Advertising controls

According to Regulation No. 21, the advertising control is performed a priori and is organized according the Council Directive 92/28/EEC. The approval is usucilly obtained by the NDI in less than one month. The fees are about US 6 for printed advertising material and US 10 for audio-visual advertising. The approval is Vcilid for the period stated by the MA of the medicinal product advertised. 

The Commission for the Control of Publicity and the Distribution of Recommendations on the Effective Use of Medicines is authorised to advise the Director General of the Agency for Advertising Control Related to Medicines (Article 5054.4 of CSP). It also issues recommendations on the good use of medicines (Article R 5054.6 of the CSP). 

The advertising control authority is the Consumer Protection Agency. The medicine regulatory authorities, however, must be involved in the procedure as professional co-authorities and their professioncd assessment of the advertisement must be accepted by the Consumer Protection Agency. 

OTHER RELATED CONTROLS Advertisements Control of Medicinal Products... 

The executive agency of the Drug Acts is the FDA in the Ministry of Public Heeilth. According to the current official infrastructure, the Thai FDA is divided into ten divisions and two units as shown in Appendix Figure 3 which is now in the process of reorganization. So far the duties and responsibilities of each division are normally indicated by its name. However, there are four official divisions whose roles and responsibilities are concerned with the pharmaceutical administration system Drug Control Inspection Public Relations and Advertisement Control and Technical. 

Regulatory functions include licensing of persons, premises and practices, inspection of pharmaceutical establishments, product assessment and registration, QC, control of dmg promotion and advertising and monitoring of ADR. 

Spedficalions regarding pharmaceutical premises, personnel and procedures must be followed by pharmaceutical manufacturers, distributors and retailers if they wish to obtain and retain their licence to operate. By means of these licences, dmg regulatory authorities control the activities of pharmaceutical manufacturers, importers and distributors and companies engaged in dmg promotion and advertising. 

Cuba stands out as the only country in this group that permits neither dmg advertising nor dmg promotion. Instead, pharmaceutical products are distributed and product information disseminated within the Ifamewoik of the centralized State-mn management system. Misinformation for commercial purposes is therefore not an issue in Cuba. In all the other survey countries, both the content and the conduct of dmg advertising and promotion are regulated. The basis of such controls is found in dmg legislation. 

Body controlling advertising/ promotion TGA Trade Practices Commission APMA Code of Conduct Committee Pharm. Services Drug Council SAM Consumer Protection Branch MAB KOAG DPM NDA RBPP Ministry of Communication s MCAZ... 

In addition to controlling information used for promotional and advertising purposes, dmg regulatory authorities in the majority of the countries also provide independent dmg information. This is hue of Cypms, Estonia, Malaysia, the Netherlands, Tunisia, Venezuela and Zimbabwe. Dmg information is mainly disseminated via regular bulletins. Other bodies besides the DRA also provide independent information about dmgs. 

Dmg information is probably disseminated over just as wide an area as dmg products are distributed, if not further. Moreover, the existence of the power to control does not necessarily guarantee that information reaching the providers and the consumers conforms with the provisions set forth in the legal documents. Monitoring, like inspection, is therefore essential in order to ensure that promotion and advertising comply with the legislation. 

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