Medicines Act 2003 (Isle of Man)

Medicines Act 2003

Published: 2014-08-01

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Medicines Act 2003

c i e
AT 4 of 2003

MEDICINES ACT 2003

Medicines Act 2003 Index

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c i e
MEDICINES ACT 2003

Index Section Page

PART 1 – DEALINGS WITH MEDICINAL PRODUCTS 7

1 Introductory..................................................................................................................... 7
2 Restrictions on dealing with medicinal products ...................................................... 8
3 Exemptions ...................................................................................................................... 9
4 General sale of medicinal products .............................................................................. 9
5 Medicinal products on prescription only .................................................................. 10
6 Regulations: general provisions ................................................................................. 10
PART 2 – CONSUMER PROTECTION 12

7 Adulteration of medicinal products ........................................................................... 12
8 Protection of purchasers of medicinal products ....................................................... 12
9 Compliance with published standards ...................................................................... 12
10 Misleading descriptions etc ......................................................................................... 15
11 Display of information on automatic machines ....................................................... 15
12 Offences .......................................................................................................................... 16
PART 3 – PROMOTION OF SALES OF MEDICINAL PRODUCTS 16

13 False or misleading advertisements and representations ....................................... 16
14 Advertisements requiring consent ............................................................................. 18
15 Regulation of advertisements and representations ................................................. 19
16 Advertisements and representations directed to practitioners .............................. 21
17 Interpretation ................................................................................................................. 22
PART 4 – ENFORCEMENT 23

18 Enforcement etc ............................................................................................................. 23
19 Rights of entry ............................................................................................................... 23
20 Power to inspect, take samples and seize goods and records ................................ 25
21 Application of sampling procedure to substance or article seized under s
20 ..................................................................................................................................... 26
22 Obstruction etc .............................................................................................................. 27
23 Analysis of samples in other cases ............................................................................. 28
Index Medicines Act 2003

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24 Liability to forfeiture .................................................................................................... 28
25 Restrictions on disclosure of information ................................................................. 29
26 Contravention due to default of other person.......................................................... 29
27 Warranty as defence .................................................................................................... 30
28 Offences in relation to warranties and certificates of analysis ............................... 31
29 Offences: general .......................................................................................................... 31
30 Presumptions ................................................................................................................ 32
PART 5 – VETERINARY MEDICINAL PRODUCTS AND ANIMAL

FEEDING STUFFS 32

31 Veterinary medicinal products ................................................................................... 32
32 Application of Parts 1 to 4 to veterinary medicinal products ................................ 33
33 Medicated animal feeding stuffs ................................................................................ 33
34 Animal feeding stuffs: enforcement .......................................................................... 34
PART 6 – PHARMACIES 35

Conduct of retail pharmacy business 35

35 Retail pharmacy business ............................................................................................ 35
36 Business carried on by individual pharmacist or firm ............................................ 36
37 Bodies corporate ........................................................................................................... 36
38 Representative of pharmacist in case of death or disability ................................... 37
39 Power to extend or modify conditions ...................................................................... 38
Registration of pharmacies 39

40 Registration of premises .............................................................................................. 39
41 Registration: supplemental ......................................................................................... 39
42 Appeals relating to registration .................................................................................. 41
43 Annual return of premises .......................................................................................... 41
Use of certain titles, descriptions and emblems 41

44 Restrictions on use of titles, descriptions and emblems ......................................... 41
45 Modification etc of restrictions under s 44................................................................ 43
Disqualification, and removal of premises from register 43

46 Power of Department to disqualify and direct removal from register ................. 43
47 Grounds for disqualification in certain cases ........................................................... 45
48 Appeal against disqualification etc ............................................................................ 45
49 Revocation of disqualification .................................................................................... 46
PART 7 – SUPPLEMENTAL 46

50 Extension of application of Act .................................................................................. 46
51 References to specified publications .......................................................................... 47
52 Regulations .................................................................................................................... 48
53 “Retail sale” and related expressions ........................................................................ 49
54 Interpretation: general ................................................................................................. 49
55 Transitional provisions, amendments and repeals.................................................. 50
56 Short title and commencement ................................................................................... 50
Medicines Act 2003 Index

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SCHEDULE 1 51

SAMPLING 51
SCHEDULE 2 55

INTERPRETATION 55
SCHEDULE 3 58

AMENDMENT OF ENACTMENTS 58
SCHEDULE 4 59

ENACTMENTS REPEALED 59
ENDNOTES 61

TABLE OF LEGISLATION HISTORY 61
TABLE OF RENUMBERED PROVISIONS 61
TABLE OF ENDNOTE REFERENCES 61

Medicines Act 2003 Section 1

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c i e
MEDICINES ACT 2003

Received Royal Assent: 8 April 2003
Passed: 8 April 2003
Commenced: See endnotes
AN ACT
to make new provision for regulating the import, manufacture, sale
and supply of and other dealings with medicinal products and veterinary
medicinal products; and for connected purposes.
PART 1 – DEALINGS WITH MEDICINAL PRODUCTS

1 Introductory

[OJ L 311, 28.11.01; OJ L 214, 24.8.93]
(1) In exercising its functions under this Part the Department of Health and
Social Care (“the Department”) shall have regard to the systems of
control of dealings with medicinal products for the time being operating
in the United Kingdom under —
(a) Directive 2001/83/EC on the Community code relating to
medicinal products for human use (“the EC code”), and any
enactment or instrument giving effect to it;
(b) Council Regulation (EEC) No 2309/93 laying down Community
procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a
European Agency for the evaluation of medicinal products (“the
EC Regulation”);
(c) the Medicines Act 1968 (an Act of Parliament) (“the UK Act”);
(d) any instrument or enactment from time to time amending or
replacing any of the instruments and enactments mentioned in
paragraphs (a), (b) and (c).1

(2) In this Act “medicinal product
” means —
(a) any substance or combination of substances presented for treating
or preventing disease in human beings; or
Section 2 Medicines Act 2003

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(b) any substance or combination of substances which may be
administered to human beings with a view to making a medical
diagnosis or to restoring, correcting or modifying physiological
functions in human beings.
(3) In this Act —
“Community authorisation
” means a marketing authorisation granted under
the EC Regulation;
“UK authorisation
” means —
(a) a marketing authorisation granted in the United Kingdom under
the Medicines for Human Use (Marketing Authorisations Etc.)
Regulations 1994 [SI1994/3144];
(b) a certificate granted in the United Kingdom under the Medicines
(Homoeopathic Medicinal Products for Human Use) Regulations
1994 [SI1994/105];
(c) a product licence granted in the United Kingdom under section 7
of the UK Act (a “product licence”);
(d) a manufacturer’s licence granted in the United Kingdom under
section 8(2) of the UK Act;
(e) a clinical trial certificate issued in the United Kingdom under
section 31 of the UK Act.
(4) The Department may by regulations amend the definitions in
subsection (3).
2 Restrictions on dealing with medicinal products

(1) The Department shall by regulations make provision for controlling,
restricting, regulating or prohibiting the following activities —
(a) selling, supplying or otherwise placing on the market any
medicinal product;
(b) manufacturing or assembling any medicinal product;
(c) distributing any medicinal product;
(d) procuring the sale, supply or placing on the market otherwise
than by sale or supply, manufacture, assembly or distribution of
any medicinal product;
(e) the import or export of any medicinal product;
(f) possessing any medicinal product, with a view to selling or
supplying it or otherwise placing it on the market.
(2) Regulations under subsection (1) may impose such requirements as the
Department considers necessary or expedient for any of the purposes
specified in subsection (3) with respect to —
(a) the labelling of containers of medicinal products;
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(b) the labelling of packages of medicinal products;
(c) the display of distinctive marks on containers and packages of
medicinal products;
(d) the supply with medicinal products of leaflets;
(e) the strength, materials, shape or other characteristics of containers
of medicinal products.
(3) The purposes referred to in subsection (2) are —
(a) securing that medicinal products are correctly described and
readily identifiable;
(b) securing that any appropriate warning or other appropriate
information or instruction is given, and that false or misleading
information is not given, with respect to medicinal products;
(c) promoting safety in relation to medicinal products; and
(d) in relation to subsection (2)(e), preserving the quality of medicinal
products.
(4) Regulations under this section —
(a) shall provide for giving effect in the Island, in such circumstances
and subject to such conditions as may be prescribed, to
Community authorisations and UK authorisations; and
(b) may provide for giving effect in the Island, subject to such
conditions as may be prescribed, to any other authorisation,
licence, consent, certificate or other document relating to any
activity mentioned in subsection (1) and granted or issued (in the
United Kingdom or elsewhere) under any EU instrument.2

3 Exemptions

(1) The Department shall by regulations provide for the exemption, in such
circumstances and subject to such conditions as are prescribed, from any
control, restriction, regulation or prohibition imposed under section 2(1),
for —
(a) prescribed activities in the course of his profession of a
practitioner;
(b) prescribed activities in a registered pharmacy, a hospital or a
health centre of, or under the supervision of, a pharmacist.
(2) The Department may by regulations provide for further exemptions, in
such circumstances and subject to such conditions as are prescribed,
from any such control, restriction, regulation or prohibition.
4 General sale of medicinal products

(1) This section applies to any medicinal product, except one which under
the terms of a Community authorisation or UK authorisation may be
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sold or supplied otherwise than by, or under the supervision of, a
pharmacist.
(2) Regulations under section 2 shall prohibit, except in such circumstances
and subject to such conditions as may be prescribed, any person, in the
course of a business carried on by him, selling by retail, offering or
exposing for sale by retail, or supplying in circumstances corresponding
to retail sale, any medicinal product to which this section applies
unless —
(a) that person is, in respect of that business, a person lawfully
conducting a retail pharmacy business;
(b) the product is sold, offered or exposed for sale, or supplied, on
premises which are a registered pharmacy; and
(c) that person, or, if the transaction is carried out on his behalf by
another person, then that other person, is, or acts under the
supervision of, a pharmacist.
(3) Subsection (2) is without prejudice to the generality of section 2, and
does not preclude the making of any other provision under that section
with respect to any medicinal product to which this section applies.
5 Medicinal products on prescription only

(1) This section applies to medicinal products which under the terms of a
Community authorisation or UK authorisation are not to be sold by retail
except in accordance with a prescription given by a person holding
specified qualifications or complying with specified conditions.
(2) Regulations under section 2 shall prohibit, except in such circumstances
and subject to such conditions as may be prescribed, any person, in the
course of a business carried on by him, selling by retail, offering or
exposing for sale by retail, or supplying in circumstances corresponding
to retail sale, a medicinal product to which this section applies unless it is
sold or supplied in accordance with a prescription given by a person
holding such qualifications, and complying with such conditions, as may
be prescribed.
(3) Subsection (2) is without prejudice to the generality of section 2, and
does not preclude the making of any other provision under that section
with respect to any medicinal product to which this section applies.
6 Regulations: general provisions

(1) Regulations under this Part may provide that any person contravening a
specified requirement of the regulations is guilty of an offence and
liable —
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(a) on summary conviction to a fine not exceeding such amount
(which shall not exceed £5,000) as may be specified in the
regulations; and
(b) if the regulations so provide, on conviction on information to
custody for a term not exceeding 2 years or to a fine, or to both.
(2) Regulations under this Part may —
(a) require —
(i) as a condition for carrying on any activity to which the
regulations relate, or
(ii) as a condition for any exemption conferred under section 3,
any person to be entered in a register kept, or the holder of a
licence or certificate issued, by a prescribed person or authority
for the purpose of the regulations, or any premises to be entered
in a register so kept;
(b) impose conditions in respect of the entry or retention of persons
or premises in such a register, or the issue of such a licence or
certificate, including conditions requiring the payment of fees;
(c) make provision as to —
(i) applications for entry or retention in such a register, or the
issue or renewal of such a licence or certificate,
(ii) the making of entries in the register or the issue of such a
licence or certificate,
(iii) the duration, renewal, suspension and revocation of
registration, licences or certificates;
(iv) reviews of, and appeals to a prescribed authority against,
any decision relating to registration, licences or certificates.
(3) Before making any regulations under this Part the Department shall
consult —
(a) any profession appearing to the Department to be substantially
affected by the regulations, and
(b) such organisations as appear to the Department to be
representative of other interests likely to be substantially affected
by the regulations;
and section 41 of the National Health Service Act 2001 applies to
consultations under paragraph (a) as it applies to consultations for the
purposes of that Act.
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PART 2 – CONSUMER PROTECTION

