The MHRA has recently updated its good manufacturing practice (GMP) and good distribution practice (GDP) standards, which will affect organisations that hold either a:
- Manufacturer's Licence;
- Wholesale Dealer Licence; or
- Blood Establishment Authorisation; and
- Non-UK sites employed by UK Marketing Authorisation holders.
These organisations will be aware that the MHRA periodically carries out inspections to check if manufacturing and distribution sites are complying with GMP or GDP. The MHRA has recently updated the GDP compliance report form.
How we can help you
We have worked for many years providing pharmaceutical services advice to NHS bodies and private sector providers at the hospital outsourcing level and in relation to retail pharmacy under the regulatory regimes which govern the supply of pharmaceutical services to the public.
We can assist clients in all aspects of an outsourcing process, including procurement advice, developing the services contract and drafting leases as well as any corporate issues associated with setting up a subsidiary company, regulatory requirements, state aid, insurance, TUPE and contractual structures.
We can advise on issues relating to the provision of pharmacy services to the public, which is subject to a number of regulatory regimes through control of access to the market for NHS services, and the registration requirements for premises and staff as well as regulatory issues associated with applying for and/or maintaining MHRA regulated licences and authorisations, including the manufacturing, supply, importation and exportation of products.
Outsourcing Pharmacy Projects:
- Advice in setting up a subsidiary company to provide outpatient dispensing services.
- Advice to a hospital provider on establishing a comprehensive pharmacy service including the provision of outpatient pharmacy services, pharmacy services to community hospitals, mental health units, health clinics, health centres and prisons. We also advised on a sub-contract with a third party private pharmacy provider, which covered the transportation services required to deliver certain elements of the contract.
- Advice on a pharmacy outsourcing project for an independent hospital in London, which encompassed both community pharmacy and hospital pharmacy provision.
- Advising various NHS Trust and Foundation Trusts to procure private sector pharmacy providers to provide a fully managed outpatient dispensing service.
Retail Pharmacy Projects:
- Advising a distance selling pharmacy provider on the acquisition of a £60 million, 5 year outsourcing contract from a care home provider. The care home provider had outsourced its pharmacy provision for approximately 250 care homes in 4 jurisdictions.
- Advising a US owned business on entry into the UK pharmaceutical market and the constraints and opportunities presented by the regulatory framework. We provided advice on the application of the regulatory framework to their proposal to acquire an internet based distance selling pharmacy with a view to developing services based on repeat prescriptions and trying to build scale.
- Advising on the relationship between primary medical care and local pharmaceutical services, including in particular the engagement of pharmacists in primary medical care, and the regulations surrounding dispensing practices.
- We have a wealth of experience advising a range of clients in respect of pharmaceutical regulation. This includes advising on the requirements of the:
Medicines Act 1968
Human Medicines Regulations 2012
- Medicines for Human Use (Clinical Trials) Regulations 2004 and
National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.
- We regularly advise clients on issues relating to control of entry, minor relocations, change of ownership applications, suspensions and removals from the pharmaceutical lists.
- We also advise clients on MHRA licensing matters including manufacturing and wholesale dealing, and importation and exportation or pharmaceutical products.
- We have advised clients in relation to the obligations and implications of the Medicines (Responsible Pharmacist) (England) Regulations 2008. This has included providing advice on issues surrounding controlled drugs in transit, for example.
- We have advised on a number of pharmaceutical pricing and drug rebate schemes, and the implications of these in relation to contractual arrangements with drug companies.
Other Pharmacy-related projects
- Advice on import, export and supply arrangements including agency arrangements and the tax treatment relating to the specific medicinal product in question.
- Advice in relation to the Health Service Branded Medicines (Control of Prices and Supply of Information (No. 2)) Regulations 2008 and the Pharmaceutical Price Regulation Scheme 2014.
- We have successfully defended a challenge from HMRC against our client. This resulted in a saving to our client of £1.5 million, with the claim relating to the reclamation of input VAT in respect of the purchase of medicinal products. We have close connections with tax lawyers who we involve to advise on such issues.
- Advice on a procurement to build and fit-out a Pharmaceutical Manufacturing Facility using competitive dialogue.
- Advice on the manufacturing arrangements, confidentiality agreements and associated documents for the manufacture of a vaccine for clinical trials both here and in Africa.
- Advice on pharmaceutical trading arms/subsidiaries on the terms and conditions for the supply of products including specials in the UK and abroad and on compliance with their manufacturing licences.
- Advice on a process manufacturing arrangements with a European company to increase the yield of an antibody to enable bulk manufacture for clinical trials.
- Advice on clinical trial arrangements, research agreements and material supply agreements.