Looking for more information about QP release import? QP, or Qualified Person, is strictly responsible for the release or certification of the drug, material or substance that will be manufactured, changed and/or used within EU boundaries.
QP release import is something that is needed when importing a product into the EU. To clarify, the product can be manufactured outside of the EU, but you need to have a QP release import to be able to take it into the EU country. This goes both for Investigational Medicinal Products (IMPs) and Medicinal Products (MP).
Why the QP release import is needed for you import procedure?
When manufacturing a drug that will be dispensed and widely distributed to the public, you need to make sure that it is certified and that it adheres to the strict GMP (Good Manufacturing Practice) requirements. When receiving the certification, you can then distribute it within EU boundaries. This is more widely known as free movement. Otherwise, the drug or substance will not be allowed to be used or even dispatched.
What the QP is requesting in a QP release import?
The Qualified Person will take full responsibility when certifying that the finished product meets all the requirements before it is going to be imported. He or she must thoroughly investigate the quality of the substance or drug. The QP is a well-educated and experienced person, that can be an employee of the company, or be under a contract just to do the investigation. His or her name will have to be present on the actual QP release import document for the QP designation to be valid. The specific requirements of the QP release import document can vary from country to country, and is dependent on the regulations and rules within each respective country.
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