The Proposal for a Regulation of the European Parliament and of the Council on markets in cryptoassets, which amends Directive (EU) 2019/1937, ("Regulation on Markets in Crypto-assets", or the "MiCA Regulation" for short) was published on 24 September 20201. The Proposal is part of the Digital Finance Package adopted on the same date by the European Commission as part of the Digital Finance Strategy for the EU financial sector2 ...
Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...
Regulation 603/2021 was approved by the Governing Board of the Institute of Public Markets, Real Estate and Construction I.P. (“IMPIC”) and came into force on 5 July 2021. The aim of this regulation (“Regulation”) is to establish and regulate the procedures to be adopted in the fight against money laundering and terrorist financing in the real estate sector ...
Some facts and figures that set out the landscape of merger control, antitrust enforcement and competition litigation in Portugal in 2020. Interim Measures The PCA ordered the Portuguese Professional Football League to suspend its decision preventing teams in the First and Second Football Leagues from signing players that have unilaterally terminated their contracts due to the COVID-19 pandemic ...
The European Insurance and Occupational Pensions Authority (“EIOPA”) is entrusted with 1 issuing guidelines and recommendations to Member States’ supervisory authorities on how insurance and reinsurance undertakings should apply the Solvency II Directive 2 in order to (i) establish consistent, efficient and effective supervisory practices and (ii) ensure the common, uniform and consistent application of Union law ...
1. Introduction Transmission services used in the provision of M2M services are growing in importance. As a result, in May 2019 ANACOM (the Portuguese communications regulatory authority) launched a public consultation1 to collect input on the possible creation of a specific range in the national numbering plan (plano nacional de numeração - PNN) to accommodate these services ...
PORTUGAL I. Courts The Competition Court reduces fine of EUR 38.3 million imposed on EDP and Sonae by 10%On 30 September 2020, the Competition, Regulation and Supervision Court (Competition Court) reduced by 10% the fine of EUR 38.3 million imposed by the Portuguese Competition Authority (PCA) on EDP and SONAE in May 2017 ...
I. Banco de Portugal Communication of Banco de Portugal on the Synopsis of Behavioural Supervisory Activities - first half of 2020. Communication of Banco de Portugal on the imposition of a capital reserve on institutions identified as “other systemically important institutions”. Banco de Portugal Communication on the Economic Bulletin of October 2020. Communication of Banco de Portugal on the implications of Brexit ...
Below, you will find the issue of our Banking and Finance and Capital Markets newsletter for the 1st quarter of 2021, which compiles the most significant news in this area. BANKING AND FINANCE I. Banco de Portugal Banco de Portugal press release on the countercyclical capital buffer for the 2nd quarter of 2021. The countercyclical capital buffer percentage in force from 1 April 2021 will remain at 0% of the total amount of exposures (link) ...
Regulation (EU) 2017/745 of 5 April came into force on 26 May to create a single set of rules applicable to all medical devices, other than in vitro diagnostic medical devices. Here are some of the main changes to the rules that now come into force: 1. Broadening of the scope of application of the rules and of the concept of medical device With this Regulation, medical devices without a medical purpose that have characteristics similar to medical devices (e.g ...
Law 58/2020 came into force on 1 September 2020 and it implements into Portuguese law: Directive (EU) 2018/843 of the European Parliament and of the Council of 30 May 2018 amending Directive (EU) 2015/849 on the prevention of the use of the financial system for money laundering or terrorist financing, commonly known as the 5th Anti-Money Laundering Directive; and Directive (EU) 2018/1673 of the European Parliament and the Council of 23 October 2018 on combating money laundering by criminal l
Law 58/2020 came into force on 1 September 2020 and it implements into Portuguese law: Directive (EU) 2018/843 of the European Parliament and of the Council of 30 May 2018 amending Directive (EU) 2015/849 on the prevention of the use of the financial system for money laundering or terrorist financing, commonly known as the 5th Anti-Money Laundering Directive; and Directive (EU) 2018/1673 of the European Parliament and the Council of 23 October 2018 on combating money laundering by cr
Law 31/22 - which approved the Angolan Code of Administrative Procedure (“new CPA”) - was published in the Official Gazette on 30 August last. This law has repealed Decree-Law 16-A/95 of 15 December, which, in turn, approved the Rules of Administrative Procedure (“former CPA”). The previous CPA, came into force in January 1996 and was only amended in 2016 by Law 9/16 of 16 June ...
The list of extensions for the adaptation of municipal and inter-municipal plans to the (new) rules on land classification and ualification contained in the Legal Framework for Territorial Management Instruments (Regime Jurídico dos Instrumentos de estão Territorial - “RGJIT”) 1 has been joined by a new one, with the publication of Decree-Law 45/2022 of 8 July ...
Electric mobility represents a new language and a new dynamic for consumers who yearn for an accessible, extensive, digital, user-friendly charging network. In Portugal and abroad, the electric mobility sector has witnessed significant developments and it has shown itself to be a particularly dynamic market that is enjoying strong growth ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare ...
Legal due diligence processes are widely known in the context ofmergers and acquisitions (M&A) and corporate reorganisation projects. Their aim is to analyse the operations and organisation ofcompanies to identify their degree of compliance with applicable legal and contractual regulations, the level of risk of non-compliance, and the potential sources of legal and contractual liability ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...
Although this issue was debated in the plenary session on 18 May 2021, the Judgment has not yet been published in the official gazette (Diário da República), so it has not yet taken effect. However, the 180-day trial periods of contracts entered into before this declaration of unconstitutionality are not safeguarded. Therefore, in practice, we will have terminations of contracts during the trial periodthat may now be declared to be illegal dismissals. 1 ...
Of the Council of Ministers Resolution no. 63/2020, which approved the National Hydrogen Strategy, was published on 14 August 2020. Also, on 17 August 2020, Decree-Law no. 60/2020 was published, which, following the National Hydrogen Strategy, establishes the mechanism for issuing guarantees of origin for low carbon gases andfor gases of renewable origin. 1 ...
In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
