Search Legislation

The Prescription Only Medicines (Human Use) Order 1997

Status:

Point in time view as at 07/02/2007. This version of this provision has been superseded. Help about Status

Close

Status

You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.

Note the term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.

Changes to legislation:

There are currently no known outstanding effects for the The Prescription Only Medicines (Human Use) Order 1997, Section 1. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997 and shall come into force on 18th August 1997.

(2) In this Order, unless the context otherwise requires–

“the Act” means the Medicines Act 1968;

[F1“additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;]

“aerosol” means a product which is dispersed from its container by a propellent gas or liquid;

[F2“clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a)

the patient to whom the plan relates,

(b)

the doctor or dentist who is a party to the plan, and

(c)

any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;]

[F3clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003;]

F4...

[F5“Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978;]

[F5“Community marketing authorization” means a marketing authorization granted by the European Community under Council Regulation (EEC) No. 2309/93 [F6or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency];]

[F7“community practitioner nurse prescriber” means a person—

(a)

who is a registered nurse or a registered midwife, and

(b)

against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for Community Practitioners in the current edition of the British National Formulary;]

“controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971(1);

“cyanogenetic substances” means preparations which–

(a)

are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17, or

(b)

contain more than 0.1 per cent by weight of any substance having the formula either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;

F8...

“dosage unit” means–

(a)

where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or

(b)

where a medicinal product is not in any such form, the unit of measurement which is used as the unit by reference to which the dose of the medicinal product is measured;

F9...

F10...

“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

F11...

[F5“Health Authority”—

(a)

in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;

(b)

in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

(c)

in relation to Northern Ireland, means a Health and Social Services Board established under Article 16 of the Health and Personal Social Services (Northern Ireland) Order 1972;]

[F12“health care” means services for or in connection with the prevention, diagnosis or treatment of disease;]

“health prescription” means a prescription issued by a doctor, dentist [F13, supplementary prescriber] , [F14a community practitioner nurse prescriber, a nurse independent prescriber or a pharmacist independent prescriber] under or by virtue of–

(a)

in England and Wales, the National Health Service Act 1977(2),

(b)

in Scotland, the National Health Service (Scotland) Act 1978(3), and

(c)

in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972(4);

[F15“health record” has the meaning given by section 68(2) of the Data Protection Act 1998(4);]

[F5“homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;]

[F16“independent clinic”—

(a)

in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000(6), and

(b)

in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;]

[F16“independent hospital”—

(a)

in relation to England and Wales, shall be construed in accordance with section 2(2), (3) and (6) of the Care Standards Act 2000, and

(b)

in relation to Scotland, means—

(i)

an independent hospital, or

(ii)

a private psychiatric hospital,

as defined by section 77(1) of the Regulation of Care (Scotland) Act 2001;]

[F16“independent medical agency”—

(a)

in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and

(b)

in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;]

“inhaler” does not include an aerosol;

[F17“IRME practitioner” means, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2000(2);]

[F18“Local Health Board” has the same meaning as in the National Health Service Act 1977;]

[F5“marketing authorization” includes a reference both to a United Kingdom marketing authorization and to a Community marketing authorization;]

“master” has the same meaning as in section 313(1) of the Merchant Shipping Act 1995(5);

“maximum daily dose” or “MDD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered in a period of 24 hours;

“maximum dose” or “MD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered at any one time;

“maximum strength” means–

(a)

the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

(b)

the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–

(i)

weight in weight,

(ii)

weight in volume,

(iii)

volume in weight, or

(iv)

volume in volume,

and if the maximum percentage calculated in those ways differs, the higher or highest such percentage;

[F19“medical exposure” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;]

“medicinal product” includes any article or substance in respect of which section 58 of the Act has effect by virtue of an order made under section 104 of the ActF20...

