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Marketing Authorisations (Licensing)

Marketing Authorisations (Licensing)

These days it is understood that medicinal products must undergo a licensing procedure. It hasn’t always been like that – it only became a legal requirement after the thalidomide tragedy back in 1961. Since then the licensing procedure has always been a thorough review of each medicinal product by the health authorities with respect to its quality, safety and efficacy – even though many details of the procedure have been changed in the meantime.

However, one marketing authorisation is not like another, there are different types of authorisations, depending on the availability of supportive data, geographical reach and/or target organism (human or veterinary use).

The more simple procedures are registrations of homeopathic products or traditional herbal medicines.

When an active ingredient has been used in the European Union for more than 10 years, the applicant would choose the Well-Established Use (WEU) Marketing Authorisation procedure. In such cases, efficacy must be proved by bibliographic data.

The most frequently used type of marketing authorisation is the generic application: Once the patent for the originator product has expired, generic applications for largely identical products may be filed. The generic application may refer to the preclinical and clinical data submitted for the originator product (the applicant does not need to submit studies of his own).

By way of contrast, a full application has to be submitted for a new active ingredient with a new indication, which requires the full scope of specific safety and efficacy data – usually compiled over several years of (clinical) development.

Biological drug products have a particularly innovative character. The range of biological products comprises immunological preparations such as sera and vaccines, blood products, tissue preparations as well as novel gene and cell therapies – with their own legal requirements. The corresponding generics are called biosimilars.

Furthermore there are some special procedures: orphan drug applications, accelerated marketing authorisations, or conditional authorisations.

The Centralized Procedure has the aim of granting one marketing authorisation valid for all EU member states. The Decentralized Procedure and the Mutual Recognition Procedure (MRP) are multinational procedures, too; but it is also possible to submit an application only in one EU member state.

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