Tasks

The Expert Advisory Committee for Prescription-Only Issues in accordance with Section 53 sub-section 2 AMG (Arzneimittelgesetz, Medicinal Products Act) generally convenes twice a year. It decides on recommendations concerning applications for amendments to the "Ordinance on Prescription-Only Medicinal Products" (Verordnung über die Verschreibungspflicht von Arzneimitteln, AMVV) in accordance with Section 48 sub-section 2 AMG.

Details regarding the work of the Expert Advisory Committee are laid down in the Committee’s Rules of Procedure. These Rules of Procedure were revised in 2020, among others introducing transmission of the BfArM‘s recommendation to the applicant for information as well as the applicant‘s opportunity of presenting the application to the Expert Advisory Committee. On 28 January 2022, a separate national Veterinary Medicinal Products Act (Tierarzneimittelgesetz, TAMG) came into force rendering the inclusion of representatives from veterinary professions in the committee no longer necessary. Subsequently, the Expert Advisory Committee again revised its Rules of Procedure in the year 2022 (published on 28 October 2022).

General Information regarding the Prescription Requirement

The prescription requirement for medicinal products is specified in Section 48 of the Medicinal Products Act. Section 48 stipulates the conditions under which medicinal products may only be dispensed to consumers if medically prescribed by a physician or dentist. This applies especially to medicinal products which contain substances that have effects not generally known in medical science as well as to medicinal products that contain substances for which the prescription requirement is determined by legal ordinance. This legal ordinance defines substances that, even if used according to their intended purpose, can endanger human health if used without medical or dental supervision, or that are used to a considerable extent in a manner not in keeping with their intended purpose and may thus represent a health risk. The prescription-only status can be repealed for medicinal products if experience gained from using them shows that the aforementioned conditions do not or no longer exist.
The applicable legal ordinance that regulates the dispensing of medicinal products subject to medical prescription as well as the prescription-only status of individual substances is the "Ordinance on Prescription-Only Medicinal Products".

General Information on Amending the AMVV and regarding the Regulatory Ordinance Procedure

Applications to introduce or repeal the prescription-only status of a medicinal product can be submitted by various interested parties. As a rule, this will be either pharmaceutical entrepreneurs or authorities. Deadlines for submitting such applications are 1 March and 15 September of each year.

With immediate effect, pharmaceutical entrepreneurs are requested to submit their applications via CESP. For further information on the submission of applications, please refer to the "Instructions for submission of an application for changing the legal status".

As a rule, the procedure to amend the "Ordinance on Prescription-Only Medicinal Products" is conducted twice a year after the Expert Advisory Committee for Prescription-Only Issues has issued its recommendation. The Federal Ministry of Health, however, is not bound by this recommendation and may deviate from it. This could be the case, for example, if the Committee’s recommendation is linked to a variation regarding the marketing authorisation of the medicinal product concerned that cannot be implemented, thus standing in the way of the recommendation's realisation.

The regulatory ordinance procedure ends with the publication of the Amendment Ordinance to the AMVV in Part I of the Federal Law Gazette. Only then will it become evident whether the legislator has endorsed the Committee’s recommendation.

Current version of the AMVV (including list of substances and preparations)

https://www.gesetze-im-internet.de/amvv/ (available in German only)

Laws and regulations amending the AMVV

Gesetze und Verordnungen zur Änderung der Arzneimittelverschreibungsverordnung (AMVV) (available in German only)

Minutes

The documents listed below are available in German only.