7 Adulteration of medicinal products

No person shall —
(a) add any substance to, or abstract any substance from, a medicinal
product so as to affect injuriously the composition of the product,
with intent that the product shall be sold or supplied in that state;
or
(b) sell or supply, or offer or expose for sale or supply, or have in his
possession for the purpose of sale or supply, any medicinal
product whose composition has been injuriously affected by the
addition or abstraction of any substance.
8 Protection of purchasers of medicinal products

(1) No person shall, to the prejudice of the purchaser, sell any medicinal
product which is not of the nature or quality demanded by the
purchaser.
(2) No person shall sell or supply, in pursuance of a prescription given by a
practitioner, any medicinal product which is not of the nature or quality
specified in the prescription.
(3) Subsection (1) or (2) shall not be taken to be contravened by reason only
that a medicinal product contains some extraneous matter, if it is proved
that the presence of that matter was an inevitable consequence of the
process of manufacture of the product.
(4) Subsection (1) or (2) shall not be taken to be contravened by reason only
that a substance has been added to, or abstracted from, the medicinal
product, if it is proved that —
(a) the addition or abstraction was not carried out fraudulently, and
did not injuriously affect the composition of the product; and
(b) the product was sold having attached to it, or to a container or
package in which it was sold, a conspicuous notice of adequate
size and legibly printed, specifying the substance added or
abstracted.
(5) For the purposes of this section, the sale of a medicinal product shall not
be taken to be otherwise than to the prejudice of the purchaser by reason
only that the purchaser buys the product for the purpose of analysis or
examination.
9 Compliance with published standards

(1) No person shall, in the course of a business carried on by him —
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(a) sell a medicinal product which has been demanded by the
purchaser by, or by express reference to, a particular name; or
(b) sell or supply a medicinal product in pursuance of a prescription
given by a practitioner in which the product required is described
by, or by express reference to, a particular name,
if that name is, or is an approved synonym for, a name at the head of the
relevant monograph and the product does not comply with the standard
specified in that monograph.
(2) No person shall, in the course of a business carried on by him, sell or
supply a medicinal product which, in the course of that business, has
been offered or exposed for sale and has been so offered or exposed for
sale by, or by express reference to, a particular name, if that name is, or is
an approved synonym for, a name at the head of the relevant monograph
and the product does not comply with the standard specified in that
monograph.
(3) Where a medicinal product is sold or supplied in the circumstances
specified in subsection (1) or (2), and the name in question is the name,
not of the product itself, but of an active ingredient of the product, then,
for the purposes of the subsection in question, the product shall be taken
not to comply with the standard specified in the relevant monograph if,
in so far as it consists of that ingredient, it does not comply with the
standard so specified.
(4) Subject to subsection (7), in this section —
“publication” means —
(a) the European Pharmacopoeia,
(b) the British Pharmacopoeia,
(c) the British Pharmaceutical Codex, or
(d) any compendium published under Part VII of the UK Act;
“the relevant monograph”, in relation to the sale or supply of a medicinal
product which has been demanded, described in a prescription, or
offered or exposed for sale, by or by express reference to a particular
name —
(a) if, together with that name, there was specified a particular
edition of a particular publication, means the monograph (if any)
headed by that name, or by a name for which it is an approved
synonym, in that edition of that publication, or, if there is no such
monograph in that edition, means the appropriate current
monograph (if any) headed by that name;
(b) if, together with that name, there was specified a particular
publication, but not a particular edition of that publication, means
the monograph (if any) headed by that name in the current
edition of that publication, or, if there is no such monograph in
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that edition, means the appropriate current monograph (if any)
headed by that name or by a name for which it is an approved
synonym, or, in default of such a monograph, means the
monograph headed by that name or by a name for which it is an
approved synonym in the latest edition of the specified
publication which contained a monograph so headed;
(c) if no publication was specified together with that name, means
the appropriate current monograph (if any);
“current” means current at the time when the medicinal product in question is
demanded, described in a prescription, or offered or exposed for sale, as
mentioned in subsection (1) or (2).
(5) In this section “the appropriate current monograph”, in relation to a
particular name, means —
(a) the monograph (if any) headed by that name, or by a name for
which it is an approved synonym, in the current edition of the
European Pharmacopoeia; or
(b) if there is no such monograph, then the monograph (if any)
headed by that name in the current edition of the British
Pharmacopoeia; or
(c) if there is no such monograph, then the monograph (if any)
headed by that name in the current edition of a compendium
published under Part VII of the UK Act; or
(d) if there is no such monograph, then the monograph (if any)
headed by that name in the current edition of the British
Pharmaceutical Codex.
(6) Subject to subsection (7), for the purposes of this section an edition of a
publication —
(a) if it is the current edition of that publication, shall be taken as it is
for the time being in force (that is to say, together with any
amendments, additions and deletions made to it up to the time
referred to in subsection (4)); or
(b) if it is an edition previous to the current edition of that
publication, shall be taken as it was immediately before the time
when it was superseded by a subsequent edition of that
publication (that is to say, together with any amendments,
additions and deletions made to it up to that time),
and any monograph in an edition of a publication shall be construed in
accordance with any general monograph or notice or any appendix, note
or other explanatory material which is contained in that edition and is
applicable to that monograph, and any reference in this section to
compliance with the standard specified in a monograph shall be
construed accordingly.
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(7) For the purposes of this section, an edition of the European
Pharmacopoeia —
(a) if it is the current edition of that Pharmacopoeia at the time in
question, shall be taken as it is for the time being in force in the
United Kingdom (that is, together with any amendments,
additions and deletions made to it which, by notice published in
the London Gazette under section 65(7) of the UK Act before the
time referred to in subsection (4), have been declared to have
effect for the purposes of the said section 65); and
(b) if it is an edition previous to the current edition of that
Pharmacopoeia, shall be taken as it was immediately before the
time when it was superseded by a subsequent edition of that
Pharmacopoeia in force in the United Kingdom (that is, together
with any amendments, additions and deletions made to it which,
by notice so published before that time, had been declared so to
have effect),
and a name shall be taken to be an approved synonym for a name at the
head of a monograph in the European Pharmacopoeia if, by a notice so
published and not withdrawn by any subsequent notice so published, it
has been declared to be approved by the Medicines Commission in the
United Kingdom as a synonym for that name.
10 Misleading descriptions etc

(1) No person shall, in the course of a business carried on by him, sell or
supply, or have in his possession for the purpose of sale or supply, a
medicinal product of any description in a container or package which is
labelled or marked in such a way that the container or package —
(a) falsely describes the product; or
(b) is likely to mislead as to the nature or quality of the product or as
to the uses or effects of medicinal products of that description.
(2) No person shall, in the course of a business carried on by him, supply
with a medicinal product of any description, or have in his possession for
the purpose of so supplying, a leaflet which —
(a) falsely describes the product; or
(b) is likely to mislead as to the nature or quality of the product or as
to the uses or effects of medicinal products of that description.
11 Display of information on automatic machines

(1) The Department may by regulations impose such requirements as it
considers necessary or expedient with respect to the display on
automatic machines of information relating to medicinal products
offered or exposed for sale by means of such machines.
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(2) No person shall offer or expose for sale any medicinal product by means
of an automatic machine in such circumstances as to contravene any
requirements imposed by regulations under subsection (1) which are
applicable to that product.
12 Offences

(1) Any person who contravenes section 7, 8(1) or (2), 9(1) or (2) or 10(1)
or (2) is guilty of an offence and liable —
(a) on summary conviction, to a fine not exceeding £5,000;
(b) on conviction of information, to custody for a term not exceeding
2 years or to a fine, or to both.
(2) Any person who contravenes section 11(2) is guilty of an offence and
liable on summary conviction to a fine not exceeding £1,000.
PART 3 – PROMOTION OF SALES OF MEDICINAL

PRODUCTS

13 False or misleading advertisements and representations

(1) Subject to the following provisions of this section, any person who, being
a commercially interested party, or at the request or with the consent of a
commercially interested party, issues, or causes another person to issue,
a false or misleading advertisement relating to medicinal products of any
description is guilty of an offence.
(2) Where —
(a) an authorisation applicable to medicinal products of a particular
description is in force, and
(b) in accordance with the provisions of the authorisation, the
purposes for which medicinal products of that description may be
recommended to be used are limited to those specified in the
authorisation,
any person who, being a commercially interested party, or at the request
or with the consent of a commercially interested party, issues, or causes
another person to issue, an advertisement relating to medicinal products
of that description which consists of or includes an unauthorised
recommendation is guilty of an offence.
(3) Any person who in the course of a relevant business carried on by him,
or while acting on behalf of a person carrying on such a business, makes
a false or misleading representation relating to a medicinal product in
connection with the sale, or offer for sale, of that product is guilty of an
offence.
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(4) Any person who, in the course of a relevant business or while acting on
behalf of a person carrying on such a business, makes a false or
misleading representation relating to medicinal products of a particular
description —
(a) to a practitioner for the purpose of inducing him to prescribe or
supply medicinal products of that description; or
(b) to a patient or client of a practitioner for the purpose of inducing
him to request the practitioner to prescribe medicinal products of
that description; or
(c) to a person for the purpose of inducing him to purchase medicinal
products of that description from a person selling them by retail,
is guilty of an offence.
(5) Where, in the circumstances specified in subsection (2), any person, in
the course of a relevant business carried on by him, or while acting on
behalf of a person carrying on such a business —
(a) in connection with the sale, or offer for sale, of a medicinal
product of the description in question, makes a representation
relating to the product which consists of or includes unauthorised
recommendations; or
(b) for any such purpose as is specified in subsection (4)(a) to (c),
makes a representation relating to medicinal products of that
description which consists of or includes unauthorised
recommendations,
that person, subject to the following provisions of this section, is guilty of
an offence.
(6) Where a person is charged with an offence under this section, it shall be a
defence for him to prove —
(a) where the offence charged is under subsection (1), (3) or (4), that
he did not know, and could not with reasonable diligence have
discovered, that the advertisement or representation was false or
misleading;
(b) where the offence charged is under subsection (2) or (5), that he
did not know, and could not with reasonable diligence have
discovered, that the recommendations made by the advertisement
or representation were unauthorised recommendations.
(7) Without prejudice to subsection (6), where a person is charged with an
offence under this section in respect of the issue of an advertisement, it
shall be a defence for him to prove that —
(a) he is a person whose business it is to issue or arrange for the issue
of advertisements, and
(b) either —
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(i) he received the advertisement for issue in the ordinary
course of business and issued it, or arranged for it to be
issued, either unaltered or without any alterations except
in respect of lettering or lay-out; or
(ii) not being a commercially interested party, he received
from a commercially interested party the information on
which the advertisement was based and in the ordinary
course of business prepared the advertisement in
accordance with that information for issue at the request of
that party, and
(c) he did not know and had no reason to suspect that the issue of the
advertisement would amount to an offence under this section.
(8) For the purposes of this section, an advertisement (whether it contains an
accurate statement of the composition of medicinal products of the
description in question or not) shall be taken to be false or misleading if
(but only if) —
(a) it falsely describes the description of medicinal products to which
it relates; or
(b) it is likely to mislead as to the nature or quality of medicinal
products of that description or as to their uses or effects,
and any reference in this section to a false or misleading representation
shall be construed in a corresponding way.
(9) In this section “unauthorised recommendation”, in relation to the
circumstances specified in subsection (2), means a recommendation
whereby medicinal products of a description to which the authorisation
in question is applicable are recommended to be used for purposes other
than those specified in the authorisation.
(10) Any person guilty of an offence under this section is liable —
(a) on summary conviction, to a fine not exceeding £5,000;
(b) on conviction on information, to custody for a term not exceeding
2 years or to a fine, or to both.3

14 Advertisements requiring consent

(1) Where an authorisation is in force which is applicable to medicinal
products of a particular description, then, except with the consent of the
holder of the authorisation —
(a) no commercially interested party (other than the holder of the
authorisation) shall issue, or cause another person to issue, any
advertisement relating to medicinal products of that description;
and
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(b) no person who is not a commercially interested party shall, at the
request or with the consent of a commercially interested party,
issue, or cause another person to issue, any such advertisement.
(2) Any person who contravenes subsection (1) is guilty of an offence and
liable on summary conviction to a fine not exceeding £1,000.4

