Animal Care
regulatory
Pharmilaboffersspecializedservicesforthedevelopmentandregulationofanimalcareproducts.Withup-to-datetechnicalknowledgeandastrongfocusonmeetinglegalrequirements,wesupportbrandsandcompaniesateverystage,ensuringthequality,safety,andcomplianceofproductsaimedatanimalwell-being.
Pharmilaboffersspecializedservicesforthedevelopmentandregulationofanimalcareproducts.Withup-to-datetechnicalknowledgeandastrongfocusonmeetinglegalrequirements,wesupportbrandsandcompaniesateverystage,ensuringthequality,safety,andcomplianceofproductsaimedatanimalwell-being.
Pharmilabisahighlyexperiencedproviderofcompletesolutionsforthedevelopment,regulation,andmarketplacementofcosmeticproducts,guaranteeinglegalcomplianceandqualityateverystep.
Application for Manufacturing Authorization for PUVs
Microbiology and Physicochemicals
Under Decree-Law No. 237/2009, manufacturing Veterinary Use Products (PUVs) requires mandatory authorization from the competent authority. This approval is only granted if the manufacturer demonstrates they have the adequate facilities, equipment, and processes necessary to guarantee product quality and adhere to good manufacturing practices.
The application must include the company's identification, detailed formulation specifications, and a description of the manufacturing and storage sites. Additionally, a supervising veterinarian must be identified to ensure technical direction; Pharmilab is available to assist you in preparing and submitting this entire request to the authorities.
Under Decree-Law No. 237/2009, manufacturing Veterinary Use Products (PUVs) requires mandatory authorization from the competent authority. This approval is only granted if the manufacturer demonstrates they have the adequate facilities, equipment, and processes necessary to guarantee product quality and adhere to good manufacturing practices.
The application must include the company's identification, detailed formulation specifications, and a description of the manufacturing and storage sites. Additionally, a supervising veterinarian must be identified to ensure technical direction; Pharmilab is available to assist you in preparing and submitting this entire request to the authorities.
Under Decree-Law No. 237/2009, manufacturing Veterinary Use Products (PUVs) requires mandatory authorization from the competent authority. This approval is only granted if the manufacturer demonstrates they have the adequate facilities, equipment, and processes necessary to guarantee product quality and adhere to good manufacturing practices.
The application must include the company's identification, detailed formulation specifications, and a description of the manufacturing and storage sites. Additionally, a supervising veterinarian must be identified to ensure technical direction; Pharmilab is available to assist you in preparing and submitting this entire request to the authorities.
Request for authorization
to sell PUVs
Mutual Recognition in the EU
To sell or import Veterinary Use Products (PUVs) under Decree-Law No. 237/2009, you must first obtain an official sales authorization. Crucially, this authorization is only available to applicants legally established within the European Economic Area (EEA).
The application requires comprehensive technical and scientific proof of the product's quality, alongside the applicant's details and the proposed product name. Additionally, all packaging, labeling, and instructions must be designed in Portuguese to meet legal market standards.
To sell or import Veterinary Use Products (PUVs) under Decree-Law No. 237/2009, you must first obtain an official sales authorization. Crucially, this authorization is only available to applicants legally established within the European Economic Area (EEA).
The application requires comprehensive technical and scientific proof of the product's quality, alongside the applicant's details and the proposed product name. Additionally, all packaging, labeling, and instructions must be designed in Portuguese to meet legal market standards.
To sell or import Veterinary Use Products (PUVs) under Decree-Law No. 237/2009, you must first obtain an official sales authorization. Crucially, this authorization is only available to applicants legally established within the European Economic Area (EEA).
The application requires comprehensive technical and scientific proof of the product's quality, alongside the applicant's details and the proposed product name. Additionally, all packaging, labeling, and instructions must be designed in Portuguese to meet legal market standards.
Request for authorization
to sell PUVs
Request for assignment of a National Product Code (CNP)
To sell or import Veterinary Use Products (PUVs) under Decree-Law No. 237/2009, you must first obtain an official sales authorization. Crucially, this authorization is only available to applicants legally established within the European Economic Area (EEA).
The application requires comprehensive technical and scientific proof of the product's quality, alongside the applicant's details and the proposed product name. Additionally, all packaging, labeling, and instructions must be designed in Portuguese to meet legal market standards.
To sell or import Veterinary Use Products (PUVs) under Decree-Law No. 237/2009, you must first obtain an official sales authorization. Crucially, this authorization is only available to applicants legally established within the European Economic Area (EEA).
The application requires comprehensive technical and scientific proof of the product's quality, alongside the applicant's details and the proposed product name. Additionally, all packaging, labeling, and instructions must be designed in Portuguese to meet legal market standards.
To sell or import Veterinary Use Products (PUVs) under Decree-Law No. 237/2009, you must first obtain an official sales authorization. Crucially, this authorization is only available to applicants legally established within the European Economic Area (EEA).
The application requires comprehensive technical and scientific proof of the product's quality, alongside the applicant's details and the proposed product name. Additionally, all packaging, labeling, and instructions must be designed in Portuguese to meet legal market standards.
01
Formulation revision
This is the first step in the whole process, and an essential moment where the regular and safety compliance of ingredients is assessed (some ingredients are restricted/prohibited)
02
Labels and claims revision
03
Preparation of the Summary of Product Characteristics for Veterinary Use
04
Request for a sales authorisation
Mutual Recognition in the EU
Labeling
The sales authorization process is conducted with the Portuguese Competent Authority – the DGAV.
Based on the principle that any goods legally sold in one European Union (EU) country can be sold in another EU country, Pharmilab can help you apply for mutual recognition to market your PUVs in another EU country.
The sales authorization process is conducted with the Portuguese Competent Authority – the DGAV.
Based on the principle that any goods legally sold in one European Union (EU) country can be sold in another EU country, Pharmilab can help you apply for mutual recognition to market your PUVs in another EU country.
The sales authorization process is conducted with the Portuguese Competent Authority – the DGAV.
Based on the principle that any goods legally sold in one European Union (EU) country can be sold in another EU country, Pharmilab can help you apply for mutual recognition to market your PUVs in another EU country.
Conquer the world
with your brand
Fill out the form today and experience expert services
Conquer the world
with your brand
Fill out the form today and experience expert services
Conquer the world
with your brand
Fill out the form today and experience expert services