The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health.
The BfArM is a departmental research institute of the German Federal Government which conducts its own as well as independent research in order to fulfil its tasks pursuant to Section 4 sub-section 3 BGA successor legislation. The BfArM’s tasks serve both public health as well as the safety of medicinal products, narcotics and medical devices.
The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines is responsible for the medicinal products listed below (pursuant to Section 77 AMG [Arzneimittelgesetz, German Medicines Act]).
Official Duties includes :
Authorisation of clinical trials for human use
Processing of applications for marketing authorisations and subsequent applications in the various national and European procedures
Reports relating to blood and tissue products
Advice for national, European, and international target groups concerning the assessment of risks and the development of guidelines
Advice to applicants of marketing authorisations and clinical trials in scientific and procedural questions
Information for patients and consumers
Antigen Tests Kit for the detection of SARS-CoV-2 is an In-Vitro Diagnostics medical device. There are two major type of antigen test kits for the detection of SARS-CoV-2.
1) antigen test kits for professional use
2) antigen test kits for layman
Self Testing Kit : around 6 -8 weeks
For Professional Use : around 5-6 weeks
Our Consultancy Fee does not include Official BfArM Fee
Our Consultancy Service includes preparation of Technical File, Risk Analysis, Product Description, Use of Labelling and EU Representative and arrangement of BfArM application.