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Home / Patient / Consumer / Know more about the Medicines Supply Chain / Medicines supply chain

Medicines supply chain

In order to ensure that medicines are of the required quality, safety and efficacy, there are rules in place throughout the entire medicines supply chain in line with standards stipulated by legislation.  Medicines are therefore manufactured, stored, transported and handled under suitable conditions until the medicines reach the patient.

A license is required for the manufacture or partial manufacture, including repackaging or relabeling, of medicines.  In Malta, all pharmaceutical companies and manufacturing plants are inspected on a regular basis to certify that European Union Good Manufacturing Practice (EUGMP) is complied with.  These inspections cover the requirements set out in Part III of the Medicines Act (Chapter 458 of the Laws of Malta).  The Medicines Act also outlines the conditions for placing a medicinal product on the market through the issue of a Marketing Authorisation by the Licensing Authority.  Medicines which have been granted a Marketing Authorisation are then distributed on the market.  A person engaging in activity as a wholesaler in medicinal products must be in possession of an authorisation to that effect.  Wholesale dealers sell medicinal products to pharmacies or other wholesalers.  Medicines can only be sold to the public from pharmacies.

The law seeks to prevent the entry of falsified medicines into the regulated medicines supply chain.  Falsified medicines, which are well defined in the Medicines Act, are also defined by the World Health Organisation (WHO) to be “medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing concern and considered to be one of the greatest current threats to public health and consumer safety also in Europe.  Falsified medicines are dangerous as they may contain a different amount of active ingredient, the wrong active ingredient or no active ingredient at all, amongst other types of falsification.

The growing global problem of falsified medicines is additionally being counteracted by international endeavours of the WHO, the pharmaceutical industry, regulatory agencies, customs control, and via ongoing European legislative reform.     In Malta, falsified medicines are combated by imposing licensing requirements and strict regulation of all steps of the medicines supply and distribution system and by the employment of investigative and enforcement measures. 

The Medicines Authority and international bodies continue to strive to prevent the penetration of falsified medicines into the legal medicines supply chain. To date, no falsified medicinal products have been found within the medicines legal supply chain for the public in Malta. 

Concerns relating to falsified medicines are accentuated by the sale of medicines over the internet.  The source of these medicines, unless reputable, is often difficult to trace and it may be hard to establish whether the manufacturers and distributors of medicines sold online conform to European standards of quality, safety and efficacy.   When Patients purchase medicines over the internet, they may not benefit from the assurances offered by the regulated supply chain.