S.L. 483.1 Art. 3Responsible person.

(1) A tissue and cell establishment, hereinafter referred to as "establishment", shall designate a person who shall be responsible for the following tasks:

(a) ensuring that human tissues and cells intended for human applications in the establishment for which that person is responsible are procured, tested, processed, stored and distributed in accordance with these regulations and with the laws in force in Malta;

(b) providing information to the competent authority or authorities as required in regulation 6;

(c) ensuring that appropriate control measures are in place within the tissue establishment and implementing the requirements of regulations 4, 5, 7, 8, 11, 12, 13, 14, 15 within the tissue establishment; and

(d) ensure that the Authority is notified of any serious adverse events and reactions and is provided with a report analysing the cause and the ensuing outcome.

(2) An establishment shall only designate a person as a responsible person if such person is in possession of:

(a) a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Authority; and

(b) at least two yearsí practical experience in the relevant fields.

(3) The responsible person may delegate any of the tasks specified in sub-regulation (1) to other persons who shall be qualified by training and experience to perform them.

(4) The establishments shall notify the Licensing Authority, hereinafter referred to as "the Authority" of the name of any persons to whom tasks have been delegated by the responsible person and the specific tasks which have been delegated to such persons.

(5) Where the responsible person or a person to whom tasks have been delegated is permanently or temporarily replaced, the establishment shall immediately provide the Authority with the name of the replacement, details of his qualifications and the date on which the replacement began his duties.

(6) If the Authority considers that the responsible person does not meet the requirements of sub-regulation (2), it may serve a notice to that effect on the establishment.

(7) If, within fourteen days of receiving a notice in accordance with sub-regulation (6), a establishment is not able to demonstrate to the reasonable satisfaction of the Authority that the responsible person does meet the requirements of sub-regulation (2), the establishment shall, without delay -

(a) relieve him of the duties of responsible person in respect of the establishment;

(b) appoint a new responsible person in his place; and

(c) notify the Authority that it has appointed a new responsible person and provide details of the name and qualifications of the person appointed.