Review of dossier for Marketing Authorisation & Licensing in UK/EU

For marketing authorisation of a medicinal product in EU, the presentation and format of the dossier (CTD) in its five modules (M1, M2, M3, M4 & M5) needs to comply with the current requirements of the EU Directives and guidelines (Notice to Applicant Vol 2B).

These requirements are of such regulatory and technical details that would need a deep knowledge and experience in revision and assessment of the standard of the dossier. This is to ensure consistency and compliance with the rules that govern marketing authorisation of medicinal products in EU laid down in the relevant guideline (Notice to Applicants Vol 2A) as well as to comply with the national requirements of the different EU competent authorities and validation upon submission. Based on that the following services are provided:

  • Assist in planning and drawing the regulatory strategy of the proposed medicinal product and intended market. This is a critical stage of the process upon which the standard and content of the dossier would be highly dependent; deciding the fate of the medicinal product as well as level of investment required.
  • Reviewing the dossier to ensure consistency and compliance with the requirements of the relevant Article of the Directive (2001/EC/83) as amended under which the application is to be submitted. In this instance annotation of the sections and subsections of the different modules dossier is clearly made along with the recommendation of action required.
  • Reviewing the pharmacovigilance system and RMP of the company to ensure compliance with the current requirements and standards. This activity is to be carried out by an associate who has deep knowledge and experience in this field including occupying a senior position in the VRMM division of MHRA and is actively engaged in a number of project of this kind with great magnitude.
  • Arrange for EU QC & batch release including qualified person.
  • Submission of the dossier and follow up with the authorities as the procedure progresses including responding to the list of question raised and request for further information to ensure conclusion in timely manner.