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Give your opinion on two clinical trials with a genetically modified medicinal product for the treatment of spinal muscular atrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on two clinical trials with the genetically modified medicinal product AVXS-101 from the company AveXis, Inc. The purpose of the trials is to evaluate the safety, tolerability and efficacy of AVXS-101 for the treatment of spinal muscular atrophy. The public consultation runs from 17 October 2018 to 17 November 2018 inclusive.

Request for information to the marketing authorisation holders for medicinal products for human use, in view of Brexit

The Federal Agency for Medicines and Health Products (FAMHP) wants to get a better view of all upcoming new MRPs (Mutual Recognition Procedures), DCPs (Decentralised Procedures) as well as of all RMS switches (Reference Member State) resulting from Brexit. Marketing authorisation holders are asked to provide the FAMHP with the necessary information as well as the information regarding the sites for which the UK is actually responsible.

Give your opinion on a clinical trial with a genetically modified medicinal product against oral mucositis in patients with cancer

De FOD VVVL en het FAGG nodigen u uit om deel te nemen aan de publieksraadpleging over een klinische proef met het genetisch gewijzigde geneesmiddel AG013 van de firma Oragenics. De proef dient om de veiligheid en werkzaamheid te beoordelen van AG013 voor de onderdrukking van orale mucositis bij patiënten met kanker van het hoofd en de hals die gelijktijdig radio- en chemotherapie krijgen. De publieksraadpleging loopt van 18 juni 2018 tot en met 18 juli 2018.

Adaptation of RMA approval procedure

Following the amendment to Article 65quater of the Royal Decree of 14 December 2006, the procedure for approval of risk minimisation activities (RMA) has been adapted. Accordingly, the RMA evaluation and approval deadlines have also been adapted. Moreover, fees must now be paid for the submission of applications for approval.

Administrative simplification of the procedures for homoeopathic and (traditional) herbal medicines

From May 1, 2018 the FAMHP is simplifying a number of procedures for homoeopathic and (traditional) herbal medecines with the intention of streamlining the process and reducing the administrative load for companies and the government.

Medical devices: autocontrol and administrative simplification. End of the transition period on 17th June 2018.

As a result of the changes in the legislation on medical devices, the FAMHP has set up a web portal in order to facilitate registration. The transition period ends on 17th June 2018. From then on, all the operators that fail to register will no longer be able to legally carry out their activities.

New Royal Decree on biobanks

The Royal Decree of 9 January 2018 on biobanks, published in the Belgian Official Gazette on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, enters into force on 01.11.2018.

Labelling and packaging for medicines for human use: amended guidelines

Market authorisation holders for medicines for human use must follow certain labelling and packaging guidelines. These guidelines are being amended.

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