EU: Marketing Authorisation needed for your ATMP
File your Marketing Authorisation now and stay compliant with regulatory requirements – Don’t miss your chance!
The regulatory environment for Advanced Therapy Medicinal Products (ATMPs) has changed. New regulations serve in the patient’s safety interest as basis for high quality preparations, but reflect also a huge challenge for regulatory compliance for ATMP manufacturers.
Since December 2008 the new regulation on ATMPs is in place (Reg. 1394/2007).
Based on these regulations, a centralised EU Marketing Authorisation procedure is mandatory for e.g.:
- Somatic Cell Therapy Medicinal Products (SCTMPs)
- Gene Therapy Medicinal Products (GTMPs)
- Tissue Engineered Products (TEPs)
Have you realized that transitional periods are defined in the new regulation on ATMPs?
For those products which are already on the market, the EU centralized procedure should be initiated and the corresponding marketing authorisation should be granted for:
- Somatic cell therapy and gene therapy medicinal products by Dec 30, 2011
- Tissue engineered products by Dec 30, 2012
These dates are deadlines for the approval of your product. Consequently, your initial submission of your Marketing Authorisation needs to reach the EMA as soon as possible to ensure the start of the procedure in time.
We know how your specific dossier needs to be prepared, and we can guide you through the regulatory process, as we have long-term experience with ATMPs in Europe and US. We can give you regulatory advice, but can also help you in fulfilling the GMP and GCP-requirements specifically considering your kind of product.
Here you can find all necessary information:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_ listing/document_listing_000265.jsp&mid=WC0b01ac05800b378a&jsenabled=true
HORN Pharmaceutical Consulting will not only guide your ATMP through the marketing authorisation requirements of the European and US market, but with our comprehensive ATMP services you will be able to stay ahead in this rapidly growing industry. Furthermore, we offer services for pre-authorisation procedures, e.g. ATMP classification as well as certification of your developmental programme. Take your chance and bring your product on the market in line with the latest regulatory requirements.