Glossary

Action taken by the manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market.

A communication sent out by the manufacturer or its representative to the device users in relation to a field safety corrective action.

A collection of sealed final containers that is homogeneous with respect to the composition of the product and the risk of contamination during filling. A final lot must therefore have been filled from a formulated bulk in one continuous working session.

A a finished dosage form (for example, suspension or lyophilized cake) that contains an active ingredient, generally but not necessarily in association with inactive ingredients (excipients) or adjuvants. Also sometimes referred to as “finished product” or “drug product”.

A finished dosage form of a pharmaceutical product that has undergone all stages of manufacture, including packaging in its final container and labelling.

A combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio of doses. This term is used generically to mean a particular combination of APIs irrespective of the formulation or brand. It may be administered as singleentity products given concurrently or as a finished pharmaceutical product.

An intermediate in the drug product manufacturing process, consisting of the final formulation of antigens, adjuvants and excipients at the concentration to be filled into primary containers.

A device to indicate when vaccines have become colder than a specified temperature for a certain period of time. These may be chemical or electronic in operation.

The freeze protection classification is based on the number of user-interventions required to ensure freeze protection:

Grade A, user-independent freeze protection (UIFP): when the appliance is used within its nominated temperature range (+43°C and minimum rated ambient temperature) no intervention is required on the part of the user to ensure that the vaccines will not be exposed to temperatures below 0°C, whatever the position of the vaccine in the vaccine compartment.

Grade B, user-dependent freeze protection (UDFP): even if the appliance is used within its nominated temperature range, the user must comply with a procedure provided by the legal manufacturer and requiring one level of intervention (e.g. the requirement to use baskets or any other single item constitutes one level of intervention by the user) in order to ensure that the vaccines will not be exposed to freezing temperatures outside of the acceptable temperature range.

Grade C, user-dependent freeze protection (UDFP): even if the appliance is used within its nominated temperature range, the user must comply with a procedure provided by the legal manufacturer requiring more than one level of intervention (e.g. the requirement to use baskets and insulation barriers or covers) in order to ensure that the vaccines will not be exposed to freezing temperatures outside of the acceptable temperature range.

A temperature excursion below -0.5°C for longer than 1 hour.

A temperature excursion equal to or below -0.5°C for any amount of time.