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FAQ "Variations" Date: 26. November 2019 Topics: Licensing Type: Article

FAQ "Variations"

FAQ "Sunset clause" Date: 26. November 2019 Topics: Licensing Type: Article

FAQ "Sunset clause"

FAQ Licensing Date: 26. November 2019 Topics: Licensing Type: Article

FAQ Licensing

New information in the topic licensing Date: 11. October 2019 Topics: Licensing Type: Article

New information in the topic licensing

New information in the topic medicinal products Date: 11. October 2019 Topics: Licensing Type: Article

New information in the topic medicinal products

Recommendations of the Jour Fixe on Delivery and Supply Shortages for drafting contracts between operators of hospital pharmacies / pharmacies supplying hospitals and pharmaceutical companies with the aim of improving the delivery excellence of relevant medicinal products in hospitals PDF, 228KB, File is accessible Date: 08. October 2019 Topics: Licensing Type: Download

Recommendations of the Jour Fixe on Delivery and Supply Shortages for drafting contracts between operators of hospital pharmacies / pharmacies supplying hospitals and pharmaceutical companies with the aim of improving the delivery excellence …

Liste der in EudraCT enthaltenen Felder, die für nicht-pädiatrische klinische Prüfungen veröffentlicht werden PDF, 107KB, File does not meet accessibility standards Date: 03. July 2019 Topics: Licensing Type: Download

Liste der in EudraCT enthaltenen Felder, die für nicht-pädiatrische klinische Prüfungen veröffentlicht werden

Liste der in EudraCT enthaltenen Felder, die für pädiatrische klinische Prüfungen veröffentlicht werden PDF, 93KB, File does not meet accessibility standards Date: 03. July 2019 Topics: Licensing Type: Download

Liste der in EudraCT enthaltenen Felder, die für pädiatrische klinische Prüfungen veröffentlicht werden

Technische Anleitung zum Format der Datenfelder ergebnisbezogener Informationen klinischer Prüfungen PDF, 277KB, File does not meet accessibility standards Date: 03. July 2019 Topics: Licensing Type: Download

Technische Anleitung zum Format der Datenfelder ergebnisbezogener Informationen klinischer Prüfungen

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