The Human Medicines (Amendment) Regulations 2013

(e) to revoke, vary or suspend the authorisation, certificate or registration; (f) to proceed to suspend, vary or remove a person’s broker registration; (g) to proceed to suspend, vary or remove a person’s active substance registration; or (h) to proceed to suspend, vary or remove a person’s entry on the list,

Insertion of Schedule 7A

33

Immediately after Schedule 7 (qualified persons) insert—

SCHEDULE7A (1) The name and address of the applicant. (2) The name and address of the person (if any) making the application on the applicant’s behalf. (3) The address of each of the premises where any operations to which the registration relates are to be carried out. (4) The address of any premises not mentioned by virtue of the above requirement, where— (a) the applicant proposes to keep any living animals, from which substance(s) used in the production of the active substance(s) to which the application relates are to be derived; (b) materials of animal origin from which an active substance is to be derived, as mentioned in the above sub-paragraph, are to be kept. (5) The address of each of the premises where active substances are to be stored, or from which active substances are to be distributed. (6) The address of each of the premises where any testing associated with the manufacture or assembly of active substances to which the registration relates. (7) The name, address, qualifications and experience of the person whose duty it will be to supervise any manufacturing operations, and the name and job title of the person to whom they report. (8) The name, address, qualifications and experience of the person who will have responsibility for the quality control of active substances, and the name and job title of the person to whom they report. (9) The name, address, qualifications and experience of the person whose duty it will be to supervise any importation, storage or distribution operations, and the name and job title of the person to whom they report. (10) The name, address and qualifications of the person to be responsible for any animals kept as mentioned in paragraph 4(a). (11) The name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of an active substance. (12) For each active substance to be manufactured, imported, or distributed— (a) the CAS registration number[^f00032] assigned to that active substance by the Chemical Abstracts Service, a division of the American Chemical Society; (b) where applicable, the Anatomical Therapeutic Category code[^f00033] assigned to that active substance under the Anatomical Therapeutic Chemical Classification System used for the classification of drugs by the World Health Organisation’s Collaborating Centre for Drug Statistics Methodology; (c) either— (i) the International Union of Pure and Applied Chemistry nomenclature, or (ii) the common name; and (d) the intended quantities of each active substance to be manufactured, imported or distributed. (13) Details of the operations to which the registration relates, including a statement of whether they include— (a) the manufacture of active substances; (b) the importation of active substances from third countries; (c) the storage of active substances; or (d) the distribution of active substances. (14) A statement of the facilities and equipment available at each of the premises where active substances are to be manufactured, stored or distributed. (15) A statement as to whether the particular active substances are intended for— (a) use in a medicinal product with an EU marketing authorisation; (b) use in a special medicinal product; or (c) export to a third country. (16) A separate statement in respect of each of the premises mentioned in the application of— (a) the manufacturing, storage or distribution operations carried out at those sites, and the specific active substances to which those activities relate; and (b) the equipment available at those premises for carrying out those activities. (17) A statement of the authority conferred on the person responsible for quality control to reject unsatisfactory active substances. (18) A description of the arrangements for the identification and storage of materials before and during the manufacture of active substances. (19) A description of the arrangements for the identification and storage of active substances. (20) A description of the arrangements at each of the premises where the applicant proposes to store active substances for ensuring, as far as practicable, the turn-over of stocks of active substances. (21) A description of the arrangements for maintaining— (a) production records, including records of manufacture and assembly; (b) records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials use in manufacture, or of active substances, with the specification for such materials or active substances; (c) records of importation; (d) records of storage and distribution. (22) A description of the arrangements for keeping reference samples of— (a) materials used in the manufacture of active substances; and (b) active substances. (23) Where the application relates to active substances intended for use in an advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow traceability containing sufficient detail to enable the linking of an active substance to the advanced therapy medicinal product it was used in the manufacture of and vice versa. (24) Details of— (a) any manufacturing, importation, storage or distribution operations, other than those to which the application for registration relates, carried on by the applicant on or near each of the premises, and (b) the substances or articles to which those operations relate.

