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.
What is the Central Register of Invoices and the National e-Invoice System
Poland as the fourth country of the EU countries decided to introduce the Central Invoice Register as another mechanism to prevent fraud against VAT. The Central Invoice Register is also known as the Central Invoice Database or the National e-Invoice System. It is a system that brings together all the invoices issued by entrepreneurs. It was established in order to tighten the tax system and prevent tax fraud. The Polish National e-Invoice System began its operation on 1 January 2022 under the Act of 29 October 2021 amending the Act on Value-added Tax and certain other acts (Journal of Laws of 2021, item 2076). The National e-Invoice System (NeIS) allows structured invoices to be issued and made available. On the basis of Art. 106nb of the Act on Value-added Tax of 11 March 2004, NeIS can be used by taxpayers, entities indicated by the taxpayer (e.g. an accounting office), enforcement bodies specified in the Act on Enforcement Proceedings in Administration of 17 June 1966 and court bailiffs performing enforcement actions within the meaning of the provisions of the Code of Civil Procedure in cases indicated in Art.106c of the VAT Act, natural persons indicated by such entities, natural persons indicated in the notice on granting or withdrawing the right to use the National e-Invoice System to whom the taxpayer or entities referred to in Art. 106c of the VAT Act have granted the right to use this system, entities other than listed, indicated by natural persons using the National System for e-Invoices, if the right to indicate another entity results from the rights granted to such natural persons.
One World Trade Center – KG Legal’s new office in New York (International Branch)
KG Legal’s office in New York: One World Trade Center, 85th Floor, New York, NY 10007, USA
KG LEGAL KIEŁTYKA GŁADKOWSKI has its address in New York, which allows direct contact and exchange of information with international Clients of the Polish law firm operating in Poland and investors from the United States, among others under the Istart1 program.
KG LEGAL KIELTYKA GLADKOWSKI has launched a new programme of accelerating international capabilities of our law firm. As a separate branch named iSTART1 (https://www.istart1.com), based in the Lower Manhattan at One World Trade Center, 85th Floor, New York, NY 10007, USA, we have differentiated our aim to develop our international legal assistance in two fields. There are two groups of our global services related therewith: on the one hand, there is transaction advisory assistance (we advise on the content of contracts, how to secure payments and the rules of international acquisition and merger of companies); and on the other hand, we offer investment advisory services. We promote cooperation between start ups and venture partners and assist in serving their transactions. These two types of services have one common goal in the form of acceleration of business (this is always the primary goal of our services).
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
