Belgium – Covid-19 coronavirus: measures affecting the life sciences sector

Tine Carmeliet

In the fight against the Covid-19 coronavirus pandemic, the Belgium government has taken several exceptional measures, including (i) restricting the sale of certain medical devices and personal protective equipment; (ii) issuing a Guideline for the reuse of surgical masks and FFP2/FFP3 masks; and (iii) communicating on how Covid-19 tests should be made available in Belgium. Read More

Belgium – FAMHP updates guidelines on labelling and packaging of medicines

Tine Carmeliet

On 3 April 2020, the Federal Agency for Medicines and Health Products (FAMHP) updated its guidelines on the labelling of medicinal products. The FAMHP stated in a communication that the update brought the guidelines in line with EU legislation and other national and international agreements. For example, to avoid medication errors, the guidance now includes Read More

Covid-19 coronavirus: Measures affecting the Belgium life sciences sector

Nieke Vanavermaete

In the fight against Covid-19 coronavirus, the Belgian government has taken several exceptional measures, including: Banning the use of rapid Covid-19 diagnostic tests for six months. Regulating the supply and distribution of essential medicines. Issuing guidelines for checking the compliance and suitability of surgical face masks. First, in order to avoid a misinterpretation of results, Read More

Covid-19 coronavirus: New guidance on managing clinical trials in Belgium

Tine Carmeliet

In the EU, clinical trials are authorised and supervised at national level. In order to complement the EU Guidance on the Management of Clinical Trials during the Covid-19 coronavirus pandemic, the Belgian government issued its own Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. The Belgian guidance is the result of Read More

Belgium – New Bill on allowing access to confidential agreements between government and pharmaceutical companies

Tine Carmeliet

As in several other European countries, Belgium has a system in place to allow the temporary use of certain innovative medicines on the Belgian market when no reimbursement decision has been taken due to the therapeutic effectiveness of the medicine not yet being proven. This system of “managed entry agreements” is institutionalised through the so-called Read More