Request for authorization to sell PUVs
According to Article 12 of Decree-Law no. 237/2009, "The placing on the market of PUVs depends on authorization, to be granted by the competent authority. Authorization to sell may only be granted to PUVs whose applicants are established in the European Economic Area (EEA)."
In addition, only PUVs with this sales authorization can be imported.
Among the information required in the application are:
- Name or corporate name and address or registered office of the applicant
- Proposed invented name for the product for veterinary use
- Technical or scientific documentation
- Carton design, labeling and literature included, where appropriate, in Portuguese
- etc.
Step 1
Formulation review
This is the first step in the entire process, and an essential moment where the Regulatory and safety compliance of the ingredients is assessed (some ingredients are restricted/banned)
Step 2
Review of Labels and Claims
A clear label is important to help consumers with their purchases and to protect their health. All important information must always be easily accessible, legible and understandable to the consumer at the time of purchase. The rule is quite simple: the end consumer must understand exactly what they are buying when they check the product.
A Label Review is a complete compliance of packaging and labels, which checks claims and other mandatory legal requirements, such as:
- Qualitative and quantitative composition of the components
- Animal species or other purposes for which the product is intended
- Sales authorization number
- Expiry date
- etc.
Step 3
Drawing up the summary of characteristics of the product for veterinary use
The granting of the authorization to sell includes the approval of the PUV's Summary of Characteristics.
This document contains the following information:
- Name of the PUV and indication of its intended purpose
- Qualitative and quantitative composition
- Animal species or other intended purposes
- Dose and/or method of use
- Overdose, identifying symptoms, emergency measures and antidotes
- Indication and justification of any preventive or safety measures to be adopted, where appropriate
- etc.
Step 4
Request for sales authorization
Pharmilab supports its customers by contacting the authority and requesting authorization to sell, by filling in the form according to the type of PUV.
The application will be validated within 30 days of receipt. Authorization must be granted within 60 days of the date on which the application is submitted to the competent authority, failing which it will be tacitly granted.
The competent authority shall notify the applicant of the authorization to sell the PUV, assigning a sales authorization number and transmitting the conditions of approval.
