2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal. 3. The person responsible...
InthecaseofdevicesreferredtointhefirstsubparagraphofArticle1(8),thequality,safetyandusefulnessofthesubstancewhich,ifusedseparately,wouldbeconsideredtobeamedicinalproductwithinthemeaningofpoint(2)ofArticle1ofDirective2001/83/EC,shallbeverifiedbyanalogywiththemethodsspecifiedinAnnexItoDirective2001/83/EC,asrequired...
It can also be categorized as extensively resistant (XDR), meaning it is not susceptible to at least one agent in all but two or fewer antimicrobial categories, leaving only one or two categories in which the bacterial isolates remain susceptible. If the bacterial isolate is non-susceptible to...
but COVID-19 forced authorities to cancel direct flights between the countries. China remains on the UK's "amber" travel list, meaning people arriving from there still have certain hurdles to overcome including tests and possibly quarantine, depending on whether they are vaccinated. ...
InthecaseofdevicesreferredtointhefirstsubparagraphofArticle1(8),thequality,safetyandusefulnessofthesubstancewhich,ifusedseparately,wouldbeconsideredtobeamedicinalproductwithinthemeaningofpoint(2)ofArticle1ofDirective2001/83/EC,shallbeverifiedbyanalogywiththemethodsspecifiedinAnnexItoDirective2001/83/EC,asrequired...
In the case of devices referred to in the first subparagraph of Article 1(8), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be ...