"reassessment of conformity" means the procedure for subsequent assessment, at the request of the owner or his authorised representative established in the Community or of the holder, of the conformity of transportable pressure equipment already manufactured and put into service before 1 July 2001 or, in the case of Article 18, within two years of that date;

first, an assessment of the PMF carried out at Community level, the result of which, i.e. a certificate of compliance with the Community legislation for each PMF, must be taken into account by any national competent authority, preventing them of any subsequent reassessment;

first, an assessment of the VAMF carried out at Community level, the result of which, i.e. a certificate of compliance with the Community legislation for each VAMF, must be taken into account by any national competent authority, preventing them from any subsequent reassessment;

The above information will be evaluated and approved by the CVMP and will form part of the subsequent annual reassessment.

For the first and subsequent annual reassessments the Marketing Authorisation Holder should provide annually an updated risk assessment on the continuous use of the vaccine taking into account the continued need for the vaccine, its history of use over the previous twelve months and progress made in addressing the items that require resolution in order for the authorisation to revert to normal status.