Food Supplements
Food Supplements
regulatory
regulatory
AtPharmilab,weprovidetechnicalandregulatorysupportinthedevelopmentoffoodsupplements,ensuringcompliancewithbothnationalandinternationalstandards.
AtPharmilab,weprovidetechnicalandregulatorysupportinthedevelopmentoffoodsupplements,ensuringcompliancewithbothnationalandinternationalstandards.
Pharmilabisahighlyexperiencedproviderofcompletesolutionsforthedevelopment,regulation,andmarketplacementofcosmeticproducts,guaranteeinglegalcomplianceandqualityateverystep.
Fromformulationtolabelling,includingsafetyassessmentandregulatorysubmissions,weoverseeeverystepwithscientificrigorandup-to-dateindustryknowledge.
Fromformulationtolabelling,includingsafetyassessmentandregulatorysubmissions,weoverseeeverystepwithscientificrigorandup-to-dateindustryknowledge.
Fromformulationtolabelling,includingsafetyassessmentandregulatorysubmissions,weoverseeeverystepwithscientificrigorandup-to-dateindustryknowledge.
Notification in
Portugal
Microbiology and Physicochemicals
Under Decree-Law No 118/2015, the mandatory notification of a food supplement to the Portuguese Competent Authority, DGAV, must be completed electronically and free of charge by submitting the "Notification Dossier" before the product is first placed on the national market, after which it can be marketed immediately.
The party responsible for placing the product on the market (manufacturer, EU distributor, or third-country importer) is accountable for both the notification process and ensuring continuous legal compliance, including communicating all subsequent product or labelling changes to DGAV via an amendment procedure.
Under Decree-Law No 118/2015, the mandatory notification of a food supplement to the Portuguese Competent Authority, DGAV, must be completed electronically and free of charge by submitting the "Notification Dossier" before the product is first placed on the national market, after which it can be marketed immediately.
The party responsible for placing the product on the market (manufacturer, EU distributor, or third-country importer) is accountable for both the notification process and ensuring continuous legal compliance, including communicating all subsequent product or labelling changes to DGAV via an amendment procedure.
Under Decree-Law No 118/2015, the mandatory notification of a food supplement to the Portuguese Competent Authority, DGAV, must be completed electronically and free of charge by submitting the "Notification Dossier" before the product is first placed on the national market, after which it can be marketed immediately.
The party responsible for placing the product on the market (manufacturer, EU distributor, or third-country importer) is accountable for both the notification process and ensuring continuous legal compliance, including communicating all subsequent product or labelling changes to DGAV via an amendment procedure.
Mutual Recognition
in the EU
Mutual Recognition in the EU
To market a food supplement in Portugal that has already been notified in another EU Member State, the responsible party may initiate the Mutual Recognition Procedure under Regulation (EU) 2019/515, which is a free-of-cost process submitted to the Portuguese Competent Authority, DGAV. This mechanism allows any economic operator to legally sell their EU-notified food supplements in another EU country, and Pharmilab offers assistance with the request to facilitate the marketing of these products.
To market a food supplement in Portugal that has already been notified in another EU Member State, the responsible party may initiate the Mutual Recognition Procedure under Regulation (EU) 2019/515, which is a free-of-cost process submitted to the Portuguese Competent Authority, DGAV. This mechanism allows any economic operator to legally sell their EU-notified food supplements in another EU country, and Pharmilab offers assistance with the request to facilitate the marketing of these products.
To market a food supplement in Portugal that has already been notified in another EU Member State, the responsible party may initiate the Mutual Recognition Procedure under Regulation (EU) 2019/515, which is a free-of-cost process submitted to the Portuguese Competent Authority, DGAV. This mechanism allows any economic operator to legally sell their EU-notified food supplements in another EU country, and Pharmilab offers assistance with the request to facilitate the marketing of these products.
Request for assignment of a National Product Code (CNP)
Request for assignment of a National Product Code (CNP)
The National Product Code (CNP) is an optional code assigned by the National Association of Pharmacies (ANF) for the national market to identify health products within the pharmacy circuit, offering added commercial value through faster communication, enhanced sales advice potential, and improved product information quality and safety.
Applying for the CNP involves submitting an electronic registration form to the ANF with manufacturer/distributor data, product documents, and associated fee payment, though the food supplement must first be registered with the Antivenom Information Centre (CIAV); Pharmilab can provide full support for managing this entire coding application process.
The National Product Code (CNP) is an optional code assigned by the National Association of Pharmacies (ANF) for the national market to identify health products within the pharmacy circuit, offering added commercial value through faster communication, enhanced sales advice potential, and improved product information quality and safety.
Applying for the CNP involves submitting an electronic registration form to the ANF with manufacturer/distributor data, product documents, and associated fee payment, though the food supplement must first be registered with the Antivenom Information Centre (CIAV); Pharmilab can provide full support for managing this entire coding application process.
The National Product Code (CNP) is an optional code assigned by the National Association of Pharmacies (ANF) for the national market to identify health products within the pharmacy circuit, offering added commercial value through faster communication, enhanced sales advice potential, and improved product information quality and safety.
Applying for the CNP involves submitting an electronic registration form to the ANF with manufacturer/distributor data, product documents, and associated fee payment, though the food supplement must first be registered with the Antivenom Information Centre (CIAV); Pharmilab can provide full support for managing this entire coding application process.
