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Boards and Committees

The BfArM is involved in the prevention of drug-associated risks, both nationally and internationally. For the purpose of monitoring and evaluating the safety of medicinal products on the EU level, scientific employees of the BfArM are active in the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency.

The Expert Advisory Committee for Prescription-Only Issues convenes twice a year at the BfArM. This committee decides on recommendations regarding requests for amendments to the "Ordinance on the Prescription of Medicinal Products" ("Verordnung über verschreibungspflichtige Arzneimittel") in accordance with Section 48 of the German Medicinal Products Act (Arzneimittelgesetz, AMG). The Expert Advisory Committee for Pharmacy-Only Issues meets as and when required and decides on recommendations regarding requests for amendments to the "Ordinance on Pharmacy-only Medicinal Products and Medicinal Products Sold outside Pharmacies" ("Verordnung über apothekenpflichtige und freiverkäufliche Arzneimittel"). These committees are chaired by the President of the BfArM; the BfArM itself, however, does not have any voting rights.

At least twice annually, the BfArM hosts an exchange of information where current issues of drug safety are discussed. These meetings are attended by all participants in the graduated plan procedure: BfArM, PEI, BVL, the competent bodies of the Federal "Länder", ZLG, BMG, BMVg, BMELV, the drug commissions of the healthcare professions, associations of the pharmaceutical industry, patient representatives, and representatives of the pharmacovigilance centres.