Please structure the documents as follows:

1. Application Letter
   Here the applicant should provide a detailed description of the rationale behind the application. If you are not applying for a switch of a substance without exceptions, you should state the precise wording of the exceptions you are applying for together with a justification. You can apply for exceptions from a legal status of a substance e.g. regarding

   • pharmaceutical form
   • indication- maximum individual/daily dose
   • package size
2. Summary of product characteristics (latest version)
3. Package leaflet (latest version)
4. Marketing of the medicinal product(s): date the medicinal product(s) was/were launched in Germany
5. National and international sales figures, estimated number of patients treated and explanation of the basis for calculation. It is advisable to submit a separate list of sales figures from other countries where the substance is already being marketed with the requested legal classification

6. Documents (e.g. publications, expert reports etc.) and data supporting and substantiating the rationale of the application (cf. 1.). Please bear in mind that the committee will be evaluating your application mainly on the basis of sound data concerning drug risks.
   The Expert Advisory Committees for Prescription-Only Issues and for Pharmacy-Only Issues both evaluate substances, therefore one report for all medicinal products concerned is sufficient.
   
   

   Please only submit publications that are relevant for the legal classification.

   Your documentation is required in written form. Additionally, please submit all data on CD-ROM.

   Please send your application to
   
   

   Bundesinstitut für Arzneimittel und Medizinprodukte
   - Geschäftsstelle der Sachverständigen-Ausschüsse für Verschreibungs- und Apothekenpflicht -
   Kurt-Georg-Kiesinger-Allee 3
   53175 Bonn