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Bibliographical Application Date: 07. June 2019 Topics: Licensing Type: Article

Bibliographical Application

Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP) Date: 08. May 2019 Topics: Licensing Type: Article

Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)

Working Group Nanomedicine Date: 29. April 2019 Topics: Licensing Type: Article

Nanomedicine is the use of nanotechnology in medicine to develop new medicinal products, diagnostic procedures and medical devices. Nanotechnology is expected to be used to a greater extent in the development of medicinal products and medical devices …

How can editorial changes be displayed in the product information texts? Date: 25. April 2019 Topics: Licensing Type: FAQ

For editorial changes as well as adjustments to the current QRD template and the special features list (Besonderheitenliste)/Excipients Guideline, please refer to the CMDh Q&A for Variations #3.16.

The procedure described above is also …

Which changes can be implemented in Module 3 as editorial changes? Date: 25. April 2019 Topics: Licensing Type: FAQ

According to the CMDh Q&A to Variations #3.16, the EMA Post-authorisation Guidance Q&A on Editorial Changes has to be considered.

This guidance is also explicitly applicable to variations of purely national marketing authorisations.

1. The …

Processing Statistics of the BfArM 2018 PDF, 293KB, File does not meet accessibility standards Date: 20. February 2019 Topics: Licensing Type: Download

State: February 2019

BfArM's recommendations regarding clinical trials with medicinal products where sponsor or legal representative are established in the United Kingdom (Current note/update from 2019.02.18) Date: 18. February 2019 Topics: Licensing Type: News

For clinical trials in which there is no sponsor or representative of the sponsor who is domiciled in a Member State of the EU or in the EEA at the time when a so-called hard Brexit becomes effective, revocation or suspension of the con-duct …

IA Checkliste PDF, 213KB, File is accessible Date: 06. February 2019 Topics: Licensing Type: Download

Pre-notification check for type IA/IAIN Variations

Renewal of Marketing Authorisations and Registrations Date: 21. January 2019 Topics: Licensing Type: Article

Renewals