The EU pharmacovigilance requirements have been implemented in the German Drug Act (Arzneimittelgesetz, AMG). All individuals or businesses involved in the marketing of medicinal products, including manufacturers, wholesalers, physicians and pharmacists, are bound by an ongoing pharmacovigilance duty to ensure that no unsafe drugs enter the market (s. 5 AMG).
According to the legal definition, a drug is to be considered "unsafe" if the current state of scientific knowledge suggests and gives rise to reasonable concerns that the adverse side-effects of the properly applied drug outweigh its benefits. This ban on the marketing of (purportedly) unsafe drugs applies irrespective of whether a marketing authorisation for the product concerned has been granted but not yet revoked. Possible legal sanctions for violations of this duty can be severe, with fines and terms of imprisonment of up to three years, or one year in the case of simple negligence (s. 95 AMG).
The holder of a German national marketing authorisation must report any serious adverse reactions within 15 days of learning of the effects to the Federal Authority for Medicinal Products and Medical Devices, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM). This is the competent authority responsible for pharmaco-vigilance in Germany.
The applicant must also make all related documentation available together with a scientific evaluation of the adverse reactions (s. 29 (1) AMG). All adverse reactions, other than serious ones, must be recorded and reported at regular intervals. The reporting form is at Appendix 11.
Both BfArM and the district governments of the German states are vested with far-reaching powers to protect public health against hazards resulting from medicinal products by imposing certain restrictions on a medicinal product and/or withdrawing the product from the market. BfArM may restrict, suspend or revoke the marketing authorisation of the drug in question, whereas the state authorities have competence for all other issues. As always in German public law, each acting authority must establish that the measure taken is appropriate and reasonable under the particular circumstances of the case.
In cases where practical experience or scientific research leads to a new risk-benefit assessment of medicinal products on the market, BfArM may order a so-called "Phased Plan Procedure'' (PPP, Stufenplanverfahren; ss. 62 and 63 AMG). The goal of the PPP is to arrive at an amicable solution for addressing and responding to health risks which come to light after the medicinal product concerned has been approved for circulation on the market.
If the available data and information support reasonable concerns that a certain drug is creating a health hazard, the competent authority must initiate the PPP by calling meetings where all parties concerned (including the manufacturers) are represented and can put forward their arguments. If no consensus can be reached, or if the majority recommendations are not voluntarily complied with, the authority may revert to its general supervisory powers and impose the above-mentioned measures, including informing the public of health hazards caused by certain medicinal products.
Each pharmaceutical company is legally obliged to appoint a PPP Officer (Stufenplanbeauftragter) whose duty is to comply with the reporting requirements of the AMG and to co-ordinate and implement pharmacovigilance activities within the company.
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