In this Part—

• “active substance” has the meaning given by regulation 8 of the Human Medicines Regulations 2012 (S.I. 2012/1916);

• “appropriate authority” has the meaning given by section 2(6);

• “clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031);

• “EU Clinical Trials Regulation” has the meaning given by section 5(2);

• “falsified human medicine” means a falsified medicinal product within the meaning given by regulation 8 of the Human Medicines Regulations 2012;

• “human medicine” means a medicinal product within the meaning given by regulation 2 of the Human Medicines Regulations 2012;

• “human medicines provision” has the meaning given by section 6(4);

• “law relating to human medicines” means—

  1. a

     sections 10 and 15, and Part 4, and section 131 of the Medicines Act 1968 (which make provision relating to pharmacies),

  2. b

     the Human Medicines Regulations 2012,

  3. c

     the Medicines for Human Use (Clinical Trials) Regulations 2004, and

  4. d

     the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190);

• “manufacture” includes assembly;

• “marketing authorisation” means an authorisation to market a human medicine in the United Kingdom;

• “pharmacy business” means a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the sale of medicinal products that are not subject to general sale;

• “supplying” includes administering within the meaning given by regulation 8 of the Human Medicines Regulations 2012 (and related expressions are to be read accordingly).