Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical) and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval or the “Registration” “Marketing Authorization” or the “Product Licensing”. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Rohtak, word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. On 29 November 2019 Cefic and ECHA held a kick-off workshop to discuss some concrete aspects of the REACH dossier review process and exchange knowledge and best practices on overcoming scientific and technical challenges related to registration dossiers. The Action Plan is not a static document, it will be adapted to developments when and if needed. However, Cefic will facilitate the support and development of tools and solutions for cross-cutting, unresolved key issues related to registration dossiers. All Cefic member companies and national association (Member / Partner federations) members are also encouraged to sign the Declaration of Intent.Ĭefic does not have access to registration dossiers, and all updates will be done by individual companies. The Action Plan will run between 2019-2026, allowing for one year of planning and setting-up and seven years of actual updates.Īll Cefic Board members have already committed to this Action Plan.
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