In this Schedule—

• “active ingredient” means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);

• “active ingredient from a new source” means an active ingredient in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted;

• “certificate of registration” means a certificate for the purposes of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

• “EU marketing authorization” means—

  1. a

     a marketing authorization; or

  2. b

     an authorization issued by a competent authority of an EEA State other than the United Kingdom for the purposes of Article 6 of the 2001 Directive;

• “the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal”;

• “new active ingredient” means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

• “new excipient” means—

  1. a

     except in Part 2, paragraph 33 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product—

     1. i

        which is intended to be administered by the same route of administration as the product in question; and

     2. ii

        in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted,

     except that in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in food or in a food product;

  2. b

     in Part 2, paragraph 33 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product which is intended to be administered by the same route of administration as the product in question and in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted, except that—

     1. i

        in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in food or in a food product; and

     2. ii

        in the case of a medicinal product intended for external use only, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in a cosmetic product;

• “Phase I trial” means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;

• “Phase II or Phase III trial” means a clinical trial, other than a Phase I trial, where the medicinal product being tested—

  1. a

     does not have an EU marketing authorization; or

  2. b

     has an EU marketing authorization, but—

     1. i

        there has been a change—

        1. aa

           to the process of manufacture of the product or its active ingredient; or

        2. bb

           of manufacturer of that product, or

     2. ii

        the product is to be used in the trial other than in accordance with the terms of the summary of product characteristics under that authorization;

• “Phase IV trial” means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;

• “TSE risk ingredient from a new source” and “TSE risk excipient from a new source” mean an active ingredient or excipient, respectively, which has been manufactured from raw materials of ruminant origin or which has had raw materials of ruminant origin used in its manufacture and in respect of which—

  1. a

     the application names as manufacturer, a manufacturer not previously named as the manufacturer of that ingredient or excipient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and

  2. b

     no European Pharmacopoeia certificate of suitability covering the excipient has been submitted with the application;

• “vitamin or mineral from a new source” means a vitamin or mineral in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that vitamin or mineral included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted.