Avrupa İlaç Ajansı (EMA)’ndan pazarlama onayının reddi ve olumsuz görüşlerin yayımlanması hakkında bildiri (İng)
EMA paper on publication of information on negative opinions and refusals of mauthorization.
The EMA has published a paper describing the documents to be published following negative opinions and refusals of marketing authorisation applications for human medicinal products. This paper updates information of the reflection paper on the publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products adopted by the European Medicines Agency (EMA) in September 2006.
The EMA will announce the negative opinion on new marketing authorisation applications and extension of indication applications in the CHMP meeting highlights published on the EMA website.
The EMA routinely publishes Q&A documents following a negative opinion on new marketing authorisation applications and extension of indication applications, as these are the applications that are most likely to generate interest among stakeholders and the general public. The Q&A document contains information in lay language on the scientific assessment of the medicine and reflects the grounds for opinion. The Q&A document is first published in English at the time of CHMP opinion, with translations in all official languages of the EU published at the time of the publication of the refusal assessment report.
The EMA will publish the CHMP refusal assessment report for all applications for new marketing authorisations and extension of indication applications. Prior to publication of any refusal assessment report the EMA will liaise with the applicant to delete commercially confidential information. The refusal assessment report will be published within four weeks of a European Commission decision.
A document entitled ‘Procedural steps taken and scientific information after authorisation’ is available on the EMA website for all centrally authorised medicines and it outlines the regulatory procedures that have taken place since the authorisation of the medicine.
Refusal European public assessment report (EPAR) is a term that describes all the relevant documents published following a negative opinion on a new marketing authorisation application: Q&A and refusal assessment report. Refusal EPARs only apply to negative opinions on a new marketing authorisation application. If the CHMP issues a negative opinion on a new marketing authorisation application, an extension of marketing authorisation or a variation application, the applicant may request in writing a re-examination of the opinion within 15 days after the receipt of the opinion (as per Article 9 (2) of Regulation (EC) No 726/20046.