PA1: Is there legal provision for the control of drug promotion and advertising?
Yes
No
PA1.1: If yes, indicate the title, date of enactment and article number of the legislation/regulations:
________________________________________________________________
PA2: State any restrictions specified in the law on drug promotion and advertising:
________________________________________________________________
PA3: Are prescription drugs advertised:
| |
Yes/No |
In the lay press? |
|
In health professional journals? |
|
On radio and television? |
|
On billboards? |
|
PA4: Which body controls drug advertising/promotion?
________________________________________________________________
PA5: Is pre-approval required for promotional and advertising materials?
Yes
No
PA5.1: If yes, what body issues the pre-approval?
________________________________________________________________
PA5.2: Is there a fee for pre-approval?
Yes
No
PA5.3: If no, how is drug advertising/promotion monitored?
________________________________________________________________
PA6: Is a product information sheet/summary of product characteristics approved at the time of registration?
Yes
No
PA6.1: Are patient information leaflets and labels subject to approval?
Yes
No
PA7: Are there sanctions for violations of laws on product information and promotion?
Yes
No
PA7.1: How many violations have been registered and administrative measures and legal sanctions taken in the last five years?
Violations and enforcement measures taken |
Year: |
Year: |
Year: |
Year: |
Year: |
Number of violations of drug promotion law/regulations registered |
|
|
|
|
|
Number of judicial sanctions implemented |
|
|
|
|
|
Number of administrative measures taken |
|
|
|
|
|
PA7.2: Are sanctions effective?
Yes
No
PI8: Is/are there association(s) of pharmaceutical manufacturers/companies that practise self-regulation?
Yes
No
PI8.1: If yes, indicate the name(s) of the association(s), obtain copies of the code of practice, and provide information on the extent to which they are effective:
________________________________________________________________
PA9: Does the drug regulatory authority provide independent drug information to prescribers, dispensers and the public?
Yes
No
PA9.1: If yes, obtain a copy the latest publication.
PA9.2: If no, does any other body provide information independent of the industry?
Yes
No
PA9.3: If yes, indicate the name (s) of such bodies:
________________________________________________________________
PA10: How are the public and prescribers informed about newly registered drugs? Explain:
________________________________________________________________
PA11: Is there a mechanism whereby false medical claims in advertisements are controlled? If yes, explain.
Yes
No
PA12: What are the main constraints, weaknesses or problems and the strengths of control of drug promotion/advertising?
Constraints/weaknesses/problems |
Strengths |
| |
|
| |
|
|
Indicators
1. Number of advertisements/promotions found to be in violation of the law, out of the total number of promotions/advertisements monitored (indicate year).
2. Number of labels/inserts found to be inconsistent with what was approved during registration, out of the total number of labels and inserts assessed (indicate year).
3. Number of product information documents found to be in inappropriate language, out of the total number of product information documents assessed (indicate year).
|
If there is any specific and important information that is not covered by the above questions, please provide additional information as appropriate.
Cargando...
