Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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articles 4

Reform history JSON API

(1) After the hearing the reviewers must provide a report to the licensing authority and to the applicant either—

(a) by the end of the period of 60 days beginning with the day after the conclusion of the hearing; or

(b) within such further period as the reviewers may notify to the licensing authority and to the applicant within that 60 day period.

(2) The licensing authority must take the report into account and decide whether—

(a) to proceed with its proposal to revoke, vary or suspend the licence;

(b) to confirm or alter its decision;

(d) to grant or renew the UK marketing authorisation, parallel import licence, certificate of registration or traditional herbal registration or to do so otherwise than in accordance with the application; ...

(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,

as the case may be.

(3) The licensing authority must notify the applicant of its decision.

SCHEDULE 6 — Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products

PART 1 — Manufacturer's licences

1

The requirements in paragraphs 2 to 12 apply to a manufacturer's licence insofar as it relates to the manufacture and assembly of exempt advanced therapy medicinal products.

2

The licence holder must inform the licensing authority of any adverse reaction or suspected adverse reaction of which the holder is aware within the period of 15 days beginning on the day following the first day on which the holder knew about the reaction.

3

The licence holder must ensure, if using human cells or tissues in an exempt advanced therapy medicinal product, that the donation, procurement and testing of those cells or tissues is in accordance with requirements imposed pursuant to—

(a) paragraphs 6 to 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b) paragraphs 9 to 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.

4

The licence holder must ensure that any human tissue or cell component imported into the United Kingdom and used by the holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those imposed pursuant to—

(a) Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b) Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.

5

The licence holder must ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer's licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product meets equivalent standards of quality and safety to those laid down in the Blood Quality and Safety Regulations 2005.

6

Where the holder of a manufacturer's licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence that person must comply with—

(a) the requirements of paragraphs 15, 16, 18 and 19; and

(b) the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;

as if that person were the holder of a wholesale dealer's licence.

7

The licence holder must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks related to the exempt advanced therapy medicinal product.

8

The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used.

9

The licence holder must, subject to paragraph 27 of Schedule 4, keep the data referred to in paragraph 8 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.

10

The licence holder must secure that the data referred to in paragraph 8 will, in the event that—

(a) the licence is suspended, revoked or withdrawn; or

(b) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a manufacturer's licence for the period described in paragraph 9 or such longer period as may be required pursuant to paragraph 27 of Schedule 4.

11

The licence holder must, where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with paragraph 8 is complementary to and compatible with the requirements imposed pursuant to—

(a) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990;

(b) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

12

The licence holder must not import or export any exempt advanced therapy medicinal product.

PART 2 — Wholesale dealer's licences

13

The requirements in paragraphs 14 to 20 apply to a wholesale dealer's licence insofar as it relates to exempt advanced therapy medicinal products.

14

The licence holder must obtain supplies of exempt advanced therapy medicinal products only from—

(a) the holder of a manufacturer's licence in respect of those products; or

(b) the holder of a wholesale dealer's licence in respect of those products.

15

The licence holder must distribute an exempt advanced therapy medicinal product by way of wholesale dealing only to—

(a) the holder of a wholesale dealer's licence in respect of those products; or

(b) a person who—

(i) may lawfully administer those products, and

(ii) solicited the product for an individual patient.

16

17

The licence holder must inform the licensing authority of any adverse reaction to any exempt advanced therapy medicinal product supplied by the holder of the wholesale dealer's licence of which the holder is aware.

18

The licence holder must, subject to paragraph 44 of Schedule 4, keep the data referred to in paragraph 16 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.

19

The licence holder must secure that the data referred to in paragraph 16 will, in the event that—

(a) the licence is suspended, revoked or withdrawn; or

(b) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a wholesale dealer's licence for the period described in paragraph 18 or such longer period as may be required pursuant to paragraph 44 of Schedule 4.

20

The licence holder must not import or export any exempt advanced therapy medicinal product.

SCHEDULE 7 — Qualified persons

PART 1 — Qualification requirements for qualified person

1

A person must satisfy the requirements in paragraphs 2 and 8 or, alternatively, the requirements in paragraphs 7 and 8, of this Schedule before acting as a qualified person (but this is subject to Part 2).

2

The person must have a degree, diploma or other formal qualification which satisfies the requirements of this Part, in one of the following subjects—

(a) pharmacy;

(b) medicine;

(d) chemistry;

(e) pharmaceutical chemistry and technology; or

(f) biology,

but this paragraph is subject to paragraph 7.

3

A qualification satisfies the requirements of this Part if it is awarded on completion of a university course of study, or a course recognised as equivalent by the licensing authority, which—

(a) satisfies the minimum requirements specified in paragraph 4; and

(b) extends over a period of at least four years of theoretical and practical study of a subject specified in paragraph 2 (but this is subject to paragraphs 5 and 6).

4

(1) A course should include at least the following core subjects—

(a) experimental physics;

(b) general and inorganic chemistry;

(d) analytical chemistry;

(e) pharmaceutical chemistry, including analysis of medicinal products;

(f) general and applied medical biochemistry;

(g) physiology;

(h) microbiology;

(i) pharmacology;

(j) pharmaceutical technology;

(k) toxicology; and

(l) pharmacognosy.

