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.

Dossier:

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