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EudraCT-Version 10.5.0.0 Date: 17. June 2021 Topics: Licensing Type: News

The EudraCT PUBLIC applications for creating the Clinical Trial Application Form (Annex 1 pdf and xml) have been upgraded to v10.5.0.0. The upgraded version should allow a more user friendly completion of the form.

List of Reference Prices for Medicinal Products Date: 11. June 2021 Topics: Licensing Type: Article

The reference price of a medicinal product is the maximum amount, which is reimbursed by the statutory health insurance fund.

SNOMED CT for Project Managers PDF, 4MB, File does not meet accessibility standards Date: 31. May 2021 Topics: Licensing Type: Download

Ian Green – Customer Relations Lead, Europe and Global Clinical Engagement Lead
Charles Gutteridge – Clinical Engagement Lead, EMEA
Jane Millar – Collaborations Lead

CHMP Meeting Highlights May 2021 Date: 31. May 2021 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2021

Points to consider in line with ICSR reporting (ICH E2B compliant XML-file) via EudraVigilance? Date: 10. May 2021 Topics: Licensing Type: FAQ

It is in the sponsor’s responsibility to submit E2B compliant ICSRs in accordance with the EU ICSR Implementation Guide provisions.

There is no particular testing with BfArM necessary, given that registration with EudraVigilance had been completed …

How can the product information of a generic or hybrid marketing authorisation be kept up-to-date if the marketing authorisation of the reference medicinal product has expired? Date: 09. March 2021 Topics: Licensing Type: FAQ

A change of the reference medicinal product of the initial marketing authorisation is generally not possible. Please refer to the CMDh Questions & Answers on Variations No. 3.13 (cf. https://www.hma.eu/20.html).

However, in order to update the …

In which language should the dossier and the product information texts in MR-/DC variations and renewals be submitted if only German-speaking member countries (DE/AT or only DE) are involved? Date: 09. March 2021 Topics: Licensing Type: FAQ

All CMDh guidance documents refer to the use of English language dossiers and English language product information texts. At the end of the procedures, the RMS should provide the final English texts for SmPC, PL and labelling. This is also required …

Expert Committees of the Homoeopathic Pharmacopoeia Commission Date: 24. February 2021 Topics: Licensing Type: Article

Expert Committees of the Homoeopathic Pharmacopoeia Commission

Processing Statistics of the BfArM 2021 PDF, 167KB, File does not meet accessibility standards Date: 21. February 2021 Topics: Licensing Type: Download

State: February 2022