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Marketing Authorization (MA)

Definition : Marketing Authorization (MA)

The marketing authorization (referred to as "AMM") is the approval given to a holder of exploitation rights of a product, which may notably arise from a patent, to market the said product. This AMM is specifically required for the marketing of medicines, biocidal products, or phytosanitary products.

It is necessary to go through a regulatory process whereby a competent authority, usually a government agency, assesses the safety, efficacy and quality of a drug, medical device or biological product before it can be marketed and used in a given region.

The primary objective of MA is to protect public health by ensuring that products placed on the market are safe, effective and of sufficient quality for their intended use. The MA process generally involves a thorough evaluation of the scientific and clinical data provided by manufacturers to prove the product's safety and efficacy.

When a product obtains an MA, it means that it has been approved to be marketed and used in a given region, according to specific conditions defined in the authorization. Competent authorities can also revise and modify MA conditions in the light of new scientific data or safety information.

Marketing authorizations can give rise to various legal problems, including:

  1. Tort liability. If a MA-approved product causes harm to a patient, manufacturers can be held liable for these damages. Victims can sue for compensation, which can entail significant financial costs for manufacturers.
  2. Intellectual property. Products that obtain marketing authorization may be protected by patents, trademarks or other forms of intellectual property. Patent issues can be particularly complex in the case of pharmaceuticals, as there may be several patents covering different aspects of the product.
  3. Competition. marketing authorizations can affect competition in the market, as they allow manufacturers to market exclusive products for a given period. Regulators must ensure that marketing authorizations do not hinder competition in the marketplace.
  4. Confidentiality.Manufacturers must provide confidential data to obtain marketing authorization, and regulatory authorities must maintain the confidentiality of this data. There can be legal problems if this data is disclosed or used inappropriately.
  5. Regulatory compliance. Manufacturers must comply with current regulations to obtain a marketing authorization.Regulatory authorities can take legal action against manufacturers who fail to comply with regulations.

A pharmaceutical regulation lawyer is likely to be able to advise on these various aspects.