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Medicines Authority

Awtorità dwar il-Mediċini

 

 

Safeguarding Your Health through Medicines Regulation

Medicines regulation is the application of sound medical, scientific and technical knowledge and skills, operating within a legal framework.  The ultimate purpose of medicines regulation is to protect consumers by ensuring that only safe, effective, high quality medicines are produced, imported and distributed, and that these medicines are made available, as well as managed and used appropriately.   

Legal provisions require pharmaceutical companies to prove the safety and efficacy of new medicines before placing them on the market for public consumption.  Pharmaceutical companies need also demonstrate that the medicines are of the required quality.    The law stipulates the regulatory control on activities such as drug manufacture, import, export, marketing, prescribing, dispensing and distribution, and the enforcement of such laws and regulations.

The innovation and production of medicines requires a high level of scientific and technical expertise.  Effective medicines are capable of curing illness; however they also cause adverse side effects which could be serious and even dangerous.

During the past decade, there have been global efforts to legally regulate the safety of medicines and provide an effective system for the licensing and monitoring of medicinal products. Due to the fact that medicines are unique products, rigorous procedures are followed before a medicine can be taken by the consumer.  The requirement of a marketing authorisation or appropriate licensing by regulatory authorities and rules on labelling, packaging and advertising make medicines one of the most legally regulated products on the global market.

A medicine is granted a license, known as marketing authorisation, in order to ensure that the medicine to be marketed has a positive risk-benefit balance (more good than harm).  Good Manufacturing Practice (GMP) is in place to ensure that the production of medicinal products is carried out to required standards in order to prevent unfavourable outcomes.

These safeguards are bypassed for counterfeit medicines. The use of counterfeit medicines which are ineffective, of poor quality and potentially harmful can result in therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death.   

The objective of the Licensing Authority, as the local regulator of medicines and pharmaceutical activities, is to ensure, through the Medicines Authority, that medicinal products are of the required quality, safety and efficacy.  Medicines regulation is intended to protect you - the consumer - from harmful and dubious medicines throughout the entire chain of supply, starting from manufacture until they reach the pharmacy shelf.