Dispatch and shipment of medicinal products within the meaning of Directive 2001/83/EC which are subject to sale in a pharmacy pursuant to Section 43(1) first sentence of the Medicinal Products Act (Arzneimittelgesetz) by a pharmacy using a logistics company to ship to the end consumer

Regulation amending the Regulations on the Operation of Pharmacies and other regulations

Under Section 17(2a) first sentence point 1 of the Regulations on the Operation of Pharmacies (Apothekenbetriebsordnung), until now the director of a pharmacy has had to ensure, when dispatching a medicinal product subject to sale in a pharmacy and in accordance with Section 43(1) first sentence of the Medicinal Products Act, that the medicinal product is packaged, transported and delivered in such a way that its quality and effectiveness are maintained. This includes compliance with temperature requirements and, where necessary, provision of proof of this for temperature-sensitive medicines in particular. The basic obligation to ensure the quality-preserving dispatch remains in Section 17(2a) first sentence point 1 of the Regulations on the Operation of Pharmacies. The requirements will be specified in the new Section 35b of the Regulations on the Operation of Pharmacies. This includes specifications in the quality management system (paragraph 1), requirements for employees (paragraph 2), guidelines for compliance with temperature requirements (paragraph 3) and contractual safeguards in relation to the contracted logistics company (paragraph 4). In addition, Section 9a of the Regulation on the Trade of Medicinal Products (Arzneimittelhandelsverordnung) lays down requirements for quality-preserving transport, including any intermediate storage by the contracted logistics company.