Medicines Law 1

• An enabling act, allowing for more detailed secondary legislation (Statutory Instruments)
• Much of the Medicines Act and many of the Statutory Instruments have been repealed and replaced with...

1. Human Medicines Regulations 2012

• brought together and simplified medicines legislation
• 349 regulations in 17 parts, followed by 35 schedules

2. Medical Devices Regulations 2002

• covers with many non-medicinal product items that pharmacists deal with

3. Misuse of Drugs Act 1971 & Regulations 2001

• controls the supply of medicines likely to be misused

4. Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008

• introduced the role of the Responsible Pharmacist

In these Regulations 'medicinal product' means - 

a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

b) any substance or combination of substances that may be used by or administered to human beings with a view to - 

i. restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

ii. making a medical diagnosis.

• A medicinal product that is manufactured, sold, supplied, exported or imported as a medicinal product in Europe, must have a Marketing Authorisation (MA), also called a Product Licence (PL)

• This is obtained from Medicines and Healthcare Products Regulatory Agency (MHRA)

• The manufacturer submits an application to MHRA with detailes of the product, intended use, side effects, containers, labels, stability and safety studies, manufacturing process etc.

• Medicines which meet the standards of safety, quality and efficacy are granted a Marketing Authorisation

Safety: Risk/benefit

Efficacy: Does it do what it should do?

Quality: Consistency is key

If necessary, a product can be used outside the terms of its Marketing Authorisation. When the medicine is licensed byt its use is not, it is called 'off label' use, e.g.:

• a product licensed for adults might be given to a child
• higher (or lower) than licensed dose may be used
• a different route of administration might be used (e.g. an injectable liquid might be given orally)
• it might be given to treat a different condition

If the patient's needs still cannot be met, further options are:

• import a medicine licensed in its home country (EU preferable to outside Europe)
• an unlicensed medicine may be manufactured in the UK
• an unlicensed medicine from outside the UK
• a non-medicine (e.g. a chemical or supplement)

It is legal to do all these things but there is an increased responsibility on the prescriber and the pharmacist.

Medicines may only legally be supplied to the public from a pharmacy, unless the medicine could safely be used without the input of a pharmacist.

Three classifications of medicinal product are defined:

• General Sales List Medicines (GSL)
• Pharmacy Medicines (P)
• Prescription Only Medicines (POM)

The longer a medication is used for and the more risks associated with its use, the stricter regulations will be.

• Can be sold with reasonable safety without the supervision of a pharmacist.

• Can be sold by retail from a premises which can be closed as to exclude the public.

• Must have been made up in a container prepared elsewhere and no opened (original packs).

• Cannot be sold from a vehicle or market stall.

• Label is not required to have GSL in a box.

Certain medicines for human use cannot be classed as GSL:

• eye ointments
• products with high doses of vitamin A or D
• anthelmintics (worming preparations, e.g. roundworms, threadworms)
• parenteral products (injections)
• enemas (large volume rectal products)
• products for use wholly or mainly for irrigating wounds, bladder, vagina, rectum
• aspirin for children

• Can be supplied from a registered pharmacy by or under the supervision of a pharmacist

• Label must contain 'P' in a box with no other material

• Must not be accessible to the public for self-selection

• Only supplied on production of a prescription (usually)
• Only supplied from a registered pharmacy by or under the supervision of a pharmacist
• A medicinal product will be classified as a POM if it:

- needs medical supervision to reduce the possibility of harm 

- is widely and frequently misused

- is a new active substance

- is for parenteral administration (to be injected)

• Label must contain POM in a box with no other material

There are many exemptions that allow supply of a POM without a prescription, e.g.:

• in an emergency at request of prescriber/patient

• Patient Group Directions (PGDs)

• by other healthcare professionals in their practice (certain POMs only)