(2) The subjects mentioned in sub-paragraph (1) should be balanced in such a way as to enable the person to fulfil the obligations specified in Part 3 of this Schedule.

5

If the course referred to in paragraph 3 is followed by a period of theoretical and practical training of at least one year, including a training period of at least six months in a pharmacy open to the public and a final examination at university level, the minimum duration of the course is three and a half years.

6

If two university courses, or courses recognised as of university equivalent standard, co-exist, one of which extends over four years and the other over three years, the three-year course is to be treated as fulfilling the condition as to the duration of the course in paragraph 3, provided that the licensing authority recognises the formal qualifications gained from each course as being equivalent.

7

If the person's formal qualifications do not satisfy the requirements of this Part, the person may act as a qualified person if the licensing authority is satisfied, on the production of evidence, that the person has adequate knowledge of the subjects specified in paragraph 4(1).

8

(1) The person must (subject to sub-paragraph (2)) have at least two years' practical experience in an undertaking authorised to manufacture medicinal products of—

(a) qualitative analysis of medicinal products;

(b) quantitative analysis of active substances; and

(2) But—

(a) if the person has completed a university course lasting at least five years, the minimum period of practical experience under this paragraph is one year; and

(b) if the person has completed a university course lasting at least six years, the minimum period of practical experience under this paragraph is six months.

PART 2 — Qualified persons with long experience

9

(1) This paragraph applies to a person who has acted as a qualified person since the coming into force of Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products .

(2) A person to whom this paragraph applies may continue to act as a qualified person.

10

(1) This paragraph applies to a person who—

(a) holds a degree, diploma or other formal qualification in a scientific discipline awarded on completion of a university course or course recognised as equivalent; and

(b) began the course before 21 May 1975.

(2) A person to whom this paragraph applies may act as a qualified person provided that sub-paragraph (3) (and, where applicable, paragraph 11) is satisfied.

(3) This sub-paragraph is satisfied if, for at least two years before 21 May 1985, the person has carried out one of the following activities in an undertaking authorised to manufacture medicinal products—

(a) production supervision;

(b) qualitative and quantitative analysis of active substances; or

(c) testing and checking, under the direct supervision of the qualified person in respect of the undertaking, to ensure the quality of the medicinal products.

11

If a person to whom paragraph 10 applies acquired the practical experience mentioned in paragraph 10(3) before 21 May 1965, the person must complete a further one year's practical experience of the kind specified in that paragraph immediately before the person may act as a qualified person.

PART 3 — Obligations of qualified person

12

(1) In Great Britain, the qualified person is responsible for securing—

(a) that each batch of medicinal products manufactured in Great Britain has been manufactured and checked in accordance with these Regulations and the requirements of the UK marketing authorisation, certificate of registration or traditional herbal registration , or an equivalent authorisation, relating to those products; ... and

(b) in the case of medicinal products imported from a country other than approved country for import, irrespective of whether the products have been manufactured in the United Kingdom or an approved country for import, that each batch has undergone—

(i) a full qualitative analysis,

(ii) a quantitative analysis of all the active substances, and

(iii) all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the UK marketing authorisation, certificate of registration or traditional herbal registration , or an equivalent authorisation, relating to those products; and

(2) In this paragraph “equivalent authorisation” means, in respect of a medicinal product that does not have a UK marketing authorisation, certificate of registration or traditional herbal registration, such equivalent authorisation or registration granted by an appropriate authority for the licensing of medicinal products in an approved country for import.

13

(1) This paragraph applies in Northern Ireland where—

(a) a medicinal product which has undergone the controls referred to in paragraph 12A in a member State is imported to Northern Ireland; and

(b) each batch of the product is accompanied by control reports signed by another qualified person in respect of the medicinal product.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12A.

14

(1) This paragraph applies where—

(a) medicinal products are imported into Great Britain from a country other than an approved country for import or into Northern Ireland from a country other than an EEA State; and

(b) appropriate arrangements have been made, in the case of import into Great Britain by the licensing authority with the country from which those products are imported and, in the case of a product for import into Northern Ireland by the European Union with that country, to ensure that—

(i) the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down—

(aa) in the case of a product for sale or supply in Great Britain, in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17, and

(bb) in the case of a product for sale or supply in Northern Ireland, by the European Union;

(ii) the controls referred to in paragraph 12(b) or 12A(b) (as appropriate) have been carried out in that country.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12 or 12A.

(3) The licensing authority must publish a list of the countries with whom it has made appropriate arrangements under sub-paragraph (1)(b) (“approved country for batch testing list”).

(4) A country may be included in the approved country for batch testing list subject to any condition or restriction that the licensing authority considers appropriate, including as to categories of medicinal product, and any such condition or restriction must be included in the list.

