Insertion of regulation 3A into the Principal Regulations
3. After regulation 3 of the Principal Regulations there shall be inserted the following regulation—
“Standard provisions for product licences, including product licences of right, for blood products and immunological medicinal products for human use
3A. In addition to the standard provisions for product licences set out in Part I of Schedule 1 to these Regulations—
(a)the standard provisions for product licences, including product licences of right, in relation to blood products shall be those provisions set out in paragraphs 1 and 2 of Schedule 1A to these Regulations, and
(b)the standard provisions for product licences, including product licences of right, in relation to vaccines, toxins, serums or allergen products for human use shall be those provisions set out in paragraph 3 of Schedule 1A to these Regulations.”.