Licensed products, promotion

Few OTC treatments are licensed and promoted specifically for PD, but many analgesic products list PD as an indication. 

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. 

A patent, therefore, encourages innovation by promoting research and development. It can also be regarded as a physical asset, which can be sold or licensed to third parties for cash. Patents also represent a unique source of technical information regarding the patented product. 

Promotional material must not include any reference to the Medicines Commission, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency, the Medicines Control Agency or the licensing authority, unless this is specifically required by the licensing authority. 

Ministry of Efealth, Labor, and Welfare, Japan (MEfLW) The unit responsible for the improvement and promotion of social welfare, social security, and public health is the Pharmaceutical Affairs bureau of the ministry. It is one of the nine bureaus within the Pharmaceuticals and Cosmetics Division and is responsible for review and licensing of all medicinal products and cosmetics. In Japan, it acts as the focal point for ICH activities. Technical advice on ICH matters is obtained through MHLW s regulatory expert groups. 

To ensure the widest access to drugs, the proposal requires open licensing of all relevant patents, thus enabling generic competition from the outset. The innovating firm, however, retains an interest in the product for some years, since its reward is based on the number of units sold. This provides incentives for promotion of the drug as well as oversight of quality control. 

Community. The administration of hormone growth promoters was prohibited because of fears about health effects from residues, although there is a need to standardise conditions of trade in animal products from countries outside the EU where these compounds are still licensed for use. The use of one particular group of synthetic anabolic agents with oestrogenic activity, the stilbene compounds,... 

Care also needs to be taken regarding the consistency between the labeling of the product itself and any promotional statements being made by third parties such as licensed distributors on behalf of the manufacturer. Should these claims cause the product to be misbranded, it is the manufacturer who may receive the actual citation from the inspector, in addition to the distributor. ... 

Anabolic steroids are also used, usually illegally, by some athletes as an ergogenic aid (a technique or substance used for the purpose of enhancing performance). The doses used for these purposes are many times the therapeutic dose, and some products may be used that are licensed only as growth-promoters in cattle rearing. The health risks are considerable and well documented. 

If not, what are the rules about unlicensed or off-label promotion, e.g. is a statement required about where the product or indication is licensed or is it forbidden to promote the products ... 

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