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Posts Tagged ‘Regulation’

Liberalization of the Belgian Distribution Channel for Medical Devices: a New Royal Decree

January 29, 2019


On 28 January 2019, the new Royal Decree of 19 DECEMBER 2018 on the liberalization of the distribution channel for medical devices has been published in the Belgian Official Gazette. The new Royal Decree will come into force on 7 February 2019.

The most important changes imply that, as of 7 February 2019, the Belgian distribution channel for Medical Devices and Active Implantable Medical Devices is no longer restricted to (hospital) pharmacies. From that date, patients and healthcare professionals can purchase medical devices, such as sterile bandages or physiological serum, directly from any distributor, from pharmacy to supermarket, and even directly from the manufacturer. The distribution of medical devices will also be facilitated for laboratories, nursing homes and private clinics.  This liberalization should ensure that the access of end-users and patients to medical devices is better aligned with the principles of free movement of products with CE Marking within Europe. Nevertheless, the liberalization shall have no impact on the safety or efficacy of the medical devices on the Belgian market and does not affect the reimbursement conditions set by the RIZIV/INAMI.

In Belgium, all distributors and exporters must be registered with the FAMHP. For manufacturers, there is currently no direct obligation to register.

More information can be found here.


New EMA regulations 2019/5 and 2019/6

January 28, 2019

European Union

On January 7th, 2019 regulation 2019/5 was published in the Official Journal of the European Union “amending Regulation 726/2004, known as the Regulation on the Centralized Procedure. The new Regulation will apply from 28 January 2019.

Regulation 2019/5 combines and integrates the “key elements” of following rules into Regulation 726/004:

–       The rules on conditional marketing authorizations, currently contained in Regulation 507/2006

–       The rules on variations, currently in Regulation 1234/2008 (These rules have also been integrated in Directive 2001/83/EC)

–       The rules on financial penalties that may be imposed on marketing authorization holders of centralized authorizations, who fail to comply with their obligations, currently set out in Regulation 658/2007.

These consolidations are accompanied by several changes within these rules. In several cases, this new Regulation empowers the Commission to adopt new delegated acts that complement the “key elements” now contained in the centralized procedure regulation. In addition to these changes, this new Regulation also describes the financing of EMA.

Regulation 2019/6 removed the rules on veterinary medicinal products from Regulation (EC) No 726/2004 on the centralized procedure and the current Directive 2001/82/EG on veterinary products at national level was repealed.

This new regulation just entered into effect in all member states of the European Union. From now on, all parties involved have three years to ensure compliance with the obligations in this Regulation. The health authorities and all parties involved will make the necessary preparations, at both national and European level to ensure the implementation of this new regulation.

Regulation 2019/6, which will apply as of 28 January 2022, covers all the routes granting marketing authorization for veterinary products in the Union – both at centralized and national level. It should provide more innovation, increase the availability of veterinary medicines by simplifying the regulatory pressure and administrative burden and increase the competition in the veterinary pharmaceutical sector. In addition, a key point of this regulation is to strengthen existing EU laws against antimicrobial resistance. The safeguarding of public health, animal welfare and animal health and the protection of the environment remain the central focus point.

More information can be found here.



New Medical Device Directive

April 14, 2017


Finally some progress! The final versions of the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, resp.) have finally been approved by the European Parliament on April 5th 2017. Formal publication of the MDR and IVDR in the Official Journal of the European Union is anticipated for early May 2017. Twenty days from that publication, likely in early June 2017, the Regulations will enter into force. Accordingly, the MDR will probably be applicable by 2020 and the IVDR by 2022.