National Procedures

Marketing authorisations are granted nationally by the Medicines Authority in accordance with the Medicines Act, 2003 and the Medicines (Marketing Authorisation) Regulations.  There are two types of national procedures:

  • Marketing Authorisation procedure in accordance with regulation 4 (1) of the Medicines (Marketing Authorisation) Regulations, in accordance with articles 8 and 10 of Directive 2001/83/EC, and 
  • Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC.


National duplicate applications

A duplicate application is defined (link to guidance document, CMDh -  Recommendations on Multiple/duplicate applications in mutual recognition and decentralised procedures, can be found here) by reference to the first application or marketing authorisation as follows:

  • same dossier
  • same legal basis according to Directive 2001/83/EC, as amended;
  • different trade name
  • same or different marketing authorisation holder

If a duplicate marketing authorisation (MA) is varied in a way that it deviates (apart from MAH or name of the medicinal product) from the ´original ´ MA it automatically will be outside the definition of a duplicate.


Module 1 may only differ from the ´original´ MA in certain aspects e.g. due to a different product name or MAH.

Modules 2-5 must be identical to the first marketing (‘original’) authorisation.

Submission of the duplicate application:

The national duplicate may only be submitted after closure of all variations of the ‘original’ application. An updated dossier/ASMF (including all post-authorisation activities) should be submitted to the MA.

Within the submission package, the applicant should submit a declaration in the cover letter confirming that an updated dossier/ASMF has been submitted. In the cover letter, the applicant should declare any changes or updates in documents of Module 1 (e.g. as per below):

  • PSMF (Summary of pharmacovigilance master file) if MAH is different from initial marketing authorisation
  • RMP (risk management plan)
  • Updated GMP (good manufacturing practice) certificates
  • Updated QP (qualified person) declarations

The applicant is reminded to ensure that:

  • the current correct fees have been paid and that a proof of payment has been provided
  • when using secure submission pathways such as Eudralink and CESP, further encryption may cause problems in uploading into our assessment tools
  • any changes made to documents should be pointed out in the covering letter and where possible track-changed version included (mainly for responses
  • correct medium for submission is used
  • product information in word version format has been submitted in the working documents section of the dossier.

Updated on: 14/05/2018