15 Regulation of advertisements and representations

(1) The Department may by regulations prohibit the issue, except in such
circumstances and subject to such conditions as may be prescribed, of
advertisements —
(a) relating to medicinal products of a description, or falling within a
class, specified in the regulations;
(b) likely to lead to the use of any medicinal product, or any other
substance or article, for the purpose of —
(i) treating or preventing a disease specified in the
regulations,
(ii) diagnosis of a disease so specified,
(iii) ascertaining the existence, degree or extent of a
physiological condition so specified,
(iv) permanently or temporarily preventing or otherwise
interfering with the normal operation of a physiological
function so specified, or
(v) artificially inducing a condition of body or mind so
specified;
(c) likely to lead to the use of medicinal products of a particular
description or falling within a particular class specified in the
regulations, or the use of any other substance or article of a
description or class so specified, for any such purpose as is
mentioned in paragraph (b);
(d) relating to medicinal products and containing a word or phrase
specified in the regulations as being a word or phrase which, in
the opinion of the Department, is likely to mislead the public as to
the nature or effects of the products or as to any condition of body
or mind in connection with which the products might be used.
(2) Regulations under subsection (1)(b), (c) or (d) may prohibit the making
of any representation —
(a) likely to lead to the use of a medicinal product or other substance
or article to which the regulations apply for a purpose specified
under subsection (1)(b), or
(b) containing a word or phrase specified in the regulations under
subsection (1)(d),
Section 15 Medicines Act 2003

Page 20 AT 4 of 2003 c

if the representation —
(i) is made in connection with the sale or supply, or offer for
sale or supply, of a medicinal product or other substance or
article to which the regulations apply; or
(ii) is made to a person for the purpose of inducing him to
purchase such a medicinal product, substance or article
from a person selling by retail medicinal products or other
substances or articles to which the regulations apply; or
(iii) in the case of medicinal products of a description to which
the regulations apply, is made to a practitioner for the
purpose of inducing him to prescribe or supply medicinal
products of that description or is made to a patient or client
of a practitioner for the purpose of inducing him to request
the practitioner to prescribe medicinal products of that
description.
(3) Without prejudice to subsection (1) and (2), the Department may, for any
of the purposes specified in subsection (4), by regulations impose such
requirements as it considers necessary or expedient with respect to —
(a) the particulars which advertisements relating to medicinal
products must contain;
(b) the form of any such advertisements;
(c) in the case of advertisements by way of cinema films or television,
the duration for which, and the manner in which, any part of such
an advertisement which contains particulars of a description
specified in the regulations must be exhibited;
and any such regulations may prohibit the use, in relation to medicinal
products of a description specified in the regulations, of advertisements
of any particular kind so specified.
(4) The purposes referred to in subsection (3) are —
(a) securing that adequate information is given with respect to
medicinal products;
(b) preventing the giving of misleading information with respect to
such products;
(c) promoting safety in relation to such products.
(5) Regulations under this section may provide that any person
contravening a specified requirement of the regulations is guilty of an
offence and liable —
(a) on summary conviction to a fine not exceeding such amount
(which shall not exceed £5,000) as may be specified in the
regulations; and
(b) if the regulations so provide, on conviction on information to
custody for a term not exceeding 2 years or to a fine, or to both.5

Medicines Act 2003 Section 16

c AT 4 of 2003 Page 21

16 Advertisements and representations directed to practitioners

(1) No advertisement relating to medicinal products of a particular
description, other than a product summary, shall be sent or delivered to
a practitioner —
(a) by a commercially interested party; or
(b) by any person at the request or with the consent of a commercially
interested party,
unless the conditions specified in subsection (3) are fulfilled.
(2) No representation likely to promote the use of medicinal products of a
particular description referred to in the representation shall be made to a
practitioner by a person carrying on a relevant business, or by a person
acting on behalf of a person carrying on such a business, unless the
conditions specified in subsection (3) are fulfilled.
(3) Those conditions are —
(a) that a product summary relating to medicinal products of the
description in question is sent or delivered to the practitioner with
the advertisement, or is delivered to him at the time when the
representation is made, or that such a product summary has been
sent or delivered to him not more than 15 months before the date
on which the advertisement is sent or delivered or the
representation is made; and
(b) that the advertisement or representation is not inconsistent with
the particulars contained in the product summary.
(4) Any person who contravenes subsection (1) or (2) is guilty of an offence
and liable —
(a) if he contravenes that subsection by not complying with the
condition specified in subsection (3)(b) —
(i) on summary conviction, to a fine not exceeding £5,000, or
(ii) on conviction on information to custody for a term not
exceeding 2 years or to a fine, or to both;
(b) in any other case, on summary conviction to a fine not exceeding
£1,000.
(5) In this section “product summary”, in relation to a medicinal product,
means the summary of the product characteristics approved by the
authority by which the authorisation relating to that product was issued.
(6) The Department may by regulations vary the provisions of this section in
its application to any particular case or class of cases.6

Section 17 Medicines Act 2003

Page 22 AT 4 of 2003 c

17 Interpretation

(1) Subject to subsections (2) and (3), in this Part, “advertisement
” includes
every form of advertising, whether —
(a) in a publication, or
(b) by the display of any notice, or
(c) by means of any catalogue, price list, letter (whether circular or
addressed to a particular person) or other document, or
(d) by words inscribed on any article, or
(e) by means of a photograph, film, sound recording, broadcast or
cable programme service, or
(f) in any other way,
and any reference to the issue of an advertisement shall be construed
accordingly.
(2) “Advertisement
” does not include spoken words except words forming
part of a sound recording or broadcast or included in a cable
programme.
(3) For the purposes of this Part (except section 15(1)(b), (c) or (d)) —
(a) the sale or supply, or offer or exposure for sale or supply, of a
medicinal product in a labelled container or package; and
(b) the supply, with a medicinal product of any description, of a
leaflet relating solely to medicinal products of that description,
shall not be taken to constitute the issue of an advertisement
(4) In this Part —
“authorisation
” means a Community authorisation or a UK authorisation;
“commercially interested party
”, in relation to medicinal products of any
description, means any person who —
(a) is the holder of an authorisation applicable to medicinal products
of that description; or
(b) not being the holder of such an authorisation or licence, is a
person who, in the course of a business carried on by him, is
engaged or concerned, in relation to medicinal products of that
description, in any such activities as are mentioned in
section 2(1)(a), (b), (c), (d) or (e); or
(c) sells by retail any medicinal products of that description in the
course of a business carried on by him;
and any reference to the request or consent of a commercially interested
party includes a reference to any request made or consent given by a
person acting on behalf of a commercially interested party;
Medicines Act 2003 Section 18

c AT 4 of 2003 Page 23

“relevant business
” means any business which consists of or includes the sale
or supply of medicinal products;
“representation
” means any statement or undertaking (whether constituting a
condition or a warranty or not) which consists of spoken words other
than words falling within subsection (2), and any reference to making a
representation shall be construed accordingly.
(5) In this section “film”, “sound recording”, “broadcast”, “cable
programme”, “cable programme service” and related expressions have
the same meanings as in the Copyright Act 1991.7

PART 4 – ENFORCEMENT

18 Enforcement etc

It is the duty of the Department to enforce this Act and any regulations and
orders made under it.
19 Rights of entry

(1) Subject to the following provisions of this section, any person duly
authorised in writing by the Department shall, on production, if
required, of his credentials, have a right at any reasonable time to enter
any premises —
(a) for the purpose of ascertaining whether there is or has been, on or
in connection with those premises, any contravention of any
provision of this Act or of any regulations or order made under
this Act; or
(b) generally for the purposes of the performance by the Department
of its functions under this Act or under any such regulations or
order.
(2) Any person duly authorised in writing by the Department shall, on
production, if required, of his credentials, have a right at any reasonable
time —
(a) to enter any ship, aircraft or hover vehicle for the purpose of
ascertaining whether there is in the ship, aircraft or vehicle any
substance or article imported in contravention of any provision of
this Act or of any regulations or order made under this Act;
(b) to enter any vehicle other than a hover vehicle, any stall or place
other than premises, or any home-going ship, for any purpose for
which under subsection (1) the person so authorised would have
a right to enter any premises.
Section 19 Medicines Act 2003

Page 24 AT 4 of 2003 c

(3) Admission to any premises used only as a private dwelling-house shall
not be demanded as of right by virtue of subsections (1) or (2) unless 24
hours’ notice of the intended entry has been given to the occupier.
(4) If a justice of the peace, on sworn information in writing, is satisfied that
there are reasonable grounds for entering any premises for any purpose
for which a person authorised by the Department has a right to enter
them in accordance with subsections (1) to (3), and is also satisfied —
(a) that admission to the premises has been refused, or that a refusal
is apprehended, and (in either case) that notice of the intention to
apply for a warrant has been given to the occupier; or
(b) that an application for admission, or the giving of such a notice,
would defeat the object of the entry; or
(c) that the case is one of urgency; or
(d) that the premises are unoccupied or the occupier is temporarily
absent,
the justice may by warrant under his hand authorise the Department, or
any person duly authorised by it, to enter the premises, if need be by
force.
(5) Subsection (4) has effect in relation to entering any ship, aircraft, vehicle,
stall or place which may be entered under subsection (2) as it has effect in
relation to entering any premises as if, in subsection (4) any reference to
the occupier were a reference to the master, commander or other person
in charge of the ship, aircraft, vehicle, stall or place.
(6) Any warrant granted under this section shall continue in force for a
period of one month.
(7) Any person entering any property by virtue of this section (whether in
pursuance of a warrant or not) —
(a) may take with him such other persons and such equipment as
may appear to him to be necessary; and
(b) on leaving any such property which he has entered in pursuance
of a warrant under subsection (4) he shall, if the property is
unoccupied or the occupier (or, in the case of a ship, aircraft,
vehicle, stall or place, the master, commander or other person in
charge of it) is temporarily absent, leave it as effectively secured
against trespass as he found it.
(8) In this section —
“home-going ship” means a ship engaged exclusively in voyages which start
and end in the Island and do not involve calling at any place outside the
Island;
“property” means any premises, ship, aircraft, vehicle, stall or place.
Medicines Act 2003 Section 20

c AT 4 of 2003 Page 25

20 Power to inspect, take samples and seize goods and records

(1) For the purpose of ascertaining whether there is or has been a
contravention of this Act or of any regulations or order made under it,
any person duly authorised in writing by the Department shall have a
right to inspect —
(a) any substance or article appearing to him to be a medicinal
product;
(b) any article appearing to him to be a container or package used or
intended to be used to contain any medicinal product or to be a
label or leaflet used or intended to be used in connection with a
medicinal product; or
(c) any plant or equipment appearing to him to be used or intended
to be used in connection with the manufacture or assembly of
medicinal products, and any process of manufacture or assembly
of any medicinal products, and the means employed, at any stage
in the process of manufacture or assembly, for testing the
materials after they have been subjected to those processes.
(2) Where, for the purpose specified in subsection (1), a person authorised as
mentioned in that subsection requires a sample of any substance or
article appearing to him to be —
(a) a medicinal product sold or supplied or intended to be sold or
supplied; or
(b) a substance or article used or intended to be used in the
manufacture of a medicinal product,
he shall (if he does not obtain the sample by purchase) have a right to
take a sample of that substance or article.
(3) For the purpose specified in subsection (1), any person authorised as
mentioned in that subsection shall have a right —
(a) to require any person carrying on a business which consists of or
includes the manufacture, assembly, sale or supply of medicinal
products, and any person employed in connection with such a
business, to produce any records relating to the business which
are in his possession or under his control;
(b) to take copies of, or of any entry in, any record produced in
pursuance of paragraph (a).
(4) Any person authorised to exercise the power conferred by
subsection (3) —
(a) is entitled at any reasonable time to have access to, and inspect
and check the operation of, any computer and any associated
apparatus or material which is or has been in used in connection
with the records in question; and
Section 21 Medicines Act 2003

