Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
How do I export Ayurvedic medicines from India?
To export Ayurvedic medicines from India, you need three things in place.
¿Qué es el certificado TIF en México?
La certificación TIF (Tipo Inspección Federal) es el reconocimiento oficial que otorga la Secretaría de Agricultura y Desarrollo Rural (SADER), a través del…
¿Qué exige REACH a las empresas en España?
REACH (Reglamento (CE) nº 1907/2006) se aplica directamente en España, igual que en el resto de la UE.
Do I need a permit for radioactive substances in England?
Yes, probably, unless an exemption applies. In England you need an environmental permit for a "radioactive substances activity" under the Environmental…
Welke regels gelden voor kankerverwekkende stoffen op het werk in Nederland?
In Nederland vallen kankerverwekkende stoffen op het werk onder de Arbowet, uitgewerkt in het Arbobesluit en de Arboregeling.
Welche Labore brauchen eine Bewilligung nach dem Schweizer Epidemiengesetz?
Nach Art. 16 Abs. 1 EpG benötigen alle Laboratorien, die mikrobiologische Untersuchungen zur Erkennung übertragbarer Krankheiten durchführen, eine Bewilligung…
Ist Flufenacet in Deutschland noch zugelassen?
Nein, Flufenacet ist in Deutschland nicht mehr zugelassen. Die EU hat die Genehmigung des Wirkstoffs nicht erneuert, und das BVL hat alle Zulassungen…
What is SCOGS?
SCOGS is the Select Committee on GRAS Substances. It was an expert committee outside FDA that, from the early 1970s, reviewed the safety of food substances…
What is IChEMS?
IChEMS is Australia's Industrial Chemicals Environmental Management Standard.
How does the FDA regulate cosmetics?
The FDA does not approve cosmetics or their ingredients before sale, with one exception: colour additives.
Bir kimyasalın CAS numarasını nasıl bulurum?
Bir kimyasalın CAS numarasını (CAS Registry Number, CAS RN) bulmanın en kolay yolu, CAS'ın ücretsiz veritabanı CAS Common Chemistry'de…
İşyerinde ortam ölçümleri ne zaman zorunludur?
Türkiye'de ortam ölçümü (iş hijyeni ölçüm, test ve analizi) risk değerlendirmesine bağlı bir zorunluluktur.
Was bedeutet Abgabekategorie B bei Arzneimitteln in der Schweiz?
Abgabekategorie B steht in der Schweiz für verschreibungspflichtige Arzneimittel: Sie werden grundsätzlich nur auf ärztliche oder tierärztliche Verschreibung…
Hva betyr forskriften om tiltaks- og grenseverdier for kjemikalier på arbeidsplassen?
Forskrift om tiltaks- og grenseverdier (FOR-2011-12-06-1358) er Arbeidstilsynets forskrift som fastsetter hvor mye arbeidstakere kan utsettes for fysiske og…
What does GLP certification mean for a testing laboratory?
GLP certification means a national GLP monitoring authority has inspected a test facility and confirmed that it runs its non-clinical safety studies under the…
How should I interpret MHRA iDAP reports?
Treat an iDAP as a list of suspected reactions, not as evidence of risk.
What does PRTR reporting mean for industrial sites in Scotland?
For an industrial site in Scotland, PRTR reporting means sending SEPA an annual return to the Scottish Pollutant Release Inventory (SPRI).
What is a TSDF for hazardous waste?
A TSDF is a treatment, storage, or disposal facility: a site that treats, stores or disposes of hazardous waste.
Vad innebär en sanktionsavgift från Arbetsmiljöverket?
En sanktionsavgift är en administrativ avgift som arbetsgivaren (och i vissa fall andra aktörer) blir skyldig att betala när en regel som uttryckligen är…
Do I need a wholesale dealer licence to distribute medicines in the UK?
Yes, in most cases. Under regulation 18(1) of the Human Medicines Regulations 2012, which applies across the UK, "a person may not except in accordance with a…