The Royal Decree of July 16th 2012 updates the definitions, procedures and fees that are applicable to requests for national scientific-technical (eg. regulatory) advice (STA). These requests are being treated by the unit for STA within the Directorate-General (DG) PRE-Authorisation of the famhp. This Royal Decree modifying the Royal Decree of March 31st 2009 in execution of Article 6sexies of the Belgian Medicines law of March 25th 1964, was published in the “Moniteur Belge” on October 8th 2012 and entered into force on October 18th 2012.
The modifications introduced by the Royal Decree of July 16th 2012 result from the experience that was gained over the past 3 years since the initial implementation of the service for national STA in April 2009. The main purpose of the introduced modifications is to ensure a performant and high quality service within the predetermined timelines and to fit the STA service better to the needs of the applicants.
The famhp offers applicants the possibility to request national scientific and/or technical (eg. regulatory) advice (STA) related to the research and development of human and veterinary drug products in view of potential clinical trial applications (CTA’s), marketing authorization applications (MAA’s) or introduction of variations / line extensions to marketed drug products. The famhp’s main objective in providing STA to applicants at a national level is to promote and facilitate as much as possible the development of new drug products from a regulatory perspective in order to enhance the availability of innovative drug products to patients.
The document “Detailed guidance for national Scientific-Technical Advice requests” intended for applicants requesting for a national STA, provides further clarifications on the definitions, scope and procedures which are applicable as a result of the new Royal Decree of July 16th 2012.
Detailed practical information regarding the submission of requests for national STA can be found on the website page “Scientific-Technical advice” under de sections “Human Medicines” and the section “Veterinary medicines”.
Any possible questions regarding the new Royal Decree can be sent to electronically to the e-mail address email@example.com, or by regular post to the following address :
Federal agency for medicines and health products
Unit for Scientific-Technical advice
Victor Hortaplein 40/40