Marketing Authorisations (MAs) granted in the Community shall have an initial duration of five years according to regulation 19(1) of the Marketing Authorisation Regulations (Article 24(1) of Directive 2001/83/EC, as amended). After these five years, the MA needs to be renewed on the basis of a re-evaluation of the risk-benefit balance.
The Marketing Authorisation Holder (MAH) shall provide the Medicines Authority with a consolidated version of the dossier in respect of quality, safety and efficacy, including all variations introduced since the MA was granted.
A completed application form and accompanying dossier, should be submitted at least nine months before the MA ceases to be valid (Article 24(2) of Directive 2001/83/EC as amended). Once renewed, the MA shall be valid for an unlimited period unless the Medicines Authority decides, on justified grounds relating to pharmacovigilance, to proceed with an additional five-year renewal (Article 24(3) of Directive 2001/83/EC as amended). In addition, the five-yearly cycle of Periodic Safety Update Reports (PSURs) with renewal will be replaced by a three-year cycle.
An application for renewal of a marketing authorisation must be made by sending the below documents:
For products authorised nationally since 2004 with the PMA-MA process (transitional arrangements), and which therefore had been on the market in Malta for a number of years before accession, the granting of the first MA in accordance with the Acquis Communautaire can be considered as a re-assessment of the benefit-risk of the product. This means that the PMA-MA process is being considered equivalent to a first renewal, rendering all MAs issued via this process as valid for an unlimited period (unless otherwise indicated). Therefore if these MAs have been kept up to date by means of variations, they do not need to be renewed. The Medicines Authority will still, however, issue a renewed licence with unlimited validity, when authorising other post-authorisation processes.
If, however, the dossier of a medicinal product authorised through the PMA-MA process is being renewed in another Member State, a renewal application should be submitted to the Medicines Authority for the dossier to be kept up to date with the latest information, regarding, in particular the efficacy and safety of the product.
For products authorised through the Mutual Recognition or Decentralised Procedure, one renewal is mandatory. Following the first renewal, no other renewals will be required, unless decided otherwise by the Reference Member State, be it Malta or any other Member State. Alternatively, the applicant may apply for an additional renewal if there is a need to consolidate the information in the dossier.
Guidelines on the processing of renewals in the centralised and mutual recognition/decentralised procedure are available on the EMA and CMDh websites respectively.
Administrative renewals
It is possible for Marketing Authorisation Holders to submit an 'administrative renewal' if the product is eligible for such procedure. In certain situations described in the CMDh Best Practice Guide on the processing of renewals in the MRP/DCP, and in agreement with the CMS, the RMS can accept a 'shortened renewal'. This procedure follows a 30-day timetable and documentation requirements are reduced. The applicant has to declare, in the cover letter, amongst other, that the full documentation is available upoin request and that there have been no changes to the dossier. The RMS has the responsibility to set the timetable and in cases where additional data is required, can choose to run the procedures in line with the normal Day 60/90 timetable. Changes to the MA particulars will not be acceptd during a shortened renewal. More information can be found on the CMDh website.
For information regarding renewals of Authorisations granted in accordance with article 126(a), please refer to this link.
For information regarding renewals of parallel import licences please refer to this link.
Information on submission requirements with respect to electronic and paper copies required can be found here.
Circular L003/2010 (May 2010) on renewals of nationally authorised products.
Updated on: 10 March 2015