Page 26 AT 4 of 2003 c

(b) may require the person by whom or on whose behalf the
computer is or has been used, or any person having charge of or
otherwise concerned with the operation of the computer,
apparatus or material, to afford him such assistance as he may
reasonably require.
(5) Any person so authorised has a right to seize and detain —
(a) any substance or article which he has reasonable cause to believe
to be a substance or article in relation to which, or by means of
which, an offence under this Act is being or has been committed,
and
(b) any document which he has reasonable cause to believe to be a
document which may be required as evidence in proceedings
under this Act.
(6) For the purpose of exercising any such right as is specified in
subsection (5), the person having that right may, so far as is reasonably
necessary in order to secure that this Act and any regulations or order
made under it are duly observed, require any person having authority to
do so to break open any container or package or open any vending
machine, or to permit him to do so.
(7) Where a person seizes any substance or article (including any record) in
the exercise of the power conferred by subsection (5), he shall inform the
person from whom it is seized and, in the case of anything seized from a
vending machine, the person whose name and address are stated on the
machine as being those of the owner of the machine, or, if no name and
address are so stated, the occupier of the premises on which the machine
stands or to which it is affixed.
(8) Notwithstanding anything in subsections (1) to (7), where a person
claiming to exercise a right by virtue of this section is required to
produce his credentials, the right shall not be exercisable by him except
on production of those credentials.
(9) The provisions of Schedule 1 have effect with respect to samples
obtained on behalf of the Department for the purposes of this Act.
(10) The Department shall by regulations prescribe any matter which under
Schedule 1 is to be prescribed.
21 Application of sampling procedure to substance or article seized

under s 20

(1) The provisions of this section have effect where a person (an “authorised
person”) seizes a substance or article (other than a record) in the exercise
of a right specified in section 20(5).
(2) If any person who, in accordance with section 20(7), is entitled to be
informed of the seizure so requests, either at the time of the seizure or at
Medicines Act 2003 Section 22

c AT 4 of 2003 Page 27

any subsequent time, not being later than 21 days after he is informed of
the seizure, then, subject to subsection (3), the authorised person shall
either —
(a) set aside a sample of the substance or article seized; or
(b) treat that substance or article as a sample,
whichever he considers more appropriate having regard to the nature of
that substance or article.
(3) An authorised person is not required by virtue of subsection (2) to set
aside a sample, or to treat a substance or article as a sample, if the nature
of the substance or article is such that it is not reasonably practicable to
do either of those things.
(4) Where, in accordance with subsection (2), an authorised person sets aside
a sample, or treats a substance or article as a sample, he shall divide it
into 3 parts, each part to be marked and sealed or fastened up in such
manner as its nature will permit, and shall supply one part of it to the
person who made the request under subsection (2).
(5) Paragraphs 10 to 12 and 15 to 21 of Schedule 1 apply in relation to a
sample set aside, or a substance or article treated as a sample, under
subsection (2) as if —
(a) any reference to a sampling officer were a reference to an
authorised person;
(b) any reference to a sample included a reference to a substance or
article treated as a sample; and
(c) in paragraph 19(1) the reference to a substance or article obtained
as mentioned in paragraph 1 were a reference to a substance or
article of which a sample has been set aside, or which has been
treated as a sample, under subsection (2).
22 Obstruction etc

(1) Any person who —
(a) intentionally obstructs a person acting in pursuance of this Act
and duly authorised so to act by the Department; or
(b) intentionally fails to comply with any requirement properly made
to him by a person so acting under section 20 (including that
section as modified under section 34(1)); or
(c) without reasonable cause, fails to give to a person so acting any
other assistance or information which that person may reasonably
require of him for the purpose of the performance of his functions
under this Act,
is guilty of an offence and liable on summary conviction to a fine not
exceeding £1,000.
Section 23 Medicines Act 2003

Page 28 AT 4 of 2003 c

(2) If any person, in giving any such information as is mentioned in
subsection (1)(c), makes any statement which he knows to be false, he is
guilty of an offence and liable —
(a) on summary conviction, to a fine not exceeding £5,000;
(b) on conviction on information, to custody for a term not exceeding
2 years or to a fine, or to both.
(3) Nothing in this section shall be construed as requiring a person to
answer any question or give any information if to do so might
incriminate that person or (where that person is married or a civil
partner) the spouse or civil partner of that person.8

23 Analysis of samples in other cases

(1) A person who, not being a person authorised for the purpose by the
Department, has purchased a medicinal product may submit a sample of
it for analysis to the public analyst who (subject to sub-paragraph (3))
shall as soon as practicable analyse the sample or cause it to be analysed
by some other person under his direction.
(2) Paragraphs 2 to 13 and 15 to 18 (except paragraph 15(1)) of Schedule 1
apply in relation a sample submitted under subsection (1) as if any
reference to the sampling officer were a reference to the person
proposing to submit or submitting the sample.
(3) Where a sample is submitted to the public analyst under subsection (1),
he may demand payment in advance of —
(a) the prescribed fee, or
(b) in the case of a sample to be sent under paragraph 15(2) of
Schedule 1, such sum as may be agreed;
and, if he demands such payment, he shall not be required to analyse the
sample or cause or send it to be analysed until the fee or sum has been
paid.
24 Liability to forfeiture

(1) For the purposes of section 46 (forfeiture of goods improperly imported)
of the Customs and Excise Management Act 1986 (“the 1986 Act”) any
imported goods shall be deemed to be imported contrary to a restriction
for the time being in force with respect to them under this Act if —
(a) they are goods falling within a class specified in an order made by
the Department for the purposes of this subsection; and
(b) they are imported in such circumstances as are specified in that
order.
(2) For the purposes of section 69 of the 1986 Act (offences in relation to
exportation of prohibited or restricted goods), any goods shall be
Medicines Act 2003 Section 25

c AT 4 of 2003 Page 29

deemed to be exported contrary to a restriction for the time being in force
with respect to them under this Act if —
(a) they are goods falling within a class specified in an order made by
the Department for the purposes of this subsection; and
(b) they are exported in such circumstances as are specified in that
order.
(3) Any class of goods specified in an order under subsection (1) or (2) shall
be so specified as to consist exclusively of goods appearing to the
Department to be goods which are, or normally are, medicinal products.
(4) An order under subsection (1) or (2) shall not have effect unless it is
approved by Tynwald.
25 Restrictions on disclosure of information

If any person discloses to any other person —
(a) any information with respect to any manufacturing process or
trade secret obtained by him in premises which he has entered by
virtue of section 19; or
(b) any information obtained by or furnished to him in pursuance of
this Act,
unless the disclosure was made in the performance of his duty, he is guilty of an
offence and liable —
(i) on summary conviction, to a fine not exceeding £5,000;
(ii) on conviction on information, to custody for a term not
exceeding 2 years or to a fine, or to both.
26 Contravention due to default of other person

(1) Where a contravention by any person of any provision to which this
section applies constitutes an offence under this Act, and is due to an act
or default of another person, then, whether proceedings are taken against
the first-mentioned person or not, that other person may be charged with
and convicted of that offence, and shall be liable on conviction to the
same punishment as might have been imposed on the first-mentioned
person if he had been convicted of the offence.
(2) Where a person who is charged with an offence under this Act in respect
of a contravention of a provision to which this section applies proves to
the satisfaction of the court —
(a) that he exercised all due diligence to secure that the provision in
question would not be contravened; and
(b) that the contravention was due to the act or default of another
person,
Section 27 Medicines Act 2003

Page 30 AT 4 of 2003 c

the first-mentioned person shall, subject to subsection (3), be acquitted of
the offence.
(3) A person shall not, without the leave of the court, be entitled to rely on
the defence provided by subsection (2), unless, not later than 7 clear days
before the date of the hearing, he has served on the prosecutor a notice in
writing giving such information identifying, or assisting in the
identification of, the other person in question as was then in his
possession.
(4) This section applies to sections 7 to 11 and 13 to 16 and any regulations
made under any of those sections.
27 Warranty as defence

(1) Subject to the following provisions of this section, in any proceedings for
an offence under this Act in respect of a contravention of a provision to
which this section applies, it shall be a defence for the defendant
to prove —
(a) that he purchased the substance or article to which the
contravention relates in the Island as being a substance or article
which could be lawfully sold, supplied, or offered or exposed for
sale, or could be lawfully sold, supplied, or offered or exposed for
sale under the name or description or for the purpose under or for
which he sold, supplied or offered or exposed it for sale, and with
a written warranty to that effect;
(b) that, at the time of the commission of the alleged offence, he had
no reason to believe that it was otherwise; and
(c) that the substance or article was then in the same state as when he
purchased it.
(2) This section applies to —
(a) sections 7(b), 8 and 9, and
(b) regulations under section 2(2).
(3) A warranty shall not be a defence by virtue of this section unless the
defendant has, not later than 3 clear days before the date of the hearing,
sent to the prosecutor a copy of the warranty with a notice stating that he
intends to rely on it and specifying the name and address of the person
from whom he received it, and has also sent a like notice to that person.
(4) Where the defendant is an employee of the person who purchased the
substance or article under the warranty, he shall be entitled to rely on the
provisions of this section in the same way as his employer would have
been entitled to do if he had been the defendant.
(5) The person by whom the warranty is alleged to have been given shall be
entitled to appear at the hearing and to give evidence, and the court may,
if it thinks fit, adjourn the hearing to enable him to do so.
Medicines Act 2003 Section 28

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(6) For the purposes of this section, a name or description entered in an
invoice shall be deemed to be a written warranty that the article or
substance to which the name or description applies can be sold, supplied
or offered or exposed for sale under that name or description by any
person without contravening any provision to which this section applies.
28 Offences in relation to warranties and certificates of analysis

(1) If a defendant in any proceedings mentioned in section 27(1)
intentionally applies to any substance or article —
(a) a warranty given in relation to a different substance or article; or
(b) a certificate issued under section 23, or under paragraph 15(3) of
Schedule 1, which relates to a sample of a different substance or
article,
he is guilty of an offence.
(2) A person who, in respect of any substance or article sold by him in
respect of which a warranty might be pleaded under section 27, gives to
the purchaser a false warranty in writing is guilty of an offence, unless he
proves that, when he gave the warranty, he had reason to believe that the
statement or description contained in it was accurate.
(3) Any person guilty of an offence under this section is liable —
(a) on summary conviction, to a fine not exceeding £5,000;
(b) on conviction on information, to custody for a term not exceeding
2 years or to a fine, or to both.
29 Offences: general

(1) A complaint may be made in respect of an offence under this Act at any
time within 12 months from the time when the cause of complaint arose.
(2) Where an offence under this Act which is committed by a body corporate
is proved to have been committed with the consent and connivance of, or
to be attributable to any neglect on the part of any of the following
persons —
(a) any director, manager, secretary or other similar officer of the
body corporate,
(b) in relation to a body corporate carrying on a retail pharmacy
business as mentioned in section 37(1), any person who —
(i) is the superintendent referred to in section 37(1)(a), or
(ii) at any premises where the business is carried on, is the
pharmacist referred to in section 37(1)(b)(i) who acts under
the direction of the superintendent,
(c) any person who was purporting to act in any capacity mentioned
in paragraph (a) or (b),
Section 30 Medicines Act 2003

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that person, as well as the body corporate, shall be guilty of that offence
and shall be liable to be proceeded against and punished accordingly.
30 Presumptions

(1) For the purposes of any proceedings under this Act for an offence
consisting of offering a medicinal product for sale, or for sale by retail, in
contravention of section 7(b) or regulations under section 2, where it is
proved that the medicinal product in question was found on a vehicle
from which medicinal products are sold, it shall be presumed, unless the
contrary is proved, that the person in charge of the vehicle offered that
medicinal product for sale, or for sale by retail, as the case may be.
(2) For the purposes of any proceedings under this Act for an offence
consisting of having a medicinal product in one’s possession for the
purpose of sale or supply, in contravention of section 7(b) or regulations
under section 2, where it is proved that the medicinal product in
question was found on premises at which the person charged with the
offence carries on a business consisting of or including the sale or supply
of medicinal products, it shall be presumed, unless the contrary is
proved, that he had that medicinal product in his possession for the
purpose of sale or supply.
(3) For the purposes of any proceedings under this Act for an offence
consisting of the supply of a leaflet with a medicinal product, where it is
proved that the leaflet in question was found on premises at which the
person charged with the offence carries on a business consisting of or
including the sale or supply of medicinal products, it shall be presumed,
unless the contrary is proved, that he had the leaflet in his possession for
the purpose of supplying it with a medicinal product.
PART 5 – VETERINARY MEDICINAL PRODUCTS AND

