Enforcement and market surveillance



Law enforcement broadly refers to any system by which some members of society act in an organised manner to promote adherence to the law by discovering and punishing persons who violate the rules and norms governing that society. Although the term may encompass entities such as courts and prisons, it is most frequently applied to those who directly engage in patrols or surveillance to dissuade and discover criminal activity, and those who investigate crimes and apprehend offenders. Furthermore, although law enforcement may be mostly concerned with the prevention and punishment of crimes, organisations exist to discourage a wide variety of non-criminal violations of rules and norms, affected through the imposition of less severe consequences.

Enforcement activities carried out by the Medicines Authority 

The Licensing Authority has delegated to the Medicines Authority (the regulatory body regulating medicinal products and pharmaceutical activities in Malta) its invested legal powers to ensure that legal requirements are abided and respected by stakeholders and all.

One of the duties of medicines inspectors within the Medicines Authority is to carry out investigations in alleged, suspected or reported cases of breaches of the Medicines Act and its subsidiary legislation. This process entails entering various types of premises at some stage or other of the investigation. This can be both a pharmaceutical and non-pharmaceutical activity. Entry of premises can be done either announced or unannounced, and entry can be either with or without consent, since article 101 of the Medicines Act gives power of entry to authorised officers under the same act to inspect any premises and takes samples, documents and other equipment and material believed to constitute an evidence for the purpose of ascertaining whether there is or has been or ther is likely to be a contravention of this Act or of any regulations or rules made there under.

It is the policy of the Inspectorate and Enforcement Directorate within the Medicines Authority to retrieve samples where it is deemed that these are necessary as evidence in any possible court proceedings and where seizure of such items is deemed to be in the best interest of public health.

Evidence is not only required to support prosecution proceeding or to protect public health, but it is also the policy of the Medicines Authority that evidence should form a basis for making decisions and action plans for investigations.

If following the investigation, it is believed that a person has committed an offence against the Medicines Act or any regulations or rules made there under, the Licensing Authority, in line with article 100 of the Medicines Act, shall give notice in writing to such person describing the offence of which the person is accused, indicating the steps to be taken to remedy the offence and the prescribed penalty at Law which he is required to pay in respect of that offence. Where the person to whom notice is given has not paid the prescribed penalty within 21 days, and has not, within the time specified, complied with the requirements, criminal proceedings may be taken against him in accordance with the provisions of the Criminal Code, of the Medicines Act and of any other law applicable to the offence.