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Home / Activities / Registration / National Procedures / Authorisation in line with Article 126(a) of Directive 2001/83/EC

Authorisation in line with Article 126(a) of Directive 2001/83/EC

Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC

Article 126a of Directive 2001/83/EC states that: In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member State in accordance with this Directive, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product.   

If a product is eligible to be authorised through the established legal routes for marketing authorisation, the Medicines Authority has the right to refuse the application under the article 126(a) legal basis. Before submitting an application, companies must consider all other possible routes for registration and a justified public health reason for going through this registration route must be provided. Authorisations granted under this legal basis will be valid for 3 years, with the possibility of an extension only if the product is the subject of a government tender with termination beyond the validity of the authorisation to ensure that the tender obligation is fulfilled. No further placing on the private market will be allowed. Please request extension in writing providing date of termination of tender (with a copy of relevant documentation) to mailbox licensing.medicinesauthority@gov.mt. 

To maintain any products authrioised through this route on the Maltese market, companies are encouraged to use the Mutual Recognition Procedure (MRP).  In some cases the Day 0 MRP procedure is also possible.  This procedure can allow the authorisation of products for the Maltese Market in certain situations, in agreement with the Reference Member State. More information about the day 0 MR procedure can be found on the European procedure page. Should you require support and more information please contact the Medicines Authority on mrp-dcp.adm@gov.mt.

Application Forms 

In order to apply for this authorisation to place a product on the Maltese market, the applicant must submit to the Medicines Authority all necessary documentation, including the Application form for this procedure and its Annexes,  as well as the relevant fee (Medicines Authority (Fees) Regulations) (Subsidiary legislation 458.46).

Please complete the form online. Once completed, select the submit button, save the form in PDF format and send via the Central European Submission Portal (CESP).

Advisory Committee 

An Advisory Committee has been set up by the Chairman, with the purpose of discussing these applications. The public health reason given by the applicant and/or reasons given for not applying for a marketing authorisation through the established registration routes will be discussed by this Committee. The list of pending applications will be published on a weekly basis. If there are any considerations by third parties with a direct interest in a product, these must be sent by the end of that week to be placed on the agenda of the next Advisory Committee meeting. Please send to the mailbox: advisorycommittee.medicinesauthority@gov.mt.

Following the granting of the product authorisation, the Authorisation holder must notify the Medicines Authority of any changes (including those resulting from variations and article 61(3) notifications, changes in marketing authorisation holders for the product in the country of source) to the authorised product, which have been approved in the Member State (EU/EEA country of source). Any source country updates that change the details of the authorisation document, the product information (that is the Summary of Product Characteristics and/or package leaflet and/or immediate and/or outer labelling and packaging) and information in the Annexes of the application form must be notified. The Notification of Changes Form for this procedure needs to be submitted before the product is placed on the market in Malta with such changes.

Please direct any queries to the mailbox licensing.medicinesauthority@gov.mt.

Article 126a applications and Brexit

In line with the guidance published on the Medicines Authority website on Brexit no appications on the basis of article 126(a) referring to products with a Marketing Authorisation in the United Kingdom will be possible after 31 December 2020.  Products authorised on the basis of applications submitted until the end of the year must have all the activities that have to be in the EU transferred to the EU-27.  This includes the authorisation holder, the batch testing site, the batch release site, the EU QPPV and the PSMF location.  Please find more information here.  Please refer to the Q&A specifically about authorisations granted with article 126(a) legal basis.

 

 

Updated on: 20 October 2020