ANIMAL FEEDING STUFFS

31 Veterinary medicinal products

In this Act “veterinary medicinal product
” means —
(a) any substance or combination of substances presented for treating
or preventing disease in animals; or
(b) any substance or combination of substances which may be
administered to animals with a view to making a medical
diagnosis or to restoring, correcting or modifying physiological
functions in animals.9

Medicines Act 2003 Section 32

c AT 4 of 2003 Page 33

32 Application of Parts 1 to 4 to veterinary medicinal products

[OJL 311, 28.11.01]
(1) Parts 1 to 4 (including Schedule 1) apply to veterinary medicinal
products as they apply to medicinal products, subject to the following
modifications.
(2) References to a medicinal product shall be construed as references to a
veterinary medicinal product.
(3) In section 1 —
(a) in subsection (1), for paragraph (a) substitute —
“(a) Directive 2001/82/EC on the Community code relating to
veterinary medicinal products (“the EC veterinary code”), and
any enactment or instrument giving effect to it;”;
(b) omit subsection (2);
(c) in subsection (3), for the definition of “UK authorisation”
substitute —
“ “UK authorisation” means —
(a) a marketing authorisation granted in the United
Kingdom under the Marketing Authorisations for Veterinary
Medicinal Products Regulations 1994 (a “UK authorisation”)”
[SI1994/3142];
(b) a product licence granted in the United Kingdom under
section 7 of the UK Act (a “product licence”);
(c) a manufacturer’s licence granted in the United Kingdom
under section 8(2) of the UK Act;
(d) an animal test certificate issued in the United Kingdom
under section 32 of the UK Act.”;
(d) the power under subsection (4) to amend the definition of “UK
authorisation” extends to the definition substituted by
paragraph (c).
(4) In section 6(3), after paragraph (b) insert “and
(c) the Department of Environment, Food and
Agriculture;”.10

(5) In section 9(4) and (5)(d), for “British Pharmaceutical Codex” substitute
“British Veterinary Codex”.11

33 Medicated animal feeding stuffs

(1) The Department may by regulations make provision for controlling,
restricting, regulating or prohibiting the following activities —
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(a) the incorporation by any person, in the course of a business
carried on by him, of a veterinary medicinal product of any
description in an animal feeding stuff;
(b) selling, supplying or otherwise placing on the market by any
person in the course of a business carried on by him of any animal
feeding stuff in which a veterinary medicinal product has been
incorporated,
(c) the importation by any person of any animal feeding stuff in
which a veterinary medicinal product has been incorporated.
(2) The Department may by regulations —
(a) prohibit or restrict the sale or supply, or the import, of animal
feeding stuffs in which veterinary medicinal products of any
description, or falling within any class, specified in the order have
been incorporated, or
(b) in such manner as may appear to it to be sufficient to identify the
feeding stuffs in question, designate particular animal feeding
stuffs in which veterinary medicinal products have been
incorporated and prohibit or restrict the sale or supply, or the
import, of those particular feeding stuffs.
(3) Section 2 applies to any animal feeding stuff in which a veterinary
medicinal product of any description has been incorporated as if the
references in section 2(2)(a) to (d) (as modified by section 32) to
veterinary medicinal products included references to any such animal
feeding stuff.
(4) Nothing in subsection (3) affects any requirement imposed by or under
the Fertilisers and Feeding Stuffs Act 1975 with respect to —
(a) marks to be made on a container or package; or
(b) statements to be made in any leaflet supplied, or intended to be
supplied, with any material.
(5) Section 6 (as modified by section 32) applies to regulations under this
section as it applies to regulations under Part 1.12

34 Animal feeding stuffs: enforcement

(1) The Department may by regulations provide that any of the provisions
of sections 20 to 30 shall apply, with or without prescribed modifications,
in relation to animal feeding stuffs as they apply to veterinary medicinal
products.
(2) The Department may by regulations make provision as to the manner in
which —
(a) samples may be taken by virtue of section 20 (as applied under
subsection (1)),
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(b) samples may be set aside, or substances or articles may be treated
as samples, by virtue of section 21 (as so applied),
(c) samples may be submitted for analysis by virtue of section 23 (as
so applied), and
(d) such samples, substances and articles are to be dealt with;
and provision under paragraph (d) may be in substitution for, or by way
of modification of or addition to, any of the provisions of Schedule 1.
(3) For the purposes of proceedings for prescribed offences under this Act
relating to animal feeding stuffs, the Department may by regulations —
(a) prescribe a method of analysis to be used in analysing samples of
animal feeding stuffs in order to determine what quantity or
proportion (if any) of a substance or article of a description or
class specified in the regulations has been incorporated in them;
and
(b) provide that, on production in the proceedings of such evidence
as may be so prescribed of the results of an analysis of a sample
performed by the method so prescribed, evidence of the results of
any analysis of any part of the sample performed by any other
method shall not be admissible in those proceedings.13

PART 6 – PHARMACIES

Conduct of retail pharmacy business
35 Retail pharmacy business

(1) Subject to any regulations under section 39, a person carrying on a retail
pharmacy business shall be taken to be a person lawfully conducting
such a business if, not being disqualified under section 46 —
(a) that person (or, if the business is carried on by a partnership, each
of the partners) is a pharmacist and the conditions specified in
section 36 are fulfilled in relation to the business; or
(b) that person is a body corporate and the conditions specified in
section 37 are fulfilled in relation to the business; or
(c) that person is a representative of a pharmacist (as defined by
section 38(4)) and the conditions specified in section 38(2) are
fulfilled in relation to him and in relation to the business and the
period applicable in accordance with section 38(3) has not
expired.
(2) For the purposes of the application of this Part to a business which —
Section 36 Medicines Act 2003

Page 36 AT 4 of 2003 c

(a) is or is to be carried on in one or more separate or distinct parts
(but not the whole) of a building, whether it is or is to be also
carried on elsewhere or not; or
(b) so far as concerns the retail sale of medicinal products, or the
supply of such products in circumstances corresponding to retail
sale, is or is to be carried on in one or more separate or distinct
parts (but not the whole) of a building, whether it is or is to be
also carried on elsewhere or not,
each such part of that building shall be taken to be separate premises.
(3) In this section and sections 36 to 38 and 43 references to medicinal
products include references to veterinary medicinal products.
36 Business carried on by individual pharmacist or firm

The conditions referred to in section 35(1)(a) are that, at all premises where the
business is carried on and medicinal products, other than medicinal products on
general sale, are sold by retail —
(a) the business, so far as concerns the retail sale at those premises of
medicinal products (whether they are medicinal products on
general sale or not), or the supply at those premises of such
products in circumstances corresponding to retail sale, is under
the personal control of the person (or, in relation to a business
carried on by a partnership, one or more of the partners) carrying
on the business or that of another pharmacist; and
(b) there are conspicuously exhibited his name and certificate of
registration or those of the other pharmacist, as the case may be
(or, in relation to a business carried on by a partnership, the name
and certificate of registration of the partner (or, if more than one,
of each partner) exercising personal control at those premises as
mentioned in paragraph (a)).
37 Bodies corporate

(1) The conditions referred to in section 35(1)(b) are that —
(a) the business, so far as concerns the keeping, preparing and
dispensing of medicinal products other than medicinal products
on general sale, is under the management of a superintendent in
respect of whom the requirements specified in subsection (2) are
fulfilled, and
(b) at all premises where the business is carried on and medicinal
products other than medicinal products on general sale, are sold
by retail —
(i) the business, so far as concerns the retail sale at those
premises of medicinal products (whether they are
Medicines Act 2003 Section 38

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medicinal products on general sale or not) or the supply at
those premises of such products in circumstances
corresponding to retail sale, if it is not under the personal
control of the superintendent, is carried on, subject to the
directions of the superintendent, under the personal
control of a manager or assistant who is a pharmacist; and
(ii) the name and certificate of registration of the person under
whose personal control the business is carried on at those
premises as mentioned in sub-paragraph (i) (whether he is
the superintendent or some other person) are
conspicuously exhibited.
(2) The requirements referred to in subsection (1) in relation to a
superintendent are that —
(a) the superintendent is a pharmacist;
(b) a statement in writing signed by him, and signed on behalf of the
body corporate, specifying his name and stating whether he is a
member of the board of that body or not, has been sent to the
registrar; and
(c) he does not act in a similar capacity for any other body corporate.
38 Representative of pharmacist in case of death or disability

(1) This section has effect where a pharmacist carries on a retail pharmacy
business and —
(a) he dies; or
(b) he is adjudged bankrupt or enters into a composition or scheme or
deed of arrangement with his creditors; or
(c) a receiver is appointed for him under Part 7 of the Mental Health
Act 1998,
and a representative of his thereafter carries on his business.
(2) The conditions referred to in section 35(1)(c) are that —
(a) the name and address of the representative, and the name of the
pharmacist whose representative he is, have been notified to the
registrar, and
(b) at all premises at which the business is carried on and medicinal
products, other than medicinal products on general sale, are sold
by retail —
(i) the business, so far as concerns the retail sale at those
premises of medicinal products (whether they are
medicinal products on general sale or not) or the supply at
those premises of such products in circumstances
corresponding to retail sale, is under the personal control
of a pharmacist; and
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(ii) his name and certificate of registration are conspicuously
exhibited.
(3) The period referred to in section 35(1)(c) is —
(a) in the case of the death of a pharmacist, 5 years from the date of
his death;
(b) in the case of the bankruptcy of the estate of a pharmacist, 3 years
from the date on which he is adjudged bankrupt;
(c) in the case of a composition or scheme or deed of arrangement, 3
years from the date on which the trustee appointed under it
becomes entitled to carry on the business; and
(d) in a case falling within subsection (1)(c), 3 years from the date of
the appointment of the receiver, or
(e) in any case, such longer period as, on the application of the
representative, the Department having regard to all the
circumstances of the case, may direct.
(4) In this section, “representative” —
(a) in relation to a pharmacist who has died —
(i) means his executor or administrator and
(ii) in respect of a period of 3 months from the date of his
death, if he has died leaving no executor who is entitled
and willing to carry on the business, includes any persons
beneficially interested in his estate;
(b) in a case within subsection (1)(b), means the trustee in bankruptcy
or any trustee appointed under the composition, scheme or deed
of arrangement; and
(c) in a case within subsection (1)(c), means the receiver.
39 Power to extend or modify conditions

(1) The Department may by regulations add to, revoke or vary any of the
provisions of sections 36 to 38, so as either —
(a) to modify, or provide new conditions in substitution for, the
conditions referred to in paragraph (a), (b) or (c) of section 35(1);
or
(b) for the purposes of any of those paragraphs, to provide
alternative conditions compliance with which is to have the like
effect as compliance with the conditions referred to in that
paragraph.
(2) Any provision made by regulations under subsection (1) may be made
either generally or in relation to any particular circumstances specified in
the regulations.
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(3) Regulations under subsection (1) may direct that section 35(1) or (2) shall
have effect subject to such exceptions or modifications as appear to the
Department to be necessary or expedient in consequence of the provision
made by the regulations in accordance with subsection (1).
(4) Where regulations under subsection (1) are for the time being in force,
any reference to section 35 in any other enactment shall be construed as a
reference to that section as modified by the regulations.
Registration of pharmacies
40 Registration of premises

(1) The registrar shall —
(a) keep a register for the purposes of this section (“the register”), and
(b) subject to the following provisions of this section, on payment of
the prescribed fee enter in the register any premises in respect of
which an application is made under this section.
(2) Any application for the registration of premises under this section
shall —
(a) be made in the prescribed manner,
(b) specify the premises to which the application relates, and shall
(c) contain such other particulars as may be prescribed.
(3) The registrar shall not enter any premises in the register in pursuance of
an application under this section unless it is shown to his reasonable
satisfaction that either —
(a) at the time of the application, the applicant is a person lawfully
conducting a retail pharmacy business; or
(b) if the premises are entered in the register, and the applicant
begins to carry on a retail pharmacy business at those premises,
then, as from the time when he begins to do so, he will be a
person lawfully conducting a retail pharmacy business.
41 Registration: supplemental

