Division a) PrinciplesF1

For the purposes of this Annex:

• Vaccine Antigen Master File shall mean a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information of biological, pharmaceutical and chemical nature concerning each of the active substances, which are part of this medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.

• A vaccine may contain one or several distinct vaccine antigens. There are as many active substance(s) as vaccine antigen(s) present in a vaccine.

• A combined vaccine contains at least two distinct vaccine antigens aimed at preventing a single or several infectious diseases.

• A monovalent vaccine is a vaccine, which contains one vaccine antigen aimed at preventing a single infectious disease.