I. Documentation

Please fill out the application form available from our website and submit it together with the following documents:

1. Statement regarding switch of the prescription and/or pharmacy requirement. This should contain the following information:

   • Information, whether centrally licensed medicinal products are affected
   • Information, as to whether – to your knowledge – medical devices are affected (possibly also in other indications and pharmaceutical forms). Should this be the case, please provide a corresponding short description of these medical devices. In this respect, we recommend initial research on the internet.

   • if you are not applying for a general complete or conditional switch of a substance, please specify precisely which exception you are seeking. Exceptions for a substance can be sought e.g. with regard to:

     • pharmaceutical form
     • therapeutic indication including age restrictions for use
     • maximum single/daily dose
     • maximum active ingredient content per package
   • national and international sales figures, estimated number of patients treated including statement of the calculation basis; submission of a separate list with sales figures from countries in which the substance is already being marketed with the requested legal status would be useful
   • Information, whether you yourself are the Marketing Authorisation Holder for corresponding medicinal products in Germany and if this is the case, information regarding the medicinal products concerned
   • justification of the application and presentation of corresponding scientific data in support of the application
2. Documentation (e.g. publications, expert reports) supporting the reasoning of the a.m. statement (see 1.); please bear in mind that the committee will be assessing your application mainly on the basis of robust findings on medical risks; please only submit such documentation as is relevant for switching the legal classification
3. Summary of Product Characteristics (in its most recent version)
4. Package Leaflet (in its most recent version)

The Expert Advisory Committees for Prescription-Only Issues/Pharmacy-Only Issues confers on active ingredients, which means that one application for all medicinal products concerned will be sufficient.

II. Submission of the Application

1. Pharmaceutical Entrepreneurs

   As of immediately, please submit your application via CESP, the Common European Submission Platform.
   Please observe the following requirements and proceed as follows:
   
   

   Delivery File Step 1:

   • For "Area" please select "Human Medicines".
   • For "Regulatory Activity" please select "Legal status switch request (Rx, OTC)".
   • For "Sub Activity“ then please select "H001 Not Applicable"
   • Please select the application you used to compile the ZIP archive under "Zip File Type"
     
     

   Delivery File Step 2:

   • For "Procedure Type" please select "National".
   • Please select "Other Submission Type" under "Submission Type"
     
     

   Delivery File Step 3:

   • „DE(BfArM)“ als “National Agency” auswählen.
     
     

   Delivery File Step 4:

   • The form fields on this page can be left blank.
   • As applications for changing the legal classification pertain to active ingredients and not to medicinal products, no procedure number/ENR/ZNR must be indicated.

   
   By clicking on the [Submit] button, the CESP delivery file is created for download to your data processor. In order to complete your submission, please first upload the ZIP container with your documentation and subsequently the aforementioned CESP delivery file via the CESP portal.

   
   You can find further information on CESP under Nutzung der Common EU Submission Platform (CESP) für Einreichungen beim BfArM

2. Other Applicants (e.g. private individuals, authorities)

   Please send your application electronically as a CD-ROM to the following address:

   
   Bundesinstitut für Arzneimittel und Medizinprodukte
   Geschäftsstelle der Sachverständigen-Ausschüsse für Verschreibungs- und Apothekenpflicht/ FG 72
   Kurt-Georg-Kiesinger-Allee 3
   53175 Bonn

III. Deadlines for the Application

Deadlines for submitting an application are 1 March and 15 September of each year.

Applicants whose application has been rejected by the Expert Advisory Committee and who wish to submit a revised application for the next meeting shall also submit it by the a.m. deadlines. In such cases, supplementation of the documents supporting the application is possible until 21 March or 7 October, provided they take the aspects from the result protocol into account..

IV. Fees

Applicants do not incur any fees for the processing of applications for changing the legal classification and the subsequent regulatory ordinance procedure.

If the legal classification of a substance is changed by way of an Amendment Ordinance, the informative texts of the medicinal products concerned must be adapted accordingly. In order to do so, a national variation notification or variation must be submitted for which fees are charged.

Information on notification of changes in the legal classification can be found at FAQ "Wie ist die Änderung der Verkaufsabgrenzung eines Arzneimittels anzuzeigen?"

V. Contact

Should you have questions regarding the submission of an application please contact us at verschreibungspflicht@bfarm.de .

Application form