Annex
21 to the EU-GMP Guidelines has been published as a draft (on 20th
March 2020), titled "Importation of medicinal Products".
The Annex
is aimed at Manufacturing and Importation Authorisation holders (MIA holders)
who import human or veterinary medicinal products from third countries.
The
Annex does not cover products that do not have a marketing authorisation in the
EU/EEA and are directly re-exported.
The
Annex includes:
·
Physical
transfer from the third country to the EU/EEA
·
Certification
by the Qualified Person (QP) (link with the requirements of Annex 16)
·
Requirements
for equipment and facilities
·
Required
documentation
·
GMP
requirements for manufacturers and exporters in third countries
·
Qualification
and audits under the responsibility of the importing company and the Qualified
Person (QP)
·
Import
testing
·
Contractual
regulations between all companies or persons involved in the import
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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