Medicinal products as defined in Directive 2001/83/EC, individually prepared medicinal product as defined in § 1a(8) of the Regulations on the Operation of Pharmacies
Ordinance amending the Medicinal Products Warning Ordinance [Arzneimittel-Warnhinweisverordnung, AMWarnV] and the Regulations on the Operation of Pharmacies [Apothekenbetriebsordnung, ApBetrO]
The Medicinal Products Warning Ordinance (AMWarnV) currently stipulates the affixation of a warning in Germany where medicinal products contain the substances ethanol (from a quantity of at least 0.05 g per single dose) for internal use in humans or tartrazine for human use. The AMWarnV is being amended, with § 1 to § 6 AMWarnV being replaced by transitional provisions. The amendments are a de facto repeal of the AMWarnV.
The protection objective currently pursued by § 1 to § 4 of the AMWarnV is to be achieved in the future for medicinal products falling under the competence of the Paul-Ehrlich-Institut (PEI) exclusively through the provisions of the Excipients Guideline and for medicinal products falling under the competence of the Federal Institute for Drugs and Medical Devices (BfArM) through the Excipients Guideline and the BfArM’s List of Special Information Required for Specific Excipients, to which a planned joint announcement by the BfArM and the PEI in the Federal Gazette will refer. As a follow-up to the amendment of the AMWarnV, the Regulations on the
Operation of Pharmacies [ApBetrO] are being amended with regard to the labelling of individually prepared medicinal products.