among other things, provide for the creation of the Polish Cyber Security Fund, which will be used to finance salary supplements for persons engaged in cyber security.
HIGHER EARNINGS OF SPECIALISTS WORKING FOR MAJOR OFFICES IN POLAND
ICT benefit, which is a salary or emoluments allowance, is to be provided to persons performing tasks in a national level CSIRT; in cybersecurity authorities; persons who serve the Plenipotentiary for Cyber-security, as well as persons who perform tasks related to ensuring cyber-security in, among others, the Internal Security Agency, the Foreign Intelligence Agency, the Central Anti-Corruption Bureau, organizational units subordinate to the Prime Minister or to ministers, the Chancellery of the Prime Minister or in offices serving ministers, the Police or the State Protection Service.
The amount of remuneration for the work, including the ICT benefit, cannot exceed twenty-one times the base amount for members of the civil service corps specified in the Budget.
As for service procedure of documents in Poland until present, the common form was a paper letter that had to be sent with an acknowledgement of receipt. The changes introduced by the 2019-2021 amendments to the Polish administrative procedure, particularly the 2021 amendment on electronic service, are intended to effectively change the way parties are informed about the stages in the procedure. The changes move correspondence with government entities to an electronic level. From 5 October 2021, there have entered into force the changes which concern, among others, the principle of written documents (Article 14 of the Code of Administrative Procedure), provisions on the power of attorney (Article 33 of the Polish Code of Administrative Procedure ), time limits (Article 35 of the Polish Code of Administrative Procedure), reminders (Article 37 of the Code of Administrative Procedure), service (Articles 39-49 of the Code of Administrative Procedure), summons (Articles 50, 54 of the Code of Administrative Procedure), time limits (Article 57), or commencement of proceedings (Articles 61, 63 of the Code of Administrative Procedure).
