Marketing Authorization
During the marketing authorization procedure, the competent authority evaluates the quality, relative safety, and efficacy of the new medicinal product. Upon compliance, the product is declared a medicinal product by administrative decision. Evaluation and authorization fall under the competence of the National Institute of Pharmacy (OGYI).
The following authorization types are possible:
MRP Authorization
Applies to a product that already holds a marketing authorization in at least one Member State at the time of submission.
DCP Authorization
Applies to a product that does not yet hold a marketing authorization in any Member State at the time of submission.
National Authorization
The marketing authorization is valid only in Hungary.
EU Authorization
An authorization valid in all Member States. Since January 2010, submissions to the authority may only be made electronically, in the so-called eCTD format. The eCTD is an electronic format for registration documents in accordance with ICH eCTD specification version 3.2 and the EU Module 1 specification.
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