(1) Where any premises have been entered in the register, then, in respect of
each year subsequent to the year in which the premises were so entered,
a further fee (a “retention fee”) of the prescribed amount shall be payable
by the person carrying on a retail pharmacy business at those premises.
(2) If, on demand being made to him in the prescribed manner, the person
carrying on a retail pharmacy business at any premises entered in the
register fails to pay a retention fee in respect of those premises within 2
months from the date on which the demand is made, the Department
may direct the registrar to remove the premises from the register; but if,
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Page 40 AT 4 of 2003 c

before the end of the year in respect of which the retention fee is payable
or such longer period as in any particular case the Department may
allow, the person carrying on the business pays to the registrar the
retention fee in respect of that year, together with such additional sum (if
any) by way of penalty as may be prescribed —
(a) the registrar shall restore the premises to the register; and
(b) if the Department so directs, the restoration shall be deemed to
have had effect as from the date on which the premises were
removed from the register.
(3) Where a change occurs in the ownership of a retail pharmacy business
carried on at any premises registered under section 40, the registration of
the premises under that section —
(a) if the change occurs on the death of the person carrying on the
business, or, in the case of a partnership, on the death of one of
the partners, shall become void at the end of the period of 3
months from the date of the death; and
(b) in any other case, shall become void at the end of the period of 28
days from the date on which the change occurs.
(4) Where the registration of any premises under section 40 in respect of a
business becomes void by virtue of subsection (3), an application for the
premises to be restored to the register may be made by the person who,
in consequence of the change of ownership, has become the owner of the
business; and, where such an application is made, and it is shown to the
reasonable satisfaction of the registrar either —
(a) that at the time of the application the applicant is a person
lawfully conducting a retail pharmacy business; or
(b) that, if the premises are restored to the register, and the applicant
thereafter carries on a retail pharmacy business at those premises,
then, as from the time when he begins to do so, he will be a
person lawfully conducting a retail pharmacy business,
and (in a case where, if the registration had not become void, a retention
fee would have become payable) a fee equal to a retention fee has been
paid, the registrar shall restore the premises to the register.
(5) A document purporting to be a certificate signed by the registrar and
stating that, on a specified date, specified premises were, or were not,
entered in the register shall be admissible in any proceedings as evidence
that those premises were, or were not, entered in the register on
that date.
(6) In this section “year” means a period of 12 months beginning on such
date as the Department may from time to time determine.
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42 Appeals relating to registration

(1) Any person who is aggrieved by the refusal of the registrar of an
application under section 40 may within 14 days of the notification of it
to him appeal to the High Bailiff.
(2) The High Bailiff may uphold an appeal under this section if he considers
that the registrar —
(a) erred in law; or
(b) based his decision on any incorrect material fact.
(3) Where the High Bailiff upholds an appeal under this section, the
registrar shall give effect to his order, and in particular shall make any
necessary entry in the register.
43 Annual return of premises

(1) Every person who carries on a retail pharmacy business shall, in the
month of January in each year, send to the registrar —
(a) a list of all premises at which his business, so far as it consists of
the retail sale of medicinal products, is carried on; and
(b) in the case of any premises where medicinal products, other than
medicinal products on general sale, are sold by retail, or are
supplied in circumstances corresponding to retail sale, the name
of the pharmacist under whose personal control the business, so
far as concerns the retail sale or supply of medicinal products at
those premises, is carried on.
(2) Any person who contravenes subsection (1) is guilty of an offence and
liable on summary conviction to a fine not exceeding £1,000.
Use of certain titles, descriptions and emblems
44 Restrictions on use of titles, descriptions and emblems

(1) No person shall —
(a) take or use any of the following titles —
chemist and druggist,
druggist,
dispensing chemist, or
dispensing druggist; or
(b) take or use the title of chemist in connection with the sale of any
goods by retail or the supply of any goods in circumstances
corresponding to retail sale,
unless the conditions specified in subsection (2) are fulfilled.
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(2) Those conditions are —
(a) in the case of an individual, that —
(i) he is a person lawfully conducting a retail pharmacy
business (either alone or as a member of a partnership),
and
(ii) he does not take or use the title in question in connection
with any premises at which any goods are sold by retail, or
are supplied in circumstances corresponding to retail sale,
unless those premises are a registered pharmacy;
(b) in the case of a body corporate, that —
(i) the body is a person lawfully conducting a retail pharmacy
business,
(ii) the title in question is not taken or used by that body in
connection with any premises at which any goods are sold
by retail, or are supplied in circumstances corresponding
to retail sale, unless those premises are a registered
pharmacy, and
(iii) that the pharmacist who, in relation to that business, is
such a superintendent as is referred to in section 37(1) is a
member of the board of the body corporate.
(3) No person shall, in connection with a business carried on by him which
consists of or includes the retail sale of any goods, or the supply of any
goods in circumstances corresponding to retail sale, use the description
“pharmacy” except in respect of a registered pharmacy or in respect of
the pharmaceutical department of a hospital or a health centre.
(4) No person who is not a pharmacist shall take or use any of the following
titles —
pharmaceutical chemist,
pharmaceutist,
pharmacist,
member of the Royal Pharmaceutical Society, and
fellow of the Royal Pharmaceutical Society.
(5) Without prejudice to subsection (4), no person shall take or use any of
those titles in connection with a business carried on (whether by him or
by some other person) at any premises which consists of or includes the
retail sale of any goods, or the supply of any goods in circumstances
corresponding to retail sale, unless those premises are a registered
pharmacy or a hospital or health centre.
(6) No person shall, in connection with any business, use any title,
description or emblem likely to suggest —
Medicines Act 2003 Section 45

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(a) that he possesses any qualification with respect to the sale,
manufacture or assembly of medicinal products or veterinary
medicinal products which he does not in fact possess; or
(b) that any person employed in the business possesses any such
qualification which that person does not in fact possess.
(7) For the purposes of subsection (8), the use of the description
“pharmacy”, in connection with a business carried on at any premises,
shall be taken to be likely to suggest that —
(a) the person carrying on the business (where that person is not a
body corporate) is a pharmacist, and
(b) any other person, under whose personal control the business (so
far as concerns the retail sale of medicinal products or veterinary
medicinal products or the supply of such products in
circumstances corresponding to retail sale) is carried on at those
premises, is also a pharmacist.
(8) Where a person is lawfully conducting a retail pharmacy business as
being a representative of a pharmacist in the circumstances specified in
section 35(1)(c), subsections (4) to (7) shall not have effect so as to prevent
the representative from taking or using, in connection with that business,
any title, description or emblem which the pharmacist himself could
have used in accordance with those subsections.
(9) Any person who contravenes this section is guilty of an offence and
liable on summary conviction to a fine not exceeding £1,000.
45 Modification etc of restrictions under s 44

(1) The Department may by regulations provide that any of the restrictions
imposed by section 44 shall cease to have effect, or shall have effect
subject to such exceptions as may be specified in the regulations.
(2) Without prejudice to subsection (1), the Department may by regulations
impose (in addition to the restrictions under section 44) such further
restrictions or other requirements with respect to the use of titles,
descriptions and emblems as may be specified in the regulations.
(3) Any person who contravenes regulations under subsection (2) is guilty of
an offence and liable on summary conviction to a fine not exceeding
£1,000.
Disqualification, and removal of premises from register
46 Power of Department to disqualify and direct removal from register

(1) Where a body corporate carries on a retail pharmacy business and —
Section 46 Medicines Act 2003

Page 44 AT 4 of 2003 c

(a) that body is convicted of an offence under any of the relevant
Acts; or
(b) any member of the board or any officer of, or person employed
by, that body is convicted of an offence, or has been guilty of
misconduct, and the offence or misconduct is such as in the
opinion of the Department renders him, or would if he were a
pharmacist render him, unfit to be a pharmacist,
then, subject to the following provisions of this Part, the Department,
after inquiring into the case, may direct that the body corporate shall be
disqualified for the purposes of this Part.
(2) In any case falling within subsection (1) —
(a) if the Department gives a direction under that subsection, it shall
direct the registrar to remove from the register all premises
entered in the register as being premises at which the body
corporate carries on a retail pharmacy business;
(b) if the Department does not give a direction under subsection (1), it
may, if it thinks fit, direct the registrar to remove from the register
all those premises, or such of them as may be specified in the
direction under this paragraph.
(3) Directions under subsection (1) or (2)(a) or (b) may, if the Department
thinks fit, be given so as to have effect for a limited period; and in that
case the registrar, at the end of that period, shall restore to the register
any premises removed from it in compliance with the direction given
under subsection (2)(a) or (b).
(4) Where, in a case mentioned in section 38(1), a representative, or a person
employed by a representative in the business there referred to —
(a) is convicted of an offence; or
(b) has been guilty of misconduct,
and the offence or misconduct is such as in the opinion of the
Department renders him, or would if he were a pharmacist render him,
unfit to be a pharmacist, the Department, after inquiring into the case,
may direct that the representative shall be disqualified for the purposes
of this Part.
(5) In this section and in section 47 “the relevant Acts
” means —
(a) the Misuse of Drugs Act 1976;
(b) this Act; and
(c) any enactment in force in any part of the British Islands (other
than the Island) corresponding to any of those enactments.
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47 Grounds for disqualification in certain cases

(1) The Department shall not give a direction under section 46(1), in a case
falling within section 46(1)(b), and shall not give a direction under
section 46(4), unless —
(a) one or more of the facts specified in subsection (2) are proved to
the satisfaction of the Department; and
(b) the Department is of the opinion, having regard to those facts,
that the board of the body corporate or the representative, as the
case may be, is to be regarded as responsible for the offence or
misconduct in question.
(2) The facts referred to in subsection (1)(a) are —
(a) that the offence or misconduct in question was instigated or
connived at by the board or by a member of the board, or by the
representative, as the case may be;
(b) that, in the case of a body corporate, a member of the board, or an
officer of or person employed by the body corporate, had, at some
time within 12 months before the date on which the offence or
misconduct in question occurred, been guilty of a similar offence
or similar misconduct and that the board had, or with the exercise
of reasonable care would have had, knowledge of that previous
offence or misconduct;
(c) that, in the case of the representative, he or a person employed by
him had, at some time within 12 months before the date on which
the offence or misconduct in question occurred, been guilty of a
similar offence or similar misconduct and (where it was a similar
offence or similar misconduct on the part of an employee) that the
representative had, or with the exercise of reasonable care would
have had, knowledge of that previous offence or misconduct;
(d) if the offence or misconduct in question is a continuing offence or
continuing misconduct, that the board, or the representative, had,
or with the exercise of reasonable care would have had,
knowledge of its continuance;
(e) in the case of an offence in respect of a contravention of an
enactment contained in any of the relevant Acts, that the board, or
the representative, had not exercised reasonable care to secure
that the enactment was complied with.
48 Appeal against disqualification etc

(1) A direction under section 46 shall not take effect —
(a) until the end of the period of 3 months from the date on which
notice of the direction is given to the body corporate or other
person to whom it relates, and
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Page 46 AT 4 of 2003 c

(b) if an appeal against the direction is brought under this section,
until that appeal has been determined or withdrawn.
(2) Where any such direction is given, the body corporate or other person to
whom it relates may, at any time before the end of the period of 3
months specified in subsection (1)(a), appeal against the direction to the
High Court.
(3) The Department may appear as respondent on any such appeal; and, for
the purpose of enabling directions to be given as to costs on any such
appeal, the Department shall be deemed to be a respondent to the appeal
whether it appears on the hearing of the appeal or not.
(4) On any such appeal, the Court may give such directions in the matter as
appear to it to be appropriate; and the Department shall comply with any
such directions and (where appropriate) the registrar shall make such
alterations in the register as are necessary to give effect to them.
(5) No appeal shall lie from any decision of the High Court under this
section.
49 Revocation of disqualification

(1) The Department may revoke a direction under section 46, either on the
application of the person to whom it relates or without any application.
(2) If, on an application to the Department to revoke such a direction, the
Department refuses to revoke it, the applicant, at any time before the end
of the period of 3 months from the date on which notice of the refusal is
given to him, may appeal to the High Court against the refusal.
(3) Section 48(3) to (5) has effect in relation to any appeal under this section
as it has effect in relation to appeals under section 48.
PART 7 – SUPPLEMENTAL