“the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1985(6) and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986(7);

[F5NHS trust”—

(a)

in relation to England and Wales, has the same meaning as in the National Health Service and Community Care Act 1990;

(b)

in relation to Scotland, has the same meaning as in the National Health Service (Scotland) Act 1978; and

(c)

in relation to Northern Ireland, means a Health and Social Services trust established under article 10 of the Health and Social Services (Northern Ireland) Order 1991;]

[F21“nurse independent prescriber” means a person—

(a)

who is a registered nurse or a registered midwife, and

(b)

against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent/supplementary prescriber;]

[F22NHS foundation trust” has the same meaning as in section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003;]

[F23“nursing home” has the meaning given by article 16 of the Registered Homes (Northern Ireland) Order 1992;]

“occupational health scheme” means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;

“offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971(8) which is within–

(a)

tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward limits of territorial waters;

(b)

waters in any area designated under section 1(7) of the Continental Shelf Act 1964(9);

[F24“operator”—

(a)

in relation to an aircraft, means the person for the time being having management of the aircraft, and

(b)

for the purposes of article 7B, has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;]

“parenteral administration” means administration by breach of the skin or mucous membrane;

[F5“Patient Group Direction” means—

(a)

in connection with the supply of a prescription only medicine as referred to in article 12A(2), [F2512B, 12C, 12D or 12E], a written direction relating to the supply and administration of a description or class of prescription only medicine; or

(b)

in connection with the administration of a prescription only medicine as referred to in article 12A(2), 12B or 12C, a written direction relating to the administration of a description or class of prescription only medicine,

  • and which, in the case of either (a) or (b)—

    (i)

    is signed by a doctor or dentist, and by a pharmacist; and

    (ii)

    relates to supply and administration, or to administration, to persons generally (subject to any exclusions which may be set out in the Direction);]

[F26“pharmacist independent prescriber” means a person—

(a)

who is a pharmacist, and

(b)

against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;]

“prescription only medicine” means a medicinal product of a description or falling within a class specified in article 3 of this Order;

[F5“Primary Care Trust” has the same meaning as in the National Health Service Act 1977;]

[F27“prison service” means—

(a)

in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952),

(b)

in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989), and

(c)

in relation to Northern Ireland, the Northern Ireland Department exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953);]

[F28“professional register” means the register maintained by the Nursing and Midwifery Council [F29under article 5 of] the Nursing and Midwifery Order 2001;]

“prolonged release” in relation to a medicinal product means a formulation of that product which–

(a)

is used to reduce the rate at which the active ingredient in that product is released after administration, and

(b)

is sold or supplied as a prolonged, controlled or sustained release medicinal product;

[F30“radioactive medicinal product” means a medicinal product which is, which contains or which generates a radioactive substance and which is, contains or generates that substance in order, when administered, to utilize the radiation emitted therefrom;]

[F31“registered chiropodist” means a person who is registered in Part 2 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;];

[F32“registered dietitian” means a person who is registered in Part 4 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F33“registered midwife” means a person registered in the Midwives' Part of the professional register;]

[F34“registered nurse” means a person registered in the Nurses' Part [F35or Specialist Community Public Health Nurses' Part] of the professional register;]

[F32“registered occupational therapist” means a person who is registered in Part 6 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F36“registered optometrist” means a person whose name is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989;]

[F31“registered orthoptist” means a person who is registered in Part 7 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;];

[F32“registered orthotist and prosthetist” means a person who is registered in Part 10 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F31“registered paramedic” means a person who is registered in Part 8 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F31“registered physiotherapist” means a person who is registered in Part 9 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F37“registered provider” means—

(a)

in relation to an independent hospital, an independent clinic or an independent medical agency—

(i)

in relation to England and Wales, the person who is registered under Part II of the Care Standards Act 2000 as the person carrying on the establishment or agency,

(ii)

in relation to Scotland, the person who is registered under Part 1 of the Regulation of Care (Scotland) Act 2001 as the person providing the establishment or agency, and

(b)

in relation to a nursing home, the person registered under Part III of the Registered Homes (Northern Ireland) Order 1992 as the person carrying on the nursing home, other than a manager who is to be treated as carrying on the home by virtue of article 17(2) of that order;]

