Vyal is dedicated to developing innovative medicines that bring value to patients living with serious diseases. From first-in-man administration to commercialization, we are currently pursuing clinical studies involving thousands of patients around the world. Our teams provide global support to achieve regulatory approvals, as well as post-approval and life-cycle management initiatives.
|Product groups pursuant to Section 32||Period for the evaluation|
|Allergens, vaccines, biotechnology medicinal products||30 days|
|Biological products (human / animal origin)||60 days|
|Somatic cell therapeutics; gene transfer medicinal products, GMOs||60 days|
|Xenogenic cell therapeutics||none|
After confirming the receipt of the documents, different periods apply for the evaluation of different medicinal products by the competent authority pursuant to the GCP regulation. The periods referenced here are not total periods for the processing of the requests but solely periods for the evaluation of the content of the documents by the CA.
If the request is without formal non-conformities, a confirmation of receipt will be sent to the applicant, and the day after the receipt at the PEI shall be the first day of the evaluation of the content by the PEI. The evaluation period is 30 days for allergens, vaccines, and biotechnology medicinal products, 60 days for biological products (of human/animal origin), and 90 days for gene transfer medicinal products and genetically manipulated organisms (GMOs). No periods apply for xenogenic cell therapeutics.
After the evaluations of the contents of the request, the applicant will either be notified of the grounds for non-acceptance or, if no such grounds have been found, the approval certificate.