Module 3 2019

What does “packaging” mean?

Immediate packaging / Primary packaging / Container

• The container or other form of packaging immediately in contact with the medicinal product (Directive 2001/83/EC amended)

• A container for pharmaceutical use is an article which contains or is intended to contain a product and is, or may be, in direct contact with it. The closure is a part of the container. (Ph. Eur. – 3.2)

Outer packaging / Secondary packaging

• The packaging into which is placed the immediate packaging (Directive 2001/83/EC amended)

The Organisation for Professionals in Regulatory Affairs