- a full meeting of an ethics committee
means a meeting at which— (a) at least 5 members of the committee are in attendance, which may include attendance in person or remote attendance;
- adult
means a person who has attained the age of 16 years;
- advanced therapy medicinal product
has the meaning given by regulation 2A of the 2012 Regulations;
- adverse event
means any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product;
- adverse reaction
means any untoward and unintended response in a participant to an investigational medicinal product which is related to any dose administered to that participant;
- an ethics committee
has the meaning given by that regulation;
- any relevant fee
means, in relation to an application to vary a manufacturing authorisation, any fee which may be payable in connection with that application under the Medicines (Products for Human Use) (Fees) Regulations 2016;
- appropriate authority
means either or both of the following—
- appropriate Research Ethics Committee
means— a an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004;
- authorisation
means a manufacturing authorisation;
- authorities
means the licensing authority and the ethics committee in collaboration with each other;
- chief investigator
means— (a) in relation to a clinical trial conducted at a single trial location, the investigator for that location, or (b) in relation to a clinical trial conducted at more than one trial location, the health care professional, whether or not that health care professional is an investigator at any particular location, who takes primary responsibility for the conduct of the trial;
- clinical trial
means any investigation in human participants, other than a non-interventional trial, intended— (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products, (b) to identify any adverse reactions to one or more such products, or (c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products;
- clinical trial on a medicinal product
means a clinical trial as defined by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004;
- conditions and principles of good clinical practice
means the conditions and principles specified in Schedule 1;
- conducting a clinical trial
includes— (a) administering, or giving directions for the administration of, an investigational medicinal product to a participant for the purposes of that trial, (b) giving a prescription for an investigational medicinal product for the purposes of that trial, (c) carrying out any other medical or nursing procedure in relation to that trial, and (d) carrying out any test or analysis— (i) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of the investigational medicinal products administered in the course of the trial, (ii) to identify any adverse reactions to those products, or (iii) to study absorption, distribution, metabolism and excretion of those products, but does not include any activity undertaken prior to the commencement of the trial which consists of making such preparations for the trial as are necessary or expedient;
- country
means a country or territory;
- Declaration of Helsinki
means the Declaration of Helsinki adopted by the World Medical Assembly in June 1964...;
- dentist
means a person registered in the dentists register under the Dentists Act 1984...;
- Directive 2001/83/EC
means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use;
- doctor
means a registered medical practitioner;
- Early Access to Medicines Scheme
means the scheme of that name established and operated under regulation 167C(1) of the 2012 Regulations;
- electronic signature
means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;
- enforcement authority
means any Minister or body on whom a duty or power to enforce any provisions of these Regulations is imposed or conferred by or under regulation 323(1) or 324(1) of the 2012 Regulations as applied by regulation 47.
- ethics committee
means— (a) a committee established... in accordance with Part 2, or (b) an Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000...
- European Economic Area
means the European Economic Area created by the EEA Agreement;
- export
means export to another country from the United Kingdom, whether by land, sea or air;
- group
has the same meaning as in Part 15 of the Companies Act 2006 (see section 474(1) of that Act).
- Health Board
means a Health Board established under the National Health Service (Scotland) Act 1978;
- health care
means services for or in connection with the prevention, diagnosis or treatment of illness;
- health care professional
means— (a) a doctor, (b) a dentist, (c) a registered nurse as defined in regulation 8(1) of the 2012 Regulations, (d) a pharmacist, (e) a person registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989,...
- health centre
means a health centre maintained under section 2 or 3 of the National Health Service Act 2006, section 2 or 3 of the National Health Service (Wales) Act 2006, section 36 of the National Health Service (Scotland) Act 1978 or Article 5 of the Health and Personal Social Services (Northern Ireland) Order 1972;
- health service body
means— (a) a...