(5) In order to satisfy itself of the matters specified in sub-paragraph (1)(b)(i) and (ii), the licensing authority may, in particular, take into account—

(a) the country's rules for good manufacturing practice;

(b) the regularity of inspections to verify compliance with good manufacturing practice;

(d) the regularity and rapidity of information provided by that country relating to non-compliant manufacturers;

(e) any on-site review of that country's regulatory system undertaken by the licensing authority;

(f) any on-site inspection of a manufacturing site in that country observed by the licensing authority;

(g) any other relevant documentation available to the licensing authority.

(6) The licensing authority must—

(a) review any appropriate arrangements it has made under sub-paragraph (1)(b) to determine if that country still satisfies the requirements of sub-paragraph (1)(b)(i) and (ii), and whether any condition or restriction in those arrangements remains appropriate;

(b) if it is not so satisfied, remove that country from the approved country for batch testing list or, as the case may be, amend or remove that condition or restriction; and

(c) undertake such a review at least every three years beginning with the date on which the country is included in that list.

15

(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.

(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.

SCHEDULE 8 — Material to accompany an application for a UK marketing authorisation

PART 1 — General requirements

1

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

2

The name of the medicinal product. This may be—

(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—

(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.

5

A description of the methods of manufacturing the medicinal product.

6

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

7

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

8

The reasons for any precautionary and safety measures to be taken for—

(a) the storage of the medicinal product;

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

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.

10

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

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

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

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.

12

A summary of the applicant's pharmacovigilance system which shall include the following elements—

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

(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;

(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

(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.

13

The risk management plan, together with a summary, that—

(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.

15

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

16

(1) Subject to sub-paragraph (2), a mock-up, in accordance with Part 13 (packaging and leaflets) of—

(a) the outer packaging of the medicinal product;

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

(2) Sub-paragraph (1)(a) and (b) does not apply to an application for a marketing authorisation for a POC medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture.

17

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

18

Where—

(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) ... 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.

19

Where an authorisation for the medicinal product to be placed on the market has been granted by , 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—

(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

20

Where , 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—

(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.

21

Where an authorisation for the medicinal product to be placed on the market has been refused—

(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.

22

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 together with a copy of the relevant Agency opinion.

PART 2 — Summary of the product characteristics

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

SCHEDULE 9 — Undertakings by non- United Kingdom manufacturers

1

The manufacturer must provide and maintain such staff, premises and plant as are necessary for the carrying out in accordance with the UK marketing authorisation of such stages of the manufacture and assembly of the medicinal products to which the authorisation relates as are undertaken by the manufacturer.

2

The manufacturer must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the medicinal products to which the UK marketing authorisation relates and which the manufacturer handles, stores or distributes as are necessary to avoid deterioration of the medicinal products.

3

The manufacturer must provide and maintain a designated quality control department having authority in relation to quality control and being independent of all other departments.

4

The manufacturer must conduct all manufacture and assembly operations in such a way as to ensure that the medicinal products to which the UK marketing authorisation relates conform with the standards of strength, quality and purity applicable to them under the UK marketing authorisation.

5

The manufacturer must maintain an effective pharmaceutical quality assurance system involving the active participation of the management and personnel of the different services involved.

6

Where animals are used in the production of any medicinal product and the UK marketing authorisation contains provisions relating to them the manufacturer must arrange for the animals to be housed in premises of such a nature and to be managed in such a way as will facilitate compliance with such provisions.

7

The manufacturer must make such adequate and suitable arrangements as are necessary for carrying out in accordance with the UK marketing authorisation any tests of the strength, quality or purity of the medicinal products to which the UK marketing authorisation relates.

8

The manufacturer must inform the holder of the UK marketing authorisation of any material alteration in the premises or plant used in connection with the manufacture or assembly of the medicinal products to which the UK marketing authorisation relates or in the operations for which such premises or plant are so used, and of any change since the granting of the relevant UK marketing authorisation in respect of any person—

(a) responsible for supervising the production operations;

(b) responsible for quality control of the medicinal products to which the UK marketing authorisation relates;

(c) in charge of the animals from which are derived any substance used in the production of the medicinal products to which the UK marketing authorisation relates; or

(d) responsible for the culture of any living tissues used in the manufacture of the medicinal products to which the UK marketing authorisation relates.

9

(1) The manufacturer shall keep readily available for inspection by a person authorised by the licensing authority durable records of—

(a) the details of manufacture and assembly of each batch of the medicinal product to which the UK marketing authorisation relates; and

(b) the tests carried out on the product,

in such a form that the records will be easily identifiable from the number of the batch as shown on each container in which the medicinal product is exported from the country where it has been manufactured or assembled.

(2) The manufacturer shall permit the person authorised to take copies of or make extracts from such records.

(3) Such records shall not be destroyed for a period of five years from the date of release of the batch concerned, or one year after the expiry date of the batch, whichever is the later.

10

The manufacturer must keep readily available for examination by a person authorised by the licensing authority samples of—

(a) each batch of finished products for at least a period of one year after their expiry date; and

(b) starting materials (other than solvents, gases or water) for at least a period of two years after release of the medicinal product of which those materials formed part,

except where the manufacturer is authorised by the licensing authority to destroy such samples earlier.

