Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
Where can I find the NPPA price list?
NPPA (India's National Pharmaceutical Pricing Authority) publishes its price lists on its official website, www.nppa.gov.in.
How do I find a registered medical device testing laboratory in India?
To find a registered lab, use CDSCO's list. Labs registered under Chapter X of the Medical Devices Rules, 2017 hold a Form MD-40 certificate, and CDSCO…
Når trenger jeg en tiltaksplan for forurenset grunn?
Du trenger tiltaksplan når du skal gjøre et terrenginngrep i grunn som er forurenset.
When must suppliers provide a safety data sheet in Ireland?
In Ireland the duty comes straight from EU REACH Article 31, which applies directly.
What does the EU Groundwater Directive require?
The Groundwater Directive (2006/118/EC) puts into practice the groundwater duties of the Water Framework Directive (2000/60/EC).
How does food safety monitoring work?
Food safety monitoring is a cycle. Authorities plan risk-based checks and sampling, test samples in accredited labs against legal limits, act on what fails…
How does HSNO classification work in New Zealand?
In New Zealand, hazardous substances are classified using the UN GHS, 7th revised edition (2017), as adopted and modified by the EPA's Hazardous Substances…
Vad innebär systematiskt arbetsmiljöarbete för arbetsgivare?
Systematiskt arbetsmiljöarbete (SAM) innebär att arbetsgivaren ska organisera, genomföra och följa upp arbetsmiljöarbetet så att risker för ohälsa och…
Wie funktioniert die Swissmedic-Zulassung für ein neues Arzneimittel?
Ein neues Arzneimittel (neue aktive Substanz, NAS) wird bei Swissmedic mit einem vollständigen CTD-Dossier zu Qualität, Präklinik und Klinik beantragt.
Which health claims does the FDA authorize on food labels?
The FDA authorizes 12 health claims on food labels. They are set out in 21 CFR 101.72 to 101.83.
What is a CPSR for cosmetics in the UK?
A Cosmetic Product Safety Report (CPSR) is the documented safety assessment that has to exist for every cosmetic product before it is placed on the GB market.
工場で労働災害を防ぐには、どんな対策がありますか？
日本の工場では、労働安全衛生法と労働安全衛生規則に沿って、主に次の5つの柱で労働災害を防ぎます。(1) 安全衛生管理体制をつくる、(2) リスクアセスメントで危険を見つけて減らす、(3) 機械・設備の物理的な防護と作業中の運転停止を徹底する、(4) 教育を行う、(5)…
How does Health Canada approve drugs?
Health Canada approves a drug by issuing a Drug Identification Number (DIN) and, if the product is a "new drug", a Notice of Compliance (NOC) under Part C of…
What rules apply to commercial shellfish harvesting in the UK?
Commercial harvesting of bivalve shellfish (mussels, oysters, cockles, clams, scallops) in the UK falls under two sets of rules.
¿Cómo sé si un residuo es peligroso en México?
En México, un residuo es peligroso si aparece en alguno de los cinco listados de la NOM-052-SEMARNAT-2005 o, si no está listado, si tiene al menos una…
살생물제 승인 업체는 어디서 확인하나요?
국내에서는 화학제품안전포털 초록누리(https://ecolife.mcee.go.kr)에서 확인하면 됩니다. 승인받은 업체의 상호·주소·연락처는 법에 따라 공개되는 정보이므로, 살생물물질 승인정보와 살생물제품 승인정보를 조회하면 승인받은 자(업체)가 나옵니다.
What are precursor chemicals?
Precursor chemicals (usually called "drug precursors") are chemicals that are needed to make illicit drugs but are also traded legally.
Welche Pflichten gelten für SVHC in der Schweiz?
In der Schweiz hängen die SVHC-Pflichten an der Aufnahme in Anhang 3 ChemV (Kandidatenliste).
Which industries need continuous emission monitoring in India?
India requires continuous (online) emission monitoring in the 17 categories of highly polluting industries, at Common Bio-Medical Waste and Common Hazardous…
Which CPCB guidelines apply to industrial pollution compliance?
CPCB doesn't have one industrial-compliance code. A unit's obligations come from several instruments that work together: CPCB's Red/Orange/Green/White/Blue…