- hospital
includes a clinic, nursing home or similar institution;
- insurance or indemnity
includes provision for meeting losses or liabilities— (a) under a scheme established under— (i) section 21 of the National Health Service and Community Care Act 1990 (schemes for meeting losses and liabilities etc. of certain health service bodies in England and Wales), (ii) section 85B of the National Health Service (Scotland) Act 1978 (schemes for meeting losses and liabilities etc. of certain health service bodies in Scotland), or (iii) Article 24 of the Health and Personal Social Services (Northern Ireland) Order 1991 (schemes for meeting losses and liabilities etc. of certain health service bodies in Northern Ireland), or (b) in accordance with guidance issued by— (i) the Secretary of State, (ii) the Scottish Ministers, (iii) the National Assembly for Wales, or (iv) the Department of Health in Northern Ireland, as to the arrangements to be adopted by health service bodies for meeting the costs arising from clinical negligence (known as NHS Indemnity);
- intervention
includes complementary or alternative therapies, the taking of tissue samples, and requirements in relation to imaging and radiotherapy;
- investigational medicinal product
means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial— (a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization, (b) used for an indication not included in the summary of product characteristics under the authorization for that product, or (c) used to gain further information about the form of that product as authorised under the authorization;
- investigational medicinal product dossier
means, in relation to an investigational medicinal product, the dossier relating to that product which accompanies a request for approval to conduct a trial in which that product is or is to be used, in accordance with paragraph 5(b) of Schedule 3;
- investigator
means, in relation to a clinical trial, the health care professional who is responsible for the conduct of that trial at that trial location or, if more than one, the trial locations;
- lay member
means an individual who does not have a formal qualification related to, or professional experience in, the field of clinical research or healthcare.
- legal representative
means, in relation to a minor or to an adult unable by virtue of physical or mental incapacity to give informed consent, and who is, or is being considered as, a participant for a clinical trial— (a) in relation to adults and minors in England, Wales and Northern Ireland, and minors in Scotland— (i) a person, other than a person connected with the conduct of the trial, who— (aa) by virtue of their relationship with that adult or that minor, is suitable to act as their legal representative for the purposes of that trial, and (bb) is available and willing to so act for those purposes, or (ii) if there is no such person, a person, other than a person connected with the conduct of the clinical trial, who is— (aa) the doctor primarily responsible for the medical treatment provided to that adult or that minor, or (bb) a person nominated by the relevant health care provider;
- Local Research Ethics Committee
means— (a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004, (b) the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000, or (c) any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State, the National Assembly for Wales or Scottish Ministers;”
- manufacturing authorisation
has the meaning given by regulation 36(1);
- manufacturing authorisation (MM)
means a manufacturing authorisation that authorises the manufacture or assembly of MM investigational medicinal products;
- manufacturing authorisation (POC)
means a manufacturing authorisation that authorises the manufacture or assembly of POC investigational medicinal products;
- marketing authorization
means— (a) a UK marketing authorization, (b) an EU marketing authorisation (as defined in the 2012 Regulations), or (c) an authorization granted by a regulatory body responsible for licensing medicinal products in a country that is included in the list referred to in regulation 2A(1);
- medication
includes nutritional products and alternative remedies.
- medicinal product
means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations. • “minor” means a person under the age of 16 years;
- medicinal test on animals
has the same meaning as in the Medicines Act 1968.”
