The Annex summarises the principles and guidelines of good practice requirements that apply to holders of a manufacturing and import authorisation (MIA) who import medicinal products (human and veterinary) from outside the EU/EEA borders and thus from third countries. Medicinal products imported with the sole intention of being exported to the EU/EEA and which are neither processed nor released for marketing in the EU/EEA are not covered by this Annex.
The draft is divided into seven chapters, following the classical structure of the EU GMP Guide:
- Principles for the physical transfer from a third country and certification by a Qualified Person (QP)
- Pharmaceutical Quality System, according to Chapter 1 of the EU-GMP Guide: This includes product quality reviews, which should be performed by the site performing QP certification for the products imported, including products imported for export.Written agreements on the responsibilities of all parties involved should be in place, along with reliable sampling practices in the third country, verification of transport deviations or a comparison of the analysis results from the third country and the import inspection on site.
- Premises and equipment at the manufacturing site should be adequate. A quarantine area for storage should be available until their further processing after QP release.
- Documentation should be set up according to Annex 16.There should be documentary evidence that the site performing QP certification has qualified the third country manufacturer and regularly monitors its performanceby periodic on-site audits, to ensure that the imported products are manufactured in accordance with EU GMP or equivalent requirements and the MA.
- Operations should be subject to an ongoing stability programme, as described in Chapter 6. This can also be carried out as an outsourced activity in the third country, provided the QP receives all necessary information. Protocols, results and reports, should be available for inspection at the MIA holder responsible for QP certification. The QP is also responsible for checking the security features. The QP is responsible for reference and retained samples.
- Complaints, quality defects and product recalls should be made in accordance to Chapter 8. Contractual agreements should be defined between the importing site, the third country manufacturer and the MAH.
The Annex 21 draft is of particular importance for importers (MIA holders) and companies involved in the supply chain. All stakeholders involved in activities related to importation of human and veterinary medicinal products, across EU/EEA borders, are invited to respond on this consultation which ends on 20 June 2020.
The necessary information and the required template for participation can be found here. A date for the entry into force of Annex 21 has not yet been set.
EC: Annex 21 draft
EC: Consultation information for stakeholders