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 terminal disinfection?
Terminal disinfection is the thorough disinfection of a place and the items in it after the source of infection has left.
Was regelt das PflSchG für Handel und Anwendung von Pflanzenschutzmitteln?
Das Pflanzenschutzgesetz (PflSchG) ergänzt die EU-Verordnung (EG) Nr.
What disinfectant should a salon use?
In the US, a salon should use an EPA-registered disinfectant whose label shows bactericidal, fungicidal and virucidal activity, used exactly as the label…
안전확인대상 생활화학제품은 무엇인가요?
안전확인대상생활화학제품은 「생활화학제품 및 살생물제의 안전관리에 관한 법률」에 따라 기후에너지환경부장관이 위해성평가를 한 결과 위해성이 있다고 인정되어 같은 법 제8조제3항 본문에 따라 지정·고시한 생활화학제품입니다.
Comment vérifier une AMM de l’Anses ?
Pour vérifier une AMM délivrée par l'Anses, il faut d'abord savoir de quel type de produit il s'agit, puis chercher son numéro ou son nom dans le registre…
What does the Federal Hazardous Substances Act require?
The Federal Hazardous Substances Act (FHSA, 15 U.S.C. 1261 et seq.) requires household and children's products that are "hazardous substances" to carry…
What is the Poisons Standard in Australia?
The Poisons Standard is Australia's national classification ("scheduling") of medicines and chemicals.
Comment reconnaître un produit CMR au travail ?
Un produit est CMR au sens du Code du travail s'il remplit les critères du règlement CLP pour la catégorie 1A ou 1B (cancérogène, mutagène ou toxique pour la…
How do I report changes to an FDA-approved drug?
For an FDA-approved drug, you tell FDA about every change to the conditions in the approved NDA.
Hur beräknar jag en näringsdeklaration för mitt livsmedel?
Du räknar fram näringsdeklarationen i tre steg. Först tar du fram genomsnittsvärden per 100 g eller 100 ml: från en analys av livsmedlet, från en beräkning…
Które jednostki certyfikują rolnictwo ekologiczne w Polsce?
W aktualnym rejestrze IJHARS (Inspekcji Jakości Handlowej Artykułów Rolno-Spożywczych) jest 14 upoważnionych jednostek certyfikujących w rolnictwie…
¿Cómo encuentro laboratorios acreditados por ENAC para analizar alimentos?
Use el Buscador de entidades acreditadas en la web oficial de ENAC (enac.es/entidades-acreditadas/buscador-de-acreditados).
Wo finde ich die Swissmedic-Liste der zugelassenen Arzneimittel?
Swissmedic veröffentlicht die Listen der zugelassenen Arzneimittel auf ihrer Website unter Services → «Listen und Verzeichnisse»…
Que signifie le Label Rouge ?
Le Label Rouge est un signe officiel français qui garantit une qualité supérieure.
Gdzie znaleźć kartę charakterystyki acetonu?
Kartę charakterystyki (SDS) acetonu dostajesz od swojego dostawcy, czyli producenta, importera lub dystrybutora, od którego kupujesz produkt.
How do I search the FDA PMA database?
You can search PMA records in two ways. One is FDA's own Premarket Approval (PMA) database form on accessdata.fda.gov.
What is AFFF firefighting foam?
AFFF (aqueous film forming foam) is a firefighting foam made for Class B fires, meaning burning liquid fuels such as gasoline, diesel and jet fuel.
What is a free sale certificate for importing cosmetics into India?
A free sale certificate (FSC) is a document from the country where the cosmetic is made.
What counts as a plant biostimulant in the EU?
In the EU, a plant biostimulant is a fertilising product that works by stimulating the plant's own nutrition processes, independently of any nutrients it…
医薬部外品の承認申請はどう進めますか？
医薬部外品は、医薬部外品製造販売業許可を持つ者が、品目ごとに薬機法第14条の製造販売承認を取得して進めます。手順は、①製品が医薬部外品に当たるかの確認、②業許可と製造所の確保、③承認基準や前例の範囲内か新規かで申請ルートを選ぶ、④規則第40条の資料をそろえて申請、⑤承認後の変更管理とGQP・GVPの順です。