Spring Intro 2023

03/03/2023

HPRA Vision and Mission

• The vision of the HPRA is ‘to be recognised as a centre of excellence for both the quality and scientific rigour we bring to the work we do and the efficient manner in which it is completed.’ • The HPRA’s mission statement is ‘to protect and enhance public and animal health through the regulation of medicine, medical devices and healthcare products.’

Common Deficiencies in CMC

03/03/2023

5

5

Marketing Authorisations (MA)

• Directive 2001/83/EEC, Article 8:

• In order to obtain a marketing authorisation (MA) to place a medicinal product on the market an application shall be made to the competent authority of the Member State concerned. • Only when a MA has been issued by the competent authority can a medicinal product be placed on the market of a Member State of the European Union. • MA granted initially for a period of 5 years • 1 renewal  indefinite validity

Common Deficiencies in CMC

03/03/2023

6

6

3