The GPO: An Essential Guide To The Graduated Plan Officer (Der Stufenplanbeauftragte)

Under §63a of the German Medicinal Products Act (AMG), any pharmaceutical entrepreneur who markets finished medicinal products defined under §2 section 1 or section 2 no. 1 AMG is required to appoint a qualified individual residing in a European Union member state. This person, known as the Graduated Plan Representative, must possess the necessary expertise and reliability to fulfill their responsibilities. This requirement applies not only to Marketing Authorization Holders (MAHs) but also to co-distributors and entities using standard marketing authorizations, as they are considered pharmaceutical entrepreneurs under §4 section 18 AMG and market medicinal products under their own name.

Pharmaceutical companies with only central marketing authorizations do not need to appoint a Graduated Plan Representative. In such cases, the EU Qualified Person for Pharmacovigilance (EU QPPV) fulfills the role, handling responsibilities in line with Art. 23 of Regulation (EC) No. 726/2004 and Article 104 of Directive 2001/83/EC.

For other responsibilities of a Graduated Plan Officer, which may extend beyond those of the EU QPPV, such as the systematic recording and analysis of complaints and the reporting of recalls, the pharmaceutical company must designate a person to handle these specific duties. If the EU QPPV is not fluent in German, it is advisable to appoint a supporting individual who can provide linguistic assistance or facilitate communication.

Even if this supporting individual is not a Graduated Plan Officer themselves, they should be tasked with performing the functions of the Graduated Plan Officer to ensure full compliance with the regulatory requirements.