Marketing authorisation (MA)

The marketing authorisation, or MA, is the administrative act that allows a regulated product to be placed on the market. It is required in particular for medicinal products, biocidal products and plant protection products. The marketing authorisation is independent from intellectual property rights such as the patent. The holder of a patent cannot market its product without a marketing authorisation. Conversely, a marketing authorisation does not allow the exploitation of an invention patented by a third party.

The authorisation procedure

The marketing authorisation is the outcome of a regulatory process. A competent authority, generally a public agency, assesses the safety, efficacy and quality of the product before it is marketed in a given territory.

The marketing authorisation is designed above all to protect public health. It guarantees that the products placed on the market are safe, effective and of sufficient quality for their use. To that end, the authority examines in depth the scientific and clinical data supplied by the applicant.

Once the authorisation is granted, the product may be marketed and used in the territory concerned, under the conditions set by the authorisation. The authority may later revise those conditions in the light of new scientific or safety data.

The legal issues raised by marketing authorisations

The marketing authorisation raises several legal questions, notably:

1. Civil liability. An authorised product may injure a patient. The manufacturer may then incur liability, and the victim may claim compensation. The resulting costs can be significant.
2. Intellectual property. Patents, trade marks or other rights may protect the authorised product. For a medicinal product the question is often complex, because several patents sometimes cover different aspects of the same product.
3. Competition. The marketing authorisation also affects competition. The regulatory protections that accompany it give the laboratory an exclusivity for a given period. Care must be taken that they do not unduly restrict competition.
4. Confidentiality. The applicant submits confidential data to the authority, which must protect them. Their disclosure or misuse can give rise to disputes.
5. Regulatory compliance. Finally, the manufacturer must comply with the applicable regulations. Failing that, the authority may impose sanctions or bring proceedings.

A pharmaceutical regulation attorney can assist on each of these aspects.

See our practice in pharmaceutical patents and medicines regulation.