Their role
The pharmaceutical regent is the company's technically responsible professional before AGEMED. In health registration they sign, together with the legal representative, the application form as certification of technical responsibility and declaration of truthfulness (RM 0909/2005, item 2.1). They also certify the technical responsibility for each product (item 2.3.1).
Profile
For medicine importers, AGEMED forms ask for a pharmaceutical professional (biochemist pharmacist, pharmaceutical chemist or pharmacist). For medical devices, the accepted profile is broader.
Accreditation
Accreditation of the regent, technical director or quality control manager is a procedure of its own before AGEMED. It follows the same Window 3 filing route as other operating licenses (CR-12-2024).
In the life of the company
The regent appears in the company's annual renewal, so their accreditation must be kept up to date.
Sources
- RM-0909-2005, items 2.1 and 2.3.1
- CR-12-2024: operating-license procedures and accreditations
- Forms FORM-092 and FORM-096 (regent profile)
- Forms FORM-102 (accreditation) and FORM-107 (annual renewal)
General information. Requirements are subject to the current AGEMED regulations.