Regulation 10 Substitution of regulation 11

For regulation 11 (interpretation of Part 3) substitute—

“Interpretation of Part 3

11

In this Part—

• “advanced therapy medicinal product” has the meaning given by regulation 2A of the 2012 Regulations^f1;

• “authorities” means the licensing authority and the ethics committee in collaboration with each other;

• “modification of an important detail” means a modification to a clinical trial approval which—

  1. (a)

     the authorities should be aware of for administrative or oversight purposes, but

  2. (b)

     does not significantly impact the safety or rights of the participants;

• “modification to a clinical trial approval” means a modification to—

  1. (a)

     the terms of the request for approval of the clinical trial,

  2. (b)

     the particulars or documents accompanying that request for approval, or

  3. (c)

     where the request for approval of the clinical trial was made under regulation 16(5)—

     1. (i)

        the terms of the request for authorisation to conduct that trial,

     2. (ii)

        the application for an ethics committee opinion in relation to that trial, or

     3. (iii)

        the particulars or documents accompanying that request for authorisation or application for ethics committee opinion;

• “relevant committee” means—

  1. (a)

     the Commission on Human Medicines, or

  2. (b)

     such other body or committee as the licensing authority may consider appropriate in relation to the application under consideration;

• “Route A substantial modification” means a modification to a clinical trial approval which is likely to have a substantial impact on the safety or rights of the participants or on the reliability or robustness of the data generated in the trial;

• “Route B substantial modification” has the meaning given in regulation 11B;

• “specialist group or committee” means a group or committee whose functions include the provision of advice on ethical or scientific issues in relation to—

  1. (a)

     tissue engineered products,

  2. (b)

     in the case of medicinal products for gene therapy or somatic cell therapy, the use of such therapies in the treatment of humans, or

  3. (c)

     in the case of medicinal products containing genetically modified organisms, the administration of such products to humans;

• “substantial modification” means—

  1. (a)

     a Route A substantial modification, or

  2. (b)

     a Route B substantial modification;

• “valid modification request” means a modification request which complies with the provisions of regulation 22;

• “valid request for approval” means a request for approval which complies with the provisions of regulation 16.”.