https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures Press release on MHRA grants first approval via the new International Recognition Procedure in 30 days. Medicines & Healthcare products Regulatory ...
Following the exit of the UK from the EU, the MHRA will continue to accept an Active Substance Master File and/or a Certificate of Suitability in new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation ...
The EMA has already stopped giving new marketing authorisation application (MAA) review contracts to the MHRA, and existing contracts with the UK regulator are being reallocated to the national regulators of other EMA member countries, reported the UK’s Guardian newspaper. How well do youreallyknow...
LUMEVOQ®is not yet licensed in the EU or in the UK for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON). Its Marketing Authorisation Application is currently under review by the European Medicines Agency, with a dec...
Marketing authorisation is based on positive Phase III ELATIVE trial data6 LONDON, U.K., 8 October, 2024– Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.K. Medicines and Healthcare products...
[SI 2004 1031]). IMPs are not 'Specials'. A clinical trialauthorisation application including a description of the IMPs has to have beensubmitted to the MHRA. A QP certification against that clinical trialauthorisation is required for each batch of IMP.“特殊”是未经许可的药物,根据制造商的特殊...
We are unable to comment on accuracy of data in journal publications or patents, as these documents do not form part of the clinical trial authorisation application. However, your report and comments on these aspects have been reviewed and considered with regard to the need for any re...
Marketing authorisation is based on positive Phase III ELATIVE trial data6 LONDON, U.K., 8 October, 2024– Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for elafibranor 80mg table...