The Human Medicines Regulations 2012

Regulation 50(1)

SCHEDULE 8 U.K. Material to accompany an application for a UK marketing authorisation

PART 1 U.K. General requirements

1.  The name or corporate name and permanent address of the applicant and (where applicable) of the manufacturer of the medicinal product. U.K.

2.  The name of the medicinal product. This may be— U.K.

(a) an invented name that is not liable to confusion with the product's common name; or

(b) a common or scientific name accompanied by a trademark or by the name of the person who is to be the marketing authorisation holder.

3.  Qualitative and quantitative particulars of the constituents of the medicinal product, including— U.K.

(a) where there is an international non-proprietary name recommended by the World Health Organisation for a constituent, a reference to that name; or

(b) otherwise, a reference to the relevant chemical name.

4.  An evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis. U.K.

5.  A description of the methods of manufacturing the medicinal product. U.K.

6.  The therapeutic indications and contra-indications for the medicinal product and the adverse reactions associated with it. U.K.

7.  The posology and pharmaceutical form of the medicinal product, its method and route of administration and its expected shelf life. U.K.

8.  The reasons for any precautionary and safety measures to be taken for— U.K.

(a) the storage of the medicinal product;

(b) the administration of the medicinal product to patients; and

(c) the disposal of the medicinal product and any waste products,

with an indication of the potential risks presented by the medicinal product for the environment.

9.  A description of the control methods employed by the manufacturer. U.K.

[F1 9A.   A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with the principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 37(5)(a) and containing— U.K.

(a) information about the date of the audit; and

(b) a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.]

Textual Amendments

F1 Sch. 8 para. 9A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 34

10.  The results of the following in relation to the medicinal product and its constituent active substances— U.K.

(a) pharmaceutical (physico-chemical, biological or microbiological) tests;

(b) pre-clinical (toxicological and pharmacological) tests; and

(c) clinical trials.

11.  A detailed summary of those results prepared and signed by an expert with appropriate technical or professional qualifications, which must be set out in a brief curriculum vitae. U.K.

12.  A summary of the applicant's pharmacovigilance system which shall include the following elements— U.K.

(a) proof that the applicant has at the applicant's disposal an appropriately qualified person responsible for pharmacovigilance [F2 who is ordinarily resident, and operates, in the United Kingdom or a member State];

[F3 (b) the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;]

(c) the contact details of the appropriately qualified person;

(d) a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and

[F4 (e) a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.]

Textual Amendments

F2 Words in Sch. 8 para. 12(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(a)(i)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Sch. 8 para. 12(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(a)(ii)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Sch. 8 para. 12(e) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(a)(iii)); 2020 c. 1, Sch. 5 para. 1(1)

13.  The risk management plan, together with a summary, that— U.K.

(a) describes the risk management system which the applicant will introduce for the medicinal product concerned; and

(b) shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

14.  Where any clinical trials have been carried out outside the European Union, a statement to the effect that the trials met the ethical requirements of the Clinical Trials Directive. U.K.

15.  A summary of the product characteristics for the medicinal product in accordance with Part 2 of this Schedule. U.K.

16.  A mock-up, in accordance with Part 13 (packaging and leaflets) of— U.K.

(a) the outer packaging of the medicinal product;

(b) the immediate packaging of the medicinal product; and

(c) the package leaflet for the medicinal product.

17.  A document showing that the manufacturer of the medicinal product is authorised to produce medicinal products in the manufacturer's own country. U.K.

[F5 18.   Where— U.K.

(a) in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—

(i) a list of the member State or States concerned, and

(ii) in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;

(b) in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.]

Textual Amendments

F5 Sch. 8 para. 18 substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(b))

19.  Where an authorisation for the medicinal product to be placed on the market has been granted by [F6 , in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission]— U.K.

(a) a copy of that authorisation;

(b) a summary of the safety data, including the data contained in the periodic safety update reports, where available; and

(c) any suspected adverse reaction reports.

