The Marketing Authorisation Holder Drug Dictionaries

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

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 Dinoxwww.dinox.nl

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].

  • EMA IDMP Task Force

    We are member of the EMA IDMP Task Force and therefore always on the pulse of IDMP issues and solutions. As expert on terminologies we are core member of the Referential Subgroup.

  • Easy and comprehensive Solutions

    We offer you tools that can boost your mapping of textual regulatory data with IDMP’s Controlled Vocabularies.

  • 25 years experience in knowledgebase development

    We worked as a Drug Dictionary Provider since 1989 (www.pharmazie.com) and therefore we can provide you with the best experience on international terminologies in the health-care sector.

  • Project Consultancy and Gap Analysis

    We also come along with skills in project consultancy. Having a lot of experience in project management of international teams consisting of very diverse members, such as IT, Pharmacists, Physicians, CEOs.

Frequently asked Questions

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IDMP Drug Dictionary
IDMP Term Browser
IDMP Text Encoder
Drug Pricing Tool
Marketing Authorization Holder Database
IDMP Match Tool
Active Pharmaceutical Ingredients Dictionary

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Ursula Tschorn
Phone: +49 (0)6101 128 201

info(at)idmp1.com

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