The German Medicines Act (AMG), the German Drug and Active Substance Manufacturing Ordinance (AMWHV) and GMP, GDP and GVP guidelines stipulate that responsible persons must be appointed by a pharmaceutical distribution company for certain functions and notified to the regulatory authority.
These responsible persons require sufficient expertise and experience and must prove this to the authorities. The employees of MIT Gesundheit GmbH have the required qualification, are continuously trained and can therefore take over the following tasks or positions and/or the application to the responsible authorities as responsible persons, among others
- QPPV / Graduated Plan Officer according to § 63a AMG
- EU-QPPV acc. Art 104 (3)(a)
- Information Officer according to § 74a AMG
- Wholesale Officer according to § 52a AMG
According to the law, you as the pharmaceutical entrepreneur (pU) must fulfill these functions in terms of personnel and content. You decide which functions you will perform yourself and which ones will be taken over by us.
If you are not yet a pharmaceutical entrepreneur, we will help you prepare the documents and apply for a manufacturer’s and/or wholesaler’s license. Our specialists will then take over all the responsibilities of a marketing authorization holder for you on a temporary basis, while you concentrate on successfully marketing your products.
Graduated Plan Officer according to § 63a AMG
In accordance with the German Medicines Act, every pharmaceutical entrepreneur (pU) has a PV system for which the Graduated Plan Officer is responsible. In addition, he collects and evaluates all reports of drug risks (including quality defects) and coordinates the necessary measures. As a result, a benefit-risk profile is established and continuously updated.
QPPV according to „Article 104 (3)(a) of Directive 2001/83/EC“.
The QPPV is required for drug approvals outside of Germany in the EU. This is a pharmacovigilance officer who, unlike the step-by-step plan officer in Germany, is not responsible for dealing with quality defects. At EU level, the QP (Qualified Person) is responsible for quality defects.
Information officer according to § 74a AMG
The information officer is responsible for ensuring that „the labeling, package leaflet, expert information and advertising are consistent with the content of the marketing authorization or registration“ (§74a AMG para. 1; resp. acc. with the German on advertising of medicinal products (HWG)). The information officer checks the informative texts (directions for use, expert information, etc.) as well as advertising texts and advertisements for their conformity with the registration documents.
Wholesale Officer according to § 52a AMG
According to §52a AMG, anyone who operates a wholesale business with medicinal products must appoint a responsible person.
The tasks of the Wholesale Representative include the following
- Control and monitoring of the whereabouts of the goods
- Ensuring that customer complaints are handled appropriately
- Monitoring that customers and suppliers are approved
- Checking the medicinal drug for counterfeiting and, if necessary, deciding on further action