What is the Human Medicines Regulations 2012 simplified?
The Human Medicines Regulations 2012 (the “Regulations”) is the main legislation in the UK covering the manufacture, importation, distribution, advertising, labelling, sale and supply of medical products for human use and pharmacovigilance (the monitoring of the effect and safety of medical drugs after they have been …
What is the purpose of the Human Medicines Regulations 2012?
The HMRs set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.
How do I reference the Human Medicines Regulations 2012?
Your Bibliography: Legislation.gov.uk. 2012. The Human Medicines Regulations 2012. [online] Available at: <http://www.legislation.gov.uk/uksi/2012/1916/regulation/8/made> [Accessed 10 April 2015].
Which legislation governs medication in the UK?
Medicines legislation The Human Medicines Regulations 2012 (SI 2012 /1916)(external link opens in a new window / tab) which came into force on 14 August 2012, consolidate the law of the United Kingdom concerning medicinal products for human use (‘products’).
How are drugs licensed in the UK?
Licences are only granted if strict safety and quality standards are met. In the UK, licences are granted by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). Licences confirm the health condition the medicine should be used for and the recommended dosage.
How is a medicine licensed?
Licensing of medicines To get a licence, the manufacturer of the medicine has to provide evidence that shows that the medicine works well enough and is safe enough to be used for a specific condition and for a specific group of patients, and that they can manufacture the medicine to the required quality.
Who Licences drugs UK?
In the UK, licences are granted by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). Licences confirm the health condition the medicine should be used for and the recommended dosage.
Who licenses medication?
To get a licence, the drug company must prove that the drug works for the illness or condition to be treated and is safe. They do this by trying it first in clinical trials, usually in adults aged 18-65 years. Information from the clinical trials is then given to the MHRA when the drug company applies for a licence.
How are medicines licensed in the UK?
