Advertising medicines Flashcards
MA 57
Restrictions on advertisements
1) No person shall publish any medical advertisement that
a- directly or by implication qualifies or is contrary to any statement or other particulars by regulations made under this Act
b- prohibited by any such regulations from being marked on or attached to product
c- omits from the name or description of medicines or medical devices advertised any word or words required by regulations to be included in name or description attached to product
d- fails to make any statement required by regulations
e- makes any statement prohibited by any such regulations from being made in advertisement
f- is false or likely to mislead any other person of the nature, quality, strength, purity, composition, origin, age, uses or effects
g-directly or by implication states or suggests the medicines or medical devices cannot harm any person or any person belonging to a particular class of persons
2) any words that must be included in an advertisement in order to avoid a contravention, where they appear to in an advertisement published by television or on screen, be disregarded unless they are exposed in clearly legible lettering for a length of time sufficient to enable to be read by an ordinary viewer
3) mislead any person with regard to uses and effects of medicine or medical device, if likely to mislead with regard to:-
a- any purpose for which the medicine or medical device can be used with reasonable safety or
b-any purpose for which it cannot be used
c- any effects that such medicine or medical device when used or when used in any particular way referred to in advertisement, produce are intended to produce
MA 58
Further restrictions on advertisements
No person shall publish any medical advertisement that
a- directly or by implication claims or indicates or suggest that it will prevent, alleviate or cure any disease or prevent, reduce or terminate any physiological condition belonging in part 1 of the schedule 1 of this act or
b-conditions belonging in part 2 of schedule 1 or
c- directly or by implication claims, indicates or suggests that a medicine or medical device or method of treatment advertised
i- is a panacea or infallible or
ii- is or has been used or recommended by practitioner, nurse or pharmacist or any person qualified to provide therapeutic treatment or person engaged in study or research
iii- has beneficially affected health of a particular person or class of person real or fictitious
d- invites correspondence affected or sending of bodily secretions or photographs of diagnosis or treatment concerning condition
MA 59
Advertisements to contain true name of advertiser
1) No person shall publish any medical advertisement that does not contain a statement of the true name of the person for whom is published and the address of that persons place of residence or business
2) Body corporate instead of address, state the name of place where its registered office is or registered company or other headquarters
3) Any statement in medical advertisement and purports to set forth the name of person for whom or on whose behalf the advertisement is published, shall until the contrary be sufficient evidence of the name of the person for whom or on whose behalf it is published
4) Nothing in this section applies to:
a- name and address of place of manufacturers or seller of medicines
b-an exemption granted under this Act from the material provisions of any such regulations
MA 60
Exemption for certain advertisements
Nothing in section 57(1)(g) or 58 or 59 of this Act shall apply to any medical advertisement that
a- is distributed only to person referred in section 58(1)(c)(ii)
b- is contained in publication that in ordinary course circulated solely or principally or is distributed solely or principally to those persons
c- not being an advert relating to prescription medicine or restricted medicine or pharmacy only is distributed solely to persons claiming to be available for consultation by other persons for therapeutic purposes and to persons privately consulting them
MA 61
Misleading branding
No person shall sell any medicine or medical device
a- that bears or attached or enclosed in package any false or misleading statement relating to product e.g. brand strength, quality, effects of medicine or medical device
b- packed or processed or treated in a manner that is false or misleading in relation to any of the matters mentioned in
MA 62
Regulations relating to advertisements
Governor General may from time to time make regulations for all or any of the following purposes
1)
a- requiring and regulating the insertion in any medical advertisement of information concerning any unwanted, incidental or untoward effects of medicines such as statement of precautions to be taken by any user of medicines
b-prohibit the advertising of any specific description of medicine or medical device or method of treatment relating to composition, properties, origin and use of medicine or medical device
