In order to obtain an authorisation under this scheme the applicant must demonstrate:
– That the product is a homeopathic product that conforms with the principles and characteristics of homeopathy as practised in the State;
– That the indication sought is appropriate;
– That any such indication is suitable for use without the intervention of a registered medical practitioner for diagnosis, or for prescription or for the monitoring of treatment;
– That the efficacy of the product is based on evidence that the particular class of product has been in use in the State as a homeopathic treatment for the indication sought and;
– That the safety of the product has been established as set down in the relevant regulations.
The HPRA regulates the procurement of human tissues and cells in two ways depending on where the tissue processing establishment is located:
1 The procurement site is supplying a tissue establishment in Ireland.
2 The procurement site is supplying a tissue establishment outside the Ireland.
Import of tissues or cells for human application is defined as receipt of tissues/cells from countries outside the EEA (i.e. third countries). This is a prescribed activity which tissue establishments must be authorised to perform.
Please note that the import of tissues and cells for human application from third countries (routine or non-routine) can only be performed by tissue establishments authorised for the purposes of this activity by the HPRA.
Application form for Notification of Non-Routine Import-Export of Tissues and Cells for Human Application has been attached.
A quality management system consists of written procedures and forms which are approved and controlled by the company. These procedures and forms define how processes and activities in the daily operation of the business are performed and recorded. They ensure that each activity is performed to a standard prescribed method.
The HPRA has produced a set of written procedures and associated record forms with a view to providing guidance on the minimum requirements for those companies with the category ‘medicinal products for general sale’ only. These procedures may be incorporated into a company’s quality system.