Evaluation of advertising materials of medicinal products, medical devices and dietary supplements in Belarus
Advertising of medicines, medical products, biologically active additives is information distributed and placed in any form by any means aimed at attracting attention, forming or maintaining interest in drugs, medical devices and dietary supplements and (or) their promotion on the market.
01
Basic requirements for advertising of medicines, medical devices, biologically active additives:
Advertising of medicines, medical products and biologically active additives must be presented in Russian or Belarusian, must comply with the instructions / recommendations for use and the requirements of the Law of the Republic of Belarus of 10.05.2007 No. 225-Z "On Advertising".
The advertisement must contain
- an indication that this information is of an advertising nature
- name of the advertising object
- information that the object of advertising is a drug, medical devices, dietary supplement
- name of the manufacturer of the advertised object
- a recommendation on the need to familiarize yourself with the instructions / recommendations for use and (or) consult a doctor
- Advertising must not contain: information addressed directly to minors
- claims that the therapeutic effect of the use of the advertised object is absolutely guaranteed
- assertions that the safety and effectiveness of the advertised object are guaranteed by its natural origin
- comparison of the advertised object with other drugs, medical devices, dietary supplements
- information on the conduct of preclinical (non-clinical) studies and clinical trials and their results
- references to specific cases of healing after the application of the advertised object, expressions of gratitude for it
- information that gives the impression that there is no need to consult a doctor in the case of the use of the advertised object of the statement that creates the impression in a healthy person of the need to use the advertised object
- indications of the possibility of using any form of material encouragement in the case of the acquisition of the object of advertising
- recommendations of government agencies and other organizations used to enhance the advertising effect
02
Stages of evaluation of advertising materials of drugs, medical devices, dietary supplements:
01
Collection of the documents according to the list
02
Submission of an application and advertising material for approval
03
Conclusion of an agreement with Republic Unitary Enterprise “Center for Examinations and Tests in Health Service” and receipt of an invoice for payment
04
Payment according to the invoice
05
Submission of documents for approval of the advertising materials
06
Evaluation of advertising materials by experts of the Republic Unitary Enterprise “Center for Examinations and Tests in Health Service”
07
Issuance of the Conclusion of the Ministry of Health of the Republic of Belarus on the approval of advertising material.
Write us
