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portugal COVID-19 Task Force


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Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“Regulation”) came into force on 31 January 2022.

Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“Regulation”) came into force on 31 January 2022. The Regulation was adopted by the European Parliament in 2014 and released in May of the same year. It was subsequently officially published in the Official Journal of the European Union on 31 July 2021 and came into force six months after that date. The Regulation repeals Directive 2001/20/EC and makes sweeping changes to the European rules on conducting clinical trials...

Amendments to the rules on horizontal property – what has changed?

Law 8/2022 (the “Law”) was published on 10 January. This Law introduces important changes to the rules on horizontal property and to the mandatory documents that must accompany the deed or the certified private document for the sale of self-contained units. A. MAIN CHANGES TO THE CIVIL CODE 1. Possibility to ask the courts to resolve any absence of agreement regarding the alteration of the certificate of establishment of horizontal property in relation to the common parts Under the previous rules, the certificate of establishment of horizontal property could only be modified1 with the agreement of all the condominium owners...

Initial Assessment of the Impact of Possible Legislative Changes in the Pharmaceutical Sector

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. The aim of the legislative changes is to make the European rules more adaptable to new technological developments, to achieve sustainability in production and accessibility to medicines and, above all, to simplify EU procedures relating to medicines...

Clinical Trials in Portugal

Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether...

Extension of the Deadline for Integration of Special Plans and Suspension of Construction on Developable Land (?)

In recent months, the need to conclude the procedures to adapt/amend/revise the municipal and inter‑municipal plans for spatial planning has been widely discussed by the municipalities, the Government, economic agents and civil society. This discussion has focused on: i) The integration into in those plans of the rules contained in special plans concerning the arrangements to safeguard territorial resources and natural values that directly bind private individuals. The obligation is contained in the General Bases of Public Policy on Land, Spatial Planning and Development – Law 31/2014 of 30 May...
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Re: Covid-19 Information Request

Firm: PLMJ

Task Force: Andre Figueiredo, Nuno Morgado, Eduardo Pinto, Duarte Schmidt Lino

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