Regulation 3 Interpretation of Part 2

In this Part—

• “clinical development” means the conduct of studies of a medicinal product in human subjects in order to—

  1. (a)

     discover or verify the effects of such a product;

  2. (b)

     identify any adverse reaction to such a product; or

  3. (c)

     study absorption, distribution, metabolism and excretion of such a product,

with the object of ascertaining the safety or efficacy of that product, in accordance with section 5 of Part 1 of Annex 1 to the 2001 Directive;

• “EC marketing authorization” means—

  1. (a)

     a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations;

  2. (b)

     a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or

  3. (c)

     a Community marketing authorization;

• “pharmacovigilance advice” means advice, other than scientific advice, which falls within one or more of the descriptions specified in paragraphs (a) and (b)—

  1. (a)

     the advice is in connection with an application for an EC marketing authorization, or is given with a view to a person making such an application, and relates to—

     1. (i)

        the obligations that would relate to the holder of such an authorization by virtue of Title IX of the 2001 Directive or Chapter 3 of the Title II of Regulation (EC) No. 726/2004,

     2. (ii)

        the pharmacovigilance and risk-management systems that the applicant would be required to introduce in accordance with Article 8(3)(ia) of the 2001 Directive, or

     3. (iii)

        a post-authorization safety study protocol;

  2. (b)

     the advice is given to the holder of a United Kingdom marketing authorization or a Community marketing authorization and relates to—

     1. (i)

        compliance with the obligations that relate to him by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Regulation (EC) No. 726/2004,

     2. (ii)

        the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive, or

     3. (iii)

        a post-authorization safety study protocol;

• “post-authorization safety study protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorization safety study;

• “product range” means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EC marketing authorization;

• “quality development” means the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a relevant medicinal product, in accordance with section 3 of Part 1 of Annex 1 to the 2001 Directive;

• “regulatory advice” means advice, other than scientific advice, in relation to the requirements of the 2001 Directive or Regulation (EC) No. 726/2004 and which falls within one or more of the descriptions specified in paragraphs (a) to (c)—

  1. (a)

     the advice is in connection with a change to the dates for renewal of one or more EC marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive;

  2. (b)

     the advice is in connection with—

     1. (i)

        a referral pursuant to Article 30, 31 or 36 of the 2001 Directive, or

     2. (ii)

        the procedure referred to in Article 35(2) of the 2001 Directive,

     in relation to a product range; or

  3. (c)

     the advice is given to a person with a view to him making—

     1. (i)

        an application for the variation or renewal of one or more EC marketing authorizations, or

     2. (ii)

        an application to amend the time periods for submitting Periodic Safety Update Reports under Article 104(6) of the 2001 Directive,

     in relation to a product range;

• “scientific advice” means advice in connection with the quality, safety or clinical development for a relevant medicinal product;

• “relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply; and

• “safety development” means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with section 4 of Part 1 of Annex 1 to the 2001 Directive.