According to article 4 of Decree-Law no. 237/2009, "The manufacture of PUVs or the carrying out of any of the processes leading to their manufacture are subject to authorization by the competent authority."

The manufacture of PUVs, which is the sole responsibility of the manufacturer, is authorized provided that the manufacturer has adequate and sufficient facilities and equipment capable of guaranteeing their quality and good PUV manufacturing practices.

Among the necessary information to be made available are:

• The company name and other identifying elements
• Specification of the formulations to be manufactured
• Indication of the place, store or laboratory of manufacture or storage, the technical equipment as well as and/or its control for correct manufacture and conservation
• Identification of the veterinarian that ensures the technical direction

Pharmilab can help you make this request to the competent authority.