Pharmacy Law Flashcards
What does relevant medicinal product mean in the human medicines regulations?
is a product that is not
a) a registrable homeopathic medicinal product
b) a traditional herbal medicinal product.
A “relevant medicinal product” in the UK typically refers to any product that is classified as a medicine according to UK law.- they hold marketing authorisation
What does medicinal product mean?
any substance or combination of substances presented as having properties of preventing or treating disease.
or any substance or combination of substances that may have been used or administered to human beings with a view to restore, correct or modify physiological function by exerting a pharmacological, immunological or metabolic action.
What does adminster mean ?
a) orally by injection or by introduction into the body in any other way or
b) by external application ( whether or not by direct application to the body)
What is medicinal purpose ?
treating or preventing disease
diagnosing disease or ascertaining the existence
contraception
inducing anaesthesia
preventing or interfering with the normal operation of a physiological function.
What are the three classes of medicinal products defined in the medicines act?
General sale medicines
pharmacy medicines
prescription only medicines
Is the human medicines act first or secondary legislation
first
what is the definition of a medicinal product found In the medicines act ?
a medicinal product subject to general sale is a product which is not a prescription only medicine or a pharmacy medicine and is therefore available for general sale (not restricted to pharmacies)
is an order or regulation first or secondary legislation ?
secondary
secondary legislation can be changed much more often and easily.
what is an authorised medicinal product ?
if it has a marketing authorisation (medicines)
if it has a certificate of registration (homeopathic)
traditional herbal registration (herbal remedies
what is a borderline substance ?
a product which is not easy to distinguish from a medicine
what makes a product medicinal ?
treats or prevents disease
interferes with normal physiological functions or operation of the body
when can a medicine be given a marketing authorisation ?
if the product is safe and efficacious
facilities for manufacture and quality control are adequate to ensure conformity with specifications
what must an MA holder keep licensing authority updated on ?
proposed changes in the products or procedures
fresh information on the validity on which license was granted
what must an MA holder keep records of ?
any adverse reports
all sales/supplies
sources of all materials
documents that will facilitate withdrawal or recall
and produce a periodic safety report (PSUR)
what does off label medicine mean ?
they are used outside of their licensed indications
what do children’s medicines require ?
paediatric use marketing authorisation
paediatric investigation plan
what should be included in an application for a UK marketing authorisation ?
Name of the medicinal product
An evaluation of the potential environmental risks posed by the medicinal product
A description of the methods of manufacturing the medicinal product.
The therapeutic indications and contra-indications for the medicinal product and the adverse reactions associated with it.
The posology and pharmaceutical form of the medicinal product, and its method and route of administration
A summary of the applicant’s pharmacovigilance system
