Renewal

Marketing authorisations 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 marketing authorisation may be renewed on the basis of a re-evaluation of the risk-benefit balance.   The marketing authorisation holder shall provide the Medicines Authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid (Article 24(2) of Directive 2001/83/EC.   Once renewed, the marketing authorisation 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 (24(3) of Directive 2001/83/EC).  In addition, the five-yearly cycle of periodic safety updates reports (PSURs) with renewal will be replaced by a three-year cycle.

For products authorised through the Mutual Recognition or Decentralised Procedure, one renewal is mandatory.  Following the first renewal, no other renewals would be required, unless decided by the Reference Member State be it Malta or any other Member State or the applicant considers the need to consolidate the information in the dossier.

Guidelines on the processing of renewals in the centralized and mutual recognition/decentralised procedure are available on the EMEA and CMDh websites respectively.

For products authorised nationally since 2004 with the PMA-MA process, and which therefore had been on the market before accession for a number of years, the granting of the first marketing authorisation in accordance with the acquis can be considered as a re-assessment of the benefit-risk of the product.  Therefore these marketing authorisations do not need to be renewed, unless the dossier is being renewed in another Member State.  In such a case, a renewal 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.

Further information on national renewals is available in Requirements for submission for National and MRP Renewals.

Renewals update Read more [11.05.2010]

For renewal of authorisations granted in accordance with article 126a, please refer to the appropriate section under http://www.medicinesauthority.gov.mt/marketingauth.htm  

For renewal of parallel import licences please refer to the section http://www.medicinesauthority.gov.mt/parimport.htm