IntroductionWhat is Pharmaceutical Legislation?Pharmaceutical legislation is a term which involves relation to manufacturing, importing, distribution, marketing, prescribing, labelling with its own country language, dispensing, licensing, inspection and often a change of pricing of pharmaceutical products. History about how pharmaceutical legislation come about is the country in South America Venezuela during the year of 1883 and slowly over the years it expands the pharmaceutical laws and regulation creating new rules and organization. Following countries would be country in North African Tunisia during the year 1942, country in North-Western Europe Netherlands during the year 1956, country in Northern Europe Estonia during the year 1991 and other countries slowly adopt these laws and adjust as such with their own languages. Till now pharmaceutical laws have been regularly revised and up to date.
It is necessary to implement pharmaceutical laws and regulations because factors of ineffective therapeutic effect, poor quality design or toxicity of the medicines can lead to therapeutic failure. And therapeutic failure equals to increasing the severity of the disease, the body reacts in a resistance way to the medicine and can be a life threatening which is death. The core foundation is to have confidence in health systems, health professionals, pharmaceutical manufacturers and distributors sectors. Pharmaceutical legislation is required to protect the public health from harm and that is why to achieve that governments need to approve the aspect laws and regulations.
Effectiveness to ensure that the manufacture, trade and the use of medicines are controlled properly. The crucial part is that the public has access to accurate information on the medicine that they bought.Singapore Pharmaceutical LegislationHow pharmaceutical legislation come about in Singapore is that the government governs the agencies and statutory boards under them is an organization which is called Attorney General Chamber (AGC). The organization is responsible for writing or amending the laws of pharmaceutical legislation.
Under pharmaceutical legislation there are 6 types of act which is Health Products Act, Medicines Act, Poisons Act, Medicines (Advertisement and Sale), Sale of Drug Act and lastly Tobacco (Control of Advertisements and Sale) Act. There is also another organization called Health Sciences Authority in short HSA and the laws are enforced by them. What HSA does is from regulating health products found in Singapore to making sure the products meet certain standards of safety, quality and efficacy. Some other roles they do would be going around pharmaceutical manufacturing companies to monitor their practices such as Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).
And also enforcement action on illegal generic drugs from other countries which can consider as unregistered, counterfeit and stated adulterated health products.Various Act have different number chapter respectively and under this chapter number of Act is the section which is numbered point in the Act, subsidiary legislation and sub-point. The chapter number of Act can be expand to look up what is the sentence of the law and this is to elaborate more on that specific law.
Different Acts cover different areas of required relevance