8 Mar 2022

Annex 21 – Importation of medicinal products

Written by

André Luz

QA Director

The highly awaited annex 21 has finally been published, shedding light on the applicable GMP requirements when importing medicinal products from outside the EU/EEA.

As usual, OWLPHARMA is ready to back you up to assure full compliance of your company. Our team of highly qualified collaborators will support you in the correct implementation of the annex guidelines either by performing on-site audits to CMOs, QMS support, annual PQR or risk assessments preparation.

Contact us through owlpharma@owlpharma.pt to know more.

DOWNLOAD

Eudralex Vol4_annex 21.pdf