Approval for Marketing Authorization of a Radiopharmaceutical

Since 1993, there is an administrative authority responsible for medicines in the entire European Union, enacted by Council Regulation (EEC) No. 2309/93. This European Agency for the Evaluation of Medicinal Products (EMEA) is responsible for coordinating the scientific resources put at its disposal by the competent authorities of the member states for the evaluation and supervision of medicinal products for human use. A marketing authorization granted under the centralized procedure by EMEA is valid for all member states. 

According to the guidelines the applicant must prove that  

If there is a monograph in the Ph. Eur. on a particular product, the manufacturer must prove that the product at least complies with the specifications of the monograph. However, normally the specifications used by the manufacturer of the finished product as well as the specifications used at in-process controls are tighter. 

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