Establishing EU Operations

EU Regulatory Environment

Within the EU, to ensure the quality, safety and efficacy of medicinal products, many activities within the pharmaceutical supply chain are considered ‘Regulated Activities’.  These ‘Regulated Activities’ may not always be obvious and can sometimes be misunderstood or missed completely leading to a company operating in non-compliance with the regulations, with possible risk to the quality, safety and efficacy of medicinal products supplied and to business continuity.


‘Regulated Activities’ are covered by the following Authorisations and Registrations:

  • Manufacturer/Importer Authorisation
  • Wholesale Distribution Authorisation
  • Active Substance Registration
  • Broker Registration
Establishing EU Operations

Quality and Compliance Considerations when setting up EU operations

How our team can help

PharmaLex Ireland brings clarity and expertise to companies who wish to set up in Europe. We help to identify the relevant authorisations and registrations for your organisation and to define a strategy for accessing European markets.  Following this initial engagement, we can then assist you with the development of your systems and process design to make sure they meet the compliance requirements of the national regulatory agency within Europe.  To enable us to do this as effectively and efficiently as possible, we have a team of consultants who are based across Europe.  These consultants are experts in their national regulatory requirements and understand the requirements of doing business in their local environment as well as having good relationships with their national regulatory agency.


Services we offer our clients when establishing EU operations include:

  • Supply Chain Mapping
  • Identification of relevant licence that applies to proposed EU operations
  • Design and development of a QMS specific to EU business operations
  • Provide interim resources – QP, RP, QA support staff
  • Provide virtual QA services eg complaint/quality defect/recall management
The European Market
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PharmaLex Ireland