Dr Ulrich Kissel, Chairman of the Board of Directors of the European QP Association (EQPA)
In February, after some delays, the new Annex 21 to the EU GMP Guideline was published as a draft. The document is entitled
“Importation of medicinal Products”.
The Guidance is aimed at Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries. The following points should be regulated:
- Physical transfer from a third country to the EU/EEA
- Certification by a Qualified Person
- Requirements for facilities and equipment
- Documentation needed
- GMP requirements for manufacturers and exporters in the third country
- Qualification and audits under the responsibility of the importing company
- Import testing
- Contractual regulations
Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries.
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This webinar will give you an overview of the most important points of the new appendix:
- What is really new and not yet addressed in any other guidance
- Are there contradictions to other documents?
- What needs to be considered?
- What is important for QPs?
Recording from 23.04.2020
Duration of recording: 1,5 h.