How is the [Strength] field as a common master data element defined?
May 14, 2019 5:47 pmIn addition to the information from section 4 “Common Master Data Elements” of the EMVS Master Data Guide, please be informed that,... View Article
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What is a Co-Marketer?
August 9, 2018 10:02 amA Co-Marketer is a company commercializing a product under a different trademark. As co-marketers commercialise the product under a different... View Article
What is a Sales Affiliate of a MAH?
August 9, 2018 10:00 amA Sales Affiliate of a MAH is a company focussing on sales which is controlled by the MAH or which... View Article
Is a designated wholesaler obliged to verify the authenticity of the unique identifier of medicinal products?
August 9, 2018 9:57 amNo, the designated wholesaler is not obliged to verify the authenticity of the unique identifier of medicinal products. The Delegated... View Article
Who is a Designated Wholesaler?
August 9, 2018 9:46 am‘Designated Wholesalers’ are wholesalers who are designated by the marketing authorisation holder, by means of a written contract, to store... View Article
Why not all countries are listed in appendix 4 of the Master Data Guide?
June 29, 2018 1:06 pmAppendix 4 of the Master Data Guide does not cover countries who made the decision of including the reimbursement number... View Article
Does the strength and pharmaceutical form need to be added to the Registered Product Name to form the Name of the Medicinal Product?
December 5, 2017 10:46 amThis question is related to one of the common data elements in the EMVS Master Data Guide (Appendix 1), Name... View Article
What is to be done if the original batch number is longer than 20 characters?
December 5, 2017 9:44 amAn inbound product suitably coded for the European market under the terms of the FMD Delegated regulation cannot have a... View Article
How is the EMVS testing the randomness of Serial Numbers (UID)?
December 5, 2017 9:36 amThe EMVS, consisting of the European Hub and the National Systems, implemented a level of testing to check the level... View Article
Is it possible to deliver a serialized product from country A to country B when this product is not registered in country B?
December 5, 2017 9:35 amIf products are sold by exceptions in countries where the products are not registered, the EMVS will allow for a... View Article