Marketing Authorisation Applications

All medicinal products need to obtain a marketing authorisation (MA) before they can be placed on the market. The MA certifies the product meets the required standards of safety, quality and efficacy.

Marketing Authorisation Applications (MAA) are submitted to competent authorities, such as the MHRA, HPRA, BfArM, FDA and EMA, to apply for a medicinal licence to market and sell a product within a country or region.

Medicines can be sold as over the counter (OTC) products (also referred to as pharmacy (P) and general sales list (GSL) in the UK) or prescription only medicines (POM). They can then fall into various categories which require the appropriate legal basis for their application.

For more information, please follow the links below:

Types of application (legal basis) | GOV.UK
Legal framework | European Medicines Agency (EMA)

Other products that fall under the medical device, homeopathic, cosmetic, food supplement or traditional herbal medicine categories have differing application and registration requirements, that also have country-specific processes. In some cases, products can fall under different categories or different legal bases in different global markets, making early strategic decisions and global regulatory awareness critical to success.

Whatever the type of licence or procedure you wish to apply for, JensonR+ can assist from start to finish to help your product receive approval and successfully reach the market.

We have experience supporting both global companies and small and medium-sized enterprises (SMEs) applying for MAAs using national procedures and EU procedures: Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP) and Centralised Procedure (CAP). Following Brexit, we have also been supporting the submission and approval of products following the European Commission (EC) Decision Reliance Procedure (ECDRP) and Mutual Recognition and Decentralised Reliance Procedure (MRDCRP) to obtain a PL, PL(NI) and/or PL(GB) licence within the United Kingdom.

MAAs are lengthy and require considerable planning and development over several years. Some key stages that JensonR+ has experience in supporting include:

In addition to local European and national procedural knowledge, JensonR+ have expertise across global markets through regulanet® our partner network that has representation in over 90 countries throughout the world and provides a diverse number of services and product expertise across the pharmaceutical and medtech areas.

Case Study

Challenge:

A MAH from a medium sized company had submitted their novel drug application globally and had partnered with a larger organisation to utilise their supply chain and several other functions such as publishing and PV. The MAH had no UK establishment and wanted to ensure compliance with BREXIT procedures and oversight within the UK.

Solution:

JensonR+ and colleagues from regenoldGmbH (the founder company of regulanet®)  collaborated with the MAH to provide expert EU and UK assistance. This included:

  • First point of contact with the MHRA and other government agencies.
  • Represented the MAH’s interests in discussions with relevant teams within the large organisation, such as PV, regulatory and eCTD publishing.
  • Created UK strategy for later line extensions and other developments.
  • Coordinated and chaired regular agency meetings.
Benefits:

JensonR+ acted as an entity of the MAH and provided them a voice when communicating with the MHRA and with the larger organisation to ensure successful lifecycle management using the new reliance route procedures.

Get in touch with us to find out more