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This platform is intended for submission of requests for a “Market Authorization Batch Certificate” (CAUL) for vaccines, medicinal products derived from human blood or plasma, or other medicines, which involve in the manufacturing process or as excipient material derived from human blood or plasma.

Considering its variability as products of biological origin, immunological medicinal products / vaccines and derivatives of blood or human plasma, should have, for each lot, an European Official Batch Release Certificate (COELL), according to the provisions of Artº 127 and Artº 135 of Decree-Law No. 128/2013 of 5 September, making the eighth amendment to Decree-Law no. 176/2006 of 30 August, and the UE Administrative Procedure For Official Control Authority Batch Release (OCABR).

In the case of immunological drugs / vaccine or medicinal products derived from human blood or plasma for which a European Official Batch Release Certificate was issued by another country in the European Union, a CAUL shall be issued by INFARMED.