Our link list helps you to orient yourself even further in your projects and products and to gather initial information. And we do the rest. 


INTERESTING LINKS.

AGES – Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
The Austrian Agency for Health and Food Safety (AGES) is a company of the Republic of Austria, owned by the Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection and the Austrian Federal Ministry for Sustainability and Tourism. AGES was founded on 1st June, 2002.

www.ages.at

BASG – Bundesamt für Sicherheit im Gesundheitswesen
Mit 02.01.2006 hat das BASG mit AGES MEA Medizinmarktaufsicht als nationale Zulassungsstelle für Arzneimittel seine Arbeit aufgenommen.
www.basg.gv.at

Das Bundesinstitut für Arzneimittel und Medizinprodukte | Germany
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.

www.bfarm.de

EDQM – European Directorate for the Quality of Medicines & HealthCare
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe. Its origins date back to 1964, when the international Convention on the Elaboration of a European Pharmacopoeia was adopted by the Council of Europe with the vision of creating a common European Pharmacopoeia.

www.edqm.eu

eSubmission
To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

http://esubmission.ema.europa.eu

EudraLex – EU Legislation
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication “The rules governing medicinal products in the European Union”. The basic legislation is supported by a series of guidelines that are also published in the following volumes of “The rules governing medicinal products in the European Union”.
https://ec.europa.eu/health/documents/eudralex_en

EuDRAcon
provides expert knowledge and support across a wide range of Regulatory Affairs services since 2007. This is achieved through a pan-European network of independent service providers in regulatory affairs specialised in the field of medicinal products, medical devices, cosmetics and food supplements.
https://eudracon.eu/

The Heads of Medicines Agencies (HMA)
is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area.

https://www.hma.eu/

MEGRA (Middle European Organisation for Regulatory Affairs)
is a registered non-profit association founded in 1988. The members are regulatory experts for medicinal products (human and veterinarian), medical devices and diagnostics working in the pharmaceutical industry or in regulatory authorities in Switzerland, Austria and Germany.

https://www.megra.org/die-megra/about-us/

Pharmig. Verband der pharmazeutischen Industrie Österreichs.
Die Pharmig vertritt rund 120 Unternehmen, von forschenden über produzierende bis hin zu Vertriebsunternehmen, von Konzernniederlassungen bis zu Ein-Personen-Unternehmen. Sie erforschen, entwickeln und vermarkten Arzneimittel für eine hochwertige Gesundheitsversorgung.
https://www.pharmig.at/

The Research Center Pharmaceutical Engineering (RCPE)
Founded in 2008, RCPE is an independent research center located in Graz (Austria) that performs cutting-edge research in the field of pharmaceutical process and product design. Every day, we help our partners to develop and pioneer novel drugs and associated production routes, providing safe and more affordable therapies to patients. From early develop­ment to commercial production, we accompany our partners through all phases, utilizing our science-based, mechanistic understanding of products and processes.
http://www.rcpe.at/en/en_home/

Die ROTE LISTE®
das sind über Jahrzehnte verlässliche, profunde Informationen rund um das Arzneimittel sowie ausgewählter Medizinprodukte in Deutschland. Die ROTE LISTE® versteht sich als Arzneimittelverzeichnis für Deutschland. Die Einträge erfolgen durch die pharmazeutischen Unternehmen auf freiwilliger Basis. Daher ist der Umfang umfassend aber nicht vollständig. Die ROTE LISTE® bietet seinen Nutzern und kritischen Lesern einen breiten Überblick über das Arzneimittelspektrum in Deutschland.

https://www.rote-liste.de/

WHO Collaborating Centre for Drug Statistics Methodology 
The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) as a measuring unit have become the gold standard for international drug utilization monitoring and research. The ATC/DDD system is a tool for exchanging and comparing data on drug use at international, national or local levels.
https://www.whocc.no/

Up to October 2019, will be updated continuously…