Safety assessments marketing authorisation

The full data package was submitted and assessed by assessors from each of the three disciplines. The Committee on Safety of Medicines and its sub-committees then considered their assessment report. If the decision was positive then a certificate was issued. If the decision was negative, then the applicant had the same appeal rights as those that apply to a marketing authorisation application (see Section 17.8.1). 

Toxicity studies are expected to be performed in compliance with Good Laboratory Practice (GLP) however, it is recognised that some studies employing specialised test systems which are often needed for biopharmaceuticals, may not be able to comply fully with GLP. Areas of non-compUance should be identified and their significance evaluated relative to the overall safety assessment. In some cases, lack of full GLP compliance does not necessarily mean that the data from these studies cannot be used to support clinical trials and marketing authorisations. 

Health claims are a very convenient tool when it comes to marketing functional foods due to consumers sensitivity to health-related communications. The use of nutrition and health claims on foods in the European Union (EU) was harmonised in 2006 by Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (EC, 2006). Only the use of authorised nutrition and health claims is allowed. All health claims require specific authorisation by the European Commission (EC) through the comitology procedure, following the scientific assessment and verification of a claim by the European Food Safety Authority (EFSA) (Pravst, 2012a). 

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