Importation & Batch Release
Medicinal products imported into the European Economic Area (EEA) from third countries have to be certified by a Qualified Person (QP) to be released into the market. Companies based in countries with Mutual Recognition Agreements have no obligation to retest the batches, although batch certification is required.
At Elara Pharmaservices we have our own licences granted by the MHRA enabling the importation of human and veterinary medicinal products. Our sister company, Elara Pharmaservices Europe, holds an MIA granted by the Irish HPRA so within the group we can service both the UK and EEA markets post Brexit.
- QP declarations for regulatory purposes
- Import of batches
- Batch testing
- Documentary review
- Batch certification for release.
We have in house QP’s to provide QP certification and a large network of associates to cover any peaks or supply demands.
We are also able to offer RP services to customers.