The pilot phase for SNSA includes scientific advice (SA) provided by SÚKL on the field of quality, safety and efficacy of medicinal products for human use and includes SA regarding Marketing Authorisations or Clinical Trials (therefore SA generally provided by Marketing Authorisation Section).
In this pilot phase could be requested simultaneously two National Competent Authorities (NCAs) involved in SNSA. Those NCAs are actually:
SÚKL – Czech Republic (innovation@suklcz)
AGES – Austria (scientificadvice@basgat)
FAMHP – Belgium (innovationoffice@fagg-afmpsbe)
FIMEA – Finland (innovation.office@fimeafi)
PEI – Germany (innovation@peide)
OGYEI – Hungary (tanacsadas@ogyeigovhu)
AIFA – Italy (scientificadvice@aifagovit)
NOMA – Norway (jan-petter.akselsen@legemiddelverketno)
URPL – Poland (magdalena.pajewska@emaeuropaeu)
AEMPS – Spain (ascina@aempses)
Application for each SNSA is possible by an informal LOI (letter of intent) to only one of the two selected NCAs or by using an existing application form for the national scientific or regulatory advice procedure at one of the two selected NCAs, according to guidance published on HMA (Heads of Medicines Agencies) website: Guidance for applicants on a pilot for SNSA
The briefing documents and list of questions need to be sent to both NCAs separately, considering special requirements with regard to submission timelines, template, scope, content and extent of the documents of each NCA. The payment of the fees will be based on the cost regulations of each NCA involved and be in accordance with the corresponding payment procedure established. The payment for the scientific advice provided by SÚKL must be made before consulting. Before providing the payment, it is necessary to complete the interactive form, which will generate a specific variable symbol under which the payment must be sent.
Link to SÚKL requirements for national scientific advice is here: http://www.sukl.cz/sukl/konzultace-sukl.
Information on EU-Innovation Network is available here.
Marketing Authorisation Section
5. 5. 2020