The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 8 (general interpretation)

10.—(1) Regulation 8(1) is amended as follows.

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

““active implantable medical device”—

(a)

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

(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(3);”;

““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(4);”;

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

““medical device”—

(a)

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

(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(5);”;

““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(6) 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(7);”; and

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

(a)

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

(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;.”.

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

(a) in the definition of “the Good Manufacturing Practice Directive” insert at the end “as modified in accordance with Schedule 2A”;

(b) in the definition of “homoeopathic medicinal product”, in paragraph (b), for “in any pharmacopoeia used officially in an EEA State” substitute “the British Pharmacopoeia, or in any pharmacopoeia used officially in a country that is included in a list published by the licensing authority for this purpose”;

(c) in the definition of “import”(8), insert at the end “and “imported” is to be construed accordingly”;

(d) in the definition of “name”, omit paragraphs (b) and (c);

(e) in the definition of “pharmacovigilance system”, “pharmacovigilance system master file” and “post-authorisation safety study”, for “marketing authorisation, traditional herbal registration or Article 126a authorisation” substitute “UK marketing authorisation or traditional herbal registration”;

(f) in the definition of “post-authorisation efficacy study”, insert “UK” before “marketing authorisation”;

(g) at the end of the definition of “Regulation (EC) No 726/2004”, insert “, as it has effect in EU law”;

(h) at the end of the definition of “Regulation (EC) No 1234/2008”, insert “, as it has effect in EU law”;

(i) in the definition of “special medicinal product” for “an EEA State” substitute “a country”;

(j) in the definition of “the summary of the product characteristics”, omit paragraph (b) (and “or” immediately preceding it); and

(k) in the definition of “UK marketing authorisation”, omit paragraph (b) (and “or” immediately preceding it).

(4) In paragraph (1), omit the following definitions—

(i) “advanced therapy medicinal product”,

(ii) “Article 126a authorisation”,

(iii) “care home”(9),

(iv) “Commission Regulation 2016/161”(10),

(v) “Directive 2002/98/EC”,

(vi) “Directive 2004/23/EC”,

(vii) “healthcare institution”(11),

(viii) “hospice”(12),

(ix) “marketing authorisation”,

(x) “Paediatric Regulation”,

(xi) “the Pharmacovigilance Risk Assessment Committee”,

(xii) “Regulation (EC) No 1394/2007”, and

(xiii) “third country”.

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

(6) In paragraph (6)(a)—

(a) insert “UK” before “marketing authorisation”; and

(b) for “or 60(1)” substitute “, 60(1) or 60A”.

(7) In paragraph (8)(13), for “References” substitute “Subject to regulation C17(6), references”.

(1)

Regulation 8 was amended by S.I. 2013/1855 and 2593, 2015/1503, 2016/186, 190 and 696, 2017/715, 2018/199 and 2019/62.

(2)

S.I. 2002/618. It was amended by S.I. 2008/2936.

(3)

Regulation 137 is inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

(4)

OJ No. L 106, 17.4.2001, p. 1, as last amended by Commission Directive (EU) 2018/350.

(5)

Regulation 69 is inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

(6)

OJ No. L 018, 22.01.2000, p. 1.

(7)

1977 c. 37. Section 128B was inserted by S.I. 2007/3293 and subsection (2) was amended by S.I.2014/2411.

(8)

The definition of “import” was inserted by S.I. 2013/1855.

(9)

The definition of “care home” was inserted by S.I. 2019/62.

(10)

The definition of “Commission Regulation 2016/161” was inserted by S.I. 2019/62.

(11)

The definition of “healthcare institution” was inserted by S.I. 2019/62.

(12)

The definition of “hospice” was inserted by S.I. 2019/62.

(13)

Paragraph (8) was inserted by S.I. 2013/1855.