Procedure on How to Advertise Drugs in a Mass Media in Kenya If you are interested to educates patients and allows them to take charge of their health you can take the following steps.Step I Fill and submit the a pplication Form.
A formal application letter should be submitted to Pharmacy and Poisons Board (PPB) this is the body which is responsible for issuing permission, Marketing authorization / and registration Department. A medical representative shall apply to the planning, drug information department for drug promotion in mass media attaching the information to be promoted with the application form ( annex -2) prepared by the PPB.
Only a medical representative who has been granted a certificate of competency from the authority is entitled to promote drugs the health professional. drugs products are available to consumers without a prescription.
Any medical representative should have a place to keep promotional materials and other documents used for his/her work and An advertisement must clearly communicate the intended use of the product.
When describing product efficacy, they must be consistent with the terms of market authorization (TMA).
An advertisement must not be misleading as to the duration of use of the advertised product ie which can lead to overdose problems.
Drug advertising must be overtly directed to adults, so not to mislead to suggest that a child is capable of making a rational decision
regarding the use of the advertised product.
Product Poison Board (PPB)must regulates commercial advertisements by monitoring the quality of information in the advertisement routinely.
The government has the responsibility to ensure compliance bwith the regulations controlling advertisements in order to improve drug usage among the population.
Wait for a few days for the reply from the department of Planning and drug information. The department, in reply to the application, shall give proper decision within five to ten working days.Step III
If the application is accepted, the authority shall write an approval letter to the concerned media on which the drug is to be promoted.
The information content of promotion in media for Analgesics, Anthilemntics shall include the right source of availability and shall state that the advice of health professional is required.
Two copies of the receipt for the purchase of the form(s),
Evidence of the Drug product registration,
A letter of introduction of Advert Agent from the Applicant, (where applicable)
GSM telephone No. and email address of the Applicant/Advert Agent.
Drug Product sample in all pack sizes
Recorded Advert messages in CD/VCD/DVD on approval of the advertisement material.
All approved Drug adverts shall be valid for three months to one year from the date of approval except in cases where extended validity, up to a period of validity of registration license is required.
processing takes only five days Advertise
The labeling of all Drug products must comply with the labeling requirements as registered.
Everyone who wants to advertise drugs or pharmaceuticals, Must obtain the approval of the Technical Committee for Drug Control, Ministry of *Health and Population before the release of those products and the interest of the health citizens.
information including composition,
indication information ,
Information Adverse effects,
information on drug interactions and warnings/precautions. . Advertise
Need for the Document
The number of mass media ads for prescription drugs has exploded in recent years. They are quite literally everywhere, but most noticeably on television.
There are currently several types of drug advertisements,According to the Medical Ethics medical practitioners are not allowed to advertise their Drugs or services,with a view in Mind that Direct-to-consumer advertisings are commonly misleading,inaccurate or loaded with unbalanced information which can mislead patients
To control commercial advertisements, the Kenya government introduced a( PPB )which organizes and regulates drug promotion in the country.
The aim is not only to monitor compliance of pharmaceutical industry to the regulation, but also to ensure that consumers get objective and complete information that does not mislead,as well as to promote the safe and effective use of drugs.
There very few countries that allow DTCPA that includes product claims but Most other countries dont allow DTCPA at all;
Therefore, Advertisement of Drugs and Cosmetics Requires Approval from Ministry of Health through the Pharmacy and Poisons Board (PPB) department in Kenya.
The PPB has the authority to enforce regulations and take action against companies that do not abide by DTCPA rules.
The PPB is responsible for assessment of all Pharmaceutical promotional in mass media adverts for human and animal drugs, use including food supplements, veterinary products ,insecticides, medical devices & cosmetics before giving permission to advertise in the media.
This is done to ensure quality & safety of products with affordable prices by applying a Transparent -Effective -Smooth & Communicable System. The information content of the drugs to be promoted on the mass media shall be strictly evaluated by the Pharmacy and Poisons Board and include the necessary precaution to be taken during application.
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