Publications

This publication describes the resulting risk priority level, based on the combination of impact to patient and likelihood of a drug shortage for the product, which is the same for all of our medicinal gases, ie. Risk Priority Level 3, with the residual risk of a drug shortage being generally accepted. Therefore, it is proposed that there is no necessity to prepare additional Shortage Mitigation Plans as the risk of a drug shortage can be generally accepted. EIGA also recommends that our medicinal products (medicinal gases) should be assessed as not required to be included in the “Union list of critical medicines” as the security in supply and prevention of shortages is assured.

This publication describes the resulting risk priority level, based on the combination of impact to patient and likelihood of a drug shortage for the product, which is the same for all of our medicinal gases, ie. Risk Priority Level 3, with the residual risk of a drug shortage being generally accepted. Therefore, it is proposed that there is no necessity to prepare additional Shortage Mitigation Plans as the risk of a drug shortage can be generally accepted. EIGA also recommends that our medicinal products (medicinal gases) should be assessed as not required to be included in the “Union list of critical medicines” as the security in supply and prevention of shortages is assured.

This publication describes the resulting risk priority level, based on the combination of impact to patient and likelihood of a drug shortage for the product, which is the same for all of our medicinal gases, ie. Risk Priority Level 3, with the residual risk of a drug shortage being generally accepted. Therefore, it is proposed that there is no necessity to prepare additional Shortage Mitigation Plans as the risk of a drug shortage can be generally accepted. EIGA also recommends that our medicinal products (medicinal gases) should be assessed as not required to be included in the “Union list of critical medicines” as the security in supply and prevention of shortages is assured.

This publication describes the resulting risk priority level, based on the combination of impact to patient and likelihood of a drug shortage for the product, which is the same for all of our medicinal gases, ie. Risk Priority Level 3, with the residual risk of a drug shortage being generally accepted. Therefore, it is proposed that there is no necessity to prepare additional Shortage Mitigation Plans as the risk of a drug shortage can be generally accepted. EIGA also recommends that our medicinal products (medicinal gases) should be assessed as not required to be included in the “Union list of critical medicines” as the security in supply and prevention of shortages is assured.

This publication describes the resulting risk priority level, based on the combination of impact to patient and likelihood of a drug shortage for the product, which is the same for all of our medicinal gases, ie. Risk Priority Level 3, with the residual risk of a drug shortage being generally accepted. Therefore, it is proposed that there is no necessity to prepare additional Shortage Mitigation Plans as the risk of a drug shortage can be generally accepted. EIGA also recommends that our medicinal products (medicinal gases) should be assessed as not required to be included in the “Union list of critical medicines” as the security in supply and prevention of shortages is assured.

This Technical Bulletin provides guidance on the interpretation of the General Safety and Performance Requirements (GSPR) in Annex I of the Medical Device Regulation (MDR), when applied to gaseous Argon as a medical device such as intended for plasma coagulation or cryoablation, and to provide implementation recommendations

Hydrogen refueling stations (HRS) are being deployed out of the industrial environment where Industrial Gas Companies are used to operate trailers. It is foreseen that a significant increase in number of deliveries to HRS will be required to support the growth of Hydrogen mobility applications. The connection between Gaseous Hydrogen (GH2) trailers and HRS are typical industrial connectors but there is a lack of harmonised standardisation of physical connectors and relevant safety systems for interoperability. The aim of this document is to represent EIGA recommendations on this topic. The scope of the document covers GH2 trailer usage in Europe, however most of the functional requirements can be extended and adapted for other geographies. The requirements of this document only apply for new installations.

If the supply pressure in cylinders/bundles is higher than the end user installation service pressure, using a pressure reducing valve with a built-in, pre-set, pressure reducer, is a popular solution to avoid the re-design of a customer installation.

A Medical Gas Pipeline System (MGPS) is a singular medical device, and this type of equipment has been put into service in several countries under the Medical Device Directive 93/42/EEC (MDD). However, the conformity assessment and classification have not been harmonised across EU Member States. With the introduction of the MDR, the requirements applying to the MGPS need to be appropriately assessed because of potential implications. This publication provides guidance on which MDR rules apply, resulting in a class IIa classification.

This publication explains what is allowed on import, export, filling, storing, transporting and use of TPED cylinders for use under DOT jurisdiction, and DOT cylinders under ADR jurisdiction.