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.

Before submitting an application, companies must consider all other possible routes of registration and a justified public health reason for going through this registration route must be provided.  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. Authorisations granted under this legal basis will be valid for a period established by the Advisory Committee, with a maximum of 3 years.

To retain the possibility to continue marketing any products previously authorised through this route, on the Maltese market, companies are encouraged to use the Mutual Recognition (MR) Procedure , especially in cases where the product is already the subject of a Decentralized or a MR procedure in other EU countries.   The Day 0 MRP procedure is also possible and is encouraged.  The Medicines Authority is doing its utmost, also through the Coordination Group for the Decentralised and Mutual Recognition Procedures (CMDh) to work with the other EU Member States such that this process is facilitated. More information about the day 0 MR procedure can be found on the European procedure page of the Malta Medicines Authority.  In some situations, some Member States have reduced fees for the Day 0 MRP including but not limited to AT, BE, CZ, DE, ES, IE, IS, NL, SE. Kindly refer to respective Member States’ websites for current fees. 

Should you require support and more information please contact the Medicines Authority on mrp-dcp.adm@gov.mt.

All products authorised in accordance with article 126(a) must bear the national details for Malta - AA number, AA holder name and address and local distributor in line with the legal requirements.

Application Form

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).  Since 1 January 2022, submission through CESP is mandatory for all applications. 

Advisory Committee 

An Advisory Committee has been set up by the Chairman, with the main function being that 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 Committee generally meets on a weekly basis.  Aspects for discussion by the Committee for applications on the agenda include, but are not limited to:

1.      The existence of marketing authorisations in Malta for similar products and their marketing status at the time of application.  If there are already three similar products authorised and marketed, further licences are only granted on condition that the additional products are placed on the market at a price that is 10% cheaper than the cheapest of the three authorised and available products.

2.      The existence of a licence in accordance with article 126a for the same product (but different 126a holder). In general, if the product is already authorised and markted, another licence will not be granted unless the price is reduced by at least 10%.

3.      If the product is already the subject of a MR or DC procedure.  In this case, the applicant will be requested to justify why this route was not also used to place the product on the market in Malta and to consider the use of the Day 0 MR procedure.

4.      If the product is nationally authorised in the source country and there is the possibility for applying through the MR procedure.

5.      If the product is subject to a tender where there are no alternative offers, an authorisation may be granted if the use of the established European procedures is not possible (to be justified by the applicant).  Having been awarded a tender is not sufficient grounds to justify the use of article 126(a) as legal basis for the application

6.      Submission to the Committee of considerations by third parties, if relevant and sufficiently justified.

7.      Applications for products containing new active substances for Malta.

8.      Other regulatory considerations specific to the case.

The Advisory Committee may deem it necessary to request information from other Competent Authorities to make an informed decision, such as an assessment report in English. The Advisory Committee may also deem necessary to recommend the issuance of a licence with a reduced validity period.

In view of the specificities of these applications, the complex regulatory landscape and issues arising out of Brexit, the Advisory Committee reserves the right to decide on applications at its own discretion. 

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 in writing 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

In view of the change in policy and procedure regarding this legal basis, the Malta Medicines Authority, may allow for an extension of an existing 126(a) licence authorised under the previous policy.  This is only applicable 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

Agendas 2024

Product applications received week starting 01 January 2024

Product applications received week starting 08 January 2024

Product applications received week starting 15 January 2024

Product applications received week starting 22 January 2024

Product applications received week starting 29 January 2024

Product applications received week starting 05 February 2024

Product applications received week starting 12 February 2024

Product applications received week starting 19 February 2024

Product applications received week starting 26 February 2024

Product applications received week starting 04 March 2024

Product applications received week starting 11 March 2024

Product applications received week starting 18 March 2024

Product applications received week starting 25 March 2024

Product applications received week starting 01 April 2024

Product applications received week starting 08 April 2024

 

Outcomes 2024

Outcomes of the 1st Advisory Committee meeting of 2024

Outcomes of the 2nd Advisory Committee meeting of 2024

Outcomes of the 3rd Advisory Committee meeting of 2024

Outcomes of the 4th Advisory Committee meeting of 2024

Outcomes of the 5th Advisory Committee meeting of 2024

Outcomes of the 6th Advisory Committee meeting of 2024

Outcomes of the 7th Advisory Committee meeting of 2024

Outcomes of the 8th Advisory Committee meeting of 2024

Outcomes of the 9th Advisory Committee meeting of 2024

Outcomes of the 10th Advisory Committee meeting of 2024

Outcomes of the 11th Advisory Committee meeting of 2024

Outcomes of the 12th Advisory Committee meeting of 2024

Outcomes of the 13th Advisory Committee meeting of 2024

 

The list of all applications received is published weekly.  Any considerations by third parties with a direct interest in a product are to be sent by the end of the week.  If considerations are made about a product, these will be reviewed when the application is being processed and not necessarily during the following Advisory Committee meeting. Please send to the mailbox: advisorycommittee.medicinesauthority@gov.mt.

 

Keeping the product information updated

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

Refer to the Brexit page here: http://www.medicinesauthority.gov.mt/brexit

Updated on: 01/04/2024