BfArM
Unterlagen für eine Erstanzeige des Parallelvertriebes oder eine Änderungsanzeige zum Parallelvertrieb beim BfArM Anzeigeverfahren für Änderungsanzeigen im Parallelvertrieb: Änderung
Unterlagen für eine Erstanzeige des Parallelvertriebes oder eine Änderungsanzeige zum Parallelvertrieb beim BfArM Anzeigeverfahren für Änderungsanzeigen im Parallelvertrieb: Änderung
In addition to the authorisation of finished medicinal products, the BfArM evaluates the following medicinal products: herbal medicinal products, traditional herbal medicinal products, homeopathic
Antworten auf die häufigsten Fragen zur Arzneimittel Zulassung: Voraussetzung, Einreichung, Änderungsanzeigen, Verfahren und weitere Themen, die wichtig sind
The BfArM provides information on medicinal products for healthcare professionals and consumers. The Public Assessement Reports state the background for scientific evaluations, discussions, and
At present there are two different procedures to apply for a marketing authorisation for the same medicinal product in the EU/EEA in more than one Member State, the Decentralised Procedure
Click here for the reporting form with which pharmaceutical companies can communicate quality defects, batch recalls and counterfeit drugs to the competent authority.
If you have a CE mark for your medical product that is valid for the European market, you can also market the product in Germany. FAQ: Do distributors or importers have to notify the distribution of
When changing the pack size (addition or deletion), the type of immediate packaging material to which this change refers always has to be stated concurrently.
BfArM and DIMDI review the submission for completeness, scientific validity, and compliance with regulatory requirements. Prepare to respond to queries and provide additional information during the
The BfArM provides an overview of the most relevant European and national regulations for Medical Devices and the national laws for digital applications. This is not an exhaustive overview of the
Notifications must be made online through BfArM website. Name and code of the medical device, its classification, its nomenclature, name of the
Is the distribution and/or the nondistribution of licensed pack sizes subject to the notification requirement? Please see under FAQ How is a variation with regard to the marketing status of
Mit dem digitalen Postfach wird die Möglichkeit eröffnet, Bescheide und weitere Dokumente rechtskonform digital zustellen zu können. Die digitale Zustellung ersetzt die
On the following pages, the BfArM provides various basic information on the regulatory framework of medical devices. In addition to links to laws and regulations and contact details for the institutions
Throughout the EU and internationally, BfArM makes a significant contribution to the supply of safe and effective medicines.
Issues Relevant for Licensing Different legal frameworks apply to medicinal products, foodstuffs, medical devices, biocides or cosmetic products. Thus, products of different product groups can be
Where their contents still comply with current requirements, the BfArM''s explanatory notes concerning applications for marketing authorisation of medicinal products, 3rd edition, 31 Octobre
Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) ist eine selbstständige Bundesoberbehörde im Geschäftsbereich des
This page lists questions about parallel distribution. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary.
Greek safety and authenticity requirements related to radiopharmaceuticals: the safety coded stickers which are described in the Greek requirements for the blue box (Guideline on Packaging Information
Upon application, the BfArM issues a certificate corresponding to the World Health Organisation''s Certification Scheme for pharmaceutical entrepreneurs located outside the scope of the German
Unterlagen für eine Erstanzeige des Parallelvertriebes oder eine Änderungsanzeige zum Parallelvertrieb beim BfArM Anzeigeverfahren für Änderungsanzeigen im Parallelvertrieb: Änderung der
Hier finden Sie eine Zusammenstellung der Webseiten, auf denen die EU -Kommission Informationen zu den europäischen Verordnungen 2017/745 (MDR) und 2017 /746 (IVDR), zu aktuellen Themen im
The Federal Institute for Drugs and Medical Devices is an independent specialised federal higher authority within the portfolio of the Federal Ministry of Health.
The location of the ''blue box'' on the package should ideally be the same for all Member States. When one pack is intended for marketing in several Member States,, this box will contain different
Do distributors or importers have to notify the distribution of medical devices that are already registered in the European Economic Area in Germany? No. If a product is already CE -marked and registered
Aufgaben Die deutschen Zulassungsbehörden informieren über die in Deutschland zugelassenen Arzneimittel, die Rücknahmen eines Zulassungsantrags sowie über die Versagung einer Zulassung
You can acquire a certificate for accessing PharmNet.Bund and BfArM from a Certificate Authority (CA) or from a distributor. The certificate can also be used for other purposes.
Pharmaceutical companies and wholesaler are able to record their data and submit it online to the federal authorities. Staff members of the federal authorities are able to research and record national
The higher federal authorities PEI and BfArM have classified medicinal products that must bear the safety features in accordance with the DVO in the public section of the AMIce database.
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