What is a variation package?

Variation packaging allows you to use various types of inner packaging, such as bottles, cans, jars, and smaller plastic containers while using a fiberboard box that meets the UN specifications and the ISTA requirements.

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) was set up in 2005. It replaced the informal Mutual Recognition Facilitation Group.

What is grouping of variations?

Variations can be grouped together in a number of instances. These are then referred to as GV, or grouped variations. Only variations requiring assessment (VRA) can be grouped. Article 64 of the Veterinary Medicinal Products Regulation provides the legal basis for grouped variations.

What is the MRP variation number?

The MRP variation number consists of the Reference Authority code, domain, product counter, speciality counter of the product followed by the worksharing qualifier and the next available variation sequence of each product included.

What is the definition of variation in pharmacy?

A variation is a change in the dossier of an authorised product. There are four different types of variations: Type IA, Type IB, Type II and Line extension.

What is variation in regulatory affairs?

Variation means any amendment to the terms of an authorisation to market a human medicine as well as any change to the summary of product characteristics and the documents forming the basis for a marketing authorisation.

Get Cmdh 173 2010

EXAMPLES FOR ACCEPTABLE AND NOT ACCEPTABLE GROUPINGS FOR MRP/DCP PRODUCTS Doc. Ref: CMDh/173/2010/Rev.10 July 2013 For future variation applications comparable to those listed below as acceptable.

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