The European Medicines Agency (EMA) is looking to expand its guidance for companies importing finished medicinal products to the EU, in response to increasing globalization and supply chain complexity.

Importation Requirements

In the EU, companies importing finished medicinal products are required to obtain a manufacturing and importation authorisation (MIA) issued by their local national competent authority.

To comply with the regulations, importers must follow good manufacturing practice (GMP) requirements and must have "a pharmaceutical quality system, have adequate personnel and premises for the activities in question, appropriate arrangements for management of complaints and recalls, and procedures in place to control their supply chains."

To clarify the requirements for importers of finished medicinal products, EMA is planning to draft a new annex to the GMP Guidelines. In preparation, EMA has released a concept paper discussing some of the issues it intends to address in the new guideline, which it expects will be adopted in March 2016.

Issues Addressed

Per EU regulation, both manufacturing sites and sites that import and test batches of medicinal products are required to hold an MIA.

In cases where there is not a mutual recognition agreement between the countries, testing must be done when the product is imported to the EU before a batch can be certified and released. However, due to growing supply chain complexities, there is some confusion about testing requirements as the importation site and testing/batch release site are often in different locations.

In 2013, the EU revised the Union Format for Manufacturer's Authorisation, which is used by both manufacturers and importers for GMP authorization. However, EMA says that in the past two years it has gained "a more detailed understanding of the importation scenarios."

Highlighting the complexity of the manufacturing and supply chain for medicinal products, EMA says even the definition of the term "import" needs clarification.

EMA says it expects the new guidance to be a benefit to industry and regulators. The agency is asking stakeholders to submit their comments, which will be reviewed prior to drafting the new annex, by 29 August 2015.

EMA Concept Paper