Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
Hvordan søker legen om godkjenningsfritak når et legemiddel mangler?
For en enkeltpasient søker legen om godkjenningsfritak via e-resept.
How do I choose a notified body for medical devices?
The way to choose a notified body is to start with your device's MDR (or IVDR) codes and class, list only the bodies designated in NANDO for those codes, then…
¿Cómo obtiene una empresa el certificado de Industria Limpia?
Para obtener el Certificado de Industria Limpia, la empresa entra voluntariamente al Programa Nacional de Auditoría Ambiental (PNAA) de PROFEPA y contrata a…
What goes in an annual environmental report in Ireland?
In Ireland, an Annual Environmental Report (AER) is a yearly public report that EPA licence holders submit.
What are occupational exposure limits in Canada?
In Canada, occupational exposure limits (OELs) are set by each jurisdiction, not by one national list.
Como controlar a exposição ao benzeno no trabalho?
No Brasil, o controle da exposição ao benzeno segue dois regimes.
Welche Höchstmengen empfiehlt das BfR für Vitamine in Nahrungsergänzungsmitteln?
Das BfR empfiehlt für Nahrungsergänzungsmittel aktuell (Vorschläge von 2021, für Vitamin D 2023, Vitamin B6 2023 und Folsäure 2024 aktualisiert) zum Beispiel…
Which meat labels need USDA approval?
Under USDA FSIS rules (9 CFR Part 412), you only have to send three kinds of meat and poultry label to FSIS before use: sketch labels for products made under…
¿Qué significa VLA-ED en prevención de riesgos laborales?
VLA-ED significa Valor Límite Ambiental-Exposición Diaria. Es el valor de referencia que fija el INSST para la Exposición Diaria (ED) de un trabajador a un…
What are EPA effluent limitations guidelines?
Effluent limitations guidelines (ELGs, usually just called "Effluent Guidelines") are, in EPA's words, "national wastewater discharge standards that are…
What is WHO prequalification?
WHO prequalification is the World Health Organization's assessment of medical products for quality, safety and efficacy.
Che cos'è il codice UDI dei dispositivi medici?
L'UDI (Unique Device Identifier, "identificativo unico del dispositivo") è un codice numerico o alfanumerico unico associato a un dispositivo medico.
What is a premanufacture notice?
A premanufacture notice (PMN) is a filing to the US EPA under Section 5 of the Toxic Substances Control Act (TSCA).
What is the FDA Enforcement Report?
The FDA Enforcement Report is FDA's public weekly list of the product recalls it monitors.
Como consultar um processo na Anvisa?
Você consulta um processo no sistema Consulta à Situação de Documentos da Anvisa, em consultas.anvisa.gov.br/#/documentos/.
Qual è la differenza tra AIA e AUA?
L'AIA (Autorizzazione Integrata Ambientale) e l'AUA (Autorizzazione Unica Ambientale) si escludono a vicenda.
What is an FDA food contact notification?
An FDA food contact notification (FCN) is a premarket submission under section 409(h) of the Federal Food, Drug, and Cosmetic Act.
What should an Irish workplace risk assessment include?
In Ireland, every employer shall identify the hazards in the workplace they control, assess the risks those hazards present, and hold a written risk…
Which organic certification bodies are accredited in India?
APEDA's list of certification bodies accredited under India's National Programme for Organic Production (NPOP), last updated 17 August 2026, has 43 entries.
Comment déterminer le régime ICPE de mon installation ?
Votre régime ICPE se déduit de la nomenclature des installations classées, c'est-à-dire de la colonne « A » de l'annexe à l'article R511-9 du Code de…