Type Approve Document For Free

Type approval describes the process applied by national authorities to certify that a model of a vehicle meets all EU safety, environmental and conformity of production requirements before authorising it to be placed on the EU market.

To apply for a GB Type Approval, you are required to provide suitable evidence from a suitably appointed Technical Service. At the time of full implementation of the GB Scheme this Technical Service must be appointed by VCA for the relevant subject you have applied for.

A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require a formal approval.

A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder.

For type II variations entailing additions of new therapeutic indication(s) or modification of already approved one(s) under scope C.I.

In terms of duration, type II variation assessments typically follow a 60-day timetable. These include all standard type II variations to implement quality changes, changes to the Product Information or to the conditions of the marketing authorisation, or submission of final (non-)clinical study results.

A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require a formal approval.