11

(1) The manufacturer must implement a system for recording and reviewing complaints in relation to medicinal products to which a UK marketing authorisation relates, together with an effective system for recalling promptly and at any time the medicinal products in the distribution network.

(2) The manufacturer must record and investigate all complaints described in sub-paragraph (1) and must immediately inform the licensing authority of any defect which could result in a recall from sale, supply or export or in an abnormal restriction on such sale, supply or export.

12

The manufacturer must inform the holder of the UK marketing authorisation of any material change since the day upon which the authorisation was granted in respect of—

(a) the facilities and equipment available at each of the premises of the manufacturer for carrying out any stage of the manufacture or assembly of the medicinal products to which the UK marketing authorisation relates;

(b) the facilities and equipment available at each of the premises of the manufacturer for the storage of the medicinal products to which the UK marketing authorisation relates on, and the distribution of the products from or between, such premises;

(c) any manufacturing operations, not being operations in relation to the medicinal products to which the UK marketing authorisation relates, which are carried on by the manufacturer on or near any of the premises on which medicinal products to which the UK marketing authorisation relates are manufactured or assembled, and the substances or articles in respect of which such operations are carried on;

(d) the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly of the medicinal products to which the UK marketing authorisation relates and the arrangements for the storage of the products after they have been manufactured or assembled;

(e) the arrangements for ensuring a satisfactory turnover of stocks of medicinal products to which the UK marketing authorisation relates;

(f) the arrangements for maintaining production records and records of analytical and other testing procedures applied in the course of manufacture or assembly of the medicinal products to which the UK marketing authorisation relates; or

(g) the arrangements for keeping reference samples of materials used in the manufacture of the medicinal products to which the UK marketing authorisation relates and reference samples of the medicinal products themselves.

SCHEDULE 10 — National homoeopathic products

Meaning of “national homoeopathic product”

1

(1) In this Schedule “national homoeopathic product” means a homoeopathic medicinal product that—

(a) is not a registrable homoeopathic medicinal product; and

(b) is indicated for the relief or treatment of minor symptoms or minor conditions in human beings.

(2) For this purpose symptoms or conditions are minor if they can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.

General requirements for application

2

(1) An application for the grant of a UK marketing authorisation for a national homoeopathic product does not need be made in accordance with, and an applicant for such an authorisation does not need to comply with—

(a) paragraphs (b) and (c) of paragraph 10 of Schedule 8 (requirement to submit results of pre-clinical tests and clinical trials);

(b) the guidance referred to in paragraph (1) in the “Introduction and general principles” of Annex 1 to the 2001 Directive in so far as it relates to the requirement to submit the results of pre-clinical tests and clinical trials; or

(i) sections 2.4 to 2.7 (non-clinical and clinical overview and non-clinical and clinical summaries),

(ii) section 4 (Module 4: non-clinical reports), or

(iii) section 5 (Module 5: clinical study reports).

(2) The applicant must submit with the application—

(a) particulars and documents relating to the safety of the product in accordance with paragraph 3 (subject to paragraph 4); and

(b) particulars and documents relating to the efficacy of the product in accordance with paragraph 5.

(3) References in Annex 1 to the 2001 Directive to non-clinical reports, non-clinical documentation and non-clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 3.

(4) References in that Annex to clinical study reports, clinical documentation and clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 5.

Requirement to submit safety data

3

(1) The applicant must submit data as to the safety of the product unless paragraph 4 applies.

(2) The data must include information about the following aspects of the safety of the product—

(a) pharmacology;

(b) pharmacokinetics; and

(3) The data must be scientific data unless sub-paragraph (5) applies.

(4) For this purpose “scientific data” means—

(a) study reports in relation to the product;

(b) published scientific data; or

(5) The applicant may submit other data in relation to an aspect of the safety of the product if having made reasonable attempts to obtain scientific data in relation to that aspect—

(a) the applicant is satisfied that no such scientific data is available; or

(b) the applicant thinks that such scientific data as is available may be inadequate to demonstrate an acceptable level of safety in relation to that aspect.

(6) The applicant must include with the data—

(a) a table of contents; and

(b) an evaluation of the scientific data, including an explanation of how it demonstrates an acceptable level of safety.

(7) If the applicant submits data other than scientific data, the applicant must include—

(a) a statement that sub-paragraph (5) applies; and

(b) an explanation of why an acceptable level of safety can be demonstrated despite the lack of scientific data.

Exceptions to requirement to submit safety data

4

(1) The applicant does not need to submit data as to the safety of the product if—

(a) condition A, B or C is met; and

(b) the application is accompanied by a written statement that the condition is met.

(2) Condition A is that the product—

(a) is derived from a homoeopathic stock that is commonly present in food; and

(b) is intended to be administered orally.

(3) For this purpose “food” has the meaning given by Council Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety .

(4) Condition B is that—

(a) the product is derived from a homoeopathic stock from which is derived a medicinal product that has a UK marketing authorisation, certificate of registration or traditional herbal registration (“the source product”);

(b) the source product is subject to general sale within the meaning of regulation 5(1); and

(5) Condition C is that the product is derived from a homoeopathic stock that—

(a) is diluted to at least 1 in 10²⁴ of the stock; and

(b) is not a material derived from a human or animal source.