- minor
means a person under the age of 16 years;
- MM
means modular manufacture;
- modification of an important detail
means a modification to a clinical trial approval which— (a) the authorities should be aware of for administrative or oversight purposes, but (b) does not significantly impact the safety or rights of the participants;
- modification to a clinical trial approval
means a modification to— (a) the terms of the request for approval of the clinical trial, (b) the particulars or documents accompanying that request for approval, or (c) where the request for approval of the clinical trial was made under regulation 16(5)— (a) the terms of the request for authorisation to conduct that trial, (b) the application for an ethics committee opinion in relation to that trial, or (c) the particulars or documents accompanying that request for authorisation or application for ethics committee opinion;
- modular unit
means a relocatable manufacturing unit;
- nearest relative
has the meaning given by section 87(1) of the Adults with Incapacity (Scotland) Act 2000;
- new rules clinical trial
means a clinical trial which is not an old rules clinical trial;
- non-interventional trial
means a study of one or more medicinal products which have a marketing authorization, where the following conditions are met— (a) the products are prescribed in the usual manner in accordance with the terms of that authorization, (b) the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice, (c) the decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study, (d) no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question, and (e) epidemiological methods are to be used for the analysis of the data arising from the study;
- non-investigational medicinal product
means a medicinal product used or to be used in a clinical trial, as described in the protocol, but not as an investigational medicinal product;
- notifiable trial
means a trial—
- old committee
means an ethics committee recognised under the old rules that has been abolished or has ceased to operate as an ethics committee for the purposes of these Regulations;
- participant
means, in relation to a clinical trial, an individual, whether a patient or not, who participates in a clinical trial— (a) as a recipient of an investigational medicinal product or of some other treatment or product, or (b) without receiving any treatment or product, as a control;
- person connected with the conduct of the trial
means— (a) the sponsor of the trial, (b) a person employed or engaged by, or acting under arrangements made with, the sponsor and who undertakes activities in connection with the management of the trial, (c) an investigator for the trial, (d) a health care professional who is a member of an investigator’s team for the purposes of the trial, or (e) a person who provides health care under the direction or control of a person referred to in paragraphs (c) and (d) above, whether in the course of the trial or otherwise;
- pharmaceutical form of an active substance
includes any substance or article to which these Regulations have effect by virtue of an order under section 104 or 105 of the Act (which relate to the application of Act to certain articles and substances which are not medicinal products);
- pharmacist
means— (a) in relation to Great Britain, a person registered as a pharmacist in Part 1... of the register maintained under article 19 of the Pharmacy Order 2010, and (b) in relation to Northern Ireland, a person registered in the register of pharmaceutical chemists for Northern Ireland made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;
- Phase I trial
means a clinical trial to study the pharmacology of an investigational 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 participants of the trial;
- POC
means point of care;
- primary endpoint
means the variable or measure capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial, for example, the period between the first receipt of treatment or a placebo by a participant and the occurrence of a pre-defined event;
- protocol
means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial;
- public registry
means a a primary or partner registry of, or a data provider to, the WHO International Clinical Trials Registry Platform, provided that the registry, or the data provider, facilitates public access to information about the trial in the United Kingdom;
- qualified person
means— (a) a person who as respects qualifications and experience satisfies the requirements of Schedule 7 to the 2012 Regulations, or (b) a person who, without satisfying the requirements referred to in paragraph (a)— (i) has been engaged in activities equivalent to those to be performed in accordance with regulation 43(2) in respect of investigational medicinal products for a period of at least 6 months prior to 1st May 2004, (ii) has, in accordance with paragraph 6(1) of Schedule 6, been named as a qualified person in a valid application for a manufacturing authorisation made prior to 1st May 2006, and (iii) is— (aa) a member of the Institute of Biology, the Pharmaceutical Society, the Royal Society of Chemistry, or such other body as may appear to the licensing authority to be an appropriate body for the purpose of this paragraph, or (bb) the holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science, which the licensing authority have stated in a notice in writing to that person to be qualificati
- radiopharmaceutical
has the same meaning as in regulation 8(1) of the 2012 Regulations;
- reference safety information
means information in the product information relating to expected serious adverse reactions associated with an investigational medicinal product, which is used to determine the adverse reactions that are to be treated as suspected unexpected serious adverse reactions in relation to that investigational medicinal product.
- relevant authority
means any government department, local or public authority or holder of public office.
- relevant committee
means— (a) the Commission on Human Medicines, or (b) such other body or committee as the licensing authority may consider appropriate in relation to the application under consideration;
- relevant health care provider
means— (a) in relation to a person receiving services in pursuance of the National Health Service Act 1977, the National Health Service (Scotland) Act 1978, or the Health and Personal Social Services (Northern Ireland) Order 1972 — (i) in a case where a health service body is providing those services, that body, or (ii) in any other case, the health service body which entered the arrangements under which those services are provided, or (b) in relation to any other person receiving health care, the person primarily responsible for providing that health care;
- relevant information
means any information which is relevant to an evaluation of—
- relevant person
includes— (a) a participant as defined in regulation 2(1);
- required minimum information
includes the particulars identifying the trial and the details of the sponsor and investigator.