Amendment of Schedule 8

34

In Schedule 8 (material to accompany an application for a UK marketing authorisation) after paragraph 9 insert—

(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— (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.

PART 3 — Revocations

The Human Medicines Regulations 2012

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Regulation 32 (sale and supply of starting materials) of the Human Medicines Regulations 2012 is revoked.

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State, — Department of Health — 18th July 2013

Edwin Poots — Minister for Health, Social Services and Public Safety — 22nd July 2013

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”) in order to implement—

• Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (“Directive 2011/62/EU”);

• Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (“the Implementing Regulation”);

• an EU Corrigendum[^f00034] which corrects an error in Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicines for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (“the EU Corrigendum).

The majority of provisions in these Regulations introduce new provisions into the 2012 Regulations in relation to brokers, active substances and the sale of medicinal products at a distance in order to implement Directive 2011/62/EU. In particular—

• regulation 3 updates the general interpretation provisions to insert new definitions;

• regulations 4 to 6, 9 to 15, 17, 19 and 20 amend provisions relating to manufacturers or wholesalers of medicinal products, marketing authorisations and traditional herbal registrations;

• regulation 16 inserts new provisions relating to brokers of medicinal products and importers, manufacturers or distributors of active substances;

• regulation 28 inserts new provisions relating to the sale at a distance of medicinal products;

• regulation 30, 34 and 35 make consequential amendments related active substances;

• regulation 32 amends provisions so that brokers of medicinal products and importers, manufacturers and distributors of active substances can apply for certain decisions to be reviewed upon oral representations; and

• regulation 33 inserts a new Schedule in relation to information requirements for registration in relation to active substances.

Regulations 21, 23 and 25 amend the 2012 Regulations in order to provide sanctions for breaches of obligations and requirements imposed by the Implementing Regulation in relation to pharmacovigilance activities and regulation 22 makes consequential changes to remove duplication of obligations.

Regulations 18 and 24 make amendments to ensure that cross-references to Regulation (EC) No 726/2004 that were amended by the EU Corrigendum are correctly reflected in the 2012 Regulations.

Regulations 7, 26 and 27 insert new provisions into the 2012 Regulations that enable physiotherapist independent prescribers and podiatrist independent prescribers to mix, sell or supply certain types of prescription only medicines.

Regulation 8 amends the 2012 Regulations so that where a licence holder wishes to make oral representations to the licensing authority a fee is payable by the licence holder.

Regulations 29 and 31 amend the 2012 Regulations to ensure that regulations related to inspections, sampling and seizure and the review of provisions can be applied in relation to new provisions for brokers, the importation, manufacture and distribution of active substances and the sale of medicines to the public at a distance.

Footnotes

[^f00001]: 1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act 2006 (2006 c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (1973 c.36).

[^f00002]: SeeS.I. 1972/1811 regarding the designation of Ministers.

[^f00003]: 1968 c.67. Relevant amendments to section 58(1) have been made by S.I. 2006/2407 and 2012/1916. Relevant amendments to section 58(4) have been made by the Medicinal Products: Prescription by Nurses etc. Act 1992 (c.28) and S.I. 2006/2407 and 2012/1916. Section 58(4A) has been amended by S.I. 2012/1916. Relevant amendments to section 58(5) have been made by the Medicinal Products: Prescription by Nurses etc. Act 1992 and the Health and Social Care Act 2001 (c.15).

[^f00004]: 1971 c.69; as amended by regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971 (“the 1971 Act”), expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) (“the 1968 Act”). See therefore section 1 of the 1968 Act, as substituted by paragraph 2 of Schedule 34 to the Human Medicines Regulations 2012 (S.I. 2012/1916) (“the 2012 Regulations”) which provides the meaning of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. By virtue of regulation 348 of, and paragraph 36 of Schedule 34 to, the 2012 Regulations, references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence, or for the variation or renewal of such a licence under Part 2 of the 1968 Act, shall have effect as a reference to any application under Parts 3 to 8 of the 2012 Regulations.