Requirement to submit efficacy data

5

(1) The applicant must submit data as to the efficacy of the product.

(2) The data must consist of at least one the following—

(a) study reports in relation to the product;

(b) published scientific literature; or

(c) the results of investigations (commonly known as homoeopathic provings) consisting of the administration of a substance to a human subject to ascertain the symptoms it produces.

(3) The applicant must include with the data—

(a) a table of contents; and

(b) an evaluation of the data, including an explanation of how the data establishes that the product has a recognised level of efficacy in the therapeutic indication for which authorisation is sought.

SCHEDULE 11 — Advice and representations

PART 1 — General procedures

Application of this Part

1

(1) This Part of this Schedule applies to—

(a) an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration;

(b) an application to renew a UK marketing authorisation, certificate of registration or traditional herbal registration; ...

(c) a proposal to revoke, vary or suspend a UK marketing authorisation, certificate of registration or traditional herbal registration (including variation by the variation or removal of a condition to which a UK marketing authorisation or a certificate of registration is subject) other than a proposal to vary the authorisation, certificate or registration on the application of or by agreement with its holder ; and

(d) a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.

(1A) Paragraphs 12 and 13 of this Part also apply to—

(a) an application for the grant of a parallel import licence;

(b) an application to renew a parallel import licence;

(c) a proposal to revoke, vary or suspend a parallel import licence (including variation by the variation or removal of a condition to which a parallel import licence is subject) other than a proposal to vary the licence on the application of or by agreement with its holder; and

(d) a refusal to vary a parallel import licence following an application for a variation by the holder.

(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.

Requirement to consult the appropriate committee

2

(1) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety, quality or efficacy—

(a) to refuse to grant or renew a UK marketing authorisation or traditional herbal registration in response to the application; or

(b) to revoke, vary or suspend a UK marketing authorisation or traditional herbal registration.

(2) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety or quality—

(a) to refuse to grant or renew a certificate of registration in response to the application; or

(b) to revoke, vary or suspend a certificate of registration.

(2A) The licensing authority must consult the appropriate committee if the authority proposes to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.

(3) This paragraph is subject to paragraphs 3 and 4 (exceptions to requirement to consult).

(4) In this Schedule “the appropriate committee” in relation to any function means whichever of the bodies listed in paragraph (5) the licensing authority considers to be the appropriate body to perform that function.

(5) Those bodies are—

(a) the Commission; and

(b) any expert committee appointed by the licensing authority.

Exceptions to requirement to consult

3

(1) Paragraph 2 does not apply to a proposal to refuse to grant or renew a UK marketing authorisation, certificate of registration or traditional herbal registration , or to a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation, if—

(a) the licensing authority has asked the applicant to supply information that the licensing authority thinks is relevant to enable the application to be determined or the decision to be made; and

(b) the information has not been supplied to the authority within the relevant period.

(2) The relevant period is—

(a) where the licensing authority has completed its initial full assessment of the application, the period of six months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1); or

(b) where the licensing authority has completed its assessment of any supplemental information, the period of three months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1).

(3) The licensing authority may extend the relevant period if—

(a) the applicant asks it to do so;

(b) the applicant provides the grounds for that request; and

4

(1) Paragraph 2 does not apply to a proposal to suspend a UK marketing authorisation, certificate of registration or traditional herbal registration if the licensing authority thinks that, in the interests of safety, it is necessary to suspend the authorisation, certificate or registration with immediate effect for not more than three months.

(2) In that event the licensing authority must report the suspension to the appropriate committee forthwith.

(3) Sub-paragraph (4) applies if, following a suspension to which this paragraph applies—

(a) the licensing authority thinks that the authorisation, certificate or registration should be further suspended, or varied or revoked; or

(b) the appropriate committee advises that the authorisation, certificate or registration should be further suspended, or varied or revoked.

(4) The provisions of this Part of this Schedule (including this paragraph) apply accordingly to the suspension, variation or revocation.

Provisional opinion against authorisation

5

(1) If the appropriate committee is consulted under paragraph 2(1) it may give a provisional opinion that on grounds relating to safety, quality or efficacy—

(a) it may be unable to advise the licensing authority to grant or renew the UK marketing authorisation or traditional herbal registration;

(b) it may be unable to advise the licensing authority to grant the authorisation or registration unless—

(i) it contains terms other than those in the application, or

(ii) it is granted subject to conditions; or

(2) If the Commission is consulted under paragraph 2(2), it may give a provisional opinion that, on grounds relating to safety or quality—

(a) it may be unable to advise the licensing authority to grant or renew the certificate of registration;

(b) it may be unable to advise the licensing authority to grant the certificate unless—

(i) it contains terms other than those in the application, or

(ii) it is granted subject to conditions; or

(2A) If the appropriate committee is consulted under paragraph 2(2A), it may give a provisional opinion that it may be unable to advise the licensing authority to decide that the orphan criteria are met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.

