Graduated Plan Officer (Stufenplanbeauftragter) - Roles and Responsibilities in Pharmaceutical Entrepreneurship

Roles and Obligations

According to Section 63a of the German Medicines Act (AMG), a pharmaceutical entrepreneur who places finished medicinal products on the market which are medicinal products within the meaning of Section 2 (1) or subsection (2) No. 1 AMG must appoint a qualified person resident in a Member State of the European Union, who has the necessary expertise and the reliability required for exercising their function (graduated plan officer).

In addition to marketing authorisation holders, this also applies to co-distributors and users of standard marketing authorisations. This is because they are also pharmaceutical entrepreneurs, according to Section 4 (18) AMG and place medicinal products on the market under their own name. ⁽¹⁾

Introduction to the GPO: Requirements in Germany

• Compared to the EU-QPPV, the functions of the graded plan officer include additional requirements (e.g., systematic recording of complaints and advising the competent local authority of any flaw that could lead to a recall or exceptional distribution restriction).
• The graduated plan officer must be competent and professional to ensure compliance with the relevant requirements, particularly the business pharmacovigilance system.
• The professional qualification should be evaluated based on the product portfolio and the potential medicinal product dangers linked with it.

Note: A specific proof of expertise is no longer required.

Legal Basis: Section 63a of the German Medicines Act (AMG)

The German Medicines Act makes no mention of language. However, because communication with authorities is mostly in German, the graduated plan officer must have 24-hour access to a properly trained individual if they are not themselves German speakers.

Note: The Graduated Plan Officer can be EU-QPPV simultaneously; an additional notification of the graduated plan officer is required.

Questions & Answers

Q1: Does an authorisation holder with only central authorisations have to appoint and report a national phased plan officer in addition to the EU QPPV?

A1: A graduated plan officer is not required for a pharmaceutical company that solely has central authorisation. In this case, the EU – QPPV suffices, as it assumes the duties of the Graduated Plan Officer per Regulation (EC) No. 726/2004 Articles 21 and 48. For the remaining obligations, some of which go beyond the tasks of the EU – QPPV, including those pursuant to Section 19 ArzneiMittel- und WirkstoffHerstellungsVerordnung (AMWHV), the pharmaceutical company must ensure that a person is appointed to assume these obligations.

In cases where the EU-QPPV does not speak German, the supporting person should help the EU-QPPV with language problems through language mediation.

Even though this individual is not the Graduated Plan Officer, they are commissioned by the AMWHV to carry out the duties of the Graduated Plan Officer. As a result, they should be reported using this site.

“Since you only have central approvals, please indicate in the comment field that you are reporting someone equivalent to the Graduated Plan Officer.”

Q2: What happens if an authorisation holder does not appoint or report a Graduated Plan Officer?

A2: A graduated plan officer must be appointed under 63a, paragraph 1 AMG. This must be reported to the competent authority and the competent higher federal authority per Section 63a (3) AMG. In addition, section 97 (Part 2) 24c AMG states that a regulatory offence should be inspected, assuming this assignment or warning is absent.

Q3: What do “pharmaceutical” and “medical” mean concerning the responsibility of different graduated plan officers?

A3: The duties that are outlined for the EU-QPPV in Article 104 (3) of Directive 2001/83/EC and for the graduated plan officer in Section 63a (1) AMG is included in the “medical” graduated plan officer’s responsibilities. In addition, the responsibilities outlined in Section 19 AMWHV apply to the “pharmaceutical” graduated plan officer: recording complaints and information to the appropriate authority about any flaw that could result in a recall or unusual distribution restriction in a systematic manner. This applies to drug-specialised gambles related to quality deformities and group reviews.

Q4: Does a Graduated Plan Officer have to be appointed for investigational medicinal products in clinical trials?

A4: No, a graduated plan officer does not have to be appointed (cf. Section 63k AMG ). However, the obligation to document all known reports of drug risks from investigational medicinal products and complaints about investigational medicinal products (quality defects) must be ensured (Section 19 IV 1 AMWHV in conjunction with Section 19 I AMWHV).

References:

1. https://www.bfarm.de/EN/Medicinal-products/Pharmacovigilance/pharmacovigilanceinspections/_node.html