[^f00005]: In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142. In the case of the Minister for Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

[^f00006]: OJ No L 311, 28.11.2001, p67. Article 85c was inserted into Directive 2001/83/EC by Article 1(2) of Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00007]: S.I. 2012/1916.

[^f00008]: S.I. 2013/532.

[^f00009]: Paragraphs 3 and 4 of Article 47 were substituted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00010]: Paragraph 5 of Article 47 was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00011]: OJ No L 91, 30.3.2004, p25; relevant amending instrument is Commission Implementing Directive 2011/38/EU (OJ No L 97, 12.4.2011, p28).

[^f00012]: Point (o) of Article 54 was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00013]: Article 76(4) was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00014]: Article 54a was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00015]: Article 47 was amended by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00016]: Article 16(4) of Regulation (EC) No 726/2004 was re-numbered as Article 16(3a) by virtue of the Corrigendum (OJ L 348, 31.12.2010, p1) to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicines for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medical Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.

[^f00017]: OJ No L 159, 20.6.2012, p5.

[^f00018]: Chapter 1 imposes requirements and obligations on holders in relation to the following aspects of the pharmacovigilance system master file: structure (Article 1), content (Article 2 and 3), maintenance and notification of certain changes (Article 4), form of documents contained in the pharmacovigilance system master file (Article 5) and availability and location (Article 7). Chapter 1 also imposes requirements on holders in relation to the sub-contracting of pharmacovigilance responsibilities (Article 6) and the submission of a logbook (Article 7).

[^f00019]: Chapter II imposes requirements and obligations on holders in relation to the following aspects of the pharmacovigilance quality system: general matters (Article 8), content (Article 8(2)), basis of system (Article 8(3)), documentation (Article 8(4)), resource management (Article 10), compliance management (Article 11), record management (Article 12) and audit (Article 13).

[^f00020]: Chapter III imposes requirements and obligations on holders in relation to the following aspects of monitoring data in the Eudravigilance database: general matters (Article 18), identification of new and changed risks (Article 19), methodology for determining signal value (Article 20) and signal management process (Article 21).

[^f00021]: Chapter V imposes requirements and obligations on holders in relation to the following aspects of transmitting suspected adverse reaction reports: use of individual case safety reports (Article 27), content of individual case safety reports (Article 28) and format of electronic transmission (Article 29).

[^f00022]: Article 32 in Chapter VI imposes requirements and obligations on holders in relation to updated risk management plans, including a requirement that updated risk management plans are submitted to the national competent authority.

[^f00023]: Chapter VII imposes requirements and obligations on holders in relation to the following aspects of periodic safety update reports: content (Article 34) and format (Article 35).

[^f00024]: Chapter VIII imposes requirements and obligations on holders in relation to the following aspects of post-authorisation safety studies: language of study information (Article 36(2)), handling and storage of study information (Article 36(3)) and format of study information (Article 38).

[^f00025]: Article 85c was inserted by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00026]: OJ No L 204, 21.7.98, p37; relevant amending instrument is Directive 1998/48/EC of the European Parliament and of the Council (OJ No L 217, 5.8.98, p18).

[^f00027]: S.I. 2002/2013.

[^f00028]: OJ No L 178, 13.7.2000, p1.

[^f00029]: Article 85c was inserted into Directive 2001/83/EC by Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00030]: Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74).

[^f00031]: Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74).

[^f00032]: Further information is available from the website of the Chemical Abstracts Service at www.cas.org.

[^f00033]: Further information is available from the website of the WHO Collaborating Centre for Drug Statistics Methodology at www.whocc.no.

[^f00034]: OJ No L 201, 27.7.2012, p138.