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Home / Activities / Enforcement and market surveillance / National Market Surveillance

National Market Surveillance

The objective of the national market surveillance is to ensure that only safe pharmaceuticals are placed on the Maltese market. In practice, market surveillance comprises of a series of interlinked activities and measures taken by the Medicines Authority to ensure that products placed on the local market comply with all the requirements set out in the Medicines Act, 2003 and in fulfilment of EU legislation and that they do not endanger health, efficacy, safety or any other aspect of public interest protection. DH circular No. 127/05 issued by the Licensing Authority was disseminated to all stakeholders.

The process involves the random collection of medicimes from the local market based on risk assessments and sampling plans of the entire national pharmaceutical network (industry, wholesalers, importers, hospitals, clinics and pharmacies). The process also involves testing these products for quality by the Medicines Authority's contract laboratories. Market surveillance is organised and performed by Medicines Inspectors who are also responsible for surveillance activities in malta.

Market surveillance and sampling is organised and performed for two main reasons:

  • The Medicines Authority monitors that products placed on the Maltese market comply with the provisions of Community harmonisation legislation transposed into the national legislation.
  •  When necessary, to bring non-compliant products into compliance, to remove unsafe products from the market and /or to ban them, or in justified cases, to destroy them.