Uganda - Apply to Advertise Drugs in Mass Media

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Procedure

If you are interested in educating patients and allows them to take charge of their health you can take the following steps.

• A person who seeks to make a publication or an advertisement for a drug shall make an application to the Authority in writing on a company letter head and complete and attach a Form 45.
  
  

Step I
Submit a written application Form 45 to the National Drug Authority (NDA).

• A formal written application letter on a company letter head should be submitted to National Drug Authority (NDA) 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.
• 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 should not be 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.
• Prior to production and/or importation, distribution or use of any Drug promotional material, or institution of arrangements to engage in any form of drug promotion activity, an application for authorization to publish or advertise shall be made by:
  • the holder of the patent of the drug;
  • a licensed person;
  • the manufacturer of the drug; or
  • an agent authorized by the manufacturer or the holder of the patent of the drug.
• 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.
• National Drug Authority (NDA) must regulates commercial advertisements by monitoring the quality of information in the advertisement routinely.
• The government has the responsibility to ensure compliance with the regulations controlling advertisements in order to improve drug usage among the population.
  

Step 2.

The application shall be accompanied by:

• A sample of the material for which approval for publication or advertisement is sought. In case of material to be developed, the applicant submits electronic copies of the material artwork showing clearly the final material in its form, colour, dimensions, and inscriptions.
  

Step 3.

• Wait for a few days for the reply from the department of publications and advertisements for drugs. The department, in reply to the application, shall give proper decision within five to ten working days.
  

Step 4.

• 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.

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Required Documents

1. Two copies of the receipt for the purchase of the form(s),
2. Evidence of the Drug product registration,
3. A letter of introduction of Advert Agent from the Applicant, (where applicable)
4. GSM telephone No. and email address of the Applicant/Advert Agent.
5. Radio (Script)
6. Outdoor (Script/Artwork)
7. Print (Script/Artwo
8. Online (Script/Artwork/Storyboard)
9. SMS (Script)
10. Drug Product sample in all pack sizes
11. Recorded Advert messages in CD/VCD/DVD on approval of the advertisement material.

Office Locations & Contacts

National Drug Authority - Head Office,
Plot 19 Lumumba Avenue (opposite TWED plaza)
Kampala, Uganda
P. O Box 23096,
Kampala, Uganda
Tel: +256 [0]417 788 100
Directorate of Product Safety : +256 [0]417 788 124
Directorate of Inspectorate Services : +256 [0]417 788 129
Email : [email protected]
Website :Link

Eligibility

All Individuals or companies interested in Advertising Drug products in Uganda and other related products are eligible provided they have registered with National Drug Authority.

Fees

Explain the fees structure which is required for obtaining the certificate/document.

Validity

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.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Processing takes only five days.

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• 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 before the release of those products and the interest of the health citizens.

Required Information

• information including composition,
• indication information ,
• information dosage/administration,
• Information Adverse effects,
• information on drug interactions and warnings/precautions.

Need for the Document

Please provide the need for the procedure. e.g. Birth Certificate - why do we need to have a birth certificate? 
 

Information which might help

• 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 advertising are commonly misleading, inaccurate or loaded with unbalanced information which can mislead patients
• To control commercial advertisements, the Uganda government introduced a( NDA )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.
• Therefore, Advertisement of Drugs and Cosmetics Requires Approval from Ministry of Health through the National Drug Authority (NDA) department in Uganda.
• The NDA has the authority to enforce regulations and take action against companies that do not abide by the rules.
• The NDA 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 National Drug Authority and include the necessary precaution to be taken during application.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
 e.g. Birth Certificate can be used as proof of identity.

External Links

• Guidelines

Others

More information which might help people.