Medicines Regulations

Legislation applies to …

the regulation of medicines which cover everything from prescribing and dispensing of medicines to the sale of medicines.

The Medicines Act 1968

The 1st comprehensive licensing system for medicines in the UK. It was created to regulate the LAM : licensing, advertisement and manufacture.

what was the medicines act 198 replaced by?

Human Medicines Regulation 2012 🏃

The misuse of drugs act 1971 and the misuse of drugs regulations 2001

certain drugs are classified as ‘controlled drugs’ which have a potential to cause harm or misuse. These two acts are both important in the UK related to controlled drugs.

Human Medicines Regulations 2012

New amendments for future needs.

from 2022 in regards to the Early Access to medicines scheme…

To give patients, who have life-threatening or debilitating conditions, access to medicines. These may not have a marketing authorisation.

There are 3 legal classifications of medicines

POM, P, GSL

POM

Prescription only medicines

P

Pharmacy medicines

GSL

General sales list

Definition of prescription

It’s a written instruction from a medical (doctor) or non-medical prescriber (prescribing nurse/ pharmacist) to a pharmacy to dispense a medicine or product for a specified patient.

A number of medicines are exempt form prescription control if…

they fulfil certain conditions

POMs can generally only be supplied in receipt of a …

prescription from an appropriate prescriber.

Exemptions of POM

specified purpose, emergencies, max strengths and quantities to be sold and certain routes of administration.

Veterinary Medicines regulations 2013

cover the supply and sale of any medicine for the use in animals.

who regulates medicines in the uk?

MHRA: Medicines and Healthcare products Regulatory Agency

CDs stand for controlled drugs

They are a type of POM medication which recquire a prescription to obtain them. Governed by the Misuse of drugs regulation 2001. They are classified as schedules 1 to 5.

Codeine max strength

20mg

Diclofenac only available as

topical prep (gel/cream)

Sildenafil

For erectile dysfunction in males

Chloramphenicol eye drops

for bacterial conjunctivitis

Pharmacy medicine - aspirin and paracetamol

In the form of non-effervescent tablets/ capsules even with a P or GSL marketing authorisation, they must be prescribed unless they have reduced pack size and quantities.

Aspirin 300mg is P med if

Pack size doesn’t exceed 32

Aspirin 75mg is P med if

Pack size doesn’t exceed 100. Total quantity of max 100 sold to a person at one time.

Paracetamol 500mg is P med if

Pack size doesn’t exceed 32. Total quantity of max 100 sold to a person at one time..

Codeine and dihydrocodeine limited to a pack size of

max 32 tablets or capsules including effervescent 

shop without pharmacist, max n* of tablets

16 tablets as pack size over 16 becomes a P medicine

features/ characteristics on a prescription

must be written in inedible ink (can’t be removed or erased) or on carbon paper material.

How long is a prescription valid for?

• A prescription (non-controlled) is valid and can be dispensed up to 6 months from the appropriate date 

• For a controlled drug, valid for 28 days from the date on the prescription.