The HPRA has introduced a pre-application step for companies who intend to apply for an MIA for the manufacture of human and veterinary medicines and investigational medicinal products.
The aim of providing pre-submission advice relating to MIA applications is to:
- assist applicants’ understanding of the regulatory requirements so that the application process can be successfully completed within the required timelines.
- help guarantee the availability of inspection resources by taking into account key project milestones.
- provide earlier notice to the HPRA of future applications.
A company can make a request for a pre-submission meeting by completing the Request for pre-submission meeting for MIA form. The form is less detailed and will help guide discussions during the pre-submission phase. The completed form can be sent to compliance@hpra.ie.
An acknowledgement email will be sent with a reference number and within a week a proposed date for a meeting will be provided.
The purpose of the meeting is to:
- understand the manufacturing activities, project timelines and key milestones.
- explain the steps involved in the MIA application process and critical aspects that should be in place at the time of inspection.
The advice given is based on the information and documentation given by the applicant. An MIA application form will be provided to the company when it is confirmed that the site will be ready for an inspection within 4 to 6 weeks.