The concept of Marketing Authorization Holding and how PLG can support your company

The concept of Marketing Authorization Holding and how PLG can support your company

Marketing Authorization Applications (MAA) within the EU and US require the company registering the product to have a legal entity within the EU or the US. For companies registered outside of the EU and US, we can act as the Market Authorization Holder (MAH) and/or applicant on behalf of the client for registration purposes. We can do this because we have legal entities within the EU and a legal entity in the US.

MAH support for PLG’s clients

MAH support for PLG’s clients

We support the applicant during the marketing authorization process for companies without an EU or US legal entity. Additionally, we can hold approved licenses for non-marketed products.

For international markets where PLG does not have a legal entity, we have local partners to assist clients in holding the MAA(s).

Once the client creates a legal entity or finds a partner within that country, we can assist in the Marketing Authorization Transfer (MAT) of the license(s) as part of Life Cycle Maintenance activities.

If PLG acts as the MAA applicant/MAH or holds the approved license, we can also provide pharmacovigilance services per the market’s legal requirements.

The services provided by PLG during MAH

The services provided by PLG during MAH

  • Acting as the MAH/MAA applicant and contact person at the registration time on the client’s behalf
  • Acting as the contact person for the scientific service of the MAH during the registration
  • Provision of a pharmacovigilance system and monitoring of the MAA during registration

PLG’s post-approval services when providing MAH for our clients

PLG’s post-approval services when providing MAH for our clients

  • Acting as the contact person for all post-approval lifecycle submissions
  • Communicating with regulatory agencies concerning all issues related to license applications
  • Receive agency invoices for assessment fees and any other charges regarding license application and lifecycle maintenance and forward them to the client

The advantage of using PLG: our geographic coverage

The advantage of using PLG: our geographic coverage

We have supported, and continue to support, many international companies in holding their licenses as part of the registration process. Our offices span the globe, including multiple legal entities in the EU (France, Czech Republic, Romania, Italy, etc.), the UK, and the US. We can also support holding licenses in other countries through our local partners.

We also cover the legal obligation of providing pharmacovigilance support while holding the license, so there is no need for third-party support.

We handle the regulatory agency communication – another burden we remove from our clients.

KEY FIGURES :

100

European licenses are currently being held.

32

Clients PLG has acted as the applicant for, over the last five years.