MAH - Marketing Authorization Holders

The Marketing Authorization governs not only what the medicine is for and how it is to be used, but also the details of the formulation, storage requirements and shelf life, so that the quality of the medicine delivered to the patient is constant.

Holders of a Marketing Authorization (or MAH - Marketing Authorization Holder) assume an important responsibility in the deployment of the Directive on falsified medicinal products.

Marketing Authorization (Marketing Authorization) holders are responsible for serialization (allocation of a unique identifier in the form of a 2D matrix code), for securing packaging (anti-burglary device) and for entering unique identifiers (UI) in the European hub which, together with the NMVS (National Medicines Verification System), constitutes the European system for verifying medicines or EMVS (European Medicines Verification System).

Obligations

The Marketing Authorization Holder is required to load data correctly for all serialized products before they are distributed through the supply chain.

It is important that all data, including the expiration date, is the same as the data in the 2D matrix code.

MAH must

register with the European Medicines Verification Organization (EMVO) to connect to the European hub (EU Hub). The EU hub allows product and packaging information to be uploaded in the National Medicines Verification Systems (NMVS). More information available on https://emvo-medicines.eu.
conclude contracts with the National Medicines Verification Bodies (NMVO) of the countries in which they market their products. The NMVOs are responsible for setting up and operating the national databases

Perimeter

The Luxembourg scope of application of the FMD directive is defined as follows (Journal officiel du Grand-Duché de Luxembourg (public.lu):

- All products under prescription according to Luxembourg law

- Plus the blacklisted products as identified in appendix 2 of the Delegated Regulation

- Minus the white list products as identified in Annex 1 of the Delegated Regulation

- Plus all the products defined by the competent Luxembourg authorities.

Collaboration agreement

If only one product in your portfolio distributed in Luxembourg falls within the scope of the FMD Directive, a collaboration agreement with the LMVO is necessary.

The agreement is made up of two documents:

The contract - operational phase of the agreement
The identification form

In both documents, the "MAH regitration number" is a number starting with "85" that has been provided to you by the Ministry of Health in Luxembourg.

Once completed and signed, the documents must be sent to info@lmvo.lu or by post.

Royalty fee

The registration fees are 4000 € for all MAH.

The annual membership fee is reviewed each year and communicated to MA holders in the fourth quarter of the previous year. This contribution is based on the turnover achieved.

* The reference year is Y-2 (eg 2022 for the 2024 package)

Please comply with the following procedure in order to benefit from the reduced package:

The MA holder must take the initiative and request to be eligible for a reduced annual fee.
The reference year is Y-2 (eg 2022 for the 2024 package).
The MA holder must provide sufficient proof of turnover for the products concerned.
LMVO can request additional information at any time.
LMVO reserves the right to reject the request at its sole discretion.
The request for a reduced package must be sent to info@lmvo.lu no later than December 15 of the year preceding the year for which it is requested (eg December 15, 2023 for the fee for the year 2024).
If the payment of the invoice established at the reduced rate is not made within the time limits provided for in the terms of payment, the standard rate becomes applicable.

Loading instructions

Instructions for loading data into the National Medicines Verification System (NMVS) that Luxembourg shares with Belgium can be found here .