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Regulation 3 Amendment of Part II of Schedule 1 to the principal regulations

Original text. Later amendments are not shown.

In Part II of Schedule 1 to the principal regulations (standard provisions for clinical trial certificates) immediately after paragraph 3 there shall be added the following paragraphs:—

“4

The clinical trial in respect of which the clinical trial certificate has been issued shall be carried out in accordance with the outline of the clinical trial contained in the application for that certificate subject to any changes thereto which the licensing authority may from time to time approve.

5
(1)

The medicinal product to which the clinical trial certificate relates shall be administered only by or under the direction of a doctor or dentist named in the application for that certificate or by or under the direction of a doctor or dentist approved by the licensing authority for this purpose.

(2)

Where the medicinal product to which the clinical trial certificate relates is to be administered by or under the direction of a doctor or dentist who has not been named in the application for that certificate or where it is intended that there shall be a change of the doctor or dentist so named, the certificate holder shall seek the approval of the licensing authority and for this purpose shall notify the licensing authority in writing of the name, address and qualifications of the doctor or dentist in question.

(3)

In the event of any doctor or dentist ceasing to participate in the clinical trial in respect of which the clinical trial certificate has been issued, the certificate holder shall as soon as is reasonably possible inform the licensing authority and shall give the reason for such cessation.

6

Before any administration of the medicinal product to which the clinical trial certificate relates takes place, the certificate holder shall communicate the provisions of that certificate to each and every doctor or dentist who, in the course of the clinical trial in respect of which that certificate has been issued, is to administer or to direct the administration of that medicinal product.”.