What special considerations are there when applying for a first-time special permit for an allergen or an immunological product? (GMP certificate, quality documentation determining the approval)
When applying for a first-time special permit for a vaccine, other medicine with an immunological effect or an allergen, Fimea requires sufficient information on the quality and/or manufacture of such preparations in addition to the summary of product characteristics. The wholesaler/pharmacy will provide the necessary documents to Fimea for assessment. Depending on the preparation, an assessment may take 2–4 weeks. We recommend that applicants contact Fimea either by telephone or in an electronic format before submitting an application for a vaccine.