Regulation 6 The responsible person for a blood establishment

ensuring that every unit of blood or blood component that has been collected or tested for any purpose has been collected and tested in accordance with the requirements of these Regulations;

ensuring that every unit of blood or blood components intended for transfusion has been processed, stored and distributed in accordance with the requirements of these Regulations;

providing information to the Secretary of State relating to the authorisation of the blood establishment for the purposes of regulation 4; and

the implementation in the blood establishment of the requirements of regulations 7, 8 and 14.

a diploma, certificate or other evidence of formal qualification in the field of medical or biological sciences awarded on completion of—

practical post-graduate experience in areas of work relevant to the responsibilities of the responsible person under these Regulations for at least 2 yearsF1—

in relation to Great Britain, in one or more establishments authorised under regulation 4, or in a country where the safety and quality standards for establishments authorised in that country are equivalent to those for establishments authorised under regulation 4, to undertake activities relating to the collection or testing (or both) of blood and blood components, or to their preparation, storage or distribution;

in relation to Northern Ireland, in one or more establishments authorised in a member State, or under regulation 4, to undertake such activities.

relieve him of the duties of responsible person in respect of the establishment;

appoint a new responsible person in his place; and

notify the Secretary of State that it has appointed a new responsible person and provide details of the name and qualifications of the person appointed.