Informed Consent Applications

Informed Consent Application - Article 10c of Directive 2001/83/EC

An Informed consent application is an application according to Article 10c of Directive 2001/83/EC as amended.

Definition: 

Following the granting of a marketing authorisation (Reference product), the authorisation holder may allow use to be made of the pharmaceutical, preclinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.

Reference Product: 

Marketing authorisation for a medicinal product supported by a complete dossier. (Reference product cannot be based on an Article 10 application)

Criteria:

• The marketing holder for the reference product has consented that the applicant could refer to all three modules containing the pharmaceutical, preclinical and clinical data for the reference product.
• The product applied for must have the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form as the reference product.
• An informed consent application can only be submitted in Member States where the reference product is authorised, i.e. the application cannot be submitted in parallel to the application for the reference product.
• The authorisation of the informed consent application should follow the same authorisation route as the initial authorisation. Therefore a national, MRP or DCP informed consent application cannot refer to a centralised approved medicinal product.
• The applicant for the second product must during the lifetime of the product have permanent access to the references in the documentation for the reference product or be in possession of this information.
• If an Active Substance Master File (ASMF) has been used for the reference product a new letter of access should be included in the application for the second product.
• The applicant could be the same as the marketing authorisation holder for the reference product or not.
• The two products must have different tradenames.
• The informed consent application is not legally obliged to cover all pharmaceutical form(s)/strength(s) of the reference medicinal product.

Dossier Requirements:

Dossier Requirements varies from one member state to other member state. As per HMA recommendation, the applicant is advised to contact the national competent authorities regarding dossier requirements.  

UK - MHRA Requirements:

• Module 1
• Informed consent letter
• Manufacturers of active ingredient and finished product 
• If using a contracted service to submit the application, include a letter of access for direct communication concerning the application
• Letter confirming the company has access to all of the data supporting the application and is in possession of the quality section of the dossier  
• If the product manufacturer is not the applicant, a letter from the manufacturer confirming that they are prepared to manufacture the product on the applicant’s behalf.
• Suppliers statements concerning TSE risk (e.g. lactose, glycerol).
• Detailed Description of the Pharmacovigilance System.

Ireland - IMB Requirements:

• A completed application form
• A Letter of access form the Marketing Authorization holder of the reference product consenting that the dossier of that product may be used for examining the application in question
• 3 copies of Module 1
• Electronic copy of SPC on disk, CD or by email to IMBReceiptsandvalidation@imb.ie
• A completed Fee Application Form

Further Reference:

1. Better Regulation of Medicines: National informed consent (Article 10c, simple abridged) applications

2. IMB - Frequently Asked Questions

3. Informed Consent Applications in Mutual Recognition and Decentralized Procedures Recommendations