Belgium

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 1 June 2019, a new Royal Decree (dated 7 April 2019) altering the notification procedure for implants and certain invasive medical devices for long-term use entered into force. Previously, the Belgian Sickness and Invalidity Institute (RIZIV/INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical Read More

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 7 April 2019, a law altering the notification procedure for implants and certain invasive medical devices for long-term use was adopted. Previously, the Belgian Sickness and Invalidity Institute (INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical devices were required to register with the Read More

Belgium modifies legislation regarding unavailability of medicines

Kaat Van Delm

On 28 March 2019, the Chamber of Representatives approved a law which changes the rules applicable to shortages of medicines. This law will amend the Law of 25 March 1964 concerning medicinal products. So far, only the draft billĀ has been made available, as the changes have not yet been published in the Belgian Official Gazette. Read More

Belgium considers creation of cannabis agency

Eveline Van Keymeulen

On 27 February 2019, the Belgian Parliamentary Health Committee adopted almost unanimously a resolution which facilitates the creation of a cannabis agency. Such agency will enable and control the production of cannabis for medical purposes. As such, it will become possible to prescribe cannabis in Belgium to patients for whom mainstream medicines have proven to Read More

New Belgian Royal Decree liberalises the distribution of medical devices

Kaat Van Delm

On 7 February 2019, the Royal Decree on the liberalisation of the distribution channel of medical devices became applicable (published in the Belgian Official Journal on 28 January 2019). The Royal Decree revokes certain articles in existing Royal Decrees relating to medical devices and two Ministerial Decrees implementing those articles, all of which restricted the Read More