Labeling
Labeling
To protect consumers and ensure informed choices, food supplement labels must be clear, accurate, and fully compliantwith European Union regulations, primarily Regulation (EU) No 1169/2011 and Regulation (EU) No 178/2002, alongside specific national rules like Decree-Law No 118/2015. Compliance requires including essential information such as the product's name, ingredients, list of allergens, nutritional details, net quantity, and mandatory warnings. Since specific product types may require additional mentions, contacting Pharmilab is recommended to guarantee all compulsory and optional labeling requirements are met for legal circulation.
To protect consumers and ensure informed choices, food supplement labels must be clear, accurate, and fully compliantwith European Union regulations, primarily Regulation (EU) No 1169/2011 and Regulation (EU) No 178/2002, alongside specific national rules like Decree-Law No 118/2015. Compliance requires including essential information such as the product's name, ingredients, list of allergens, nutritional details, net quantity, and mandatory warnings. Since specific product types may require additional mentions, contacting Pharmilab is recommended to guarantee all compulsory and optional labeling requirements are met for legal circulation.
To protect consumers and ensure informed choices, food supplement labels must be clear, accurate, and fully compliantwith European Union regulations, primarily Regulation (EU) No 1169/2011 and Regulation (EU) No 178/2002, alongside specific national rules like Decree-Law No 118/2015. Compliance requires including essential information such as the product's name, ingredients, list of allergens, nutritional details, net quantity, and mandatory warnings. Since specific product types may require additional mentions, contacting Pharmilab is recommended to guarantee all compulsory and optional labeling requirements are met for legal circulation.
Nutritional and Health Claims
Nutritional and Health Claims
Import, Export and Intra-Union Trade
Using Nutritional and Health Claims on food supplement labels is optional, but highly valuable for effective marketing, helping to attract your target audience and encourage product interest or purchase. Any claim used must strictly comply with Regulation (EC) No 1924/2006, which sets the legal requirements for businesses wishing to advertise the specific beneficial nutritional or health effects of their products. If you plan to incorporate these claims to enhance your product's appeal and require expert guidance on their correct and compliant application, Pharmilab is ready to assist.
Using Nutritional and Health Claims on food supplement labels is optional, but highly valuable for effective marketing, helping to attract your target audience and encourage product interest or purchase. Any claim used must strictly comply with Regulation (EC) No 1924/2006, which sets the legal requirements for businesses wishing to advertise the specific beneficial nutritional or health effects of their products. If you plan to incorporate these claims to enhance your product's appeal and require expert guidance on their correct and compliant application, Pharmilab is ready to assist.
Placing food supplements from a non-EU third country into the European Economic Area constitutes an import process, which requires careful evaluation and compliance with varying EU Member State procedures, as ingredient composition may affect feasibility or even prohibit entry. Conversely, selling EU-based food supplements to a third country is an export process, often requiring documents like the Free Selling Certificate (CCL), which attests to legal production and marketing, and Export Certification per consignment, both of which must be timely requested from the National Authority (DGAV) with the involvement of the DRAP.
Ingredients, food
Additives and Novel Food
Ingredients, food
Additives and Novel Food
Nutritional and Health Claims
The range of ingredients available for food supplements has expanded far beyond traditional vitamins and minerals, now offering a vast variety to consumers. Modern formulations can safely incorporate elements like fibers, fatty acids, amino acids, plant enzymes, and plant extracts. This growing diversity, which also includes novel foods approved for consumption, allows for the creation of innovative and comprehensive dietary supplements tailored to meet diverse consumer needs.
The range of ingredients available for food supplements has expanded far beyond traditional vitamins and minerals, now offering a vast variety to consumers. Modern formulations can safely incorporate elements like fibers, fatty acids, amino acids, plant enzymes, and plant extracts. This growing diversity, which also includes novel foods approved for consumption, allows for the creation of innovative and comprehensive dietary supplements tailored to meet diverse consumer needs.
Using Nutritional and Health Claims on food supplement labels is optional, but highly valuable for effective marketing, helping to attract your target audience and encourage product interest or purchase. Any claim used must strictly comply with Regulation (EC) No 1924/2006, which sets the legal requirements for businesses wishing to advertise the specific beneficial nutritional or health effects of their products. If you plan to incorporate these claims to enhance your product's appeal and require expert guidance on their correct and compliant application, Pharmilab is ready to assist.
Import, Export and
Intra-Union Trade
Import, Export and
Intra-Union Trade
Ingredients, food
Additives and Novel Food
Placing food supplements from a non-EU third country into the European Economic Area constitutes an import process, which requires careful evaluation and compliance with varying EU Member State procedures, as ingredient composition may affect feasibility or even prohibit entry. Conversely, selling EU-based food supplements to a third country is an export process, often requiring documents like the Free Selling Certificate (CCL), which attests to legal production and marketing, and Export Certification per consignment, both of which must be timely requested from the National Authority (DGAV) with the involvement of the DRAP.
Placing food supplements from a non-EU third country into the European Economic Area constitutes an import process, which requires careful evaluation and compliance with varying EU Member State procedures, as ingredient composition may affect feasibility or even prohibit entry. Conversely, selling EU-based food supplements to a third country is an export process, often requiring documents like the Free Selling Certificate (CCL), which attests to legal production and marketing, and Export Certification per consignment, both of which must be timely requested from the National Authority (DGAV) with the involvement of the DRAP.
The range of ingredients available for food supplements has expanded far beyond traditional vitamins and minerals, now offering a vast variety to consumers. Modern formulations can safely incorporate elements like fibers, fatty acids, amino acids, plant enzymes, and plant extracts. This growing diversity, which also includes novel foods approved for consumption, allows for the creation of innovative and comprehensive dietary supplements tailored to meet diverse consumer needs.
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