Promotion

Question 1

What are the changes to HMR 2012?

Answer 1

Removal of statutory warning for OTC products, except from paracetamol -now contained within MA

Medicine optimisation in labelling- pharmacist can exercise professional judgement to change 456

Water for injection -can be sold or supplied

Question 2

Recent changes to HMR 2012? Amendment no 2

Answer 2

HMR (amendment no 2) July 18th 2014: allow supply of salbutamol inhalers to schools for use in an emergency

Question 3

When did the salbutamol inhaler change (in HMR) came into effect

Answer 3

1st October 2014

Question 4

Non healthcare prof eg head teacher of school will need to state 3 things to inhaler supplier

Answer 4

Name of the school
The purpose of product
Total quantity required

Question 5

What’s the purpose of consultation document Jan 2015 (regard to changes to HMR

Answer 5

To strengthen health protection response to outbreaks of infectious disease and other incidents through use of PGDs to staff from PHE. PHA

Question 6

What’s not an advert?

Answer 6

Reference materials- factual statements

• information relating to human health or disease
• answer to query about product
• journal articles
• PIL labelling

Question 7

Promotion is regulated by?

Answer 7

Statutory measures enforced by MHRA -executive agency
Self regulation though codes of practice for the pharmaceutical industry PMCPA- ABPI
PAGB
HFMA
OFCOM
ASA

Question 8

Who is responsible for advert?

Answer 8

Licence holder -responsibility delegated to qualified signatories
Advertiser
Publisher
Offence for ‘any person’ to breach the reg

Question 9

How long does the MHRA keep copied of complaints for?

Answer 9

7 years

Question 10

Adverts needs to be up to date and consist with? Sample kept for how many years?

Answer 10

SPC

3 years

Question 11

What type of med are allowed to be advertised?

Answer 11

P, GSL

Question 12

Info needed on an advert:

Answer 12

Clear msg that it’s is an advert
Name of medicine and common name
Indications
Read the pIL /label

Question 13

Is it accept to feature or sponsored by an individual celebrity in an advert?

Answer 13

No

Question 14

Who can sponsor what med?

Answer 14

A manufacture can sponsor OTC product advert not POM

Question 15

Is medicine sample OK to be given to public via magazine, vouchers?

Answer 15

No, it’s PROHIBITED

Question 16

Who’s PQPS

Answer 16

Person qualified to prescribe or supply

Question 17

What must be appeared in an abbreviated ad?

What’s size requirement

Answer 17

Not to exceed 420 sq cm in area
Must refer at least one of SPC indciations, contains info compatible with SPC, name n list of API, name add of MA holder, name add of part of business responsible for supply, legal classification, statement that further info Availble

Question 18

Promotional aid is a form of what

Answer 18

Remainder advertisement

Question 19

What should a reminder ad consist of

Answer 19

Name of product INN (generic ) NOT AN AD/ other info not needed

Question 20

Cost of promotional aid

Answer 20

Less than £6 can be pens notepad mugs

Question 21

What needs to be on ad for reg homeopathic med

Answer 21

1- name or stock n dilution
2- N/a of certificate holder/ manufacture
3- certificate no
4- administration details
5- form expiry date storage details
6- warning
7- bath no
8- content of the sales presentation
9-‘word’ homeopathic med product without approved TE
10- waning to consult a dr is symptom persist