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Assumption of responsibility

The Medicines Law (AMG), the Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AM-WHV), GMP, GDP and GVP regulations specify that “responsible persons” are to be appointed by a pharmaceutical distribution company for certain functions and the supervisory authority is to be notified of them.

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Assumption of respon­sibility

Overview of services

These responsible persons need to have sufficient specialist knowledge and experience and must prove this to authorities. The employees of MIT Gesundheit GmbH possess the required qualifications, are trained on an ongoing basis and can therefore take on, among other things, the following tasks and/or positions and/or application to the responsible authorities:

Phased plan officer according to § 63a AMG

According to the Medicines Law (AMG), every pharmaceutical entrepreneur has to have a PV system for which the phased plan officer is responsible. In addition to this, the phased plan officer gathers and analyses all reports about risks of medicines (includ-ing deficiencies in quality) and coordinates the necessary measures. As a result, a benefit-risk profile is produced and updated on an ongoing basis.

QPPV according to “Article 104 (3)(a) of Directive 2001/83/EC”

The QPPV is required for medicinal product approvals outside Germany in the EU. This refers to a pharmacovigilance officer who – unlike the phased plan officer in Germany – is not respon-sible for the processing of quality defects. At EU level, the QP (qualified person) is responsible in the case of quality defects.

Information officer according to § 74a AMG

The information officer is to ensure that “the labelling, the patient information leaflet, the prescribing information and the advertising are consistent with the content of the approval or of the registration” (§ 74a AMG para. 1). The information officer checks the informative texts (package information leaflet, prescribing information, etc.), advertising texts and advertisements for their con-formity with the approval documents.

Wholesale officer according to § 52a AMG

According to § 52a AMG, anyone carrying out wholesale business with pharmaceuticals must appoint a responsible person.

The tasks of the wholesale officer include, among others

  • Checking the pharmaceutical for counterfeiting and, if necessary, deciding how to proceed Oversight
  • and monitoring of the whereabouts of the goods
  • Ensuring that customer complaints are processed in an appropriate way
  • Monitoring that customers and suppliers are approved

According to the law, you as a pharmaceutical entrepreneur must fulfil these functions in terms of personnel and content. You decide which functions you yourself will perform and which are to be assumed by us.

If you are not yet a pharmaceutical entrepreneur, we will support you in the production of the documents and application for a manufacturer’s and/or wholesale permit. Our specialists will then temporarily assume for you all the responsibilities of a product license holder, while you concentrate upon the successful marketing of your products.

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47533 Kleve

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Phone

+49 (2821) 7277-0