Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
What is an FDA medical device product code?
An FDA medical device product code is a three-letter code that FDA's Center for Devices and Radiological Health (CDRH) assigns to a generic category of device.
How does a prescription medicine switch to over-the-counter status?
How a medicine switches from prescription to over-the-counter depends on the jurisdiction, but the logic is the same everywhere.
What is a new drug application?
In the US, a new drug application (NDA) is the application a sponsor submits to the FDA under section 505 of the Federal Food, Drug, and Cosmetic Act to get…
Vilka krav gäller för CE-märkning i Sverige?
Det finns inga särskilda svenska regler för CE-märkning. I Sverige gäller EU:s produktlagstiftning, alltså de förordningar och direktiv som kräver CE-märkning…
What does FDA compliant mean for food packaging?
"FDA compliant" packaging has no definition of its own in the law.
Czym jest REACH i kogo obowiązuje?
REACH to rozporządzenie (WE) nr 1907/2006 w sprawie rejestracji, oceny, udzielania zezwoleń i stosowanych ograniczeń w zakresie chemikaliów.
What must cosmetic labels include in Canada?
Under the Cosmetic Regulations (C.R.C., c. 869) and the Consumer Packaging and Labelling Act, a cosmetic sold in Canada needs five things on its label: the…
Qu’est-ce qu’une substance active dans un produit phytosanitaire ?
Dans l'Union européenne, une substance active est le composant d'un produit phytopharmaceutique qui agit sur les organismes nuisibles ou sur les plantes.
Who needs to report to Canada's NPRI?
You have to report to the NPRI if you own or operate a facility in Canada that meets at least one substance-specific reporting threshold in the current NPRI…
¿Qué exige la normativa europea de seguridad general de los productos?
La normativa vigente es el Reglamento (UE) 2023/988 relativo a la seguridad general de los productos (RGSP).
What does PPWR require for packaging sold in the EU?
Regulation (EU) 2025/40 (PPWR) has applied since 12 August 2026.
What is OIG exclusion?
An OIG exclusion is a sanction from the US Department of Health and Human Services Office of Inspector General (HHS-OIG) that bars a person or entity from…
What is Canada's Cosmetic Ingredient Hotlist?
Health Canada's Cosmetic Ingredient Hotlist is a list Health Canada uses to tell manufacturers and others that certain substances may be prohibited or…
Vad är HACCP och vem måste använda det?
HACCP (faroanalys och kritiska styrpunkter) är en förebyggande metod där livsmedelsföretag identifierar och styr biologiska, kemiska och fysikaliska faror i…
What does the EU Drinking Water Directive require?
Directive (EU) 2020/2184, the recast Drinking Water Directive, sets EU quality standards for water used for domestic purposes and food production, whether it…
How should allergens be labelled on food in the UK?
Across the UK, food businesses must declare 14 named allergens whenever they are used as an ingredient or processing aid and are still in the finished food.
What does the Flammable Fabrics Act require for clothing?
Under the Flammable Fabrics Act, clothing textiles have to meet the CPSC's Standard for the Flammability of Clothing Textiles (16 CFR Part 1610).
What is an OIG background check?
An OIG background check is a screening of a person or company against the List of Excluded Individuals/Entities (LEIE).
How does UK REACH work for chemical importers?
UK REACH treats a GB-established importer much like a manufacturer.
What does TSCA compliance require for chemical importers?
Under TSCA an importer counts as a "manufacturer." EPA's import policy says importers "are responsible for insuring that chemical importation complies with…