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 licence granted by the HPRA enabling the importation of human medicinal products.

Elara offers:

  • 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.

Extensive experience of human and veterinary medicines, medical devices, general products, herbal medicines, borderline products, food supplements and cosmetics.

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