Home Human Medicines Regulatory Affairs

forms

Application form for new applications and variations (National, MRP, DCP and Centralised Procedures)

Notice to applicants (EudraLex website)

Braille

Braille declaration

Consultation procedure medical devices

application / variation form medical devices

Decentralised Procedure (DCP)

Planning tool to support application for time slots for DCP (NL=RMS) - application form included (last update 2010)

Duplex authorisations

Declaration applicant and declaration marketing authorisation holder (last update 2010)

Marketing Authorisation withdrawal

Withdrawal form

Package leaflets

Statement on the technical readability aspects of package leaflets with pharmaceutical products

Parallel import of medicinal products authorised in The Netherlands

Pharmacovigilance

RMS Request for Mutual Recognition Procedure

Application form mutual recognition procedure

Scientific advice

Application form purely scientific advice (last update 2010)
Application form regulatory advice (last update 2010)

Sunset clause

Declaration with respect to marketing of medicinal product

Updating of old dossiers

Application form

Usage patents

Declaration of the deletion of information from the printed SmPC and leaflet in connection with patented indications (last update: December 2009)

Variations

Application form for new applications and variations: Notice to applicants (via website EudraLex)
Request variation number for grouped applications concerning more than one MA and worksharing applications (last update: 2010)