A Marketing Authorisation is the only way in which a medicine produced by a pharmaceutical company can be made available for a doctor to write a prescription in normal clinical practice. To learn more about the work of the MHRA visit the Licensing of medicines section of the MHRA website.
The MHRA also issues manufacturing authorisations which entitle a company to manufacture medicines in the UK. The ABPI works through its Pharmaceutical Quality Expert Network to monitor regulatory activity on these topics and participate actively in the development of legislation at both national and European levels. The Network also facilitates the exchange between members of good practice in these important areas.
We work with many partners to ensure that the UK benefits by having a sound manufacturing, quality and early supply base for pharmaceuticals, helping the stability of the UK economy. Pharmaceutical manufacture provides the highest balance of trade surplus of any manufacturing sector in the UK and in 2009 contributed around £7 billion to the UK balance of trade.
Good environmental health and safety performance is a major consideration in all aspects of pharmaceutical industry activity.
Through the Environmental Health and Safety Network, we monitor regulatory activity on these topics and participate actively in the development of legislation at both national and European levels, as well as facilitating the sharing of good practice amongst member companies.
The Medicines Manufacturing Industry Partnership (MMIP) represents the voice of medicines manufacturers in the UK. It was established jointly by Government and the biopharmaceutical industry in 2014 to ensure that the UK is recognised by the global medicines industry as a world-class, advanced centre for medicines manufacturing.
Delegated Regulation to the Falsified Medicines Directive (FMD) 2011/62/EU, published on the 9 February 2016, will come in to force by February 2019. The new regulation will require manufacturers to place safety features on all medicines and contribute financially to the establishment of an IT verification system that will allow the assessment of the authenticity of a medicine at the time of supply to the patient.
Vaccination has saved more lives and prevented more serious diseases than any advance in recent medical history. Every year, 2 – 3 million lives are saved across the world because of immunisation and only clean water rivals vaccines at reducing infectious diseases and deaths.