c- insertion of particular words specified by the Minister in or the omission of particular words or other matter specified from, any particular medical advertisement and give directions with respect to location size and appearance of any such inseertion
d- Governer General may make regulations for generally regulating medical adverts
2)
a- any regulations in 1(a) shall be made only on recommendation of minister after consultations with such organisations or bodies as the Minister considers likely to be substantially affected by regulations and
b- shall be designed to achieve a fair and balanced indication of potential effects of medicine or medical device or method
c-shall not be require the disclosure of info that may be regarded as confidential or that cannot be reasonably be expected to be in the possession of person on whose behalf the advertisement is published or inclusion of which in the advertisement is otherwise impacticable
MR 7
Advertisement not claim official approval
No advertisement relating to any medicine, related product, or medical device shall contain a statement to the effect that an advisory or technical committee or any officer in service of the government has approved or refrained from disapproving the advertisement or any claims or statements made in it
MR 8
Advertisements for medicines
1) advertisement for prescription medicine must include
a- the words prescription medicine or similar meaning
b-true name of active ingredient
c- quantity of active ingredient
d- purpose of medicine which it is intended for
e- risks and benefits
f- how to find further information
2) Every advertisement for restricted medicine must include
a- following statements or similar meaning to
i- available only from pharmacists
ii- if symptoms persist see Dr or other health professional
iii- use only as directed and
b- name of active ingredient and always read label
c- statement of purpose of medicine
d- warning statement that may be required by guidelines issued from time to time by MoH
3) Pharmacy only medicine
i- if symptoms persist see Dr
ii- use only as directed
b- active ingredient and always read label
statement of purpose of medicine
warning statement issued by MoH
4) If supplied by mail order, direct marketing or via internet must include
a- name of active ingredient
b-include the quantity of active ingredient
c- comply with 1, 2 and 3
5- statements need to be clearly printed or clearly spoken
6- statement may be bother clearly printed and clearing spoken
7- this regulation does not apply to
a- advert that does not refer to therapeutic purpose
b-advertisement that is located at point of sale and positioned immediately below, above or next to medicine to which it relates to
c-labels
d- price lists
8- An advert for medicine that is subsequently reclassified must be treated as compliant with this regulation if
a- compliant with regulation before reclassification
b- not more than 3 months have elapse since medicine reclassified
MR 9
Advertisements for related products
1) Every Advert shall include a statement of the uses of the related product (other than label or price list)
2) Every advert that refers to an active ingredient by name shall state the appropriate designation of the ingredient
MR 10
Advertisements of medical devices
Every advert other than label or price list shall include where appropriate the following
a- accurate description
b- statement of uses
c- appropriate precautions to be taken in the use
d- contraindications to use of medical device
MR 11
Advertisements intended for health professions
1) this applies to member of medical, dental, pharmaceutical and related professions in addition to reg 7, 9 and 10
2) Every advert must include
a)
classification of med
name of each active ingredient
quantity of active ingredient
purpose of med
precautions
effectiveness and limitations
distribution restriction
dose regimen and mode of admin and method
contraindications
likely effects and interactions
known or likely to be poisonous effects or ADRs
b) not include
statement of effectiveness or safety that omits relevant parts of report in such a way that another meaning is intended
unsubstantiated comparison with other med
data previously considered as valid but made obsolete or false by subsequent findings
statement of use of medicine or dosage that contravenes 20, 23.24 of Act
3) Nothing in 2 applies to advert that is for practitioner with details of a major therapeutic indication of a medicine or in pharmac schedule or new of changed strength of medicine
4) Advert of related product or medical device must include a statement of distribution restriction and dose regimen and mode of admin or method of use and effectiveness and limitations
MDR 50
Restrictions on advertising of controlled drugs
1) No person shall publish or cause or permit to be published any advert
2) Nothing in subsection 1 shall apply to any advert distributed to practitioners or pharmacists that is specifically distributed to those people and
a- states the true name and address of business of person whom request advert to be published
b-Indicates it is a controlled drug or CD