50 Extension of application of Act

(1) The Department may by order —
(a) specify any description or class of articles or substances appearing
to it to be articles or substances which are not medicinal products
or veterinary medicinal products but are manufactured, sold,
supplied, imported or exported for use wholly or partly for a
medicinal purpose, and
(b) direct that, subject to such exceptions and modifications as may be
specified in the order, such provisions of this Act as may be so
specified (including provisions so specified which relate to
offences or penalties) shall have effect in relation to articles or
substances of that description or class as those provisions have
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effect in relation to medicinal products or veterinary medicinal
products, as the case may be.
(2) The Department may by order —
(a) specify any substance appearing to the Department to be a
substance which is not itself a medicinal product or veterinary
medicinal product but —
(i) is used as an ingredient in the manufacture of medicinal
products or veterinary medicinal products; or
(ii) if used without proper safeguards, is capable of causing
danger to the health of the community, or of causing
danger to the health of animals generally or of one or more
species of animals, and
(b) direct that, subject to such exceptions and modifications as may be
specified in the order, such provisions of this Act as may be so
specified (including any provisions so specified which relate to
offences or penalties) shall have effect in relation to that substance
as those provisions have effect in relation to medicinal products
or veterinary medicinal products, as the case may be.
(3) The power conferred by subsection (2) may be exercised in relation to a
class of substances if it appears to the Department that the conditions
specified in subsection (2)(a)(i) or (ii) are fulfilled in relation to all
substances falling within that class.
(4) An order under this section shall not have effect unless it is approved by
Tynwald.
51 References to specified publications

(1) In this section “specified publication” means —
(a) the European Pharmacopoeia;
(b) the British Pharmacopoeia;
(c) the British Pharmaceutical Codex;
(d) the British Veterinary Codex;
(e) the British National Formulary;
(f) the Dental Practitioners’ Formulary;
(g) any compendium prepared and published under section 99(3) and
(6) of the UK Act;
(h) any list of names prepared and published under section 100 of the
UK Act.
(2) Where any authorisation, licence or certificate refers to a specified
publication, but not to a particular edition of that publication, then, for
the purpose of determining whether anything done, at a time when the
licence or certificate is in force, is done in accordance with the licence or
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certificate, the reference shall, unless the licence or certificate otherwise
expressly provides, be construed as a reference to the current edition of
that publication as in force at that time.
(3) Subsection (4) applies where —
(a) under any statutory provision other than this Act (whenever
made) there is power to make any public document, list or other
instrument which is to have effect by virtue of, or for the purposes
of, that provision, and
(b) an instrument made in exercise of that power —
(a) could be made so as to refer to the current edition of a
specified publication as in force at the time when the
instrument is made, but
(b) could not, apart from subsection (4), be made so as to refer
to the current edition of a specified publication as in force
at a subsequent time;
unless, in the case of a statutory provision made after 1985, it otherwise
expressly provides.
(4) The power to make an instrument referred to in subsection (3) may be
exercised so as to refer to the current edition of a specified publication as
in force at such time (whether before, at or after the time when the
instrument is made) as may be specified in, or determined in accordance
with, the instrument.
(5) In this section —
(a) any reference to the current edition of a specified publication as in
force at any particular time is a reference to the edition of that
publication in force at that time together with any amendments,
additions or deletions made to it up to that time; and
(b) any reference to making an instrument in the exercise of a power
conferred by a statutory provision includes a reference to issuing,
approving or varying such an instrument.
52 Regulations

(1) The Department may by regulations prescribe anything which is to be
prescribed under or for purposes of this Act.
(2) Regulations under this Act shall not have effect unless they are approved
by Tynwald.
(3) Regulations under this Act —
(a) may for the purposes of the regulations apply any UK medicines
legislation to the Island as part of the law of the Island, subject to
such exceptions, adaptations and modifications as may be
specified in the regulations; and
Medicines Act 2003 Section 53

c AT 4 of 2003 Page 49

(b) may so apply any order or regulations made under the UK Act
which may from time to time be in force in the United Kingdom
(that is, any such order or regulations made after as well as before
the making of the regulations under this Act).
(4) Regulations under this Act may include provision repealing or amending
any provision of an enactment (other than this Act) which appears to the
Department to be inconsistent with, or to be unnecessary or to require
modification in consequence of, the order or regulations or any UK
medicines legislation thereby applied to the Island.
(5) Where regulations under this Act make provision —
(a) under subsection (3), or
(b) corresponding to any UK medicines legislation,
that provision may be made retrospective to such date as may be
specified in the regulations, not being earlier than the date from which
the relevant UK medicines legislation had effect in England and Wales.
(6) A statement contained in regulations under this Act that any provision of
them corresponds to any UK medicines legislation shall be conclusive
evidence of that fact.
53 “Retail sale” and related expressions

(1) In this Act any reference to selling by retail, or to retail sale, is a reference
to selling a substance or article to a person as being a person who buys it
for a purpose other than that of —
(a) selling or supplying it; or
(b) administering it or causing it to be administered to one or more
human beings,
in the course of a business carried on by that person.
(2) In this Act any reference to supplying anything in circumstances
corresponding to retail sale is a reference to supplying it, otherwise than
by way of sale, to a person as being a person who receives it for such a
purpose as is mentioned in subsection (1).
(3) For the purposes of this section the provision of services by or on behalf
of the Department under the National Health Service Act 2001 shall be
treated as the carrying on of a business by that Department.
54 Interpretation: general

Schedule 2 has effect for the purpose of defining certain expressions in this Act.
Section 55 Medicines Act 2003

Page 50 AT 4 of 2003 c

55 Transitional provisions, amendments and repeals

(1) The following provisions, as they have effect immediately before the
coming into operation of section 2, shall continue to have effect as if
contained in regulations under Part 1 (or, where appropriate, that Part as
modified by section 32), and may be amended or revoked accordingly —
(a) sections 7 to 15 of the Medicines Act 1976, and any order made
under any of those sections;
(b) so far as they relate to wholesale licences, sections 18 to 24, 28 to
30, 44 and 47 of that Act, and any order made under any of those
sections;
(c) section 34, 45 and 46 of that Act.
(2) An order under section 56(2) may make such further transitional
provision as appears to the Department to be necessary or expedient.
(3) The enactments specified in Schedule 3 are amended in accordance with
that Schedule.
(4) The enactments specified in Schedule 4 are repealed to the extent
specified in column 3 of that Schedule.
56 Short title and commencement

(1) This Act may be cited as the Medicines Act 2003.
(2) This Act shall come into operation on such day or days as the
Department may by order appoint.14

Medicines Act 2003 Schedule 1

c AT 4 of 2003 Page 51

SCHEDULE 1

SAMPLING

Section 20(9)
Introductory
1. This Schedule has effect where a person authorised for the purpose by the
Department (a “sampling officer”) obtains a sample of any substance or article —
(a) for the purpose of ascertaining whether there is or has been, in
connection with that substance or article, any contravention of
any provisions of this Act or of any regulations or order made
under it; or
(b) otherwise for any purpose connected with the performance by the
Department of its functions under this Act or under any such
regulations or order,
and the sampling officer obtains the sample by purchase or in the exercise of any
power conferred by section 20.
Division of sample
2. The sampling officer shall forthwith divide the sample into 3 parts, each part to
be marked and sealed or fastened up in such manner as its nature will permit.
3. If the sample was purchased by the sampling officer, otherwise than from an
automatic machine, he shall supply one part of the sample to the seller.
4. If the sampling officer obtained the sample from an automatic machine, then —
(a) if a person’s name, and an address in the Island, are stated on the
machine as being the name and address of the owner of the
machine, the sampling officer shall supply one part of the sample
to that person;
(b) in any other case, the sampling officer shall supply one part of the
sample to the occupier of the premises on which the machine
stands or to which it is affixed.
5. If the sample is of goods consigned from outside the Island and was taken by
the sampling officer before delivery to the consignee, the sampling officer shall supply
one part of the sample to the consignee.
6. If, in a case not falling within paragraphs 3 to 5, the sample was obtained by the
sampling officer at the request or with the consent of a purchaser, the sampling officer
shall supply one part of the sample to the seller.
Schedule 1
Medicines Act 2003

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7. If, in a case not falling within paragraphs 3 to 6, the sample was taken in transit,
the sampling officer shall supply one part of the sample to the consignor.
8. In any case not falling within paragraphs 3 to 7, the sampling officer shall
supply one part of the sample to the person appearing to him to be the owner of the
substance or article from which the sample was taken.
9. In every case falling within paragraphs 3 to 8, the sampling officer shall inform
the person to whom the part of the sample in question is supplied that the sample has
been obtained for the purpose of analysis or other appropriate examination.
10. Of the remaining parts of the sample into which the sample is divided in
accordance with paragraph 2, the sampling officer, unless he decides not to submit the
sample for analysis or other appropriate examination, shall —
(a) retain one part for future comparison; and
(b) submit the other part for analysis or examination in accordance
with the following provisions of this Schedule.
11. Where a sample consists of substances or articles enclosed in unopened
containers, and it appears to the sampling officer that to open the containers and divide
the containers into parts —
(a) is not reasonably practicable; or
(b) might affect the composition or impede the proper analysis or
other examination of the contents,
the sampling officer may divide the sample into parts by dividing the containers into 3
lots without opening them.
12. Section 40 of the Interpretation Act 1976 applies to supplying any part of a
sample in pursuance of the preceding paragraphs of this Schedule as it applies to the
service of a document.
13. If, after reasonable inquiry, the sampling officer is unable to ascertain the name
of a person to whom, or the address at which, a part of a sample ought to be supplied
in pursuance of paragraphs 1 to 12, he may retain that part of the sample instead of
supplying it.
Notice to person named on container
14. (1) Where it appears to the sampling officer that a substance or article of
which he has obtained a sample was manufactured or assembled by a person whose
name and address in the Island are stated on the container, and who is not a person to
whom a part of the sample is required to be supplied under the preceding provisions
of this Schedule, the sampling officer, unless he decides not to submit the sample for
analysis or other appropriate examination, shall serve notice on that person —
Medicines Act 2003 Schedule 1

c AT 4 of 2003 Page 53

(a) stating that the sample has been obtained by the sampling officer;
and
(b) specifying the person from whom the sampling officer purchased
it, or, if he obtained it otherwise than by purchase, the place from
which he obtained it.
(2) The notice required to be served under paragraph (1) shall be served
before the end of the period of 3 days beginning with the day on which the sample was
obtained.
Analysis or other examination of sample
15. (1) If the sampling officer decides to submit the sample for analysis, he shall
submit it to the public analyst, who (subject to sub-paragraph (2)) shall as soon as
practicable analyse the sample or cause it to be analysed by some other person under
his direction.
(2) If —
(a) the office of public analyst is vacant and no provision has been
made under section 20 of the Interpretation Act 1976 for some other
person to exercise his functions, or
(b) the public analyst determines that he is for any reason unable to
perform an effective analysis,
the sampling officer or the public analyst, as the case may be, shall send the sample to a
public analyst in the United Kingdom with the request that, on payment to him of such
sum as may be agreed, he shall analyse it or cause it to be analysed by some other
person under his direction, and issue to the sampling officer a certificate under sub-
paragraph (3).
(3) A public analyst who has analysed a sample under this paragraph shall
issue to the sampling officer a certificate specifying the result of the analysis.
(4) Where a sample taken or purchased by a sampling officer has been
analysed by a public analyst, any person to whom a part of the sample was given in
accordance with paragraphs 2 to 8 is entitled, on paying the prescribed fee to the
Department, to be supplied with a copy of the certificate given by the analyst under
sub-paragraph (3).
(5) A certificate under sub-paragraph (3) shall be in a prescribed form and
signed by the public analyst who issues it.
Provisions as to evidence
16. In any proceedings for an offence under this Act, a document produced by one
of the parties to the proceedings and purporting to be a certificate issued under
paragraph 15 shall be sufficient evidence of the facts stated in the document, unless the
other party requires that the person who issued the certificate shall be called as a
witness.
Schedule 1
Medicines Act 2003

