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The "Questions & Answers" part on the EMA website deals with special issues regarding the European marketing authorisation procedure. In irregular intervals, the EMA updates this collection of questions and answers and publishes it on the website under "Regulatory - pre-authorisation" (Q&A: Innovative products und Q&A: Generic/hybrid applications). The Q&A collection is also provided as a single PDF document. The latest update dates back to 26 January. Three new questions have been included regarding the following matters: - When and how are Rapporteur and Co-Rapporteur appointed?
- When can I submit my generic/hybrid application considering the protection period of the reference medicinal product?
- What is an Urgent Safety Restriction (USR)?
The answer to the latter question is: an USR is a kind of urgent regulatory action to prevent risk to public health, which is triggered by new clinical information about the medicinal product. Generally, risks regarding the secure use of a medicinal product are based on recent clinical data. Nevertheless, quality problems can also lead to an USR. An USR is a regulatory measure which can be triggered by a marketing authorisation holder or by the European Commission. The marketing authorisation holder must submit an USR application to the CHMP. The application will then be proceeded i.e. assessed within 24 hours. Afterwards, the EMA will inform the marketing authorisation holder that the changes with the respective updated formulations can be introduced into the product information. Finally, the marketing authorisation holder must submit a type IB variation application within 15 days. With these three new Questions and Answers the EMA tries to clarify facts and circumstances which are partially really complex. It can be read in the document entitled "EMA Procedural advice for users of the centralised procedure for generic/hybrid applications". Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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