Regulations and directives


1 - 12 of 23 items

Revision of the Sterile Medicinal Products

Revision of the Sterile Medicinal Products

Monday, 29 de Augost de 2022

The European Commission has issued a revision on the Sterile Medicinal Products, which will come into operation on a ywar from now. In this docment, the scope, principle, Pharmaceutical Quality System (PQS), premises, equipment, utilities, personnel, and production and the specificl technologies are revised. 

Revision of the Sterile Medicinal Products

Revision of the Sterile Medicinal Products

Monday, 29 de Augost de 2022

The European Commission has issued a revision on the Sterile Medicinal Products, which will come into operation on a ywar from now. In this docment, the scope, principle, Pharmaceutical Quality System (PQS), premises, equipment, utilities, personnel, and production and the specificl technologies are revised. 

More transparent and predictable working conditions for workers in EU

More transparent and predictable working conditions for workers in EU

Monday, 8 de Augost de 2022

With the Directive on transparent and predictable working conditions, workers in the EU will have the right to more complete information, a limit to the length of probationary periods, take up another job with another employer, be informed within a reasonable period in advance when work will have to be done, effective measures that prevent abuse of zero-hour contract work, receive a written reply to a request for transfer to another more secure job or receive cost-free mandatory training related to the job. 

Circular Economy Package

Circular Economy Package

Monday, 8 de Augost de 2022

The European Commission has proposed a Circular Economy package to mainstream circular economy products on the European market, scale up circular economy business models and increase circularity literacy in Europe. As part of the EU Industrial Strategy and the EU Green Deal, the new Circular Economy Package outlines measures to accelerate circular economy in the European Union. The outlined measures will target companies and consumers alike.

Unitary Patent & Unified Patent Court

Unitary Patent & Unified Patent Court

Thursday, 21 de July de 2022

The Unitary Patent and the Unified Patent Court are the building blocks which supplement and strengthen the existing centralised European patent granting system. A reform of European patents has been long awaited, and it will come into effect on January 2023. With the new European patent with unitary effect, companies are free from the choice of countries of application. 

Commission amends the Temporary Crisis Framework

Commission amends the Temporary Crisis Framework

Thursday, 21 de July de 2022

The European Commission has adopted an amendment to the State aid Temporary Crisis Framework, initially adopted on 23 March 2022 to support the economy in the context of Russia's invasion of Ukraine. This amendment extends the Temporary Crisis Framework by providing for the following additional types of aid measures in line with the REPowerEU Plan: accelerating the rollout of renewable energy and facilitating the decarbonisation of industrial processes. 

Stronger rules for greater safety and quality of blood, tissues, and cells

Stronger rules for greater safety and quality of blood, tissues, and cells

Monday, 18 de July de 2022

By proposing new rules to further increase the safety and quality of substances of human origin, the Commission is taking another step towards building a strong European Health Union. The new Regulation will aim at facilitating cross-border circulation of critical health products such as blood, tissues and cells, or even breast milk or microbiota. 

Commission welcomes the adoption by the European Parliament of the EU's new rulebook for digital services

Commission welcomes the adoption by the European Parliament of the EU's new rulebook for digital services

Monday, 11 de July de 2022

The Commission welcomes the adoption by the European Parliament of the Digital Services Act and Digital Markets Act, proposed by the Commission in December 2020. The Digital Services Package sets out a first comprehensive rulebook for the online platforms that we all depend on in our daily lives. These new rules will be applicable across the whole of the EU and will create a safer and more open digital space, grounded in respect for fundamental rights.

Health system performance assessment: a framework for policy analysis

Health system performance assessment: a framework for policy analysis

Friday, 1 de July de 2022

Health policy-making and reform require, first and foremost, a sound understanding of how a health system is performing. To assist countries in this process, the Health Systems Performance Assessment Framework for Universal Health Coverage offers a comprehensive attempt at guiding the collection and analysis of health system data in relation to policy goals and 21st century challenges.

Council and European Parliament reach a provisional political agreement to extend the regulation establishing the EU digital COVID certificate

Council and European Parliament reach a provisional political agreement to extend the regulation establishing the EU digital COVID certificate

Tuesday, 14 de June de 2022

The regulation establishing the EU digital COVID certificate will be prolonged by one year, until 30 June 2023. The extension of the regulation will ensure that EU travellers as well as those from third countries connected to the system can continue to use their EU digital COVID certificate for travel within the Union in member states where these travel certificates are required. 

Commission welcomes political agreement on adequate minimum wages for workers in the EU

Commission welcomes political agreement on adequate minimum wages for workers in the EU

Monday, 13 de June de 2022

The Directive establishes a framework for the adequacy of statutory minimum wages, promoting collective bargaining on wage setting, and enhancing the effective access of workers to minimum wage protection in the EU. The main elements of the Directive are: A framework for setting and updating statutory minimum wages, Promoting and facilitating collective bargaining on wages, and Improved monitoring and enforcement of minimum wage protection. 

Public health: Stronger rules for placing medical tests on the market

Public health: Stronger rules for placing medical tests on the market

Friday, 3 de June de 2022

New rules on in vitro diagnostic medical devices (IVDR) such as HIV tests, pregnancy tests or COVID-19 tests, are now applicable. The rules will better protect public health and patient safety in respect to these devices, bringing EU law in line with technological advances and progress in medical science. By aligning market access requirements in the different EU Member States, it also safeguards fair market access for manufacturers.