(3) The appropriate committee must notify the applicant for the grant or renewal , the applicant intending to demonstrate that the orphan criteria are met in relation to a medicinal product, or (as the case may be) the holder of the authorisation, certificate or registration in writing of its provisional opinion.

Opportunity to make representations

6

(1) An applicant or holder notified under paragraph 5 may, by notice in writing to the appropriate committee, request the opportunity to make written or oral representations to the appropriate committee.

(2) The applicant or holder must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

Written representations

7

(1) If the applicant or holder requests the opportunity to make written representations, the applicant or holder must provide the appropriate committee with those representations and any documents on which the applicant or holder wishes to rely in support of them—

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representations

8

(1) If the applicant or holder requests the opportunity to make oral representations, the applicant or holder must provide the appropriate committee with a written summary of those representations and any documents on which the applicant or holder wishes to rely in support of them—

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant or holder to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committee

9

(1) This paragraph applies if the applicant or holder—

(a) does not request the opportunity to make written or oral representations to the appropriate committee within the period mentioned in paragraph 6;

(b) requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(i) fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii) fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority

10

(1) After receiving the appropriate committee's report under paragraph 7 or 8 or notification under paragraph 9 the licensing authority must—

(a) decide whether to grant or renew the UK marketing authorisation, certificate of registration or traditional herbal registration;

(b) decide whether to grant or renew the authorisation, certificate or registration in accordance with the application; ...

(c) decide whether to proceed with its proposal to revoke, vary or suspend the authorisation, certificate or registration ; or

(d) decide whether to proceed with its proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,

as the case may be.

(2) If the appropriate committee has given a report under paragraph 7 or 8, the licensing authority must take the report into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a) its decision; and

(b) any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 10 notification

11

(1) A person to whom a notification is given under paragraph 10 may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(2) The person must give the notification within the period of 28 days beginning with the day on which the notification under paragraph 10 is given or such longer period as the licensing authority may allow.

(3) The review must be conducted in accordance with Schedule 5.

(4) This paragraph does not apply if—

(a) the person has not made any representations in accordance with paragraph 7 or 8; and

(b) the decision of the licensing authority is in accordance with the advice of the appropriate committee.

Licensing authority decisions in other cases

12

(1) This paragraph applies if the appropriate committee has not been consulted under paragraph 2(1) because the licensing authority proposes on grounds not relating to safety, quality or efficacy—

(a) to refuse to grant or renew a UK marketing authorisation , parallel import licence or traditional herbal registration in response to the application;

(b) to grant or renew a UK marketing authorisation , parallel import licence or traditional herbal registration otherwise than in accordance with the application; or

(c) to revoke, vary or suspend a UK marketing authorisation , parallel import licence or traditional herbal registration.

(2) This paragraph also applies if, having been consulted under paragraph 2(1), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(1), and the licensing authority proposes—

(a) to determine the application for the UK marketing authorisation or traditional herbal registration in a way that differs from the appropriate committee's advice;

(b) to revoke, vary or suspend the authorisation or registration against such advice; or

(i) to refuse to grant or renew the authorisation or registration,

(ii) to grant or renew the authorisation or registration otherwise than in accordance with the application, or

(iii) to revoke, vary or suspend the authorisation or registration.

(3) This paragraph also applies if the appropriate committee has not been consulted under paragraph 2(2) because the licensing authority proposes on grounds not relating to safety or quality—

(a) to refuse to grant or renew a certificate of registration in response to the application;

(b) to grant or renew a certificate of registration otherwise than in accordance with the application; or

(4) This paragraph also applies if, having been consulted under paragraph 2(2), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2), and the licensing authority proposes—

(a) to determine the application for the certificate of registration in a way that differs from the appropriate committee's advice;

(b) to revoke, vary or suspend the authorisation against such advice; or

(i) to refuse to grant or renew the certificate,

(ii) to grant or renew the certificate otherwise than in accordance with the application, or

(iii) to revoke, vary or suspend the certificate.

(4A) This paragraph also applies if, having been consulted under paragraph 2(2A), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2A) and the licensing authority proposes to decide, against that committee's advice, that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.

(5) The licensing authority must notify the applicant for the grant or renewal or (as the case may be) the holder of the authorisation , licence, certificate or registration in writing of its proposal.

(6) The notification must state—

(a) the reasons for the proposal; and

(b) any advice of the appropriate committee and any reasons it has given for that advice.

Right to review or representations after paragraph 12 notification

13

(1) A person to whom a notification is given under paragraph 12 may—

(a) notify the licensing authority in writing that the person wishes the licensing authority to submit the proposal to review upon oral representations, or

(b) make representations in writing to the licensing authority with respect to the proposal.

(2) The person must give the notification or make the representations within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(3) A review in accordance with sub-paragraph (1)(a) must be conducted in accordance with Schedule 5.

(4) If the person makes written representations in accordance with sub-paragraph (1)(b) the licensing authority must take them into account before determining the matter.

PART 2 — Type II variation applications, complex variation applications and new excipient variation applications

Application of this Part

14

This Part applies—

(a) to an application (a “Type II variation application”) to vary a UK marketing authorisation if the variation is a major variation of Type II within the meaning of Article 2(3) of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products or paragraph 1 of Schedule 10A; and

(b) to an application to vary a traditional herbal registration that is—

(i) a complex variation application, or

(ii) a new excipient variation application.

