36 results found

Ministerial Order 97/2023 was published on 31 March and it introduces the fifth amendment to Ministerial Order 224/2015 of 27 July.

PLMJ - Law Firm is pleased to announce the arrival of PLMJ alumnus Pedro Lomba, who had previously worked for the firm as a senior associate and who returns as of counsel joining the healthcare, life sciences and pharmaceuticals team.

Concerns have been raised over recent months by various industry stakeholders who argue that the demanding challenges posed by the MDR's implementation...

Two significant new EU Regulations came into force on 28 January 2022. The first is Regulation (EU) 2019/4 of the Parliament and of the Council of 11 December 2018 on the manufacture...

Ordinance No. 90-A/2020, of April 9, has just arrived and it brings about an exceptional and temporary regime for electronic prescription of medicines and respective medical prescriptions...

Recommendation of the Portuguese Parliament no. 33/2018 2 February - The Portuguese Parliament recommends that the Government ...

On 13 March 2023, INFARMED published the Informative Circular 024/CD/100.20.200 of 10 March 2023, which addresses the European guidelines for devices manufactured...

The European Commission has adopted a proposal for legislative amendments to Regulation (EU) 2017/745 of 5 April 2017 ("MDR") and Regulation (EU) on In Vitro Diagnostic Medical Devices 2017/746 ("IVDR").

Ministerial Order 264/2023 of 17 August was published to establish the operating model for the Autumn-Winter 2023-2024 Seasonal Vaccination Campaign against influenza and Covid-19 in community pharmacies.

The public expenditure on medicines sold in pharmacies increased significantly in 2022 when compared to the previous year.

Given the growing demand and limited availability of these technologies, the exceptional regime seeks to guarantee fair access for patients with diabetes.

In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs ("EPSCO") Council...

Decree-Law No. 14-E/2020, of April 13, establishes an exceptional and temporary regime for the design, manufacture, import, national commercialisation and use of medical devices for human use...

On 26 June 2025, Commission Implementing Regulation (EU) 2025/1234 was adopted, amending Implementing Regulation (EU) 2021/2226 with regard to medical devices for which instructions for use may be provided electronically.

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 aim of this newly published legislation is to establish the regulations for distribution of these devices, and this activity is of the greatest importance throughout the integrated circuit of supply of medical devices

The new rules for the identification, protection, and resilience of critical entities aim to ensure that entities providing essential services for maintaining social functions and vital economic activities can prevent...