Regulation on Medicinal Products, Clinical Trials and Pharmaceutical Industry in the UK
Imagine that you are an entrepreneur in the pharmaceutical industry having recently made a scientific breakthrough in a critical field. Your first instinct is to get this breakthrough certified and licensed, so it can be manufactured and sold to the masses who require it. You approach 'Authority A' only for them to tell you to get approval from 'Authority C' first. While trying to get approval from 'Authority C', the lack of required documentation from 'Authority B' causes the application to be rejected. The lack of the technical know-how of how to go about with this process makes it seem like a very expensive, daunting and confusing task, making you nearly reach the point of not going through with it. The seemingly complex nature of multiple regulations can appear this way to countless individuals, whereas in reality, it is merely a straightforward and structured path that has been set up to follow. This article aims to provide a guidance for the same by explaining in detail how simple the regulations that govern the pharmaceutical industry are.
In the UK, the pharmaceutical industry is primarily governed and regulated by the Department of Health and Social Care (DHSC). The primary objective of the department is to improve the quality of care through the issue of guidelines and policies that are to be followed by all personnel and establishments involved. The legislation adhered by the DHSC is:
The Medicines Act, 1968 The Poisons Act, 1972 The Health and Social Care Act, 2008 The Pharmacy Order, 2010 The Human Medicines Regulations, 2012 The Department of Health and Social Care oversees 15 bodies that help provide healthcare-related services across the United Kingdom. With respect to pharmaceuticals, there is an executive agency under the DHSC, known as the Medicines and Healthcare Products Regulatory Agency (MHRA) which is responsible for regulating and assessing medicines and devices. The General Pharmaceutical Council established using the Health and Social Care Act 2008, is an independent statutory regulator which regulates pharmacists, pharmacy technicians and pharmacies.
Regulations on Medicinal Products
The Human Medicines Regulations, 2012 govern medicinal products across the UK. As per the guidelines, only an individual with a license may manufacture, import or distribute medicinal products. The MHRA is the competent authority to grant such permissions and has the right to refuse any application if it deems to be appropriate. It also has the power to suspend or revoke licenses, if it thinks fit, on the following grounds:
The information in the application was false. There is a material change of circumstances in relation to the matters of the form. The license holder has contravened any provisions of the license. The license holder fails to provide the competent authority with relevant information regarding the medicinal products of the license. Regulation on Pharmaceutical Establishments
Pharmaceutical establishments in the UK are regulated by the Medicines Act, 1968 and the Pharmacy Order 2010. The regulations require these establishments to acquire a license prior to setting up shop and prohibit anyone apart from the pharmacist who is responsible, from being in charge of the registered store. The establishments must comply with the guidelines set forth in the...