the date of the last periodic health review; and

2. The medical record shall include information regarding the nature of the employment, the results of the medical examinations prior to employment or classification as a category A worker, the periodic reviews of health and the record of doses required by Article 43.

periodic reviews of health at least once a year, in order to determine whether the category A workers remain fit to perform their duties.

However, in the interests of public health, the competent authorities should require periodic safety update reports for such medicinal products when concerns arise relating to pharmacovigilance data or as a result of the lack of available safety data when the use of the active substance concerned is concentrated in medicinal products for which periodic safety update reporting is not routinely required.

RECALLS that under Article 168 of the Treaty on the Functioning of the European Union, Union action is to complement national policies and be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health; it is also to encourage cooperation between Member States in those areas where Member States, in liaison with the Commission, coordinate among themselves their policies and programmes, and the Commission may, in close contact with the Member States, take any useful initiative to promote such coordination, in particular initiatives aiming at the establishment of guidelines and indicators, the organisation of exchange of best practice, and the pre ...[+++]paration of the necessary elements for periodic monitoring and evaluation;

However, in the interest of public health the authorities should require periodic safety update reports for such products when there is a need to assess their risk or review the adequacy of product information.