- research ethics committee
means— (a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004, or (b) any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State or the National Assembly for Wales;”
- Route A substantial modification
means a modification to a clinical trial approval which is likely to have a substantial impact on the safety or rights of the participants or on the reliability or robustness of the data generated in the trial;
- Route B substantial modification
means a modification to the approval of a clinical trial (“the relevant clinical trial”)—
- signatory
means a natural person who creates an electronic signature;
- specialist group or committee
means a group or committee whose functions include the provision of advice on ethical or scientific issues in relation to— (a) tissue engineered products, (b) in the case of medicinal products for gene therapy or somatic cell therapy, the use of such therapies in the treatment of humans, or (c) in the case of medicinal products containing genetically modified organisms, the administration of such products to humans;
- specified publication
has the meaning given by regulation 321(1) of the 2012 Regulations.
- sponsor
means, in relation to a clinical trial, the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial.
- substantial modification
means— (a) a Route A substantial modification, or (b) a Route B substantial modification;
- the 2012 Regulations
means the Human Medicines Regulations 2012;
- the Act
means the Medicines Act 1968;
- the Clinical Trials Directive
means Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;”
- the Clinical Trials Regulations
means the Medicines for Human Use (Clinical Trials) Regulations 2004;”
- the Commission on Human Medicines
means the Commission on Human Medicines within the meaning of regulation 9 of the 2012 Regulations;
- the EU Regulation
means Regulation 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, as that Regulation has effect in EU law;
- the European Medicines Agency
means the European Medicines Agency established by Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
- the new rules
means these Regulations as in force on and after the relevant day;
- the old rules
means these Regulations as in force immediately before the relevant day;
- the principles and guidelines of good manufacturing practice
means the principles and guidelines of good manufacturing practice set out in Commission Directive 2003/94/ECin respect of Great Britain or Commission Delegated Regulation 2017/1569 in respect of Northern Ireland;
- the relevant day
means the day on which this Schedule comes into force.
- the United Kingdom Ethics Committees Authority
(“the Authority”) means any one or more of the Health Research Authority, the Welsh Ministers, the Scottish Ministers and the Department of Health in Northern Ireland, and, in the case of anything falling to be done by the Authority, means any one or more of them acting as mentioned in paragraph (2).
- time allowed
means the period of 28 days or such extended period as the licensing authority may in any particular case allow.
- trial location
means a hospital, health centre, surgery or other establishment, or facility or premises at or from which a clinical trial, or any part of such a trial, is conducted;
- unexpected adverse reaction
means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out— (a) in the case of a product with a marketing authorization, in the summary of product characteristics, or equivalent document, for that product, (b) in the case of any other investigational medicinal product, in the investigator’s brochure relating to the trial in question.
- unexpected serious adverse reaction
means any adverse event, adverse reaction or unexpected adverse reaction, respectively, that— (a) results in death, (b) is life-threatening, (c) requires hospitalisation or prolongation of existing hospitalisation, (d) results in persistent or significant disability or incapacity, or (e) consists of a congenital anomaly or birth defect;
- valid application
means an application— (a) made to the licensing authority, (b) in writing and signed by or on behalf of the applicants, (c) specifying the variation requested by the applicant, (d) accompanied by— (a) such particulars as are necessary to enable the licensing authority to consider the application, and (ii) unless arrangements have been made with the licensing authority for the payment of any relevant fee other than at the time of the application, any such fee, and (e) where the application, and any accompanying material, is in the English language.
- valid modification request
means a modification request which complies with the provisions of regulation 22;
- valid request for approval
means a request for approval which complies with the provisions of regulation 16.