Export certificates for pharmaceutical factories and wholesales
Visa kopplingar →Certificates of compliance with the GMP and the GDP for the export of a pharmaceutical factory or wholesale medicinal product
Publicerare: Fimea · Statlig organisation
Beskrivningens språk: Engelska
Täckning: Hela Finland
Om tjänsten
Beskrivning
Upon request, Fimea will issue certificates to pharmaceutical factories supervised by Fimea on compliance with good manufacturing practices (GMP) and good distribution practices (GDP) to pharmaceutical wholesalers if Fimea has determined that they have been implemented during the inspection.
Så använder du tjänsten
The application form can be found on Fimea’s website. The request for a certificate is primarily sent by e-mail to certificates@fimea.fi
Villkor
Requires Fimea to perform and pass an inspection. As a rule, the holder of a marketing authorisation for a medicinal product can apply for an export certificate. However, the certificate may also be applied by a representative of the marketing authorisation holder, whose details must be included in the application. Export certificates shall be issued for medicinal products for human use or for animals that are authorised but not for active substances.
Var och hur du får hjälp
Exportcertifikat (CPP) · Webbplats
Blankett och anvisningar för ansökan om exportcertifikat för läkemedelsfabriker och läkemedelspartiaffärer
Beskrivning: Svenska · Servicespråk: Svenska, Engelska, Finska
Öppna leverantörens webbplats →
Kontrollera aktuella öppettider, undantag, identifieringskrav och kontaktuppgifter på tjänstens officiella sida.