The Marketing Authorisation Holder Drug Dictionaries

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The Marketing Authorisation is described in the legislative framework

  • EU Directive 2001/83/EC for the European Union
  • US Directive Federal Food, Drug, and Cosmetic Act (FDCA)
  • applies to all types of products
  • 1 Marketing Authorisation (MA) = 1 Marketing Authorisation Holder (MAH)

The Marketing Authorisation Holder

      • must have a legal address in the marketable area
      • is legally accountable for Quality, Safety and Efficacy of the product
      • is listed in the database Marketing Authorisation Holder Germany if there is minimum one product authorised in the German market

Manufacturing of the drug product

  • can take place in- or outside the marketable area
  • multiple manufacturing sites are allowed on the same Marketing Authorisation (MA)
  • quality must be verified by Good Manufacturing Practice (GMP) status and inspection

The Marketing Authorisation Holder Drug Dictionaries in a Nutshell

    • check out all the structured data to Marketing Authorisation Holders´ (MAH) contact details
    • overview of search results in all [pharmazie.com] databases with this special MAH (35+ drug dictionaries)
    • check out the MAH of 120.000 international marketed medicinal products in 52 countries
    • Including active ingredients and their pharmacological and toxicological information, Clinical Particulars such as Interactions, Adverse Reactions, Contra-Indications etc.
    • The Marketing Authorisation Holders Germany Database is updated twice a month

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What our customers say

Christine Klipping

For me as CRO the Marketing Authorisation Holder Drug Dictionaries are a big help to find SmPCs of the different MAHs in the authorised markets.

Christine KlippingPresident Dinox – www.dinox.nl

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About Us

IDMP1 GmbH was founded in 2015. Parent company is DACON Datenbank Consulting GmbH (DACON), Bad Vilbel, Germany founded in 1989. DACON has worked as a Drug Dictionary Provider since 1989 and is the provider of the portal [pharmazie.com] with information on medicinal products authorised in 52 countries. For the German speaking countries (Austria, Switzerland and Germany) information on drug prices and interactions are provided on [pharmazie.com].

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