[F1Early Access to Medicines Scheme: data collectionU.K.
167H.—(1) Data may be collected and handled in respect of patients for the purposes of assessing the quality, safety and efficacy of an EAMS medicine as part of the Early Access to Medicines Scheme without the need for an authorisation granted by the licensing authority under the Clinical Trials Regulations, if—
(a)informed consent is obtained from the patient and such consent is evidenced in writing, dated and signed, or otherwise marked by the patient as to indicate their consent; and
(b)the licensing authority has consented to the data collection.
(2) This is without prejudice to—
(a)the need for the EAMS scientific opinion holder to obtain other approvals in respect of the handling of patient data, where appropriate; and
(b)the powers that the EAMS scientific opinion holder and the licensing authority have to handle patient data (in accordance with the requirements of the Data Protection Act 2018) without the patient’s consent.
(3) For the avoidance of doubt, patient consent to data collection or handling is not, and must not be made, a condition of the supply of an EAMS medicinal product to a patient as part of the Early Access to Medicines Scheme.]
Textual Amendments