15

(1) In paragraph 14(b)(i) “complex variation application” means an application by the holder of the registration to vary it so that one or more of the following changes can be made to the product to which it relates—

(a) a change in the product's active ingredients by the addition of an active ingredient from a new source;

(b) a change in the product's excipients by the addition of a TSE risk excipient from a new source; or

(c) a change by the addition of a vitamin or mineral from a new source, where no European Pharmacopoeia certificate of suitability for the vitamin or mineral is submitted with the application.

(2) For the purpose of sub-paragraph (1), an ingredient, vitamin or mineral is “from a new source” if its manufacturer as named in the application has not been named as its manufacturer in a UK marketing authorisation or traditional herbal registration granted for a medicinal product including the ingredient, vitamin or mineral.

(3) For the purpose of sub-paragraph (1), an excipient is a “TSE risk excipient from a new source” if—

(a) it has been manufactured from raw materials of ruminant origin or such raw materials have been used in its manufacture; and

(b) its manufacturer as named in the application has not been named as its manufacturer in a UK marketing authorisation or traditional herbal registration granted for a medicinal product that includes the excipient.

16

(1) In paragraph 14(b)(ii) “new excipient variation application” means an application (other than a complex variation application) by the holder of the registration to vary it so that the formulation of the medicinal product to which it relates can be changed by the addition of a new excipient.

(2) For the purpose of sub-paragraph (1) “new excipient” means, subject to paragraphs (3) and (4), an ingredient of a medicinal product that is not an active ingredient and that has not been included in a medicinal product—

(a) intended to be administered by the same route as the product to which the application relates; and

(b) for which a UK marketing authorisation (other than a product licence of right) or traditional herbal registration has been granted.

(3) In the application of sub-paragraph (1) to a medicinal product intended to be administered orally, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in food or in a food product.

(4) In the application of sub-paragraph (1) to a medicinal product intended for external use only, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in a cosmetic product.

(5) In this paragraph “enactment” includes an enactment comprised in subordinate legislation ....

17

In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.

Opportunity to make representations

18

(1) This paragraph applies if the licensing authority notifies the applicant for a variation to which this Part applies that it has decided, on grounds relating to safety, quality or efficacy—

(a) to refuse to grant the application, or

(b) to grant it otherwise than in accordance with the application.

(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.

Written representations

19

(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representations

20

(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committee

21

(1) This paragraph applies if the applicant—

(a) requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b) requests the opportunity to make oral representations, but—

(i) fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii) fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority following report

22

(1) After receiving the appropriate committee's report under paragraph 19 or 20 or notification under paragraph 21 the licensing authority must confirm or alter its decision.

(2) If the appropriate committee gives a report under paragraph 19 or 20, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a) its decision; and

(b) any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 22 notification

23

(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 22—

(a) to refuse the application; or

(b) to grant it otherwise than in accordance with the application.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 19 or 20.

PART 3 — Referral to the appropriate committee for traditional herbal registrations

Application of this Part

24

(1) This Part applies if the licensing authority proposes to refer an application for a traditional herbal registration to the appropriate committee in accordance with regulation 130A(1).

(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.

Opportunity to make representations

25

(1) The licensing authority must notify the applicant of the authority's proposal.

(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.

Written representations

26

(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 25.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 25.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representations

27

(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 25.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 24.

(3) The applicant may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the appropriate committee.

(5) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committee

28

(1) This paragraph applies if the applicant—

(a) requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b) requests the opportunity to make oral representations, but—

(i) fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii) fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority following report

29

(1) After receiving the appropriate committee's report under paragraph 26 or 27 or notification under paragraph 28 the licensing authority must decide whether to grant or refuse the application.

(2) If the appropriate committee gives a report under paragraph 26 or 27, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a) its decision; and

(b) any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 29 notification

30

(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 29 to refer the applicant to the Committee on Herbal Medicinal Products as proposed.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the licensing authority's notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 26 or 27.

PART 4 — Exceptions to Schedule

31

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

This Schedule does not apply to an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration if the application has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive.

33

This Schedule ceases to apply if at any time the matter in question is referred to the Committee for Medicinal Products for Human Use or the Committee for Herbal Medicinal Products under Article 30 or 31 of the 2001 Directive for the application of the procedure laid down in Articles 32 to 34 of that Directive.

34

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

36

This Schedule does not apply if the application or proposal relates to the renewal, revocation, suspension or variation of a UK marketing authorisation that—

(a) was granted in accordance with the provisions of Chapter 4 of Title III to the 2001 Directive (mutual recognition procedure and decentralised procedure);

(b) was granted before 1st January 1995 by member States in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology ; or

(c) was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the authorisation.

37

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

38

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39

This Schedule does not apply if—

(a) the licensing authority refuse to grant an application for a traditional herbal registration;

(b) the application was referred to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive; and

SCHEDULE 12 — Material to accompany an application for a traditional herbal registration

PART 1 — General requirements

1

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

2

The name of the medicinal product. This may be—

(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 holder of the traditional herbal registration.

