Regulation 10 Amendment of regulation 8 (general interpretation)

Regulation 8^f1 is amended as follows.

In paragraph (1), at the appropriate places, insert—

• ““active implantable medical device”—

  1. (a)

     has the meaning given in regulation 2 of the Medical Devices Regulations 2002^f2; or

  2. (b)

     to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 137 of those Regulations^f3;”;

• ““agreed paediatric investigation plan” means a paediatric investigation plan which the licensing authority has agreed in accordance with regulation 50B;”;

• ““Annex I to the 2001 Directive” means Annex I to the 2001 Directive, as modified in accordance with Schedule 8B;”;

• ““approved country for batch testing list” means the list published by the licensing authority under paragraph 14(3) of Schedule 7 (obligations of qualified persons) and “approved country for batch testing” means a country included in that list;”;

• ““approved country for import list” means the list published by the licensing authority under regulation 18A (approved country for import) and “approved country for import” means a country included in that list;”;

• ““the Committee for Medicinal Products for Human Use” means the committee established under Article 5(1) of Regulation (EC) No 726/2004;”;

• ““conditional marketing authorisation” means a UK marketing authorisation granted under regulation 49(1)(a) in accordance with regulation 58F;”;

• ““country” means a country or territory;”;

• ““Directive 2001/18/EC” means Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration^f4;”;

• ““EU Exit Regulations” means the Human Medicines Regulations 2012 (Amendment etc.) (EU Exit) Regulations 2019;”;

• ““medical device”—

  1. (a)

     has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or

  2. (b)

     to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 69 of those Regulations^f5;”;

• ““orphan criteria” means the criteria listed in regulation 50G(2);”;

• ““orphan marketing authorisation” means a UK marketing authorisation granted under regulation 49(1)(a) in accordance with regulation 58C;”;

• ““Orphan Regulation” means Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products^f6 as it has effect in EU law;”;

• ““paediatric indication” means a term of a UK marketing authorisation enabling the medicinal product to which the authorisation relates to be used by or administered to persons under the age of 18 years;”;

• ““paediatric population” means that part of the population consisting of persons under the age of 18 years;”;

• ““supplementary protection certificate” has the meaning given in section 128B(2) of the Patents Act 1977^f7;”; and

• ““variation to the terms of a UK marketing authorisation” means any change to—

  1. (a)

     the information provided in accordance with regulations 50 to 57 and Schedule 8; or

  2. (b)

     the terms of the decision granting the UK marketing authorisation, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting that UK marketing authorisation, or changes to the labelling or the package leaflet connected with changes to the summary of the product characteristics,

  and “vary” and “variation” in relation to a UK marketing authorisation are to be construed accordingly;.”.

In paragraph (1), amend or substitute (as the case may be) the following definitions—

In paragraph (1), omit the following definitions—

In paragraph (5)(a) insert “UK” before “marketing authorisation”.

In paragraph (6)(a)—

In paragraph (8)^f13, for “References” substitute “Subject to regulation C17(6), references”.