Step-by-step plan procedure (Medicines Act)

from Wikipedia, the free encyclopedia

The phased plan procedure according to the German Medicines Act (AMG) is an administrative regulation of the federal government for the observation, collection and evaluation of drug risks with the aim of being able to initiate appropriate countermeasures.

Recognizing and evaluating drug risks (in particular the occurrence of adverse drug reactions , interactions with other agents, adulteration and the occurrence of potential dangers to the environment when using veterinary medicinal products) and the implementation of appropriate risk prevention measures ensure that the medicinal products are continuously monitored even after their approval ( Pharmacovigilance ), with ongoing adaptation to the state of knowledge. In Germany, the responsible higher federal authorities ( Federal Institute for Drugs and Medical Devices , Paul Ehrlich Institute and Federal Office for Consumer Protection and Food Safety ) have the legal mandate to organize and coordinate all necessary activities. You are in a constant exchange of information

The step-by-step plan procedure is divided into two danger levels.

Danger level I

Here, an introduction to the possibility of drug risks is sufficient. The authorities then request a substantive statement from the pharmaceutical company concerned, together with a compilation of the reported adverse effects from various aspects, information on the international approval status and the scope of the drugs dispensed. The pharmaceutical entrepreneur must also state whether and to what extent he intends to take action on his own responsibility. If the suspicion of a risk can be dispelled or the pharmaceutical company takes measures to avert the risk itself, the procedure is concluded at this stage.

Danger level II

If a stage I procedure cannot be completed, the authority shall follow a stage II procedure. Stage II can also be initiated directly without proceeding to stage I if there is justified suspicion of a health drug risk. In a hearing, the company concerned, represented by the obligatory step-by-step plan officer, comments on the allegations.

The higher federal authorities can order the following measures:

  • Revocation of admission
  • Withdrawal of approval
  • Admission is suspended
  • Conditions (change or addition to the wording of the instructions for use and specialist information and / or the outer packaging with regard to the indications, side effects or contraindications; inclusion of warnings; restrictions on use; arrangement of a therapy-appropriate pack size or a specific container; arrangement of a systematic collection and documentation of findings approval such as phase IV studies and others)

Qualified Person for Pharmacovigilance

Pharmaceutical companies who place finished medicinal products on the market are obliged to commission a suitably qualified person to collect and evaluate reports that have become known about drug risks and to coordinate the necessary measures (step-by-step plan officer according to Section 63a of the Medicines Act , in the European Economic Area also synonymous with the competent person for pharmacovigilance ).

Web links