3

Qualitative and quantitative particulars of the constituents of the medicinal product, including—

(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 or botanical name.

4

5

A description of the methods of manufacturing the medicinal product.

6

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

7

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

8

The reasons for any precautionary and safety measures to be taken for—

(a) the storage of the medicinal product;

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

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.

10

Results of pre-clinical (toxicological and pharmacological) tests in relation to the medicinal product and its constituent active substances.

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.

12

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

13

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

(a) the outer packaging of the medicinal product;

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

14

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

15

Where the medicinal product consists of a combination of one or more herbal substances and one or more herbal preparations, or the medicinal product contains one or more vitamins or minerals—

(a) data on the traditional use of the medicinal product as a whole; and

(b) if any of the medicinal product's individual active ingredients are not sufficiently known, data on the traditional use of those active ingredients.

16

Details of any authorisation or registration obtained by the applicant in a country other than the United Kingdom allowing the medicinal product to be placed on the market.

17

Details of any decision in a country other than the United Kingdom to refuse to grant an authorisation or registration allowing the medicinal product to be placed on the market, with the reasons for any such decision.

18

Bibliographical or expert evidence of the traditional use of the medicinal product or a product corresponding to the medicinal product.

19

A bibliographic review of safety data.

20

An expert report on safety.

PART 2 — Summary of the product characteristics

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

SCHEDULE 13 — Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners

Co-danthramer Capsules NPF

Co-danthramer Capsules Strong NPF

Co-danthramer Oral Suspension NPF

Co-danthramer Oral Suspension Strong NPF

Co-danthrusate Capsules

Co-danthrusate Oral Suspension NPF

Mebendazole Tablets NPF

Mebendazole Oral Suspension NPF

Miconazole Oral Gel NPF

Nystatin Oral Suspension

Nystatin Pastilles NPF

Streptokinase and Streptodornase Topical Powder NPF

Water for injections

In this Schedule “NPF” means the Nurse Prescribers’ Formulary Appendix in the British National Formulary.

SCHEDULE 14 — Prescription etc by supplementary prescribers: particulars of clinical management plan

A clinical management plan must contain the following particulars—

(a) the name of the patient to whom the plan relates;

(b) the illnesses or conditions which may be treated by the supplementary prescriber;

(c) the date on which the plan is to take effect and when it is to be reviewed by the doctor or dentist who is a party to the plan;

(d) reference to the class or description of medicinal product which may be prescribed or administered under the plan;

(e) any restrictions or limitations as to the strength or dose of any product which may be prescribed or administered under the plan, and any period of administration or use of any medicinal product which may be prescribed or administered under the plan;

(f) relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products;

(g) the arrangements for notification of—

(i) suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan, and

(ii) suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan; and

(h) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan.

SCHEDULE 15 — Requirements for specific products subject to general sale

1

A medicinal product that contains aloxiprin, aspirin or paracetamol (or, where appropriate, any combination of those substances) and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—

2

A medicinal product that contains ibuprofen and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—

SCHEDULE 16 — Patient group directions and vaccine group directions

PART 1 — Particulars to be included in a patient group direction and a vaccine group direction

1

The period during which the direction is to have effect.

2

The description or class of medicinal product to which the direction relates.

3

The clinical situations which medicinal products of that description or class may be used to treat or manage in any form.

4

Whether there are any restrictions on the quantity of medicinal product that may be sold or supplied on any one occasion and, if so, what restrictions.

5

The clinical criteria under which a person is to be eligible for treatment.

6

Whether any class of person is excluded from treatment under the direction and, if so, what class of person.

7

Whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances.

8

The pharmaceutical form or forms in which medicinal products of that description or class are to be administered.

9

The strength, or maximum strength, at which medicinal products of that description or class are to be administered.

10

The applicable dosage or maximum dosage.

11

The route of administration.

12

The frequency of administration.

13

Any minimum or maximum period of administration applicable to medicinal products of that description or class.

14

Whether there are any relevant warnings to note and, if so, what warnings.

15

Whether there is any follow up action to be taken in any circumstances and, if so, what action and in what circumstances.

16

Arrangements for referral for medical advice.

17

Details of the records to be kept of the supply, or the administration, of products under the direction.

PART 2 — Persons on whose behalf a patient group Direction must be signed

Column 1: Class of person by whom product is supplied	Column 2: Person on whose behalf direction must be signed
Common Services Agency	The Agency
Health authority	The health authority
Special health authority	The special health authority
NHS trust or NHS foundation trust	The trust
Primary Care Trust	The Trust
A person who supplies medicinal products pursuant to an arrangement made with— the Common Services Agency; a health authority; a special health authority; an NHS trust; an NHS foundation trust; or a Primary Care Trust.	The Common Services Agency (where the arrangement has been made with the Agency); otherwise the— health authority, special health authority, NHS trust, NHS foundation trust, or Primary Care Trust, with which the arrangement has been made.

PART 3 — Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed

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