EU’s Regulatory System for Medicines

Due to the complexity, companies can sometimes misunderstand or miss completely these regulations, which can lead to non-compliance and possible risk to the quality, safety and efficacy of medicinal products supplied. This can also have a negative impact on companies’ operations and business continuity.

Pharmaceutical Regulatory Authorities in the EU

Here is a brief graphical representation of the regulation system for medicinal products.

• The role of the European Commission(EC)
  • The European Commissionis the governing legal entity that may grant or refuse, amend or suspend marketing authorisations for medicines within the EU
• The role of the European Medicines Agency (EMA)
  • The EMA is the scientific body that evaluates the medicines for which the EC issues authorisations. They provide the scientific data that allows the EC to make their decision to authorise a medicine
• The role of HPRA
  • HPRA is the national competent authority of Ireland. They provide representatives from Ireland to the EMA/EC to assist in applying policies and regulations to ensure that medicines that are safe, effective and fit for purpose across all EU countries, in addition to ensuring that applicable EC/EMA regulations are adhered to within Ireland.

Required Authorisations

To legally operate in the European pharmaceutical supply chain, companies need relevant authorisations. These include, but are not limited to:

1. Manufacturing Importation Authorisation (MIA)
   1. This is a licence that allows a company to participate in manufacturing, processing, primary/secondary packaging, importation, and batch certification of medicines from within and outside the EEA.  There are 3 types:
      1. Commercial – for products approved for human use by the relevant regulatory authority
      2. Investigational Medicinal Product – for medicines undergoing clinical trials to determine if they are safe and effective for human use
      3. Veterinary – for products approved for use in animals
   2. Wholesale Distribution Authorisation (WDA)
      1. Licence held by any company that procures, stores and distributes medicines to anyone other than the patient that uses the medicine. The purpose of a WDA is to ensure that the regulations and guidelines relating to the procurement, supply, holding and export of medicinal products are upheld, and that the quality and integrity of the medicines are maintained throughout the supply chain, from the manufacturer to the end user, and to prevent the introduction of falsified, counterfeit, substandard, or unauthorised products into the market.
   3. Active Substance Registration (ASR)
      1. Each manufacturer of a medicine for human or veterinary use is required to maintain a register of active substances – a regulatory document listing the physico-chemical, ecotoxicological and toxicological properties of the agents within a medicine that are intended to produce a physical or chemical change in the patient to treat a disease or condition.
   4. Broker Registration
      1. Brokering of medicinal products for human use means all activities in relation to the procurement (purchase) or supply (sale) of medicinal products for human use, except for wholesale distribution and sale by wholesale.  In other words, a company brokering a product never physically handles the product and never purchases, owns or sells the product. Their activity consists solely of negotiating independently and on behalf of another legal or natural person in relation to the sale or purchase of a product
2.     Marketing Authorisation (MA)
   1. A marketing authorisation lays down the terms under which the marketing of a medicinal product is authorised in the EU.  The company that is granted a marketing authorisation is referred to as the Marketing Authorisation Holder (MAH).

Compliance with the Regulations

All authorisations must be held by legal entities located within the EU. Pharma companies entering the EU market must be fully compliant with appropriate regulations. Failure to adhere to these regulations can result in significant fines, withdrawal of marketing authorisations and loss of trust for the company.

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