National & EU procedures preparations and submission

Marketing authorisation of medicinal products in UK and EU are governed by Directive 2001/83/EC as amended. Reference to the relevant Article under which the application is submitted is vital and should be clearly made. As an expert in this filed the following services are provided:

  • Drawing regulatory affair strategy and planning for marketing authorisation of medicinal products. These may be licensed via different regulatory procedures directly affecting the content and the way the dossier is constructed. This is to ensure successful outcome and issue of license in timely manner.
  • Reviewing the content of the dossier to ensure compliance with the current regulatory requirements and the procedure under which the application is to be submitted.
  • Submission of Marketing Authorisation Forms (MAA) and dossiers in line with national and EU requirements and procedures including DCP, MRP and centralised.
  • Following up applications with the relevant European competent authorities to ensure progress and conclusion within the legislative time frame.
  • Organizing and preparation of responses and accompanied documentations requested by the different EU competent authorities during the assessment process of the application ensuring submission within the time frame of the procedure agreed.
    Guidance through the compliance national stage usually followed completion of EU procedure.
  • Management & follow up of post approval commitment made

Reference: Directive 2001/EC/83