Portugal

In order to market the medicinal product in Portugal, you need to apply for a Wholesaler Distribution License (WDL) issued by INFARMED, the national competent health authority. This license mandatorily implies the existence of a Portuguese warehouse and a Portuguese qualified person – the so called Technical Director. Due to the size of the operation in Portugal, Responsible Person and Warehousing are outsourced – the warehouse is usually a local pharmaceutical logistic operator, and the RP is not a full-time employee, but outsourced to a company.

Our team of experts at PTR Pharma Consulting can support you with:

• Compile and maintain Quality System as required for maintenance of WDL
• Act as a Responsible Person
• Supervise a set of Technical Quality Agreements tailored to your specific situation