Medical devices: am I an ACTOR?

23.11.2021.

Registration obligation for medical devices according to the regulation of European Union

Rules from January 31, 2022 of the Regulation on the European Clinical Trials

24.09.2021.

The European Parliament and the Council of the European Union adopted the Regulation 536/2014 on clinical trials on medicinal products for human use („Clinical Trial Regulation”/CTR, hereinafter referred to as „Regulation”), and repealed Directive 2001/20/EC on 16th April 2014.

From breast implants to legislation

24.08.2021.

In the first part of our news series on Regulation (EU) 2017/745 of European Parliament and the Council on medical devices (hereinafter referred to as: “MDR Regulation”),

we briefly refer to the major changes between MDD Directive and MDR Regulation.

The effect of MDR Regulation on public procurement contracts

16.08.2021.

The MDR Regulation containing the rules on medical devices became fully applicable in the European Union, including Hungary, as of May 26, 2021.

Under MDR, former certificates of medical devices under MDD decree will expire on May 26, 2024.

THE MEDICINE ECONOMY ACT HAS BEEN CHANGED SIGNIFICANTLY

12.07.2021.

Our summary shows how the terms ‘promotion’ and ‘commercial practice’ have changed, what new rules govern the interactions between healthcare professionals and pharmaceutical companies, and we cover the new changes concerning promotional events and patient support programs, as well.  On 18 June 2021, the provisions of Act XCVIII of 2006 (”Medicine Economy Act”) entered into force. Without claiming completeness, our office has compiled the most important changes of the legislation:

RENEWED RULES OF REMOTE WORK
– OR THE REDEFINITION OF THE FRAMEWORK OF REMOTE WORK –

08.07.2021.

The Hungarian Government amended the rules of remote work by a government decree. Although the provisions of the government decree are basically applicable during the state of emergency period, however, having regard to the background, i.e. the lack of legal determination of the home office in last year, there is a legitimate presumption among legal interpreters that these provisions – at least a significant part thereof – may also be finalized beyond the emergency period.

MORE FLEXIBLE REMOTE WORKING RULES

17.11.2020.

On the basis of the provisions of new regulation, the rules of distance working are changing. Although – according to the news – the specifying the rules regarding the home office have been expected, but the government decree exclusively contains provisions concerning distance working. These provisions basically fill significant gaps, therefore it will be possible the distance working for employers under much more lenient conditions than before.

CHANGES IN THE REGULATION OF ADULT EDUCATION

28.08.2020.

The provisions of the Act LXXVII of 2013 on Adult Education (Adult Education Act), which will enter into force on 1 September 2020, mean significant additional obligations for adult education organisers, especially regarding the notification and the related data providing obligations.

ANNIVERSARY

02.05.2020.

It has been a year now that László Nagy patent attorney passed away in May 2019.

ADDITIONAL FACILITATIONS FOR COMPANIES

23.04.2020.

Having regard to the current state of emergency, the Government intends to lay down the frame of the legal entities’ operation by continuous legislation in the Economy Protection Action Plan.

MODIFICATIONS IN THE DAILY OPERATION OF THE LEGAL ENTITIES

16.04.2020.

The Government issued the Decree No. 102/2020 (IV.10.) (Decree) on 10 April, 2020, which declares the different rules of operation of the companies and any other legal entities (foundations, associations, etc.).

NATIONAL SUBSIDY FOR EMPLOYERS AND EMPLOYEES

14.04.2020.

As unfortunately every participant of the labor market, thus both the employers and the employees, have experienced themselves, the pandemic situation occurring due to the spread of COVID-19 contagion causes significant difficulties in the Hungarian economy. Having regard to such economic difficulties, the Hungarian Government intends to assist the employers and employees being in challenging situation by a three-stage economic program.

LIFE AFTER THE EXTRAORDINARY JUDICIAL VACATION

07.04.2020.

In Hungary, several government decrees aimed at controlling the pandemic situation and protecting citizens came into force following the order of the state of emergency by the Hungarian Government on 11 March, 2020. The mostly restrictive measures have obviously impact on the contentious and non-contentious civil court and other procedures, therefore, on the entire law enforcement.

E-SIGNATURE TO MAINTAIN THE NORMAL BUSINESS OPERATION

27.03.2020.

In the current pandemic situation, companies are forced to adapt to the difficulties of home office work. In order to mitigate the difficulties and the atypical conditions of work, there are several digital solutions available, which may support the continuance of the normal business operation. 

CORONAVIRUS: QUESTIONAIRE YES, THERMOMETER NO!!!

11.03.2020.

Hungarian Data Protection Authority (“NAIH”) has just published its guidance on data processing activities related to coronavirus for employers. We shortly summarized the main content thereof.

’Becoming broken due to the quarantine, or not?’

– potential labor law aspects of COVID-19 coronavirus –

05.03.2020.

Simultaneously with the global spread of COVID-19 coronavirus and the increased appearance thereof in the surrounding countries, Hungary and also the private individuals prepare for the management of a potential epidemiological situation.

DATA PROTECTION NEWSLETTER 2019/1.

Regulation regarding computer-, and mobile phone use at workplaces and rules of employer’s data processing in connection with extracts from the penal register are to be amended; as well as legislation of direct marketing activities.

Labor law newsletter 2019/1

We hereby summarize the recently adopted and promulgated amendment of Act I of 2012 on the labor code (hereinafter referring to as: ‘Labor Code’).

Data Protection Newsletter 2018/1.

As we believe that the up-to-date information on the amendment of legal provisions is essential for our Clients, we intend to inform our Client on the significant amendments regularly or on ad-hoc basis by publishing newsletters.

Pharmaceutical Newsletter 2018/1.

Highlights regarding the regulations on databases and notification forms and Guide regarding the application of nutrition and health claims released by OGYÉI We consider significantly important to provide up-to-date information to all of our Clients operating in the field of pharmaceutical sector not only regarding the amendments of legal regulations, but regarding the recommendations, resolutions and practice of the given authority as the every-day operation thereof may be legally defined upon such information.

Professional medical events – Stricter supervision by the Authority

It is vital for our Clients in the field of the pharmaceutical sector to be familiar with the different recommendations and resolutions of the authorities beside the changes to the relevant legislations so that our clients can conduct their everyday business behaviours in compliance with the current legislation and also the requirements of the authorities. Therefore it is particularly important to Germus & Partners Attorneys-At-Law to keep our clients up-to-date on the changes to the relevant legislations as well as such decisions and resolutions, which can be especially relevant to the business decisions of our Clients.

Clarification of competition restricting agreements in the public procurement procedure

It is certainly worth paying a special attention to one of the several changes of the “new” Act CXLIII of 2015 on Public Procurement (hereinafter: PPA), which entered into force November 1st 2015, to the changes in grounds for exclusion and to the new institution of self- clarification which seats new challenges for the participants of public procurement procedures.

The latest “traps” in the act on Competition Law

It is vital for every undertaking to conduct their market behaviours in accordance with the provisions of the competition law of Hungary and the European Union, since any lack of the compliance may be detrimental to our clients.

New EU Regulation on data protection has been published

New EU Regulation on data protection has been published   The new General Data Protection May 4, 2016. It imposes – compared to the currently existing rules – stricter obligations on data controllers and on data processors as well, expands the rights of data subjects, in particular by increasing the transparency of the procedure of data controlling. In this Newsletter we summarize the