Paragraph 11 F1

Technical note: this Part does not control medical products or vaccines which is intended for the development of medical products or vaccines. For the purpose of this Part—

• “medical products” means pharmaceutical formulations—

  1. (a)

     designed for testing or human (or veterinary) administration in the treatment of medical conditions, and

  2. (b)

     prepackaged for distribution as clinical or medical products;

• “vaccine” means a medicinal (or veterinary) product in a pharmaceutical formulation that is—

  1. (a)

     intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered, and

  2. (b)

     pre-packaged for distribution as a medicinal product.