Textual Amendments

F6 Words in Sch. 8 para. 19 substituted (31.12.2020) by S.I. 2019/775, reg. 50(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(c))

20.  Where [F7 , in the case of a medicinal product for sale or supply in Northern Ireland,] an authorisation for the medicinal product to be placed on the market has been granted by a member State in accordance with the 2001 Directive, a copy of— U.K.

(a) the summary of the product characteristics approved by the competent authority of the member State; and

(b) the package leaflet approved by that competent authority.

Textual Amendments

F7 Words in Sch. 8 para. 20 inserted (31.12.2020) by S.I. 2019/775, reg. 50(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(d))

[F8 21.   Where an authorisation for the medicinal product to be placed on the market has been refused— U.K.

(a) in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or

(b) in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,

details of that decision and of the reasons for it.]

Textual Amendments

F8 Sch. 8 para. 21 substituted (31.12.2020) by S.I. 2019/775, reg. 50(6) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(e))

22.   [F9 In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any] designation of the medicinal product as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products M1 together with a copy of the relevant Agency opinion.

Textual Amendments

F9 Words in Sch. 8 para. 22 substituted (31.12.2020) by S.I. 2019/775, reg. 50(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(f))

Marginal Citations

M1 OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

PART 2 U.K. Summary of the product characteristics

The summary of the product characteristics must contain the following information in the following order—

[F10 23.   For medicinal products included on the list referred to— U.K.

(a) in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or

(b) in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.]

Textual Amendments

F10 Sch. 8 para. 23 substituted (31.12.2020) by S.I. 2019/775, reg. 50(8) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(g))

24.  The name of the medicinal product followed by its strength and pharmaceutical form. U.K.

25.  The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of— U.K.

(a) the active substances; and

(b) those excipients of which knowledge is essential for proper administration of the medicinal product.

[F11 25A.   In the case of an advanced therapy medicinal product for sale or supply in Great Britain which contains cells or tissues, a detailed description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.] U.K.

Textual Amendments

F11 Sch. 8 para. 25A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(9) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(h)); 2020 c. 1, Sch. 5 para. 1(1)

26.  The pharmaceutical form of the medicinal product. U.K.

27.  Clinical particulars in relation to the medicinal product, covering— U.K.

(a) therapeutic indications;

(b) posology and method of administration for adults and, where necessary, for children;

therapeutic indications;

(c) contra-indications;

(d) special warnings and precautions for use and, in the case of immunological medicinal products any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient;

(e) interaction with other medicinal products and other forms of interactions;

(f) use during pregnancy and lactation;

(g) effects on ability to drive and to use machines;

(h) other undesirable effects; and

(i) information on overdose (including symptoms, emergency procedures and antidotes).

28.  The pharmacological properties of the medicinal product, covering— U.K.

(a) pharmacodynamic properties;

(b) pharmacokinetic properties; and

(c) pre-clinical safety data.

29.  Pharmaceutical particulars in relation to the medicinal product, covering— U.K.

(a) a list of excipients;

(b) major incompatibilities;

(c) shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

(d) special precautions for storage;

(e) nature and contents of container; and

(f) special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

30.  The holder of the UK marketing authorisation. U.K.

31.  The number of the UK marketing authorisation. U.K.

32.  The date of the first UK marketing authorisation or, where the UK marketing authorisation has been renewed, the date of the last renewal. U.K.

33.  The date of any revisions of the text of the summary of the product characteristics. U.K.

34.  For radiopharmaceuticals, full details of internal radiation dosimetry. U.K.

35.  For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications. U.K.

[F12 36.   In the case of an advanced therapy medicinal product for sale or supply in Great Britain— U.K.

(a) references in this Part of this Schedule to administration of a product include references to the advanced therapy medicinal product's use, application or implantation; and

(b) descriptions, instructions and warnings must include explanatory drawings and pictures where necessary.]

Textual Amendments

F12 Sch. 8 para. 36 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(10) (as amended by (S.I. 2020/1488, reg. 1, Sch. 2 para. 38(i)); 2020 c. 1, Sch. 5 para. 1(1)