Export certificates for pharmaceutical factories and wholesales
Показать связи →Certificates of compliance with the GMP and the GDP for the export of a pharmaceutical factory or wholesale medicinal product
Издатель: Fimea · Государственная организация
Язык описания: Английский
Охват: Вся Финляндия
Об услуге
Описание
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.
Как пользоваться
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
Условия
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.
Где и как получить помощь
Certificates of a Pharmaceutical Product (CPP) · Сайт
Form and instructions for applying for an export certificates of pharmaceutical plants and wholesales
Описание: Английский · Языки обслуживания: Шведский, Английский, Финский
Актуальные часы работы, исключения, требования к идентификации и контакты указаны на официальной странице услуги.