Page 54 AT 4 of 2003 c

17. In any proceedings for an offence under this Act, a document produced by one
of the parties to the proceedings, which has been supplied to him by the other party as
being a copy of such a certificate, shall be sufficient evidence of the facts stated in the
document.
18. (1) If, in any such proceedings before a court of summary jurisdiction, a
defendant intends to produce such a certificate, or to require that the person by whom
such a certificate was issued shall be called as a witness, a notice of his intention, and
(where he intends to produce such a certificate) a copy of the certificate, shall be given
to the other party at least 3 clear days before the day on which the summons is
returnable.
(2) If sub-paragraph (1) is not complied with, the court may, if it thinks fit,
adjourn the hearing on such terms as it thinks proper.
Analysis under direction of court
19. (1) In any proceedings for an offence under this Act, where the proceedings
relate to a substance or article of which a sample has been obtained as mentioned in
paragraph 1, the part of the sample retained in pursuance of paragraph 10(a) shall be
produced as evidence; and the court —
(a) at the request of either party to the proceedings, shall; and
(b) in the absence of any such request, may if it thinks fit,
cause that part of the sample to be sent for analysis to the person having the
management or control of a laboratory specified by the court.
(2) If, in a case where an appeal is brought, no action has been taken under
sub-paragraph (1), that sub-paragraph shall have effect in relation to the court by
which the appeal is heard.
(3) A person to whom a part of a sample is sent under this paragraph for
analysis or other examination shall analyse or examine it, or cause it to be analysed or
examined, on his behalf, and shall transmit to the court a certificate specifying the
result of the analysis or examination.
(4) Any such certificate shall be signed by that person, or signed on his
behalf by the person who made the analysis or examination or a person under whose
direction it was made.
(5) Any such certificate shall be evidence of the facts stated in the certificate
unless any party to the proceedings requires that the person by whom it was signed
shall be called as a witness.
20. The costs of any analysis or examination under paragraph 19 shall be paid by
the prosecutor or the defendant, as the court may order.
Medicines Act 2003 Schedule 2

c AT 4 of 2003 Page 55

Power to modify sampling provisions
21. The Department may by regulations provide that, in relation to substances or
articles of any prescribed description, paragraphs 1 to 20 shall have effect subject to
such exceptions and modifications as may be prescribed.
Payment for sample taken under compulsory powers
22. (1) Where a sampling officer takes a sample in the exercise of any power
conferred by section 20, he shall, if payment is demanded, pay the value of the sample
to the person to whom a part of the sample is required under paragraph 5, 7 or 8, as the
case may be, to be supplied.
(2) In default of agreement between the sampling officer and the person
mentioned in sub-paragraph (1), the value of the sample shall be determined by the
arbitration of a single arbitrator appointed by the sampling officer and the other person
in question or, if they are unable to agree on the appointment of an arbitrator, shall be
determined by the High Bailiff.
Application of section 8 to samples
23. Where a medicinal product is taken as a sample by a sampling officer in the
exercise of any power conferred by section 20, section 8(1) to (4) applies as if the taking
of the product as a sample were a sale of it to the sampling officer by the person from
whom it is taken; and, if the product was prepared in pursuance of a prescription given
by a practitioner, section 8(1) to (4) shall so apply as if, in section 8(1), for “demanded
by the purchaser” there were substituted “specified in the prescription”.
SCHEDULE 2

INTERPRETATION

Section 54
Expression Meaning analysis
includes micro-biological assay but no other form of
biological assay, and “analyse
” has a corresponding
meaning
animal
includes any bird, fish or reptile
assemble (in relation to a

medicinal product or veterinary

medicinal product)

means enclosing the product (with or without other
products of the same description) in a container which is
labelled before the product is sold or supplied, or, where
the product (with or without other products of the same
description) is already enclosed in the container in which it
is to be sold or supplied, labelling the container before the
product is sold or supplied in it, and “assembly” has a
corresponding meaning
board (in relation to a body

corporate)

means the body of persons controlling the body corporate,
by whatever name called
Schedule 2
Medicines Act 2003

Page 56 AT 4 of 2003 c

Expression Meaning business
includes a professional practice and any activity carried on
by a body or persons, whether corporate or unincorporated
certificate of registration
means a certificate of registration under the Pharmacy Act
1954 (an Act of Parliament) or any Act of Parliament
replacing that Act
Community authorisation
has the meaning given by section 1(3)
EU instrument
15
has the meaning given by section 1(1) of the European
Communities (Isle of Man) Act 1973
composition (in relation to a

medicinal product)

means the ingredients of which the product consists and
the proportions, and the degrees of strength, quality and
purity, in which those ingredients are contained in it
respectively
container (in relation to a

medicinal product or veterinary

medicinal product)

means the bottle, jar, box, packet or other receptacle which
contains or is to contain the product, not being a capsule,
cachet or other article in which it is or is to be administered,
and, where any such receptacle is or is to be contained in
another such receptacle, includes the former but does not
include the latter receptacle
contravention
includes failure to comply, and “contravene
” has a
corresponding meaning
dentist
means a registered dentist within the meaning of the Dental
Act 1985
Department
means the Department of Health and Social Care16

disease
includes any injury, ailment or adverse condition, whether
of body or mind
doctor
means a registered medical practitioner17

EC code
means Directive 2001/83/EC on the Community code
relating to medicinal products for human use
EC Regulation
means Council Regulation (EEC) No 2309/93 laying down
Community procedures for the authorisation and
supervision of medicinal products for human and
veterinary use and establishing a European Agency for the
evaluation of medicinal products
EC veterinary code
means Directive 2001/82/EC on the Community code
relating to veterinary medicinal products
health centre
means a health centre maintained under section 15 of the
National Health Service Act 2001
hospital
includes a clinic, nursing home or similar institution
ingredient (in relation to the

manufacturer or preparation of a

substance)

includes anything which is the sole active ingredient of that
substance as manufactured or prepared
label (in relation to a container

or package of a medicinal

product or veterinary medicinal

product)

means a notice describing or otherwise relating to the
contents and affixed to or otherwise displayed on the
container or package, and “labelling
” has a corresponding
meaning
Medicines Act 2003 Schedule 2

c AT 4 of 2003 Page 57

Expression Meaning manufacture (in relation to a

medicinal product or veterinary

medicinal product)

includes any process carried out in the course of making
the product, but does not include dissolving or dispersing
the product in, or diluting or mixing it with, some other
substance used as a vehicle for the purpose of
administering it and does not include the incorporation of
the product in any animal feeding stuff
medicinal product
has the meaning given by section 1(2)
medicinal product (or veterinary

medicinal product) on general

sale

medicinal means a medicinal product (or veterinary
medicinal product) to which section 4 applies
offence under this Act
includes an offence under any regulations or order made
under this Act
package (in relation to any

medicinal products or veterinary

medicinal products)

means any box, packet or other article in which one or
more containers of the products are or are to be enclosed,
and, where any such box, packet or other article is or is to
be itself enclosed in one or more other boxes, packets or
other articles, includes each of the boxes, packets or articles
in question
pharmacist
means a person registered in the register of pharmaceutical
chemists maintained under section 2(1) of the Pharmacy
Act 1954 (an Act of Parliament)
practitioner
means —
(a) in relation to medicinal products —
(i) a doctor,
(ii) a dentist,
(iii) a registered nurse holding prescribed
qualifications or fulfilling prescribed
conditions,
(iv) a registered midwife holding prescribed
qualifications or fulfilling prescribed
conditions, or (v) any other person holding
prescribed qualifications or fulfilling
prescribed conditions;
(b) in relation to veterinary medicinal products —
(i) a veterinary surgeon,
(ii) [Repealed] [or
[Subpara (ii) repealed by Veterinary Surgeons Act
2005 Schs 2 and 3.]
(iii) any other person holding prescribed
qualifications or fulfilling prescribed
conditions
prescribed
means prescribed by regulations under this Act
registered
in relation to a nurse or midwife, has the same meaning as
in the Nursing and Midwifery Order 2002 [SD159/02]
registered pharmacy
means premises for the time being entered in the register
required to be kept under section 40
registrar (in Part 6)
means the person appointed by the Department to be
registrar for the purposes of Part 6
requirement
includes a restriction
Schedule 3
Medicines Act 2003

Page 58 AT 4 of 2003 c

Expression Meaning retail pharmacy business
means a business (not being a professional practice carried
on by a practitioner) which consists of or includes the retail
sale of medicinal products other than medicinal products
on general sale (whether medicinal products on general
sale are sold in the course of that business or not)
retail sale (or selling by retail)
has the meaning given by section 53
substance
means any natural or artificial substance, whether in solid
or liquid form or in the form of a gas or vapour
supply in circumstances

corresponding to retail sale

has the meaning given by section 53
treat (in relation to disease)
includes doing or providing anything for alleviating the
effects of the disease, whether it is done or provided by
way of cure or not, and “treatment
” has a corresponding
meaning
UK Act
means the Medicines Act 1968 (an Act of Parliament)
UK authorisation
subject to section 32, has the meaning given by section 1(3)
UK medicines legislation
means—
(a) any provision of the UK Act,
(b) any provision of any Act of Parliament, or of any
statutory instrument, amending, varying,
modifying or replacing the UK Act, whether
directly or indirectly;
(c) any statutory instrument made under the UK Act or any
Act referred to in paragraph (b); or
(d) any statutory instrument made under the European
Communities Act 1972 (an Act of Parliament) and
giving effect to any provision of —
(i) the EC code,
(ii) the EC veterinary code,
(iii) the EC Regulation, or
(iv) any EU instrument from time to time
amending or replacing any of the
instruments mentioned in sub-
paragraphs (i), (ii) and (iii).18

veterinary medicinal product
has the meaning given by section 31
veterinary practitioner
[Repealed]19

veterinary surgeon
means a person registered in the register of veterinary
surgeons kept under section 2 of the said Act of 1966

SCHEDULE 3

AMENDMENT OF ENACTMENTS

Section 55(3)
[Sch 3 amended by Veterinary Surgeons Act 2005 Schs 2 and 3, and amends the
following Acts —
Medicines Act 2003 Schedule 4

c AT 4 of 2003 Page 59

Cancer Act 1942 q.v.
Consumer Protection (Trade Descriptions) Act 1970 q.v.
Misuse of Drugs Act 1976 q.v.
Poisons Act 1979 q.v.
Local Government (Miscellaneous Provisions) Act 1984 q.v.
Consumer Protection Act 1991 q.v.
Licensing Act 1995 q.v.
Value Added Tax Act 1996 q.v.
Food Act 1996 q.v.
Cruelty to Animals Act 1997 q.v.
Shops Act 2000 q.v.
National Health Service Act 2001 q.v.]
SCHEDULE 4

ENACTMENTS REPEALED

Section 55(4)
[Sch 4 repeals the following Acts in part —
Medicines Act 1976
Poisons Act 1979
Medical Act 1985
Treasury Act 1985
Dental Act 1985
Customs and Excise Management Act 1986
Statute Law Revision Act 1989
Copyright Act 1991
Statute Law Revision Act 1992
National Health Service Act 2001.]
Medicines Act 2003 Endnotes

c AT 4 of 2003 Page 61

ENDNOTES

Table of Legislation History

Legislation Year and No Commencement

Table of Renumbered Provisions

Original Current

Table of Endnote References

1
Subs (1) amended by SD155/10 Sch 4 and by SD2014/08. 2
Para (b) amended by SD0606/12. 3
S 13 not yet in force. 4
S 14 not yet in force. 5
S 15 not yet in force. 6
S 16 not yet in force. 7
S 17 not yet in force. 8
Subs (3) amended by Civil Partnership Act 2011 Sch 14. 9
S 31 not yet in force. 10
Subs (4) amended by SD155/10 Sch 3. 11
S 32 not yet in force. 12
S 33 not yet in force. 13
S 34 not yet in force. 14
ADO (whole Act, except Parts 3 and 5) 1/11/2004 (SD761/04). 15
Entry amended by SD0606/12. 16
Definition of “the Department” amended by SD155/10 Sch 4 and by SD2014/08. 17
Definition of “doctor” substituted by Health Care Professionals Act 2014 s 14. 18
Subpara (iv) amended by SD0606/12. 19
Definition of “veterinary practitioner” repealed by Veterinary Surgeons Act 2005
Schs 2 and 3.