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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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  1. Click the ‘Get Form’ button to access the Cmdh 173 2010 form and open it in the online editor.
  2. Review the introductory section of the form. Familiarize yourself with its purpose and the types of grouping applications outlined in the update.
  3. Begin filling in your details in the personal information section. Ensure all fields are completed accurately.
  4. Proceed to the sections detailing acceptable and not acceptable groupings for MRP/DCP products. Carefully read each entry and assess how they apply to your particular circumstance.
  5. Complete any additional sections regarding updates to the dossier or notifications that pertain to your application.
  6. Once all relevant sections are filled out, double-check your entries for accuracy and completeness.
  7. After reviewing, save your changes, and consider downloading or printing a copy for your records.
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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.

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.

➢ 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.

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.

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

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.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232