Decentralised Procedure (DCP)

A procedure type in which the competent authority from the lead state (the first to review) agrees to approve the request. Other participating states then review the request and decide whether they want to accept the approval or not. If they don’t, they send back their own decision.

    More information about Decentralised Procedure (DCP)

    Procedure,application,products,decentralised procedure,mutual recognition procedure,medicinal products,company,risk,documents.

    Centralised procedure,phase,quality,approval,public health,treatment,draft assessment report,reports,condition,route,package leaflet,positive opinion,centralized procedure,national procedure,assessment procedure,decentralized procedure.

    Marketing authorisation applications,application for marketing authorisation,assessment phase,deficiency,MHRA,immune dysfunctions,period,advanced therapy,Notice to Applicants,viral diseases,pharmaceutical form,regulatory pathway,European procedure,CMDh referral procedures,procedure type,60-day procedure.

    RUP procedure,0-Day procedure,60-days procedure,abbreviated procedure,administrative procedure,arbitration procedures,Decentralised procedure form,innovative products,product characteristics,Testavan Summary of Product Characteristics,(so-called grandfathered products,Applicants of products,biotechnology products,Cardiovascular products,choice of reference product,subsequent application,Generic applications,separate marketing authorisation application,advance of application submissions,application for time slots,bibliographic applications,National phase,phase II open-label studies,30)-day national phase,clinical phase,earlier phases,quality of life,improvements in quality,substantial quality,Concerns on quality,discussion on quality,post approval,national approval,approval of medicines,delay in approvals,health,adverse bone health,consumer health care,reproductive health,convenient treatment,Effects of testosterone treatment,lack of treatment options,treatment on bone mineral,cardiovascular risk factors,risk of transference,benefit risk concerns,5-digit company number,applicant company,company responses,assessment reports,commission decision reports,Androgen deficiency,symptoms of testosterone deficiency,testosterone deficiency syndrome,MHRA Submissions,MHRA Submission Portal,analysis of source documents,Draft response documents,medical conditions,urologic conditions,erectile dysfunction,dysfunction,study period,time period,European authorisation route,administration route,testosterone replacement gel therapy,cell therapies.

    Why trust Agatha Life during your clinical trials?

    Every day, more than 200 companies trust Agatha to manage their clinical trial documentation
    Mablink
    Gustave Roussy
    Beyond Spring
    Clinical Services
    NS Pharma
    Share via
    Copy link
    Powered by Social Snap