[F31“registered radiographer” means a person who is registered in Part 11 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F32“registered speech and language therapist” means a person who is registered in Part 12 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;]

[F37“relevant manager” means—

(a)

in relation to an independent hospital, an independent clinic or an independent medical agency—

(i)

in relation to England and Wales—

(aa)

a person who is registered under Part II of the Care Standards Act 2000 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or

(bb)

if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person,

(ii)

in relation to Scotland, a person, other than the registered provider, who was identified as an individual who is to manage the establishment or agency on the application for registration of that establishment or agency under Part 1 of Regulation of Care (Scotland) Act 2001, and

(b)

in relation to a nursing home, the manager of the nursing home, unless they are the registered provider for that home;]

[F37“relevant register” means—

(a)

in relation to a [F38registered] nurse [F39or registered midwife], the professional register, F40...

(b)

in relation to a pharmacist, [F41Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007] or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976; F42...

(c)

[F43in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic

that register [F44; and]

(d)

[F45in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989;]]

“repeatable prescription” means a prescription which contains a direction that it may be dispensed more than once;

“sell” means sell by retail as defined in section 131 of the Act and “sale” has a corresponding meaning;

“soap” means any compound of a fatty acid with an alkali or amine;

[F5“Special Health Authority”—

(a)

in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;

(b)

in relation to Scotland, means a Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

(c)

in relation to Northern Ireland, means a Special Health and Social Services Agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990;]

F46...

F46...

[F47“Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;]

[F48“supplementary prescriber” means—

(a)

a [F49registered] nurse, F50...

(b)

a pharmacist, F51[F52...

(c)

a registered midwife,] F53...

(d)

[F54a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

radiographers diagnostic or therapeutic [F55or]]

(e)

[F56a registered optometrist, ]

against whose name is recorded in the relevant register an annotation [F57or entry] signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber [F58or, in the case of a nurse or midwife, as a nurse independent/supplementary prescriber]; ]

“supply” means supply in circumstances corresponding to retail sale as defined in section 131 of the Act;

“unit preparation” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances.

[F5“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Medicines For Human Use (Marketing Authorisations Etc.) Regulations 1994 (including a product licence having effect as such an authorization by virtue of Schedule 6 to those Regulations [F59or an authorization granted by the licensing authority in accordance with Article 126a of Directive 2001/83/EC]).]

(3) For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units of activity, those units.

(4) In this Order, unless the context otherwise requires, a reference–

(a)to a numbered section is to the section of the Act which bears that number,

(b)to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number,

(c)in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or Part of that Schedule which bears that number, and

(d)in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.

(5) In [F60Schedules 1, 2, 3A and 5]

(a)entries specified in columns 2 to 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in columns 2 to 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;

(b)the following abbreviations are used:

  • “g” for gram,

  • “iu” for international unit of activity,

  • “mcg” for microgram,

  • “mg” for milligram,

  • “ml” for millilitre.

(6) In Schedule 3, the abbreviation “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.

[F61(7) In articles 12 to [F6212E], a reference to a prescription only medicine being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a particular person, or in accordance with a Patient Group Direction, includes a reference to it being sold or supplied in accordance with such directions or such a Direction.

(8) In articles 12A and 12C, a reference to an arrangement for the supply or adminstration of prescription only medicines includes a reference to an arrangement which covers such supply or administration and other matters.

(9) In Schedule 7, Part I, a reference to treatment of a clinical situation includes a reference to any form of management of that situation.]]

Textual Amendments

F36Words in reg. 1(2) substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(a)

F41Words in art. 1(2) substituted (coming into force in accordance with art. 1(2)(3) of the amending S.I.) by The Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), Sch. 1 para. 20

(8)

1971 c. 61; section 1 was substituted by section 24 of the Oil and Gas (Enterprise) Act 1982 (c. 23).

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.

Close

See additional information alongside the content

Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources