The document focuses on the legislative requirements for the production of medicinal gases (medical air, synthetic air and oxygen) that may be generated inside hospitals or clinics under the responsibility of the hospital pharmacist.
The European Directive on Medicinal Products for Human Use, (2001/83 EC) requires manufacturers and suppliers of medicinal products to conform to requirements established to ensure patient safety.
This Directive, which requires medicinal products to be manufactured under Good Manufacturing Practice, (GMP) and supplied under a Marketing Authorisation (MA), only applies to medicinal products that are ‘placed on the market’. However, medicinal products manufactured by the hospital ‘on-site’ and used solely by the hospital, are not covered by the European legislation.
It is considered that this could lead to hospital patients being exposed to higher risks due to the difference in the quality control requirements for on-site manufacture and licensed product.
To address these potential issues EIGA proposes that regulations are developed to ensure GMP principles are also followed for on-site manufacture of medicinal gases for distribution by a hospital pipeline system, to ensure that patients’ safety is not jeopardised.
The scope of the Position Paper excludes the concentrators used in homecare therapy.
Reference: PP 38/11
Size: 36 KByte
Date added: 15/12/11 - 17:59:30